Sudden cardiac death in low- and middle-income countries. Prevalence of a healthy lifestyle among individuals with cardiovascular disease in high-, middle- and low-income countries: The Prospective Urban Rural Epidemiology (PURE) study. A systematic review of online interventions for mental health in low and middle income countries: a neglected field Improving mental health among people living with HIV: a review of intervention trials in low- and middle-income countries Interventions for domestic violence among pregnant women in low- and middle-income countries: a systematic review protocol Laboratory-based and office-based risk scores and charts to predict 10-year risk of cardiovascular disease in 182 countries: a pooled analysis of prospective cohorts and health surveys. Prevalence, awareness, treatment, and control of hypertension in rural and urban communities in high-, middle-, and low-income countries. Gender (in) differences in prevalence and incidence of traumatic experiences among orphaned and separated children living in five low- and middle-income countries Rationale and design of a randomized controlled trial evaluating community health worker-based interventions for the secondary prevention of acute coronary syndromes in India (SPREAD). Physical activity and sedentary behaviors associated with risk of progression from gestational diabetes mellitus to type 2 diabetes mellitus: a prospective cohort study. Hypertension management using mobile technology and home blood pressure monitoring: results of a randomized trial in two low/middle-income countries. A model of translational research for diabetes prevention in low and middle-income countries: The Diabetes Community Lifestyle Improvement Program (D-CLIP) trial. A Home-Based Type 2 Diabetes Self-Management Intervention in Rural Guatemala Routine prophylaxes every 3 months improves chronic periodontitis status in type 2 diabetes. The effect of physical activity on mortality and cardiovascular disease in 130 000 people from 17 high-income, middle-income, and low-income countries: the PURE study A culturally targeted self-management program for African Americans with type 2 diabetes mellitus. A Common Elements Treatment Approach for Adult Mental Health Problems in Low- and Middle-Income Countries. Effectiveness of a brief community outreach tobacco cessation intervention in India: a cluster-randomised controlled trial (the BABEX Trial) Structured Caregiver Feedback Enhances Engagement and Impact of Mobile Health Support: A Randomized Trial in a Lower-Middle-Income Country. Missed opportunities for family planning: an analysis of pregnancy risk and contraceptive method use among postpartum women in 21 low- and middle-income countries. Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial Gestational diabetes and type 2 diabetes in reproductive-aged women with polycystic ovary syndrome. Impact of a Focused Nutrition Educational Intervention Coupled With Improved Access to Fresh Produce on Purchasing Behavior and Consumption of Fruits and Vegetables in Overweight Patients With Diabetes Mellitus Availability, affordability, and consumption of fruits and vegetables in 18 countries across income levels: findings from the Prospective Urban Rural Epidemiology (PURE) study. Estimated Global, Regional, and National Disease Burdens Related to Sugar-Sweetened Beverage Consumption in 2010 Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder. ForgIng New paths in DIabetes PrevenTion (FINDIT): Study Protocol for a Randomized Controlled Trial Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program
Cardiovascular disease , and the incidence of sudden cardiac death ( SCD ) , will increase significantly in low- and middle-income countries ( LMIC ) . Thus , SCD threatens to become a global public health problem . We present a summary of the current research that has investigated the epidemiology of SCD in LMIC . Few studies of SCD in LMIC exist , and they are of variable method ological quality . Risk factors for SCD are described , taking into account recent global burden of disease and risk factor statistics . We describe 1 proposal for a community-based , prospect i ve , multiple- source methodology for SCD monitoring and surveillance that can be implemented in LMIC . Further research into the epidemiology of SCD in LMIC , using st and ardized methodology , would allow investigators and policy makers to determine the regions , communities , and individuals most at need for SCD prevention . Focusing on SCD and its prevention in LMIC should be a priority for the global health community IMPORTANCE Little is known about adoption of healthy lifestyle behaviors among individuals with a coronary heart disease ( CHD ) or stroke event in communities across a range of countries worldwide . OBJECTIVE To examine the prevalence of avoidance or cessation of smoking , eating a healthy diet  , and undertaking regular physical activities  by individuals with a CHD or stroke event . