Cost of a group translation of the Diabetes Prevention Program: Healthy Living Partnerships to Prevent Diabetes. Examination of costs for a lay health educator-delivered translation of the Diabetes Prevention Program in senior centers. Culturally adapting the prevention of diabetes and obesity in South Asians (PODOSA) trial. The Sydney Diabetes Prevention Program: A community-based translational study Effects of lifestyle intervention on health care costs: Improving Control with Activity and Nutrition (ICAN). The cost-effectiveness of diabetes prevention: results from the Diabetes Prevention Program and the Diabetes Prevention Program Outcomes Study Translating lifestyle intervention to practice in obese patients with type 2 diabetes: Improving Control with Activity and Nutrition (ICAN) study. Healthy Living Partnerships to Prevent Diabetes (HELP PD): design and methods. The Lifestyle Intervention for the Treatment of Diabetes study (LIFT Diabetes): Design and baseline characteristics for a randomized translational trial to improve control of cardiovascular disease risk factors. Cost-effectiveness of medical nutrition therapy provided by dietitians for persons with non-insulin-dependent diabetes mellitus. Nutritional counselling in general practice: a cost effective analysis. Design of a cluster-randomized controlled trial of a diabetes prevention program within African-American churches: The Fit Body and Soul study. A model of translational research for diabetes prevention in low and middle-income countries: The Diabetes Community Lifestyle Improvement Program (D-CLIP) trial. Behavioural interventions for type 2 diabetes: an evidence-based analysis. Translating the Diabetes Prevention Program: a comprehensive model for prevention training and program delivery. 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Implementation of a lifestyle intervention for type 2 diabetes prevention in Dutch primary care: opportunities for intervention delivery Cost-Effectiveness of Automated Telephone Self-Management Support With Nurse Care Management Among Patients With Diabetes Ngāti and healthy: translating diabetes prevention evidence into community action Outcomes of Minimal and Moderate Support Versions of an Internet-Based Diabetes Self-Management Support Program SLIMMER: a randomised controlled trial of diabetes prevention in Dutch primary health care: design and methods for process, effect, and economic evaluation Canadian clinical practice guidelines for nutrition support in mechanically ventilated, critically ill adult patients. Community-based care for the management of type 2 diabetes: an evidence-based analysis. A large-scale diabetes prevention program in real-life settings in Qingdao of China (2006-2012). Enhancing the effectiveness of diabetes self-management education: the diabetes literacy project. Development and evaluation by a cluster randomised trial of a psychosocial intervention in children and teenagers experiencing diabetes: the DEPICTED study. The effectiveness of group medical visits on diabetes mellitus type 2 (dm2) specific outcomes in adults: a systematic review Seeing the forests and the trees—innovative approaches to exploring heterogeneity in systematic reviews of complex interventions to enhance health system decision-making: a protocol Estudio Parto: postpartum diabetes prevention program for hispanic women with abnormal glucose tolerance in pregnancy: a randomised controlled trial – study protocol Design and methods of "diaBEAT-it!": a hybrid preference/randomized control trial design using the RE-AIM framework. Improving the reporting of public health intervention research: advancing TREND and CONSORT. A Community-Based Diabetes Prevention Program Economic Analysis of the Mediterranean Lifestyle Program for Postmenopausal Women With Diabetes
BACKGROUND Although numerous studies have translated the Diabetes Prevention Program lifestyle intervention into various setting s , no study to date has reported a formal cost analysis . PURPOSE To describe costs associated with the Healthy Living Partnerships to Prevent Diabetes ( HELP PD ) trial . DESIGN HELP PD was a 24-month RCT testing the impact of a lifestyle weight-loss intervention administered through a diabetes education program and delivered by community health workers ( CHWs ) on blood glucose and body weight among prediabetics . SETTING / PARTICIPANTS In all , 301 participants with prediabetes were r and omized in Forsyth County NC . Data reported in these analyses were collected in 2007 - 2011 and analyzed in 2011 - 2012 . INTERVENTION The lifestyle weight-loss group had a 7 % weight loss goal achieved and maintained by caloric restriction and increased physical activity . The usual care group received two visits with a registered dietitian and monthly newsletters . MAIN OUTCOME MEASURES Measures are direct medical costs , direct nonmedical costs , and indirect costs over the 2-year study period . Research costs are excluded . RESULTS The direct medical cost ( in 2010 dollars ) to identify one participant was $ 16.85 . Direct medical costs per capita for participants in the usual care group were $ 142 and $ 850 for lifestyle weight-loss participants . Per capita direct costs of care outside the study were $ 7454 for the usual care group and $ 5177 for the lifestyle weight-loss group . Per capita direct nonmedical costs were $ 12,881 for the usual care group and $ 13,836 for the lifestyle weight-loss group . The lifestyle weight-loss group in HELP PD cost $ 850 in direct medical costs for 2 years , compared to $ 2631 in direct medical costs for the first 2 years of DPP . CONCLUSIONS A community-based translation of the DPP can be delivered effectively and with reduced costs OBJECTIVE Older adults in the U.S. have high rates of obesity . Despite the demonstrated efficacy of lifestyle interventions among older adults , lifestyle interventions are not widely implemented in community setting s. Program delivery by lay health educators ( LHEs ) might support greater dissemination because of lower delivery cost and greater accessibility . We examined the costs of a LHE-delivered translation of the Diabetes Prevention Program ( DPP ) evidence -based lifestyle intervention for older adults in Arkansas senior centers . METHODS This examination of costs used data from a cluster r and omized control trial ( conducted 2008 - 2010 ) in which 7 senior centers ( 116 participants ) were r and omized to implement a LHE-delivered 12-session translation of the DPP lifestyle intervention . We compiled direct lifestyle intervention  implementation costs , including training , recruitment , material s , and ongoing intervention implementation support . Weight loss data ( at 4-month follow-up ) were collected from participants . RESULTS Participant weight loss averaged 3.7 kg at 4-months . The total estimated cost to implement the lifestyle intervention is $ 2731 per senior center , or $ 165 per participant . The implementation cost per kilogram lost is $ 45 . CONCLUSIONS A LHE-delivered DPP translation in senior centers is effective in achieving weight loss at low cost and offers promise for the dissemination of this evidence -based intervention Type 2 diabetes is extremely common in South Asians , e.g. in men from Pakistani and Indian population s it is about three times as likely as in the general population in Engl and , despite similarities in body mass index . Lifestyle interventions reduce the incidence of diabetes . Trials in Europe and North America have not , however , reported on the impact on South Asian population s separately or provided the details of their cross-cultural adaptation processes . Prevention of diabetes and obesity in South Asians ( PODOSA ) is a r and omized , controlled trial in Scotl and of an adapted , lifestyle intervention aim ed at reducing weight and increasing physical activity to reduce type 2 diabetes in Indians and Pakistanis . The trial was adapted from the Finnish Diabetes Prevention Study . We describe , reflect on and discuss the following key issues : The core adaptations to the trial design , particularly the delivery of the intervention in homes by dietitians rather than in clinics . The use of both a multilingual panel and professional translators to help translate and /or develop material s. The processes and challenges of phonetic translation . How intervention re sources were adapted , modified , newly developed and translated into Urdu and Gurmukhi ( written Punjabi ) . The insights gained in PODOSA ( including time pressures on investigators , imperfections in the adaptation process , the power of verbal rather than written information , the utilization of English and the mother-tongue language s simultaneously by participants and the costs ) might help the research community , given the challenge of health promotion in multi-ethnic , urban societies Background Type 2 diabetes is a major public health problem in Australia with prevalence increasing in parallel with increasing obesity . Prevention is an essential component of strategies to reduce the diabetes burden . There is strong and consistent evidence from r and omised controlled trials that type 2 diabetes can be prevented or delayed through lifestyle modification which improves diet , increases physical activity and achieves weight loss in at risk people . The current challenge is to translate this evidence into routine community setting s , determine feasible and effective ways of delivering the intervention and providing on-going support to sustain successful behavioural changes . Methods / Design The Sydney Diabetes Prevention Program ( SDPP ) is a translational study which will be conducted in 1,550 participants aged 50 - 65 years ( including 100 indigenous people aged 18 years and older ) at high risk of future development of diabetes . Participants will be identified through a screening and recruitment program delivered through primary care and will be offered a community-based lifestyle modification intervention . The intervention comprises an initial individual session and three group sessions based on behaviour change principles and focuses on five goals : 5 % weight loss , 210 min/week physical activity ( aerobic and strength training exercise ) , limit dietary fat and saturated fat to less than 30 % and 10 % of energy intake respectively , and at least 15 g/1000 kcal dietary fibre . This is followed by 3-monthly contact with participants to review progress and offer ongoing lifestyle advice for 12 months . The effectiveness and costs of the program on diabetes-related risk factors will be evaluated . Main outcomes include changes in weight , physical activity , and dietary changes ( fat , saturated fat and fibre intake ) . Secondary outcomes include changes in waist circumference , fasting plasma glucose , blood pressure , lipids , quality of life , psychological well being , medication use and health service utilization . Discussion This translational study will ascertain the reach , feasibility , effectiveness and cost-effectiveness of a lifestyle modification program delivered in a community setting through primary health care . If demonstrated to be effective , it will result in recommendations for policy change and practical methods for a wider community program for preventing or delaying the onset of type 2 diabetes in high risk people OBJECTIVE To evaluate program and health care costs of a lifestyle intervention in a high-risk obese population . DESIGN Twelve-month r and omized controlled trial comparing lifestyle case management to usual care . SUBJECTS/ SETTING Health plan members ( n=147 ) with obesity ( body mass index > /=27 ) and type 2 diabetes . INTERVENTION Lifestyle case management entailed individual and group education , support , and referrals by registered dietitians . Those in the usual-care group received educational material . MAIN OUTCOME MEASURES Medical and pharmaceutical health care costs reimbursed by the participant 's primary insurance company . STATISTICAL ANALYSIS Total costs were modeled using the four-equation model using previous year cost as a predictor . RESULTS Net cost of the intervention was $ 328 per person per year . After incorporating program costs , mean health plan costs were $ 3,586 ( 95 % confidence interval [ CI ] : -$8,036 , -$25 , P<0.05 ) lower in case management compared to usual care . The difference was driven by group differences in medical ( -$3,316 , 95 % CI : -$7,829 to -$320 , P<0.05 ) but not pharmaceutical costs ( -$239 , 95 % CI : -$870 to $ 280 , not statistically significant ) , with fewer inpatient admissions and costs among case management compared with usual care ( admission prevalence : 2.8 % vs 22.5 % respectively , P<0.001 ) . CONCLUSION Addition of a modest-cost , registered dietitian-led lifestyle case-management intervention to usual medical care did not increase health care costs and suggested modest cost savings  among obese patients with type 2 diabetes . Larger trials are needed to determine whether these results can be replicated in a broader population . The findings can be judiciously applied to support that the addition of a registered dietitian-led lifestyle case-management program to medical care does not increase health care costs Background The Diabetes Prevention Program ( DPP ) was a r and omized , controlled clinical trial . It demonstrated that among high-risk individuals with impaired glucose tolerance , diabetes incidence was reduced by 58 % with lifestyle intervention and 31 % with metformin compared to placebo . During the Diabetes Prevention Program Outcomes Study ( DPPOS ) , all DPP participants were unmasked to their treatment assignments , the original lifestyle intervention group was offered additional lifestyle support , the metformin group continued metformin , and all three groups were offered a group-implemented lifestyle intervention . Over the 10 years of combined DPP/DPPOS follow-up , diabetes incidence was reduced by 34 % in the lifestyle group and 18 % in the metformin group compared to placebo . The purpose of this article is to review and synthesize analyses published by the DPP/DPPOS Research Group that have described the cost-effectiveness of diabetes prevention . Methods We describe the re source utilization and costs of the DPP and DPPOS interventions , the costs of non-intervention-related medical care , the impact of the interventions on diabetes progression and quality -of-life , and the cost-effectiveness of the interventions from health system and societal perspectives . Cost-effectiveness analyses were performed with a 3-year time horizon using DPP data , a lifetime time horizon that simulated 3-year DPP data , and a 10-year time horizon using combined DPP/DPPOS data . Results Although more expensive than the placebo intervention , the greater costs of the lifestyle and metformin interventions were offset by reductions in the costs of nonintervention-related medical care . Every year after r and omization , quality -of-life was better for participants in the lifestyle intervention compared to those in the metformin or placebo intervention . In both the simulated lifetime analysis and the 10-year within trial economic analysis , lifestyle and metformin were extremely cost-effective ( that is , improved outcomes at a low incremental cost ) or even cost-saving ( that is , improved outcomes and reduced total costs ) compared to the placebo intervention . Conclusions The implementation of diabetes prevention programs in high-risk individuals will result in important health benefits and represents a good value for money . Trial registration NCT00004992 ( DPP ) and NCT00038727 ( DPPOS ) OBJECTIVE To assess the efficacy of a lifestyle intervention program that can be readily translated into clinical practice for obese patients with type 2 diabetes . RESEARCH DESIGN AND METHODS The study consisted of a 12-month r and omized controlled trial of 147 health plan members with type 2 diabetes and