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve Urban Rural Epidemiology ( PURE ) was a large , prospect i ve cohort study that used an epidemiological survey of 153,996 adults , aged 35 to 70 years , from 628 urban and rural communities in 3 high-income countries ( HIC ) , 7 upper-middle-income countries ( UMIC ) , 3 lower-middle-income countries ( LMIC ) , and 4 low-income countries ( LIC ) , who were enrolled between January 2003 and December 2009 . MAIN OUTCOME MEASURES Smoking status ( current , former , never ) , level of exercise ( low , < 600 metabolic equivalent task [MET]-min/wk ; moderate , 600 - 3000 MET-min/wk ; high , > 3000 MET-min/wk ) , and diet ( classified by the Food Frequency Question naire and defined using the Alternative Healthy Eating Index ) . RESULTS Among 7519 individuals with self-reported CHD ( past event : median , 5.0 [ interquartile range { IQR } , 2.0 - 10.0 ] years ago ) or stroke ( past event : median , 4.0 [ IQR , 2.0 - 8.0 ] years ago ) , 18.5 % ( 95 % CI , 17.6%-19.4 % ) continued to smoke ; only 35.1 % ( 95 % CI , 29.6%-41.0 % ) undertook high levels of work- or leisure-related physical activity , and 39.0 % ( 95 % CI , 30.0%-48.7 % ) had healthy diets ; 14.3 % ( 95 % CI , 11.7%-17.3 % ) did not undertake any of the 3 healthy lifestyle behaviors and 4.3 % ( 95 % CI , 3.1%-5.8 % ) had all 3 . Overall , 52.5 % ( 95 % CI , 50.7%-54.3 % ) quit smoking ( by income country classification : 74.9 % [ 95 % CI , 71.1%-78.6 % ] in HIC ; 56.5 % [ 95 % CI , 53.4%-58.6 % ] in UMIC ; 42.6 % [ 95 % CI , 39.6%-45.6 % ] in LMIC ; and 38.1 % [ 95 % CI , 33.1%-43.2 % ] in LIC ) . Levels of physical activity increased with increasing country income but this trend was not statistically significant . The lowest prevalence of eating healthy diets was in LIC ( 25.8 % ; 95 % CI , 13.0%-44.8 % ) compared with LMIC ( 43.2 % ; 95 % CI , 30.0%-57.4 % ) , UMIC ( 45.1 % , 95 % CI , 30.9%-60.1 % ) , and HIC ( 43.4 % , 95 % CI , 21.0%-68.7 % ) . CONCLUSION AND RELEVANCE Among a sample of patients with a CHD or stroke event from countries with varying income levels , the prevalence  of healthy lifestyle behaviors  was low , with even lower levels in poorer countries Background . Low and middle income countries ( LMICs ) are facing an increase of the impact of mental health problems while confronted with limited re sources and limited access to mental health care , known as the ‘ mental health gap ’ . One strategy to reduce the mental health gap would be to utilize the internet to provide more widely-distributed and low cost mental health care . We undertook this systematic review to investigate the effectiveness and efficacy of online interventions in LMICs . Methods . We systematic ally search ed the data -bases PubMed , PsycINFO , JMIR , and additional sources . MeSH terms , Thesaurus , and free text keywords were used . We included all r and omized controlled trials ( RCTs ) of online interventions in LMICs . Results . We found only three articles reported results of RCTs on  online interventions for mental health conditions in LMICs , but none of these interventions was compared with an active control condition . Also , the mental health conditions were diverse across the three studies . Conclusions . There is a dearth of studies examining the effect of online interventions  in LMICs , so we can not draw a firm conclusion on its effectiveness . However , given the effectiveness of  online interventions in high income countries and sharp increase of internet access in LMICs , online interventions may offer a potential to help reduce the ‘ mental health gap ’ . More studies are urgently needed in LMICs People living with HIV ( PLWH ) experience greater psychological distress than the general population . Evidence from high-incomes countries suggests that psychological interventions for PLWH can improve mental health symptoms , quality of life , and HIV care engagement . However , little is known about the effectiveness of mental health interventions for PLWH in low- and middle-income countries ( LMICs ) , where the large majority of PLWH reside . This systematized review aims to synthesize findings from mental health intervention trials with PLWH in LMICs to inform the delivery of mental health services in these setting s. A systematic search strategy was undertaken to identify peer- review ed published papers of intervention trials addressing negative psychological states or disorders ( e.g. depression , anxiety ) among PLWH in LMIC setting s. Search results were assessed against pre-established inclusion and exclusion criteria . Data from papers meeting criteria were extracted for synthesis . Twenty-six papers , published between 2000 and 2014 , describing 22 unique interventions were identified . Trials were implemented in sub-Saharan Africa ( n = 13 ) , Asia ( n = 7 ) , and the Middle East ( n = 2 ) , and addressed mental health using a variety of approaches , including cognitive-behavioral ( n = 18 ) , family-level ( n = 2 ) , and pharmacological ( n = 2 ) treatments . Four r and omized controlled trials reported significant intervention effects in mental health outcomes , and 11 preliminary studies demonstrated promising findings . Among the limited mental health intervention trials with PLWH in LMICs , few demonstrated efficacy .  