obesity ( BMI > or=27 kg/m(2 ) ) . Participants were r and omized to lifestyle case management or usual care . Case management entailed individual and group education , support , and referral by registered dietitians ; intervention cost was US dollars 350 per person . Individuals treated with usual care received educational material . Both groups received ongoing primary care . Outcomes were difference between groups for change in weight ( kilograms ) , waist circumference ( centimeters ) , HbA(1c ) , fasting lipid levels , use of prescription medications , and health-related quality of life . RESULTS Case management result ed in greater weight loss ( P < 0.001 ) , reduced waist circumference ( P < 0.001 ) , reduced HbA(1c ) level ( P = 0.02 ) , less use of prescription medications ( P = 0.03 ) , and improved health-related quality of life ( P < 0.001 ) compared with usual care . The 12-month group difference in weight loss and waist circumference was 3.0 kg ( 95 % CI -5.4 to -0.6 ) and -4.2 cm ( -6.8 to -1.6 ) . HbA(1c ) differences were greatest at 4 months ( -0.59 % , P = 0.006 ) but not significant by 12 months ( -0.19 % , P = 0.45 ) . Participants in the case management group lowered their use of medications , primarily diabetes medications , by 0.8 medications per day more than participants treated with usual care ( P = 0.03 ) . In seven of nine quality -of-life domains , the case management group improved compared with usual care ( P < 0.05 ) . CONCLUSIONS Moderate-cost dietitian-led lifestyle case management may improve diverse health indicators among obese patients with type 2 diabetes Although the Diabetes Prevention Program ( DPP ) developed a lifestyle weight loss intervention that has been demonstrated to prevent type 2 diabetes in high-risk individuals , it has yet to be widely adopted at the community level . The Healthy Living Partnership to Prevent Diabetes study ( HELP PD ) was design ed to translate the DPP approach for use in community setting s as a cost-effective intervention led by Community Health Workers ( CHW 's ) and administered through a Diabetes Care Center ( DCC ) . Approximately 300 overweight and obese ( BMI 25 - 40 kg/m(2 ) ) individuals with prediabetes ( fasting blood glucose 95 - 124 mg/dl ) were r and omly assigned to either a lifestyle weight loss intervention ( LW ) or an enhanced usual care comparison condition ( UC ) . The goal of LW is > or=7 % weight loss achieved through increases in physical activity ( 180 min/wk ) and decreases in caloric intake ( approximately 1500 kcal/day ) . The intervention consists of CHW-led group-mediated cognitive behavioral meetings that occur weekly for 6 months and monthly thereafter for 18 months . UC consists of 2 individual meetings with a registered dietitian and a monthly newsletter . The primary outcome is change in fasting blood glucose . Secondary outcomes include cardiovascular risk factors , health-related quality of life , and social cognitive variables . Outcomes are masked and are collected every 6 months . The cost-effectiveness of the program will also be assessed . A community-based program that is administered through local DCC 's and that harnesses the experience of community members ( CHW 's ) may be a promising strategy for the widespread dissemination of interventions effective at preventing type 2 diabetes in high risk individuals The prevalence of type 2 diabetes continues to increase in minority and underserved patients , who are also more likely to have poorer control of diabetes and related risk factors for complications . Although the Look AHEAD trial has demonstrated improved risk factor control among overweight or obese diabetes patients who received an intensive lifestyle intervention  , translating such findings into accessible programs is a major public health challenge . The purpose of this paper is to report the design and baseline characteristics of the Lifestyle Interventions for the Treatment of Diabetes study ( LIFT Diabetes ) . The overall goal is to test the impact of a community-based lifestyle weight loss ( LWL ) intervention adapted from Look AHEAD on cardiovascular disease risk at 12-months and 24-months among minority and lower income diabetes patients . Secondary outcomes include body weight , physical activity , medication use , cost , re source utilization , and safety . The primary hypothesis being tested is that the  LWL  will result in 10 % relative reduction in CVD risk compared to the DSM . We have r and omized 260 overweight or obese adults with diabetes one of two 12-month interventions : a LWL condition delivered by community health workers or a diabetes self-management ( DSM ) education condition . The baseline demographic characteristics indicate that our sample is predominantly female , obese , low income , and ethnic minority . Translating evidence -based , lifestyle strategies , and targeting minority and underserved patients , will yield , if successful , a model for addressing the burden of diabetes and may favorably impact health disparities OBJECTIVE To conduct a cost analysis and cost-effectiveness study based on a r and omized clinical trial of basic nutrition care ( BC ) and practice guidelines nutrition care ( PGC ) provided by dietitians in outpatient clinics . DESIGN Subjects with non-insulin-dependent diabetes mellitus ( NIDDM ) from three states ( Minnesota , Florida , Colorado ) were r and omly assigned to a group receiving BC or a group receiving PGC for a 6-month clinical trial . Along with data about medical and clinical outcomes , data about cost re sources were collected . The cost-effectiveness of PGC compared with BC was calculated using per-patient costs and glycemic outcomes for the 6 months of the study . A net cost-effectiveness ratio comparing BC and PGC , including the cost savings result ing from changes in medical therapy , was also calculated . SUBJECTS The study reports on a sample of 179 subjects with NIDDM between the ages of 38 and 76 years who completed the clinical trial . RESULTS Patients in the PGC group experienced a mean 1.1 + /- 2.8 mmol/L decrease in fasting plasma glucose level 6 months after entry to the study , for a total per-patient cost of $ 112 .  PGC costs included one glycated hemoglobin assay used by the dietitian to evaluate nutrition outcomes . Patients in the BC group experienced a mean 0.4 + /- 2.7 mmol/L decrease , for a total per-patient cost of $ 42 . In the PGC group , 17 persons had changes in therapy , which yielded an average 12-month cost savings prorated for all patients of $ 31.49 . In contrast , in the BC group , 9 persons had changes in therapy , for an average 12-month prorated cost savings of $ 3.13 . Each unit of change in fasting plasma glucose level from entry to the 6-month follow-up can be achieved with an investment of $ 5.75 by implementing BC or of $ 5.84 by implementing PGC . If net costs are considered ( per-patient costs -- cost savings due to therapy changes ) , the cost-effectiveness ratios become $ 5.32 for BC and $ 4.20 for PGC , assuming the medical changes in therapy were maintained for 12 months . APPLICATIONS These findings suggest that individualized nutrition interventions can be delivered by experienced dietitians with a reasonable investment of re sources . Cost-effectiveness is enhanced when dietitians are engaged in active decision making about intervention alternatives based on the patient 's needs STUDY OBJECTIVE : To study the clinical and cost outcomes of providing nutritional counselling to patients with one or more of the following conditions : overweight , hypertension and type 2 diabetes . DESIGN : The study was design ed as a r and om controlled trial . Consecutive patients were screened opportunistically for one or more of the above conditions and r and omly allocated to one of two intervention groups ( doctor/dietitian or dietitian ) or a control group . Both intervention groups received six counselling sessions over 12 months from a dietitian . However , in the doctor/dietitian group it was the doctor and not the dietitian who invited the patient to join the study and the same doctor also review ed progress at two of the six counselling sessions . SETTING : The study was conducted in a university group general practice set in a lower socioeconomic outer suburb of Perth , Western Australia . PATIENTS : Of the 273 patients r and omly allocated to a study group , 198 were women . Age ranged from 25 to 65 years . Seventy eight per cent of patients resided in the lower two socioecnomic quartiles , 56 per cent described their occupation as home duties and 78 per cent were partnered . RESULTS : Both intervention groups reduced weight and blood pressure compared with the control group . Patients in the doctor/dietitian group were more likely to complete the 12 month programme than those in the dietitian group . Patients in the doctor/dietitian group lost an average of 6.7 kg at a cost of $ A9.76 per kilogram , while the dietitian group lost 5.6 kg at a cost of $ A7.30 per kilogram . CONCLUSION : General practitioners , in conjunction with a dietitian , can produce significant weight and blood pressure improvement by health promotion methods Evidence from varied community setting s has shown that the Group Lifestyle Balance ( GLB ) Program and other adaptations of the Diabetes Prevention Program ( DPP ) intervention are effective in lowering diabetes risk . Most DPP data originated from studies of pre-diabetic whites , with only sparse evidence of the effect of DPP in African Americans ( AAs ) in community setting s. This paper describes the design , methods , baseline characteristics and cost effective measures , of a single-blinded , cluster-r and omized trial of a faith-based adaptation of the GLB program , Fit Body and Soul ( FBAS ) . The major aims are to test efficacy and cost utility of FBAS in twenty AA churches . R and omization occurred at the church level and 604 AA overweight/obese ( BMI ≥25kg/m(2 ) ) adults with fasting plasma glucose range from normal to pre-diabetic received either FBAS or a health-education comparison program . FBAS is a group-based , multi-level intervention delivered by trained church health advisors ( health professionals from within the church ) , with the goal of ≥7 % weight loss , achieved through increasing physical activity , healthy eating and behavior modification . The primary outcome is weight change at 12weeks post intervention . Secondary outcomes include hemoglobin A1C , fasting plasma glucose , waist circumference , blood pressure , physical activity level , quality of life measures , and cost-effectiveness . FBAS is the largest known cohort of AAs enrolled in a faith-based DPP translation . Reliance on health professionals from within the church for program implementation and the cost analysis are unique aspects of this trial . The design provides a model for faith-based DPPs and holds promise for program sustainability and widespread dissemination AIMS The Diabetes Community Lifestyle Improvement Program ( D-CLIP ) aims to implement and evaluate in a controlled , r and omized trial the effectiveness , cost-effectiveness , and sustainability of a culturally appropriate , low-cost , and sustainable lifestyle intervention for the prevention of type 2 diabetes mellitus in India . METHODS D-CLIP , a translational research project adapted from the methods and curriculum developed and tested for efficacy in the Diabetes Prevention Program , utilizes innovated methods ( a step-wise model of diabetes prevention with lifestyle and metformin added when needed ; inclusion of individuals with isolated glucose tolerance , impaired fasting glucose , and both ; classes team-taught by professionals and trained community educators ) with the goals of increasing diabetes prevention , community acceptability , and long-term dissemination and sustainability of the program . The study outcomes are : diabetes incidence ( primary measure of effectiveness ) , cost-effectiveness , changes in anthropometric measures , plasma lipids , blood pressure , blood glucose , and HbA(1c , ) Program acceptability and sustainability will be assessed using a mixed methods approach . CONCLUSION D-CLIP , a low-cost , community-based , research program , addresses the key components of translational research and can be used as a model for prevention of chronic diseases in other low and middle-income country setting UNLABELLED In June 2008 , the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project , an evidence -based review of the literature surrounding strategies for successful management and treatment of diabetes . This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry 's newly released Diabetes Strategy .After an initial review of the strategy and consultation with experts , the secretariat identified five key areas in which evidence was needed . Evidence -based analyses have been prepared for each of these five areas : insulin pumps , behavioural interventions , bariatric surgery , home telemonitoring , and community based care . For each area , an economic analysis was completed where appropriate and is described in a separate report . To review these titles within the Diabetes Strategy Evidence series , please visit the Medical Advisory Secretariat Web site , http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html,DIABETES STRATEGY EVIDENCE PLATFORM : Summary of Evidence -Based AnalysesContinuous Subcutaneous Insulin Infusion Pumps for Type 1 and Type 2 Adult Diabetics : An Evidence -Based Analysis Behavioural Interventions for Type 2 Diabetes : An Evidence -Based Analysis  BARIATRIC SURGERY FOR PEOPLE WITH DIABETES AND MORBID OBESITY : An Evidence -Based Summary Community-Based Care for the Management of Type 2 Diabetes : An Evidence -Based Analysis Home Telemonitoring for Type 2 Diabetes : An Evidence -Based Analysis Application of the Ontario Diabetes Economic Model ( ODEM ) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario OBJECTIVE The objective of this report is to determine whether behavioural interventions are effective in improving glycemic control in adults with type 2 diabetes . BACKGROUND Diabetes is a serious chronic condition affecting millions of people worldwide and is the sixth leading cause of death in Canada . In 2005 , an estimated 8.8 % of Ontario 's population had diabetes , representing more than 816,000 Ontarians . The direct health care cost of diabetes was $ 1.76 billion in the year 2000 and is projected to rise to a total cost of $ 3.14 billion by 2016 . Much of this cost arises from the serious long-term complications associated with the disease including : coronary heart disease , stroke , adult blindness , limb amputations and kidney disease . Type 2 diabetes accounts for 90 - 95 % of diabetes and while type 2 diabetes is more prevalent in people aged 40 years and older , prevalence in younger population s is increasing due to a rise in obesity and physical inactivity in children . Data from the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) has shown that tight glycemic control can significantly reduce the risk of developing serious complications in type 2 diabetics . Despite physicians ' and patients ' knowledge of the importance of glycemic control , Canadian data has shown that only 38 % of patients with diabetes have HbA1C levels in the optimal range of 7 % or less . This statistic highlights the complexities involved in the management of diabetes , which is characterized by extensive patient involvement in addition to the support provided by physicians . An enormous dem and is , therefore , placed on patients to self-manage the physical , emotional and psychological aspects of living with a chronic illness . Despite differences in individual needs to cope with diabetes , there is general agreement for the necessity of supportive programs for patient self-management . While traditional programs were didactic models with the goal of improving patients ' knowledge of their disease , current models focus on behavioural approaches aim ed at providing patients with the skills and strategies required to promote and change their behaviour . Several meta-analyses and systematic review s have demonstrated improved health outcomes with  self-management support programs in type 2 diabetics . They have all , however , either looked at a specific component of self-management support programs ( i.e. self-management education ) or have been conducted in specific population s. Most review s are also qualitative and do not clearly define the interventions of interest , making findings difficult to interpret . Moreover , heterogeneity in the interventions has led to conflicting evidence on the components of effective programs . There is thus much uncertainty regarding the optimal design and delivery of these programs by policymakers . EVIDENCE -BASED ANALYSIS OF EFFECTIVENESS : RESEARCH QUESTIONS Are behavioural interventions  effective in improving glycemic control in adults with type 2 diabetes?Is the effectiveness of the intervention impacted by intervention characteristics ( e.g. delivery of intervention , length of intervention , mode of instruction , interventionist etc . ) ? INCLUSION CRITERIA English Language Published between January 1996 to August 2008 Type 2 diabetic adult population ( > 18 years)R and omized controlled trials ( RCTs ) Systematic review s , or meta-analyses Describing a multi-faceted self-management support intervention as defined by the 2007 Self-Management Mapping Guide (1)Reporting outcomes of glycemic control ( HbA1c ) with extractable data Studies with a minimum of 6-month follow up EXCLUSION CRITERIA Studies with a control group other than usual care Studies with a sample size < 30 Studies without a clearly defined intervention OUTCOMES OF INTEREST PRIMARY OUTCOME glycemic control ( HbA1c ) SECONDARY OUTCOMES systolic blood pressure ( SBP ) control , lipid control , change in smoking status , weight change , quality of life , knowledge , self-efficacy , managing psychosocial aspects of diabetes , assessing dissatisfaction and readiness to change , and setting and achieving diabetes goals . SEARCH STRATEGY A search was performed in OVID MEDLINE , MEDLINE In-Process and Other Non-Indexed Citations , EMBASE , the Cumulative Index to Nursing & Allied Health Literature ( CINAHL ) , The Cochrane Library , and the International Agency for Health Technology Assessment ( INAHTA ) for studies published between January 1996 and August 2008 . Abstract s were review ed by a single author and studies meeting the inclusion criteria outlined above were obtained . Data on population characteristics , glycemic control outcomes , and study design were extracted . Reference lists were also checked for relevant studies . The quality of the evidence was assessed as being either high , moderate , low , or very low according to the GRADE methodology . SUMMARY OF FINDINGS The search identified 638 citations published between 1996 and August 2008 , of which 12 met the inclusion criteria and one was a meta- analysis ( Gary et al. 2003 ) . The remaining 11 studies were RCTs ( 9 were used in the meta- analysis ) and only one was defined as small ( total sample size N=47 ) . SUMMARY OF PARTICIPANT DEMOGRAPHICS ACROSS STUDIES : A total of 2,549 participants were included in the 11 identified studies . The mean age of participants reported was approximately 58 years and the mean duration of diabetes was approximately 6 years . Most studies reported gender with a mean percentage of females of approximately 67 % . Of the eleven studies , two focused only on women and four included only Hispanic individuals . All studies evaluated type 2 diabetes patients exclusively . STUDY CHARACTERISTICS : The studies were conducted between 2002 and 2008 . Approximately six of 11 studies were carried out within the USA , with the remaining studies conducted in the UK , Sweden , and Israel ( sample size ranged from 47 to 824 participants ) . The quality of the studies ranged from moderate to low with four of the studies being of moderate quality and the remaining seven of low quality ( based on the Consort Checklist ) . Differences in quality were mainly due to method ological issues such as inadequate description of r and omization , sample size calculation allocation concealment , blinding and uncertainty of the use of intention-to-treat ( ITT ) analysis . Patients were recruited from several setting s : six studies from primary or general medical practice s , three studies from the community ( e.g. via advertisements ) , and two from outpatient diabetes clinics . A usual care control group was reported in nine of 11 of the studies and two studies reported some type of minimal diabetes care in addition to usual care for the control group . INTERVENTION CHARACTERISTICS : All of the interventions examined in the studies were mapped to the 2007 Self-management Mapping Guide . The interventions most often focused on problem solving , goal setting and encouraging participants to engage in activities that protect and promote health ( e.g. modifying behaviour , change in diet , and increase physical activity ) . All of the studies examined comprehensive interventions targeted at least two self-care topics ( e.g. diet , physical activity , blood glucose monitoring , foot care , etc . ) . Despite the homogeneity in the aims of the interventions , there was substantial clinical heterogeneity in other intervention characteristics such as duration , intensity , setting , mode of delivery ( group vs. individual ) , interventionist , and outcomes of interest ( discussed below ) . DURATION , INTENSITY AND MODE OF DELIVERY : Intervention duration s ranged from 2 days to 1 year , with many falling into the range of 6 to 10 weeks . The rest of the interventions fell into categories of ≤ 2 weeks ( 2 studies ) , 6 months ( 2 studies ) , or 1 year ( 3 studies ) . Intensity of the interventions varied widely from 6 hours over 2 days , to 52 hours over 1 year ; however , the majority consisted of interventions of 6 to 15 hours . Both individual and group sessions were used to deliver interventions . Group counselling was used in five studies as a mode of instruction , three studies used both individual and group sessions , and one study used individual sessions as its sole mode of instruction . ( ABSTRACT BACKGROUND The Diabetes Prevention Program ( DPP ) demonstrated that lifestyle intervention reduces risk for type 2 diabetes and the metabolic syndrome . A universal framework for translation of multiple aspects of the DPP intervention , including training , support , and evaluation is needed to enhance treatment fidelity in a variety of setting s. PURPOSE This study aims to develop a comprehensive model for diabetes prevention translation using a modified DPP lifestyle intervention . METHODS The DPP lifestyle intervention was adapted to a 12-session group-based program called Group Lifestyle Balance for implementation in the community setting . A model for training and support mirroring that of the DPP was developed for prevention professionals administering the program . The process of training/support and program implementation was evaluated for feasibility and effectiveness using a nonr and omized prospect i ve design in two phases ( N=51 , Phase 1 : 2005 - 2006 ; N=42 , Phase 2 : 2007 - 2009 ; data analysis completed 2008 - 2009 ) . A total of 93 nondiabetic individuals with BMI > or=25 kg/m(2 ) and the metabolic syndrome or prediabetes participated . Measures were collected at baseline and post-intervention for all and 6 and 12 months post-intervention for Phase 2 . RESULTS Significant decreases in weight , waist circumference , and BMI were noted in both phases from baseline . Participants in Phase 2 also demonstrated decreases in total cholesterol , non-HDL cholesterol , and systolic and diastolic blood pressure that were maintained at 12 months . Average combined weight loss for both groups over the course of the 3-month intervention was 7.4 pounds ( 3.5 % relative loss , p<0.001 ) ; 23.8 % and 52.2 % of those who completed the program reached 7 % and 5 % weight loss , respectively . More than 80 % of those achieving 7 % weight loss in the Phase-2 group maintained their weight loss at 6 months . CONCLUSIONS A comprehensive diabetes prevention model for training , intervention delivery , and support was shown to be successful and was effective in reducing diabetes and cardiovascular disease risk factors in this group of high-risk individuals Purpose Translating strategies and approaches from the successful clinical ly based Diabetes Prevention Program ’s lifestyle intervention to community setting s is a key next step . This article describes a lifestyle program developed in partnership by research ers at a major university and public health professionals at a local health department . Methods The Live Well , Be Well ( LWBW ) program was design ed to meet the needs of lower income , minority , and low-literacy adults at risk for diabetes . It was adapted from interventions with demonstrated efficacy and delivered in Spanish and English by health department staff . The program consisted of a 6-month active phase and a 6-month maintenance phase and was primarily telephone based , with one in-person planning session and several group workshops . In-person and group sessions were held in convenient community-based setting s. Counselors provided education and skills training to modify diet and increase physical activity . Self-selected and attainable goal - setting and action plans were emphasized to enhance self-efficacy . LWBW is the intervention component of a r and omized trial with primary outcomes of fasting glucose , weight , and other clinical measures . Conclusions The program provides a unique translational model for implementing diabetes risk reduction programs for underserved population s. Individually tailored and non-prescriptive , it utilized existing health department infrastructure , focused on telephone counseling , used culturally appropriate , low-literacy material s , and was delivered in local , community-based facilities OBJECTIVE The Diabetes Prevention Program ( DPP ) demonstrated that intensive lifestyle and metformin interventions reduced the incidence of type 2 diabetes compared with a placebo intervention . The aim of this study was to assess the cost-effectiveness of the lifestyle and metformin interventions relative to the placebo intervention . RESEARCH DESIGN AND METHODS Analyses were performed from a health system perspective that considered direct medical costs only and a societal perspective that considered direct medical costs , direct nonmedical costs , and indirect costs . Analyses were performed with the interventions as implemented in the DPP and as they might be implemented in clinical practice . RESULTS The lifestyle and metformin interventions required more re sources than the placebo intervention from a health system perspective , and over 3 years they cost approximately US dollars 2250 more per participant . As implemented in the DPP and from a societal perspective , the lifestyle and metformin interventions cost US dollars 24400 and US dollars 34500 , respectively , per case of diabetes delayed or prevented and US dollars 51600 and US dollars 99200 per quality -adjusted life-year ( QALY ) gained . As the interventions might be implemented in routine clinical practice and from a societal perspective , the lifestyle and metformin interventions cost US dollars 13200 and US dollars 14300 , respectively , per case of diabetes delayed or prevented and US dollars 27100 and US dollars 35000 per QALY gained . From a health system perspective , costs per case of diabetes delayed or prevented and costs per QALY gained tended to be lower . CONCLUSIONS Over 3 years , the lifestyle and metformin interventions were effective and were cost-effective from the perspective of a health system and society . Both interventions are likely to be affordable in routine clinical practice , especially if implemented in a group format and with generic medication pricing Purpose The purpose of this article is to describe efforts to develop and administer a formal curriculum to train community workers to deliver a group-based adaptation of the Diabetes Prevention Program ( DPP ) lifestyle intervention in YMCA setting s. The DPP demonstrated that a structured diet and physical activity intervention that achieves and maintains modest weight loss for overweight adults with impaired glucose tolerance can significantly reduce the development of diabetes . Although tens of millions of American adults could benefit from access to the DPP lifestyle intervention , there currently is no available model for nationwide dissemination of this highly beneficial and cost-effective approach to diabetes prevention . A description of 2 ongoing r and omized pilot studies provides information about the feasibility and effectiveness of future efforts to apply this new training curriculum on a national scale . Conclusions Diabetes educators are challenged to partner with community organizations and other health care workers for extensive distribution of the DPP lifestyle intervention messages Objective : The US Diabetes Prevention Program ( DPP ) and other large trials internationally have shown that an intensive lifestyle intervention can reduce the development of type 2 diabetes  . We evaluated long-term effects of a lower cost , group-based adaption of the DPP lifestyle intervention offered by the YMCA . Methods : Participants were adults with BMI ≥24 kg/m2 and r and om capillary blood glucose 6.1–11.1 mmol/L who had been previously enrolled in a cluster-r and omized trial comparing a group-based DPP lifestyle intervention versus brief advice alone . Four to 12 months after completion of the initial trial , 72 % of 92 participants enrolled in an extension study , and all were offered a group lifestyle maintenance program at the YMCA . Paired t-tests were used to assess within-group changes ; ANCOVA with adjustment was used for between-group comparisons . Results : At 28 months , after both arms were offered the same 8-month lifestyle maintenance intervention , both arms had statistically significant weight losses compared to baseline ( brief advice controls : −3.6 % ; 95 % CI : −5.8 to −1.4 ; intensive lifestyle : −6.0 % ; 95 % CI : −8.8 to −3.2 ) . Participants initially assigned to the DPP also experienced significant improvements in blood pressure and total cholesterol . Discussion : The YMCA is a promising channel for dissemination of a low-cost model for lifestyle diabetes prevention . Future studies are needed to verify these findings Objective To explore the reasons for enrolling , experiences of participating and reasons for remaining in a family-based , cluster r and omised controlled trial of a dietitian-delivered lifestyle modification intervention aim ing to reduce obesity in South Asians at high risk of developing diabetes . Design Qualitative study using narrative interviews of a purposive sample of trial participants following completion of the intervention . Data were thematically analysed . Setting The intervention was conducted in Scotl and and result ed in a modest decrease in weight , but did not statistically reduce the incidence of diabetes . Participants We conducted 21 narrative interviews with 24 participants ( 20 trial participants and four family volunteers ) . Results Many participants were motivated to participate because of : known family history of diabetes and the desire to better underst and diabetes-related risks to their own and their family 's health ; ways to mitigate these risks and to benefit from personalised monitoring . Home-based interventions , communication in the participant 's chosen language ( s ) and continuity in dietitians supported their continuing engagement with the trial . Adaptations in food choices were initially accommo date d by participants , although social and faith-based responsibilities were reported as important barriers to persevering with agreed dietary goals . Many participants reported that increasing their level of physical activity was difficult given their long working hours , physically dem and ing employment and domestic commitments ; this being compounded by Scotl and 's challenging climate and a related reluctance to exercise in the outdoors . Conclusions Although participants had strong personal interests in participation and found the information provided by dietitians useful , they nonetheless struggled to incorporate the dietary and exercise recommendations into their daily lives . In particular , increasing levels of physical exercise was described as an additional and in some cases unachievable burden . Consideration needs to be given to strengthening and supporting lifestyle interventions with community-based approaches in order to help overcome wider social and environmental factors OBJECTIVE To describe the costs of the Diabetes Prevention Program ( DPP ) interventions to prevent or delay type 2 diabetes . RESEARCH DESIGN AND METHODS We describe the direct medical costs , direct nonmedical costs , and indirect costs of the placebo , metformin , and intensive lifestyle interventions over the 3-year study period of the DPP . Re source use and cost are summarized from the perspective of a large health system and society . Research costs are excluded . RESULTS The direct medical cost of laboratory tests to identify one subject with impaired glucose tolerance ( IGT ) was $ 139 . Over 3 years , the direct medical costs of the interventions were $ 79 per participant in the placebo group , $ 2,542 in the metformin group , and $ 2,780 in the lifestyle group . The direct medical costs of care outside the DPP were $ 272 less per participant in the metformin group and $ 432 less in the lifestyle group compared with the placebo group . Direct nonmedical costs were $ 9 less per participant in the metformin group and $ 1,445 greater in the lifestyle group compared with the placebo group . Indirect costs were $ 230 greater per participant in the metformin group and $ 174 less in the lifestyle group compared with the placebo group . From the perspective of a health system , the cost of the metformin intervention relative to the placebo intervention was $ 2,191 per participant and the cost of the lifestyle intervention was $ 2,269 per participant over 3 years . From the perspective of society , the cost of the metformin intervention relative to the placebo intervention was $ 2,412 per participant and the cost of the lifestyle intervention was $ 3,540 per participant over 3 years . CONCLUSIONS The metformin and lifestyle interventions are associated with modest incremental costs compared with the placebo intervention . The evaluation of costs relative to health benefits will determine the value of these interventions to health systems and society Obesity affects individuals physically and emotionally , contributing to direct and indirect employer costs . Targeted obesity interventions through the Diabetes Prevention Program Lifestyle Core Curriculum offered at the worksite could promote healthy lifestyle decisions result ing in weight improvement among overweight and obese employees . A pretest-posttest cohort design was used to evaluate changes in weight and body mass index among 35 Diabetes Prevention Program participants ; they achieved statistically significant changes in body weight ( p < .001 ) and body mass index ( p < .001 ) . As a process measure , Diabetes Prevention Program session attendance moderately correlated with weight loss ( r = .51 ; p = .002 ) . Many health care professionals , including occupational health nurses , can implement evidence -based worksite obesity interventions to support employee weight loss BACKGROUND Since the Diabetes Prevention Project ( DPP ) demonstrated that lifestyle weight-loss interventions can reduce the incidence of diabetes by 58 % , several studies have translated the DPP methods to public health-friendly context s. Although these studies have demonstrated short-term effects , no study to date has examined the impact of a translated DPP intervention on blood glucose and adiposity beyond 12 months of follow-up . PURPOSE To examine the impact of a 24-month , community-based diabetes prevention program on fasting blood glucose , insulin , insulin resistance as well as body weight , waist circumference , and BMI in the second year of follow-up . DESIGN An RCT comparing a 24-month lifestyle weight-loss program ( LWL ) to an enhanced usual care condition ( UCC ) in participants with prediabetes ( fasting blood glucose=95 - 125 mg/dL ) . Data were collected in 2007 - 2011 ; analyses were conducted in 2011 - 2012 . SETTING / PARTICIPANTS 301 participants with prediabetes were r and omized ; 261 completed the study . The intervention was held in community-based sites . INTERVENTION The LWL program was led by community health workers and sought to induce 7 % weight loss at 6 months that would be maintained over time through decreased caloric intake and increased physical activity . The UCC received two visits with a registered dietitian and a monthly newsletter . MAIN OUTCOME MEASURES The main measures were fasting blood glucose , insulin , insulin resistance , body weight , waist circumference , and BMI . RESULTS Intent-to-treat analyses of between-group differences in the average of 18- and 24-month measures of outcomes ( controlling for baseline values ) revealed that the LWL participants experienced greater decreases in fasting glucose ( -4.35 mg/dL ) ; insulin ( -3.01 μU/ml ) ; insulin resistance ( -0.97 ) ; body weight ( -4.19 kg ) ; waist circumference ( -3.23 cm ) ; and BMI ( -1.40 ) , all p-values < 0.01 . CONCLUSIONS A diabetes prevention program administered through an existing community-based system and delivered by community health workers is effective at inducing significant long-term reductions in metabolic indicators and adiposity Background Depression is a common comorbidity in individuals with cognitive impairment . Those with cognitive impairments face unique challenges in receiving the benefits of many conventional therapies for depression , and may have poorer outcomes in areas such as recovery and quality of life . However , the stigmatization of mental health disorders , cost barriers and physical disabilities may prevent these individuals from seeking mental health care . An online , self-help intervention specifically developed for adults with cognitive deficits and depression may be particularly beneficial to this population . We aim to inform the design of such an intervention through a systematic review by answering the following research question : among adults with cognitive impairment ( including those with acquired brain injuries or neurodegenerative diseases ) , which technology-amenable interventions have been shown to effectively decrease symptoms of depression ? Specifically , psychotherapeutic and /or behavioural interventions that could be delivered in a self-guided , online system will be included . Methods Comprehensive electronic search es will be conducted in MEDLINE , EMBASE , PsycINFO and CINAHL . Additional studies will be obtained through manually search ing the references of relevant systematic review s , contacting primary authors of select articles and tracking conference proceedings and trial registries . Article titles and abstract s will be screened using predefined eligibility criteria , and then judged for their amenability to the proposed self-help , technology-based intervention . The full text of those articles with selected interventions will then be screened to determine final eligibility for inclusion . Included articles will be categorized by intervention type and assessed for risk of bias using the Cochrane Effective Practice and Organization of Care Risk of Bias tool for non-r and omized trials , controlled before-after studies and interrupted time series . The primary outcome will be a change in score on a vali date d depression scale , and adverse events will be documented as a secondary outcome . After data extraction from selected articles , pooling of data and meta- analysis will be conducted if a sufficient pool of studies with comparable methodology and quality are identified . Alternatively , plain language summaries will be developed . The quality of evidence will be assessed using the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) system . Systematic review registration PROSPERO Context The Diabetes Prevention Program ( DPP ) showed that lifestyle changes or metformin effectively decreased the development of  type 2 diabetes in adults with impaired glucose tolerance . The economics of these interventions is important to policymakers . Contribution This cost-effectiveness model estimates that the DPP life-style intervention would cost society about $ 8800 and metformin would cost about $ 29900 per quality -adjusted life-year saved . While lifestyle intervention had a favorable cost-effectiveness profile at any adult age , metformin was not cost-effective after age 65 years . Implication s The cost-effectiveness of lifestyle intervention to prevent type 2 diabetes  in high-risk individuals is within the range that American society typically finds acceptable for health care interventions . The Editors During the past half century , the number of persons with diagnosed diabetes in the United States has increased 4- to 6-fold ( 1 ) . Recent large clinical trials from Asia , Europe , and North America have demonstrated that behavioral and medication interventions can delay or prevent the development of type 2 diabetes in persons with impaired glucose tolerance , which is defined by a plasma glucose level between 7.77 mmol/L ( 140 mg/dL ) and 11.04 mmol/L ( 199 mg/dL ) 2 hours after a 75-g oral glucose load ( 2 - 6 ) . The Diabetes Prevention Program ( DPP ) r and omly assigned 3234 nondiabetic persons 25 years of age or older with impaired glucose tolerance and fasting glucose levels between 5.27 mmol/L ( 95 mg/dL ) and 6.94 mmol/L ( 125 mg/dL ) to placebo ; a lifestyle-modification program with the goals of at least a 7 % weight loss and 150 minutes of physical activity per week ; or metformin , 850 mg twice daily ( 4 ) . The mean age of participants was 51 years , and the mean body mass index was 34.0 kg/m2 ; 68 % were women and 45 % were members of minority groups ( 4 ) . The average follow-up was 2.8 years . Compared with the placebo intervention , the lifestyle intervention reduced the incidence of type 2 diabetes by 58 % and the metformin intervention reduced the incidence of type 2 diabetes by 31 % ( 4 ) . We have previously described the costs of the DPP interventions and their cost-effectiveness within the 3-year trial period ( 7 , 8) . In this analysis , we project the costs , health outcomes , and cost-effectiveness of the DPP lifestyle and metformin interventions over a lifetime relative to the placebo intervention . Methods Clinical Trial The lifestyle intervention involved a healthy , low-calorie , low-fat diet and moderate physical activity , such as brisk walking . The lifestyle intervention was implemented with a 16-lesson core curriculum covering diet , exercise , and behavior modification that was taught by case managers on a one-on-one basis , followed by individual sessions ( usually monthly ) and group sessions with case managers ( 9 ) . At the end of the study , 38 % of participants in the lifestyle intervention group had lost at least 7 % of their initial body weight .  The metformin and placebo interventions were initiated at a dosage of 850 mg once a day . At 1 month , the dosage of metformin or placebo was increased to 850 mg twice daily . Case managers reinforced adherence during individual quarterly sessions ( 10 ) . At the end of the study , 72 % of participants in the metformin intervention group and 77 % of participants in the placebo intervention group took at least 80 % of the prescribed dose . All participants received st and ard lifestyle recommendations through written information and an annual 20- to 30-minute individual session that emphasized the importance of a healthy lifestyle ( 10 ) . Simulation Model We assessed the progression from impaired glucose tolerance to onset of diabetes to clinical ly diagnosed diabetes to diabetes with complications and death by using a lifetime simulation model originally developed by the Centers for Disease Control and Prevention and Research Triangle Institute International . The model has a Markov structure and includes annual transition probabilities between disease states ( 11 ) . In addition to disease progression , the model tracks costs and quality -adjusted life-years ( QALYs ) . The model has been described elsewhere ( 11 ) . For our analyses , we modified the model to include data from the DPP on progression , costs , and quality of life associated with impaired glucose tolerance , data from the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) on diabetes progression and complications , and new data on cost and quality of life associated with diabetes . A technical report describing the model is available . Supplement . Technical Report Disease Progression , Complications , and Comorbid Conditions Impaired Glucose Tolerance to Onset of Type 2 Diabetes We analyzed data from the DPP to assess the annual hazard of diabetes onset in the lifestyle , metformin , and placebo intervention groups . For patients receiving the placebo intervention , the annual hazard of diabetes onset was 10.8 per 100 person-years . At 3 years of follow-up , the risk reductions for the lifestyle and metformin interventions were 55.8 % and 29.9 % , respectively . In the base-case analysis , we assumed that the lifestyle and metformin interventions would be applied until diabetes onset and that the health and quality -of-life benefits associated with the interventions persisted until diabetes onset . Complications and Comorbid Conditions Associated with Impaired Glucose Tolerance We analyzed data from the DPP and other published sources to assess the prevalence of complications and comorbid conditions in participants with impaired glucose tolerance . At baseline , 6.0 % of DPP participants had microalbuminuria and 0.4 % had nephropathy .  The DPP did not measure peripheral neuropathy , but previous studies found that the prevalence of neuropathy in persons with impaired glucose tolerance was 74 % of that in persons with newly diagnosed type 2 diabetes ( 12 ) and 12.3 % of persons with newly diagnosed type 2 diabetes have neuropathy ( 13 ) . Therefore , we assumed that at baseline , 8.5 % of DPP participants had clinical neuropathy . At baseline , 28 % of DPP participants had hypertension , 45 % had dyslipidemia , 7 % were smokers , 1.1 % had a history of cerebrovascular disease , and 2.0 % had a history of myocardial infa rct ion . No other complications were present . We assumed that during impaired glucose tolerance , microvascular or neuropathic complications would not progress . We assumed that hypertension and dyslipidemia developed at the rates observed in the DPP . On the basis of 2 large studies ( 14 , 15 ) , we assumed that the incidences of coronary heart disease and cerebrovascular disease in patients with impaired glucose tolerance were 58 % and 56 % , respectively , of those observed in patients with type 2 diabetes . We further assumed that nondiabetes-related mortality for persons with impaired glucose tolerance was the same as for persons with diabetes ( 16 ) . Onset of Type 2 Diabetes to Clinical Diagnosis of Type 2 Diabetes In the DPP , participants were tested for diabetes every 6 months ; diabetes was diagnosed at onset . In routine clinical practice , type 2 diabetes is estimated to develop 8 to 12 years before its clinical diagnosis ( 17 , 18 ) . In our base-case analysis , we therefore assumed that a 10-year delay occurred between the onset and clinical diagnosis of diabetes . Participants in the DPP  had a mean hemoglobin A1c level of 6.4 % at the onset of diabetes . Participants in the UKPDS had a mean hemoglobin A1c of 7.1 % after a dietary run-in period but before r and omization ( 13 ) . Both DPP placebo participants and UKPDS participants received st and ard lifestyle recommendations . Accordingly , we assumed that during the 10-year interval between onset and clinical diagnosis of diabetes , patients were treated for type 2 diabetes and that hemoglobin A1c level increased at 0.07 % per year from 6.4 % to 7.1 % . Complications and Comorbid Conditions Associated with Undiagnosed Diabetes We further assumed that between onset and clinical diagnosis of diabetes , microvascular and neuropathic complications progressed slowly , such that by clinical diagnosis of type 2 diabetes , their prevalence reached the level observed in the UKPDS cohort at r and omization ( 13 , 19 , 20 ) . We assumed that blood pressure and lipid levels progressed as they did in DPP participants and that cardiovascular complications occurred as they would in type 2 diabetes according to risk factors and hemglobin A1c level ( 21 , 22 ) . Clinical Diagnosis of Type 2 Diabetes to Diabetes with Complications and Death We assumed that after clinical diagnosis , all persons with type 2 diabetes received intensive glycemic management as described in the UKPDS ( 13 ) . We modeled changes in hemoglobin A1c and diabetes treatments to reflect those observed in the UKPDS intensive therapy group . We based risk for retinopathy progression on UKPDS 38 ( 23 ) , risk for nephropathy progression on UKPDS 64 ( 20 ) , and risk for neuropathy progression on UKPDS 33 ( 13 ) . We based risk for cerebrovascular disease on UKPDS 60 ( 22 ) and risk for coronary heart disease on UKPDS 56 ( 21 ) . Costs Costs of Impaired Glucose Tolerance To estimate the total direct medical costs of impaired glucose tolerance , we considered the costs of the DPP interventions ( the cost of identifying participants , implementing and maintaining the interventions , and monitoring and treating the side effects of the interventions ) and the costs of the medical care outside the DPP ( 7 ) . In analyses from the perspective of society , we included both direct medical costs and direct nonmedical costs . We did not include indirect costs because they are captured in the assessment of QALYs ( 24 ) . Table 1 shows the total direct medical costs by treatment group , sex , and year in the DPP ( 7 ) . Costs were higher in the lifestyle and metformin interventions than in the placebo intervention and higher in women than in men . Costs decreased over time in all 3 intervention groups but after year 1 tended to decrease more in the lifestyle than Context A previous Markov modelbased analysis estimated that use of the Diabetes Prevention Program diet and exercise intervention to forestall diabetes in high-risk people would be cost-effective from a societal perspective . Contribution Using a vali date d model design ed to be more complete and realistic than previous models , the authors estimated that the intervention would cost society about $ 62600 per quality -adjusted life-year saved . It would be cost-saving if the annual cost of the intervention decreased from $ 672 to $ 100 . Implication s This model suggests that the Diabetes Prevention Program intervention costs more per quality -adjusted life-year saved than previously estimated , and health plans and insurers may consider it too expensive to cover . The Editors Recent r and omized , controlled studies have shown that diabetes can be prevented or delayed in high-risk individuals by intensive lifestyle modification programs ( 1 , 2 ) or glucose-lowering drugs ( 2 - 4 ) . For example , in the Diabetes Prevention Program ( DPP ) , the relative reductions in the 2.8-year incidence of diabetes were 58 % in the lifestyle modification group and 31 % in the metformin group ( 2 ) . This raises hopes of substantially reducing the morbidity , mortality , and cost of this important disease . However , the trial was too short to observe the effects on microvascular or macrovascular outcomes , and the programs cost several hundred dollars a year ( 5 ) . These findings generate obvious questions : What are the long-term effects of trying to prevent diabetes in high-risk people ? Does lifestyle modification truly prevent or just postpone diabetes ? Is such a prevention program cost-effective ? What is the best strategy ? A previous analysis has suggested that lifestyle modification would be cost-effective over 75 years from a societal perspective ( 6 ) . We used a more thorough , clinical ly realistic , and independently vali date d model to estimate the short- and intermediate-term health and economic effects of different prevention programs for high-risk individuals and health plans , as well as for society . Methods We conducted the analysis by using the Archimedes model , which has been described elsewhere ( 7 - 9 ) . Briefly , it is a simulation model written at a relatively high level of anatomic , physiologic , clinical , and administrative detail . It uses object-oriented programming to create in the model objects that correspond to objects in reality , one-to-one . Among the hundreds of objects are  people , pancreases , cells , plasma glucose levels , coronary arteries , plaque , chest pain , emergency departments , electrocardiograms , aspirin , and angioplasties  . Helpful analogies might be a flight simulator ( in which the objects include the plane and its wings , airports , runways , buildings , and the wind ) , or the SimCity computer game . In the Archimedes model , each individual is simulated down to the level of hepatic glucose production , insulin resistance , -cell fatigue , and similar biological variables . The core of the model is a set of differential equations that represent the anatomy and physiology pertinent to diseases and their complications . Currently , the model includes diabetes , congestive heart failure , coronary artery disease , stroke , hypertension , and asthma in a single integrated model . The structure and equations of the model pertinent to diabetes and its complications are described elsewhere ( 8 , 9 ) . The Appendix and a technical report available through our Web site ( 10 ) describe additional aspects of the model and its validations that are pertinent to this analysis . Calculations are performed by using a distributed computing network . Clinical Events The model includes the biological variables and outcomes relevant to diabetes and its complications . Examples are basal hepatic glucose production ; insulin amount ; insulin resistance ; fasting plasma glucose ; hemoglobin A1c ( HbA1c ) ; 2-hour oral glucose tolerance ; high-density lipoprotein ( HDL ) cholesterol , low-density lipoprotein ( LDL ) cholesterol , and total cholesterol ; triglycerides ; systolic and diastolic blood pressures and their determinants ( for example , cardiac output , arterial compliance , peripheral resistance ) ; weight and body mass index ( BMI ) ; stenosis of coronary arteries ; retinopathy ( assessed by the Early Treatment of Diabetic Retinopathy scale ) ; urine protein ; creatinine ; peripheral neuropathy ; foot ulcers of varying degrees of severity ; and amputations . The use of differential equations preserves the continuous nature of biological variables as well as the interactions between them . Clinical outcomes are defined in terms of the underlying variables , as occurs in reality . For example , a person is said to have diabetes if his or her fasting plasma glucose level exceeds 6.9375 mmol/L ( 125 mg/dL ) or results on a 2-hour oral glucose tolerance test exceed 11.0445 mmol/L ( 199 mg/dL ) . This enables the model to incorporate different definitions and changes in definitions . The model is continuous : Biological variables are changing and interacting continuously , the natural histories and severity of conditions progress smoothly , any clinical event can occur at any time , and the timing of events is as condensed or drawn out as occurs in reality . The model also includes a detailed representation of the processes and logistics of clinical care and their related costs . Interventions , both to prevent diabetes and to manage it when it occurs , are modeled at the level of the underlying biology . Pertinent to this analysis is that in the model , diet and exercise reduce weight ( 2 ) ; reduce blood pressure ( 11 ) ; improve LDL cholesterol , HDL cholesterol , and total cholesterol levels ( 12 ) ; and decrease fasting plasma glucose levels ( 2 ) . The effects of metformin in the model are to reduce fasting plasma glucose and 2-hour oral glucose tolerance test results ( 2 ) ( by reducing basal hepatic glucose production ) , decrease LDL cholesterol and triglyceride levels ( 13 ) , and retard weight gain . Data used to build the model were derived from basic physiologic studies , surveys , epidemiologic studies , and clinical trials using methods described in the technical report ( 10 ) . Every variable in the model is estimated from at least 1 empirical source ; no variables are simply assumed . We identified specific sources by search ing MEDLINE from 1970 to 28 February 2005 and by consulting textbooks and clinical experts . Because the model includes scores of continuously valued , interacting variables , it does not have simplified states , transitions , or events at discrete time intervals that can be tabulated , as is commonly done for a Markov-type model . The equations themselves are in the technical report ( 10 ) . For nonmathematical readers , we have calculated annualized rates of change of representative biological variables and annualized rates of occurrence of representative clinical events , and compared them with rates for comparable events observed in epidemiologic studies and clinical trials . The Appendix reports those results . Costs The DPP measured the direct medical costs of delivering the lifestyle and metformin interventions  ( for example , personnel , health education material s , medications , and laboratory tests ) . Compared with the placebo group 's costs , costs in the lifestyle group were $ 1356 more per person in the first year , with approximately $ 672 in annual costs thereafter ; for the metformin group , costs were $ 977 in the first year and averaged $ 742 per year thereafter ( 5 ) . Following the completion of the DPP , metformin became generic . When this is considered , the cost of the metformin program is reduced to about $ 780 for 3 years , or about $ 260 a year . In the DPP study , costs apply to the year 2000 . To calculate the routine costs of providing health care to high-risk people before they develop diabetes , as well as to people with diabetes and its complications , the model includes a detailed mathematical representation of a health care system , including such elements as facilities , personnel , tests and treatments , protocol s , and provider behaviors . For the base-case analysis , we obtained itemized costs from Kaiser Permanente , a nonprofit , group- practice , integrated managed care organization that provides comprehensive care ( with no deductibles or copayments ) . The facilities , personnel , protocol s , and costs in the model are based on that organization 's records , at the level of detail at which actual accounts are kept ( for example , 37 different kinds of office visits ) . The model calculates costs by keeping track of the occurrence of every event that has cost implication s and adding them up . The costs assigned to any event or item were calculated by Kaiser Permanente 's cost-accounting department using micro-costing methods ( 14 ) , and they represent the real costs to the organization , not charges , reimbursements , or diagnosis-related groups . Because costs vary from setting to setting , the implication s of different cost structures are examined in the sensitivity analysis . Calculation of costs applies to the year 2000 . Indirect costs , such as lost time from work and decreased productivity , are included in the cost-effectiveness analysis through the Quality of Well-Being Index ( 14 ) . We calculated the effects of lifestyle and metformin interventions  on quality of life . For people who do not yet have diabetes , we used utility weights reported for the participants of the DPP study ( 15 ) . For people who have diabetes and its complications , we used the results of a published survey by Coffey and colleagues ( 16 ) . Both surveys used the Quality of Well-Being Index . The decrements in quality of life were assumed to be additive for people who have 2 or more complications , with a limit that quality of life could not be less than 0 . Use of an additive rule biases the calculation of cost/ quality -adjusted life-year ( QALY ) in favor of a prevention program , making the program appear more cost-effective than would occur if a multiplicative model were used . We discuss the Objectives To describe the design and baseline population characteristics of an adapted lifestyle intervention trial aim ed at reducing weight and increasing physical activity in people of Indian and Pakistani origin at high risk of developing type 2 diabetes . Design Cluster , r and omised controlled trial . Setting Community-based in Edinburgh and Glasgow , Scotl and , UK . Participants 156 families , comprising 171 people with impaired glycaemia , and waist sizes ≥90 cm ( men ) and ≥80 cm ( women ) , plus 124 family volunteers . Interventions Families were r and omised into either an intensive intervention of 15 dietitian visits providing lifestyle advice , or a light ( control ) intervention of four visits , over a period of 3 years . Outcome measures The primary outcome is a change in mean weight between baseline and 3 years . Secondary outcomes are changes in waist , hip , body mass index , plasma blood glucose and physical activity . The cost of the intervention will be measured . Qualitative work will seek to underst and factors that motivated participation and retention in the trial and families ’ experience of adhering to the interventions . Results Between July 2007 and October 2009 , 171 people with impaired glycaemia , along with 124 family volunteers , were r and omised . In total , 95 % ( 171/196 ) of eligible participants agreed to proceed to the 3-year trial . Only 13 of the 156 families contained more than one recruit with impaired glycaemia . We have recruited sufficient participants to undertake an adequately powered trial to detect a mean difference in weight of 2.5 kg between the intensive and light intervention groups at the 5 % significance level . Over half the families include family volunteers . The main participants have a mean age of 52 years and 64 % are women . Conclusions Prevention of Diabetes & Obesity in South Asians ( PODOSA ) is one of the first community-based , r and omised lifestyle intervention trials in a UK South Asian population . The main trial results will be su bmi tted for publication during 2013 . Trial registration Current controlled trials IS RCT N25729565 ( http://www.controlled-trials.com/is rct n/ ) BACKGROUND The Diabetes Prevention Program ( DPP ) found that an intensive lifestyle intervention can reduce the development of diabetes by more than half in adults with prediabetes , but there is little information about the feasibility of offering such an intervention in community setting s. This study evaluated the delivery of a group-based DPP lifestyle intervention in partnership with the YMCA . METHODS This pilot cluster-r and omized trial was design ed to compare group-based DPP lifestyle intervention delivery by the YMCA to brief counseling alone ( control ) in adults who attended a diabetes risk-screening event at one of two semi-urban YMCA facilities and who had a BMI > or=24 kg/m2 , > or=2 diabetes risk factors , and a r and om capillary blood glucose of 110 - 199 mg/dL. Multivariate regression was used to compare between-group differences in changes in body weight , blood pressures , HbA1c , total cholesterol , and HDL-cholesterol after 6 and 12 months . RESULTS Among 92 participants , controls were more often women ( 61 % vs 50 % ) and of nonwhite race ( 29 % vs 7 % ) . After 6 months , body weight decreased by 6.0 % ( 95 % CI=4.7 , 7.3 ) in intervention participants and 2.0 % ( 95 % CI=0.6 , 3.3 ) in controls ( p<0.001 ; difference between groups ) . Intervention participants also had greater changes in total cholesterol ( -22 mg/dL vs + 6 mg/dL controls ; p<0.001 ) . These differences were sustained after 12 months , and adjustment for differences in race and gender did not alter these findings . With only two matched YMCA sites , it was not possible to adjust for potential clustering by site . CONCLUSIONS The YMCA may be a promising channel for wide-scale dissemination of a low-cost approach to lifestyle diabetes prevention Background As in clinical practice re sources may be limited compared to experimental setting s , translation of evidence -based lifestyle interventions into daily life setting s is challenging . In this study we therefore evaluated the implementation of the APHRODITE lifestyle intervention for the prevention of type 2 diabetes in Dutch primary care . Based on this evaluation we discuss opportunities for refining intervention delivery . Methods A 2.5-year intervention was performed in 14 general practice s in the Netherl and s among individuals at high risk for type 2 diabetes ( FINDRISC-score ≥ 13 ) ( n = 479 ) and was compared to usual care ( n = 446 ) . Intervention consisted of individual lifestyle counselling by nurse practitioners ( n = 24 ) and GPs ( n = 48 ) and group-consultations .  Drop-out and attendance were registered during the programme . After the intervention , satisfaction with the programme and perceived implementation barriers were assessed with question naires . Results Drop-out was modest ( intervention : 14.6 % ; usual care : 13.2 % ) and attendance at individual consultations was high ( intervention : 80 - 97 % ; usual care : 86 - 94 % ) . Providers were confident about diabetes prevention by lifestyle intervention in primary care . Participants were more satisfied with counselling from nurse practitioners than from GPs . A major part of the GPs reported low self-efficacy regarding dietary guidance . Lack of counselling time ( 60 % ) , participant motivation ( 12 % ) , and financial reimbursement ( 11 % ) were regarded by providers as important barriers for intervention implementation . Conclusions High participant compliance and a positive attitude of providers make primary care a suitable setting for diabetes prevention by lifestyle counselling . Results support a role for the nurse practitioner as the key player in guiding lifestyle modification . Further research is needed on strategies that could increase cost-effectiveness , such as more stringent criteria for participant inclusion , group-counselling , more tailor-made counselling and integration of screening and / or interventions for different disorders PURPOSE This study evaluated the cost-effectiveness of an automated telephone self-management support with nurse care management ( ATSM ) intervention for patients with type 2 diabetes , which was tested among patients receiving primary care in publicly funded ( safety net ) clinics , focusing on non-English speakers . METHODS We performed cost analyses in the context of a r and omized trial among primary care patients comparing the effects of ATSM ( n = 112 ) and usual care ( n = 114 ) on diabetes-related outcomes in 4 San Francisco safety net clinics .  ATSM uses interactive phone technology to provide surveillance , patient education , and one-on-one counseling , and was implemented in 3 language s for a 9-month period . Cost utility was examined using quality -adjusted life-years ( QALYs ) derived from changes in scores on the 12-Item Short Form Health Survey . We also examined cost-effectiveness for costs associated with a 10 % increase in the proportion of patients meeting diabetes-specific public health goals for increasing exercise , as recommended by Healthy People 2010 and the American Diabetes Association . RESULTS The annual cost of the ATSM intervention per QALY gained , relative to usual care , was $ 65,167 for start-up and ongoing implementation costs combined , and $ 32,333 for ongoing implementation costs alone . In sensitivity analyses , costs per QALY ranged from $ 29,402 to $ 72,407 . The per-patient cost to achieve a 10 % increase in the proportion of intervention patients meeting American Diabetes Association exercise guidelines was estimated to be $ 558 when all costs were considered and $ 277 when only ongoing costs were considered . CONCLUSIONS The ATSM intervention for diverse patients with diabetes had a cost utility for functional outcomes similar to that of many other accepted interventions targeted at diabetes prevention and treatment , and achieved public health physical activity objectives at modest costs . Because a considerable proportion of costs were fixed , cost-utility and cost-effectiveness estimates would likely be substantially improved in a scaled-up ATSM program Introduction : Type 2 diabetes mellitus ( T2DM ) is a major health issue in New Zeal and Māori . Clinical trials have demonstrated potential for the prevention of T2DM , but whether community public health programmes aim ing to prevent diabetes are effective is untested . Objective : To describe the planning and design of an intervention aim ing to translate T2DM prevention clinical trial evidence into a community-wide population health intervention in a high risk predominantly Māori community . Approach : Community concerns about the diabetes burden were heard by the local diabetes nurse , herself a tribal member , and discussed with a locally raised academic . Project planning ensued . The intervention and its evaluation were design ed using a participatory community development model . The planned intervention had three components : community-wide health promotion initiatives conveying healthy lifestyle messages , community education and monitoring for identified high-risk individuals and their extended families , and a structural strategy aim ed at adapting local environments to support lifestyle changes . The evaluation plan involved interrupted time series surveys coupled with formative and process evaluations rather than a r and omised control trial design . Discussion : Consulting communities , validating community concerns and prioritising cultural and ethical issues were key steps . Time spent developing good relationships amongst the health provider and academic research team members at the outset proved invaluable , as the team were united in addressing the project planning and implementation challenges , such as funding obstacles that arose because of our ethically and culturally appropriate non-r and omised control trial evaluation design . The pre-intervention survey demonstrated high rates of diabetes ( 13 % ) , insulin resistance ( 33 % ) and risk factors , and provided evidence for positive , as opposed to negative , lifestyle intervention messages . Conclusion : Community-wide lifestyle interventions have the potential to reduce rates of type 2 diabetes and other chronic diseases in high-risk communities , but require a high level of commitment from the health sector and buy-in from the community . Adequate commitment , leadership , planning and re sources are essential OBJECTIVE Internet and other interactive technology-based programs offer great potential for practical , effective , and cost-efficient diabetes self-management ( DSM ) programs capable of reaching large numbers of patients . This study evaluated minimal and moderate support versions of an Internet-based diabetes self-management program , compared to an enhanced usual care condition . RESEARCH DESIGN AND METHODS A three-arm practical r and omized trial was conducted to evaluate minimal contact and moderate contact versions of an Internet-based diabetes self-management program , offered in English and Spanish , compared to enhanced usual care .  A heterogeneous sample of 463 type 2 patients was r and omized and 82.5 % completed a 4-month follow-up . Primary outcomes were behavior changes in healthy eating , physical activity , and medication taking . Secondary outcomes included hemoglobin A1c , body mass index , lipids , and blood pressure . RESULTS The Internet-based intervention produced significantly greater improvements than the enhanced usual care condition on three of four behavioral outcomes ( effect sizes [ d ] for healthy eating = 0.32 ; fat intake = 0.28 ; physical activity= 0.19 ) in both intent-to-treat and complete-cases analyses . These changes did not translate into differential improvements in biological outcomes during the 4-month study period . Added contact did not further enhance outcomes beyond the minimal contact intervention . CONCLUSIONS The Internet intervention meets several of the RE- AIM criteria for potential public health impact , including reaching a large number of persons , and being practical , feasible , and engaging for participants , but with mixed effectiveness in improving outcomes , and consistent results across different subgroups . Additional research is needed to evaluate longer-term outcomes , enhance effectiveness and cost-effectiveness , and underst and the linkages between intervention processes and outcomes Background Implementation of interventions in real-life setting s requires a comprehensive evaluation approach . The aim of this article is to describe the evaluation design of the SLIMMER diabetes prevention intervention in a Dutch real-life setting . Methods / Design The SLIMMER study is a r and omised , controlled intervention study including subjects aged 40 through 70 years with impaired fasting glucose or high risk of diabetes . The 10-month SLIMMER intervention involves a dietary and physical activity intervention , including case management and a maintenance programme . The control group receives usual health care and written information about a healthy lifestyle . A logic model of change is composed to link intervention activities with intervention outcomes in a logical order . Primary outcome is fasting insulin . Measurements are performed at baseline and after 12 and 18 months and cover quality of life , cardio-metabolic risk factors ( e.g. glucose tolerance , serum lipids , body fatness , and blood pressure ) , eating and physical activity behaviour , and behavioural determinants . A process evaluation gives insight in how the intervention was delivered and received by participants and health care professionals . The economic evaluation consists of a cost-effectiveness analysis and a cost-utility analysis . Costs are assessed from both a societal and health care perspective . Discussion This study is expected to provide insight in the effectiveness , including its cost-effectiveness , and delivery of the SLIMMER diabetes prevention intervention conducted in Dutch primary health care . Results of this study provide valuable information for primary health care professionals , research ers , and policy makers . Trial registration The SLIMMER study is registered with Clinical Trials.gov ( NCT02094911 ) since March 19 , 2014 OBJECTIVE This study was conducted to develop evidence -based clinical practice guidelines for nutrition support ( ie , enteral and parenteral nutrition ) in mechanically ventilated critically ill adults . OPTIONS The following interventions were systematic ally review ed for inclusion in the guidelines : enteral nutrition ( EN ) versus parenteral nutrition ( PN ) , early versus late EN , dose of EN , composition of EN ( protein , carbohydrates , lipids , immune-enhancing additives ) , strategies to optimize delivery of EN and minimize risks ( ie , rate of advancement , checking residuals , use of bedside algorithms , motility agents , small bowel versus gastric feedings , elevation of the head of the bed , closed delivery systems , probiotics , bolus administration ) , enteral nutrition in combination with supplemental PN , use of PN versus st and ard care in patients with an intact gastrointestinal tract , dose of PN and composition of PN ( protein , carbohydrates , IV lipids , additives , vitamins , trace elements , immune enhancing substances ) , and the use of intensive insulin therapy . OUTCOMES The outcomes considered were mortality ( intensive care unit [ ICU ] , hospital , and long-term ) , length of stay ( ICU and hospital ) , quality of life , and specific complications . EVIDENCE We systematic ally search ed MEDLINE and CINAHL ( cumulative index to nursing and allied health ) , EMBASE , and the Cochrane Library for r and omized controlled trials and meta-analyses of r and omized controlled trials that evaluated any form of nutrition support in critically ill adults . We also search ed reference lists and personal files , considering all articles published or unpublished available by August 2002 . Each included study was critically appraised in duplicate using a st and ard scoring system . VALUES For each intervention , we considered the validity of the r and omized trials or meta-analyses , the effect size and its associated confidence intervals , the homogeneity of trial results , safety , feasibility , and the economic consequences . The context for discussion was mechanically ventilated patients in Canadian ICUs .  BENEFITS , HARMS , AND COSTS The major potential benefit from implementing these guidelines is improved clinical outcomes of critically ill patients ( reduced mortality and ICU stay ) . Potential harms of implementing these guidelines include increased complications and costs related to the suggested interventions . SUMMARIES OF EVIDENCE AND RECOMMENDATIONS : When considering nutrition support in critically ill patients , we strongly recommend that EN be used in preference to PN . We recommend the use of a st and ard , polymeric enteral formula that is initiated within 24 to 48 hours after admission to ICU , that patients be cared for in the semirecumbent position , and that arginine-containing enteral products not be used . Strategies to optimize delivery of EN ( starting at the target rate , use of a feeding protocol using a higher threshold of gastric residuals volumes , use of motility agents , and use of small bowel feeding ) and minimize the risks of EN ( elevation of the head of the bed ) should be considered . Use of products with fish oils , borage oils , and antioxidants should be considered for patients with acute respiratory distress syndrome . A glutamine-enriched formula should be considered for patients with severe burns and trauma . When initiating EN , we strongly recommend that PN not be used in combination with EN . When PN is used , we recommend that it be supplemented with glutamine , where available . Strategies that maximize the benefit and minimize the risks of PN ( hypocaloric dose , withholding lipids , and the use of intensive insulin therapy to achieve tight glycemic control ) should be considered . There are insufficient data to generate recommendations in the following areas : use of indirect calorimetry ; optimal pH of EN  ; supplementation with trace elements , antioxidants , or fiber ; optimal mix of fats and carbohydrates ; use of closed feeding systems ; continuous versus bolus feedings ; use of probiotics ; type of lipids ; and mode of lipid delivery . VALIDATION This guideline was peer- review ed and endorsed by official representatives of the Canadian Critical Care Society , Canadian Critical Care Trials Group , Dietitians of Canada , Canadian Association of Critical Care Nurses , and the Canadian Society for Clinical Nutrition . SPONSORS This guideline is a joint venture of the Canadian Critical Care Society , the Canadian Critical Trials Group , the Canadian Society for Clinical Nutrition , and Dietitians of Canada . The Canadian Critical Care Society and the Institute of Nutrition , Metabolism , and Diabetes of the Canadian Institutes of Health Research provided funding for development of this guideline UNLABELLED In June 2008 , the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project , an evidence -based review of the literature surrounding strategies for successful management and treatment of diabetes . This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry 's newly released Diabetes Strategy .After an initial review of the strategy and consultation with experts , the secretariat identified five key areas in which evidence was needed . Evidence -based analyses have been prepared for each of these five areas : insulin pumps , behavioural interventions , bariatric surgery , home telemonitoring , and community based care . For each area , an economic analysis was completed where appropriate and is described in a separate report . To review these titles within the Diabetes Strategy Evidence series , please visit the Medical Advisory Secretariat Web site , http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html,DIABETES STRATEGY EVIDENCE PLATFORM : Summary of Evidence -Based AnalysesContinuous Subcutaneous Insulin Infusion Pumps for Type 1 and Type 2 Adult Diabetics : An Evidence -Based Analysis Behavioural Interventions for Type 2 Diabetes : An Evidence -Based Analysis BARIATRIC SURGERY FOR PEOPLE WITH DIABETES AND MORBID OBESITY : An Evidence -Based Summary Community-Based Care for the Management of Type 2 Diabetes : An Evidence -Based Analysis Home Telemonitoring for Type 2 Diabetes  : An Evidence -Based Analysis Application of the Ontario Diabetes Economic Model ( ODEM ) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario OBJECTIVE The objective of this report is to determine the efficacy of specialized multidisciplinary community care for the management of type 2 diabetes compared to usual care . CLINICAL NEED TARGET POPULATION AND CONDITION Diabetes ( i.e. diabetes mellitus ) is a highly prevalent chronic metabolic disorder that interferes with the body 's ability to produce or effectively use insulin . The majority ( 90 % ) of diabetes patients have type 2 diabetes . ( 1 ) Based on the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) , intensive blood glucose and blood pressure control significantly reduce the risk of microvascular and macrovascular complications in type 2 diabetics . While many studies have documented that patients often do not meet the glycemic control targets specified by national and international guidelines , factors associated with glycemic control are less well studied , one of which is the provider(s ) of care . Multidisciplinary approaches to care may be particularly important for diabetes management . According guidelines from the Canadian Diabetes Association ( CDA ) , the diabetes health care team should be multi- and interdisciplinary . Presently in Ontario , the core diabetes health care team consists of at least a family physician and /or diabetes specialist , and diabetes educators ( registered nurse and registered dietician ) . Increasing the role played by allied health care professionals in diabetes care and their collaboration with physicians may represent a more cost-effective option for diabetes management . Several systematic review s and meta-analyses have examined multidisciplinary care programs , but these have either been limited to a specific component of multidisciplinary care ( e.g. intensified education programs ) , or were conducted as part of a broader disease management program , of which not all were multidisciplinary in nature . Most review s also do not clearly define the intervention(s ) of interest , making the evaluation of such multidisciplinary community programs challenging . EVIDENCE -BASED ANALYSIS METHODS RESEARCH QUESTIONS What is the evidence of efficacy of specialized multidisciplinary community care provided by at least a registered nurse , registered dietician and physician ( primary care and /or specialist ) for the management of type 2 diabetes compared to usual care ? [ Henceforth referred to as Model 1]What is the evidence of efficacy of specialized multidisciplinary community care provided by at least a pharmacist and a primary care physician for the management of type 2 diabetes compared to usual care ? [ Henceforth referred to as Model 2 ] INCLUSION CRITERIA English language full-reportsPublished between January 1 , 2000 and September 28 , 2008R and omized controlled trials ( RCTs ) , systematic review s and meta-analysesType 2 diabetic adult population ( ≥18 years of age)Total sample size ≥30Describe specialized multidisciplinary community care defined as ambulatory-based care provided by at least two health care disciplines ( of which at least one must be a specialist in diabetes ) with integrated communication between the care providers . Compared to usual care ( defined as health care provision by non-specialist(s ) in diabetes , such as primary care providers ; may include referral to other health care professionals/services as necessary)≥6 months follow-up EXCLUSION CRITERIA Studies where discrete results on diabetes can not be abstract edPredominantly home-based interventions Inpatient-based interventions OUTCOMES OF INTEREST The primary outcomes for this review were glycosylated hemoglobin ( rHbA1c ) levels and systolic blood pressure ( SBP ) . SEARCH STRATEGY A literature search was performed on September 28 , 2008 using OVID MEDLINE , MEDLINE In-Process and Other Non-Indexed Citations , EMBASE , the Cumulative Index to Nursing & Allied Health Literature ( CINAHL ) , the Cochrane Library , and the International Agency for Health Technology Assessment ( INAHTA ) for studies published between January 1 , 2000 and September 28 , 2008 . Abstract s were review ed by a single review er and , for those studies meeting the eligibility criteria , full-text articles were obtained . Reference lists were also examined for any additional relevant studies not identified through the search . Articles with unknown eligibility were review ed with a second clinical epidemiologist , then a group of epidemiologists until consensus was established . The quality of evidence was assessed as high , moderate , low or very low according to GRADE methodology . Given the high clinical heterogeneity of the articles that met the inclusion criteria , specific models of specialized multidisciplinary community care were examined based on models of care that are currently being supported in Ontario , models of care that were commonly reported in the literature , as well as suggestions from an Expert Advisory Panel Meeting held on January 21 , 2009 . SUMMARY OF FINDINGS The initial search yielded 2,116 unique citations , from which 22 RCTs trials and nine systematic review s published were identified as meeting the eligibility criteria . Of these , five studies focused on care provided by at least a nurse , dietician , and physician ( primary care and /or specialist ) model of care ( Model 1 ; see Table ES 1 ) , while three studies focused on care provided by at least a pharmacist and primary care physician ( Model 2 ; see Table ES 2 ) . Based on moderate quality evidence , specialized multidisciplinary community care Model 2 has demonstrated a statistically and clinical ly significant reduction in HbA1c of 1.0 % compared with usual care . The effects of this model on SBP , however , are uncertain compared with usual care , based on very-low quality evidence . Specialized multidisciplinary community care Model 2 has demonstrated a statistically and clinical ly significant reduction in both HbA1c of 1.05 % ( based on high quality evidence ) and SBP of 7.13 mm Hg ( based on moderate quality evidence ) compared to usual care . For both models , the evidence does not suggest a preferred setting of care delivery ( i.e. , primary care vs. hospital outpatient clinic vs. community clinic ) . Table ES1 : Summary of Results of Meta-Analyses of the Effects of Multidisciplinary Care Model 1 Outcome Estimate of effect(95 % CI)Heterogeneity I(2)(p-value ) GRADE Glycosylated Hemoglobin ( HbA1c [%])-1.00 [ -1.27 , -0.73]4 % (p=0.37)Moderate- quality Subgroup : Moderate-to-High Quality -0.91 [ -1.19 , -0.62]0 % (p=0.74)Systolic Blood Pressure ( mm Hg)-2.04 [ -13.80 , 9.72]89 % (p=0.002)Very-low quality * Mean change from baseline to follow-up between intervention and control groupsTable ES2 : Summary of Results of Meta-Analyses of the Effects of Multidisciplinary Care Model 2 Outcome Estimate of effect(95 % CI)Heterogeneity I(2)(p-value ) GRADE Glycosylated Hemoglobin ( HbA1c [%])-1.05 [ -1.57 , -0.52]0 % (p=0.75)High- quality Systolic Blood Pressure ( mm Hg)-7.13 [ -11.78 , -2.48]46 % (p=0.17)Moderate quality * Mean change from baseline to follow-up between intervention and control groups AIMS Qingdao Diabetes Prevention Program aims to translate the trial experience to real-life setting s with goals to : ( 1 ) raise the public awareness of diabetes and diabetes risk factors , and promote healthy diet and physical activity ; ( 2 ) reduce the number of high-risk people developing diabetes through lifestyle counselling ; ( 3 ) early diagnosis of diabetes ; ( 4 ) evaluate the effectiveness , cost-effectiveness , feasibility , acceptability and sustainability of the programs . PROGRAM DESIGN The project 's first phase ( 2006 - 2009 ) was focused on health promotion targeting at the entire population of 1.94 million , and training of professionals ; and the second phase ( 2009 - 2012 ) on  lifestyle counselling targeting at individuals with a diabetes risk score of > or=14 . The effectiveness of the intervention and the cost-effectiveness of the program between the intervention arm ( n=8000 ) and the control arm ( n=4000 ) who are r and omly selected from the project targeting and not-targeting areas will be evaluated with the diabetes incidence as the primary outcome . Milestone achieved from 2006 to 2009 : 3993 health professionals finished training courses ; 724,130 educational booklets were distributed to families and 318,284 high-risk individuals recorded and 130,164 underwent at least one follow-up counselling session Patient empowerment through self-management education is central to improving the quality of diabetes care and preventing Type 2 Diabetes .  Although national programs exist , there is no EU-wide strategy for diabetes self-management education , and patients with limited literacy face barriers to effective self-management . The Diabetes Literacy project , initiated with the support of the European Commission , aims to fill this gap . The project investigates the effectiveness of diabetes self-management education , targeting people with or at risk of Type 2 Diabetes in the 28 EU Member States , as part of a comprehensive EU-wide diabetes strategy . National diabetes strategies in the EU , US , Taiwan , and Israel are compared , and diabetes self-management programs inventorized . The costs of the diabetes care pathway are assessed on a per person basis at national level . A comparison is made of the (cost)-effectiveness of different methods for diabetes self-management support , and the moderating role of health literacy , organization of the health services , and implementation fidelity of education programs are considered . Web-based material s are developed and evaluated by r and omized trials to evaluate if interactive internet delivery can enhance self-management support for people with lower levels of health literacy . The 3-year project started in December 2012 . Several literature review s have been produced and protocol development and research design are in the final stages . Primary and secondary data collection and analysis take place in 2014 . The results will inform policy decisions on improving the prevention , treatment , and care for persons with diabetes across literacy levels OBJECTIVE To develop and evaluate a health-care communication training programme to help diabetes health-care professionals ( HCPs ) counsel their patients more skilfully , particularly in relation to behaviour change . DESIGN The HCP training was assessed using a pragmatic , cluster r and omised controlled trial . The primary and secondary analyses were intention-to-treat comparisons of outcomes using multilevel modelling to allow for cluster ( service ) and individual effects , and involved two-level linear models . SETTING Twenty-six UK paediatric diabetes services . PARTICIPANTS The training was delivered to HCPs ( doctors , nurses , dietitians and psychologists ) working in paediatric diabetes services and the effectiveness of this training was measured in 693 children aged 4 - 15 years and families after 1 year ( 95.3 % follow-up ) . INTERVENTIONS A blended learning programme was informed by a systematic review of the literature , telephone and question naire surveys of professional practice , focus groups with children and parents , experimental consultations and three developmental workshops involving a stakeholder group . The programme focused on agenda- setting , flexible styles of communication ( particularly guiding ) and a menu of strategies using web-based training and practical workshops . MAIN OUTCOME MEASURES The primary trial outcome was a change in glycosylated haemoglobin ( HbA1c ) levels between the start and finish of a 12-month study period . Secondary trial outcomes included change in quality of life , other clinical [ including body mass index ( BMI ) ] and psychosocial measures ( assessed at participant level as listed above ) and cost ( assessed at service level ) . In addition , patient details ( HbA1c levels , height , weight , BMI , insulin regimen ) , health service contacts and patient-borne costs were recorded at each clinic visit , along with details of who patients consulted with , for how long , and whether or not patients consulted on their own at each visit . Patients and carers were also asked to complete an interim question naire assessing patient enablement ( or feelings towards clinic visit for younger patients aged 7 - 10 years ) at their first clinic visit following the start of the trial . The cost of the intervention included the cost of training intervention teams . RESULTS Trained staff showed better skills than control subjects in agenda- setting and consultation strategies , which waned from 4 to 12 months . There was no effect on HbA1c levels ( p = 0.5 ) . Patients in intervention clinics experienced a loss of confidence in their ability to manage diabetes , whereas controls showed surprisingly reduced barriers ( p = 0.03 ) and improved adherence ( p = 0.05 ) . Patients in intervention clinics reported short-term increased ability ( p = 0.04 ) to cope with diabetes . Parents in the intervention arm experienced greater excitement ( p = 0.03 ) about clinic visits and improved continuity of care ( p = 0.01 ) without the adverse effects seen in their offspring . The mean cost of training was £ 13,145 per site or £ 2163 per trainee . There was no significant difference in total NHS costs ( including training ) between groups ( p = 0.1 ) . CONCLUSIONS Diabetes HCPs can be trained to improve consultation skills , but these skills need reinforcing . Over 1 year , no benefits were seen in children , unlike parents , who may be better placed to support their offspring . Further modification of this training is required to improve outcomes that may need to be measured over a longer time to see effects . TRIAL REGISTRATION Current Controlled Trials IS RCT N61568050 . FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 15 , No. 29 . See the HTA programme website for further project information Background The prevalence of diabetes mellitus is ubiquitous . Complications and costs of diabetes are rising and are depleting limited re sources . It is imperative for healthcare professionals and patients alike to confront this chronic condition by exploring new interventions . An innovative health care delivery model has emerged in the last 25 years in the form of the group medical visit . Group medical visits can range from of six to twenty patients scheduled together with time allotted for individual care as well as in the group setting . Objectives The review objective was to conduct a systematic review and meta‐ analysis to synthesize the best available evidence related to effectiveness of group medical visits on HbA1c , blood pressure and cholesterol measurements /levels for adult patients with type II diabetes in outpatient setting s. Search strategy A three‐step literature search for studies in English language from 1990 to 2010 was conducted utilising ( a ) a primary search of Medline , CINAHL , PsycINFO and Cochrane Central Register of Controlled Trials , ( b ) a secondary search of non‐indexed data bases , and ( c ) a search of the grey literature . In addition , a manual review of the reference lists of all identified reports and articles was performed to identify additional studies . Inclusion criteria All r and omised and quasi‐experimental studies of adult patients ( > 18 ) with type II diabetes mellitus seen in outpatient health setting s were considered if they met one or more of the following diagnostic outcome measurements : haemoglobin A1c , systolic and diastolic blood pressure , and low density lipoprotein cholesterol . Critical appraisal , data collection and analysis Each of the eligible articles was review ed by two independent review ers . Disagreements between the review ers were resolved through discussion , or with a third review er . Studies that met the inclusion criteria were assessed for method ological quality using the JBI st and ardized critical appraisal tools . Data extraction was undertaken using the st and ardised data extraction tool from JBI‐MAStARI . Main results The search strategy identified 2,040 articles in the published and unpublished literature . Of these , 11 r and omised controlled trials and 4 quasi‐experimental trials met the inclusion criteria and represented 2240 patients included in the final review . There are clear benefits of group medical visits for patients ' HbA1c levels which are consistent in the post‐intervention and change from baseline effect sizes . The most significant effect observed is with the change from baseline results . Some evidence suggests post‐intervention and change from baseline systolic blood pressure improvement at the nine to twelve month interval and change from baseline improvement at the 4 year timeframe . There is no evidence that group visits improve LDL cholesterol values of the group visit participants . Conclusions Group medical visits should be considered by clinicians as an effective non‐pharmacologic intervention that can have a positive impact on biologic markers such as haemoglobin A1c and systolic blood pressure . Implication s for practice The evidence suggests that the most powerful model of Group medical visits ( GMV ) is when a clinician prescriber is present during or immediately after GMV sessions for medication reconciliation or individual patient needs . Implication s for research Future research should include this GMV intervention in r and omised controlled trials across different health systems and socio‐economic and ethnic groups Background To improve quality of care and patient outcomes , health system decision-makers need to identify and implement effective interventions . An increasing number of systematic review s document the effects of quality improvement programs to assist decision-makers in developing new initiatives . However , limitations in the reporting of primary studies and current meta- analysis methods ( including approaches for exploring heterogeneity ) reduce the utility of existing syntheses for health system decision-makers . This study will explore the role of innovative meta- analysis approaches and the added value of enriched and up date d data for increasing the utility of systematic review s of complex interventions . Methods / Design We will use the data set from our recent systematic review of 142 r and omized trials of diabetes quality improvement programs  to evaluate novel approaches for exploring heterogeneity . These will include exploratory methods , such as multivariate meta-regression analyses and all-subsets combinatorial meta- analysis . We will then up date our systematic review to include new trials and enrich the data set by surveying authors of all included trials . In doing so , we will explore the impact of variables not , reported in previous publications , such as details of study context , on the effectiveness of the intervention . We will use innovative analytical methods on the enriched and up date d data set to identify key success factors in the implementation of  quality improvement interventions  for diabetes . Decision-makers will be involved throughout to help identify and prioritize variables to be explored and to aid in the interpretation and dissemination of results . Discussion This study will inform future systematic review s of complex interventions and describe the value of enriching and updating data for exploring heterogeneity in meta- analysis . It will also result in an up date d comprehensive systematic review of diabetes quality improvement interventions that will be useful to health system decision-makers in developing interventions to improve outcomes for people with diabetes . Systematic review registration PROSPERO registration no. Background Diabetes and obesity have reached epidemic proportions in the U.S. with rates consistently higher among Hispanics as compared to non-Hispanic whites . Among Hispanic women diagnosed with gestational diabetes mellitus ( GDM ) , 50 % will go on to develop type 2 diabetes within 5 years of the index pregnancy . Although r and omised controlled trials among adults with impaired glucose tolerance have shown that diet and physical activity reduce the risk of type 2 diabetes , such programs have not been tested in high-risk postpartum women . The overall goal of this r and omised controlled trial is to test the efficacy of a culturally and linguistically modified , individually-tailored lifestyle intervention to reduce risk factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a history of abnormal glucose tolerance during pregnancy . Methods / Design Hispanic pregnant women who screen positive for GDM will be recruited and r and omly assigned to a Lifestyle Intervention ( n = 150 ) or a Health & Wellness ( control ) Intervention ( n = 150 ) . Multimodal contacts ( i.e. , in-person , telephone , and mailed material s ) will be used to deliver the intervention from late pregnancy ( 29 weeks gestation ) to 12 months postpartum . Targets of the intervention are to achieve Institute of Medicine Guidelines for postpartum weight loss ; American Congress of Obstetrician and Gynecologist guidelines for physical activity ; and American Diabetes Association guidelines for diet . The intervention draws from Social Cognitive Theory and the Transtheoretical Model and addresses the specific cultural and environmental challenges faced by low-income Hispanic women . Assessment s will be conducted at enrollment , and at 6-weeks , 6-months , and 12-months postpartum by trained bicultural and bilingual personnel blinded to the intervention arm . Efficacy will be assessed via postpartum weight loss and biomarkers of insulin resistance and cardiovascular risk . Changes in physical activity and diet will be measured via 7-day actigraph data and three unannounced 24-hour dietary recalls at each assessment time period . Discussion Hispanic women are the fastest growing minority group in the U.S. and have the highest rates of sedentary behavior and postpartum diabetes after a diagnosis of GDM . This r and omised trial uses a high-reach , low-cost strategy that can readily be translated into clinical practice in underserved and minority population s . Trial registration BACKGROUND Diabetes prevention is a public health priority that is dependent upon the reach , effectiveness , and cost of intervention strategies . However , underst and ing each of these outcomes within the context of r and omized controlled trials is problematic . PURPOSE To describe the methods and design of a hybrid preference/r and omized control trial using the RE- AIM framework . METHODS The trial , which was developed using the RE- AIM framework , will contrast the effects of 3 interventions : ( 1 ) a st and ard care , small group , diabetes prevention education class ( SG ) , ( 2 ) the small group intervention plus 12 months of interactive voice response telephone follow-up ( SG-IVR ) , and ( 3 ) a DVD version of the small group intervention with the same IVR follow-up ( DVD-IVR ) . Each intervention includes personal action planning with a focus on key elements of the lifestyle intervention from the Diabetes Prevention Program ( DPP ) .  Adult patients at risk for diabetes will be r and omly assigned to either choice or RCT . Those assigned to choice ( n=240 ) will have the opportunity to choose between SG-IVR and DVD-IVR . Those assigned to RCT group ( n=360 ) will be r and omly assigned to SG , SG-IVR , or DVD-IRV . Assessment of primary ( weight loss , reach , & cost ) and secondary ( physical activity , & dietary intake ) outcomes will occur at baseline , 6 , 12 , and 18 months . CONCLUSION This will be the first diabetes prevention trial that will allow the research team to determine the relationships between reach , effectiveness , and cost of different interventions BACKGROUND Evidence -based public health decision-making depends on high quality and transparent accounts of what interventions are effective , for whom , how and at what cost . Improving the quality of reporting of r and omized and non-r and omized study design s through the CONSORT and TREND statements has had a marked impact on the quality of study design s. However , public health users of systematic review s have been concerned with the paucity of synthesized information on context , development and rationale , implementation processes and sustainability factors . METHODS This paper examines the existing reporting frameworks for research against information sought by users of systematic review s of public health interventions and suggests additional items that should be considered in future recommendations on the reporting of public health interventions . RESULTS Intervention model , theoretical and ethical considerations , study design choice , integrity of intervention/process evaluation , context , differential effects and inequalities and sustainability are often overlooked in reports of public health interventions . CONCLUSION Population health policy makers need synthesized , detailed and high quality a priori accounts of effective interventions in order to make better progress in tackling population morbidities and inequalities . Adding simple criteria to reporting st and ards will significantly improve the quality and usefulness of published evidence and increase its impact on public health program planning Purpose With growing numbers of people at risk for diabetes and cardiovascular disease , diabetes educators report increasing referrals for intervention in prevention of these conditions . Diabetes educators have expertise in diabetes self-management education ; however , they are generally not prepared for delivery of chronic disease primary prevention . The purpose of this project was to determine if individuals at risk for diabetes who participate in an intervention delivered by trained diabetes educators in existing diabetes self-management education community-based programs can reduce risk factors for diabetes and cardiovascular disease . Methods Diabetes educators in 3 outpatient-hospital programs ( urban , suburban , and rural ) received training and support for implementation of the Group Lifestyle Balance program , an adaptation of the Diabetes Prevention Program lifestyle intervention , from the Diabetes Prevention Support Center of the University of Pittsburgh . Adults with prediabetes and /or the metabolic syndrome were eligible to enroll in the program with physician referral . With use of existing diabetes educator networks , recruitment was completed via on-site physician in-services , informative letters , and e-mail contact as well as participant-directed newspaper advertisement . Results Eighty-one participants enrolled in the study ( 71 women , 10 men ) .  Mean overall weight loss was 11.3 lb ( 5.1 % , P < .001 ) ; in addition , significant decreases were noted in fasting plasma glucose , low-density lipoprotein cholesterol , triglycerides , and blood pressure . Conclusions These results suggest that the Group Lifestyle Balance program delivered by diabetes educators was successful in reducing risk for diabetes and cardiovascular disease in high-risk individuals . Furthermore , diabetes educators , already integrated within the existing health care system , provide yet another re source for delivery of primary prevention programs in the community PURPOSE The purpose of this study was to evaluate costs associated with the primary intervention of the Mediterranean Lifestyle Program ( MLP ) , which targeted postmenopausal women with type 2 diabetes at risk for coronary heart disease . METHODS Using retrospective data collected during MLP development and implementation , the authors estimated costs for the first 6 months relative to the usual care condition and incremental costs per behavioral , biologic , and quality -of-life change . Sensitivity analyses were conducted using variations in inflation rates , implementation setting s , labor and nonlabor inputs , and market wage rates . RESULTS Of the sample of 279 study participants , 163 were r and omized into the MLP condition .  Total intervention costs were estimated at $ 211 061 ( $ 148 022 direct costs ) or $ 1295 per MLP participant relative to usual care ( $ 908 direct costs ) . This translates to $ 3808 per average change in coronary heart disease risk as measured by an average 1-point reduction in hemoglobin A1C . Relative to other measured improvements , this corresponds to $ 2345 per unit reduction in body mass index and $ 644 per unit improvement in Problem Areas in Diabetes Quality -of-Life Self-care Summary score , and a $ 196 per-gram reduction in intake of saturated fatty acids as noted by the Food Frequency Question naire . A significant portion of the direct costs were related to the re sources used during the recruitment phase . CONCLUSIONS Providing a relatively intensive lifestyle self-management program for this high-risk group is associated with modest incremental costs compared with usual care , making the program potentially appealing to policy makers
The cost of intervention per participant delivered by dietitians was lower than interventions delivered by non-dietitians , although few studies reported costs .
Lifestyle interventions are effective in reducing body weight and glucose-related outcomes .
Dietitian-delivered interventions , compared with those delivered by other personnel , achieved greater weight reduction .
No consistent trend was identified across different delivery channels
BACKGROUND Type 2 diabetes is a significant public health concern .
With the completion of the Diabetes Prevention Program , there has been a proliferation of studies attempting to translate this evidence base into practice .
However , the cost , effectiveness , and cost-effectiveness of these adapted interventions is unknown .
OBJECTIVE The purpose of this systematic review was to conduct a comprehensive meta- analysis to synthesize the effectiveness , cost , and cost-effectiveness of lifestyle diabetes prevention interventions and compare effects by intervention delivery agent ( dietitian vs non-dietitian ) and channel ( in-person vs technology-delivered ) .