Mental health interventions for PLWH in LMICs must be further developed and adapted for re source -limited setting s to improve effectiveness Background Violence during pregnancy is a global problem , associated with serious health risks for both the mother and baby . Evaluation of interventions targeted for reducing or controlling domestic violence ( DV ) is still in its infancy , and the majority of findings are primarily from high-income countries ( HICs ) . Therefore , there is an urgent need for generating evidence of DV interventions among pregnant women in low- and middle-income countries ( LMICs ) . Methods Preferred Reporting Items for Systematic Review s and Meta-Analyses ( PRISMA ) guidelines will be employed to structure the review . A comprehensive search will be carried out via electronic data bases including MEDLINE , CINAHL , Scopus , Embase , Web of Science , PsycINFO , and The Cochrane library . Gray literature will also be scrutinized for potential articles . An optimal search strategy has been developed following consultations with subject-matter experts and librarians . This search strategy will be adapted to the different data bases . Experimental studies evaluating DV interventions among pregnant women from LMICs will be included in the review . The review will only include literature written in English . Two review ers will independently screen and assess studies for inclusion in the review . A third author will resolve any discrepancies between the review ers . Risk of bias will be assessed based on the Cochrane risk of bias assessment tool , and overall quality of the evidence will be judged using Grading of Recommendations , Assessment , Development , and Evaluation ( GRADE ) criteria . Findings will be presented with the narrative synthesis , and if applicable , they will be further quantified using r and om-effects meta- analysis . Effect size , risk ratio for dichotomous variables , and st and ardized mean differences for continuous variables will be calculated for each outcome using Review Manager 5.3 . Discussion Systematic review s to evaluate the efficacy of interventions to address DV within the perinatal context have been limited . Hence , no one intervention has emerged as substantially effective towards addressing perinatal DV and associated health consequences . The evidence generated from this systematic review will inform research ers and policy makers about the effectiveness of existing DV interventions among pregnant women in LMICs and provide recommendations for future research in this area . This in turn will contribute towards violence prevention in LMICs . Systematic review registration PROSPERO BACKGROUND Worldwide implementation of risk-based cardiovascular disease ( CVD ) prevention requires risk prediction tools that are contemporarily recalibrated for the target country and can be used where laboratory measurements are unavailable . We present two cardiovascular risk scores , with and without laboratory-based measurements , and the corresponding risk charts for 182 countries to predict 10-year risk of fatal and non-fatal CVD in adults aged 40 - 74 years . METHODS Based on our previous laboratory-based prediction model ( Globorisk ) , we used data from eight prospect i ve studies to estimate coefficients of the risk equations using proportional hazard regressions . The laboratory-based risk score included age , sex , smoking , blood pressure , diabetes , and total cholesterol ; in the non-laboratory ( office-based ) risk score , we replaced diabetes and total cholesterol with BMI . We recalibrated risk scores for each sex and age group in each country using country-specific mean risk factor levels and CVD rates . We used recalibrated risk scores and data from national surveys ( using data from adults aged 40 - 64 years ) to estimate the proportion of the population at different levels of CVD risk  for ten countries from different world regions as examples of the information the risk scores provide ; we applied a risk threshold for high risk of at least 10 % for high-income countries ( HICs ) and at least 20 % for low-income and middle-income countries ( LMICs ) on the basis of national and international guidelines for CVD prevention . We estimated the proportion of men and women who were similarly categorised as high risk or low risk by the two risk scores . FINDINGS Predicted risks for the same risk factor profile were generally lower in HICs than in LMICs , with the highest risks in countries in central and southeast Asia and eastern Europe , including China and Russia . In HICs , the proportion of people aged 40 - 64 years at high risk of CVD ranged from 1 % for South Korean women to 42 % for Czech men ( using a ≥10 % risk threshold ) , and in low-income countries ranged from 2 % in Ug and a ( men and women ) to 13 % in Iranian men ( using a ≥20 % risk threshold ) . More than 80 % of adults were similarly classified as low or high risk by the laboratory-based and office-based risk scores . However , the office-based model substantially underestimated the risk among patients with diabetes . INTERPRETATION Our risk charts provide risk assessment tools that are recalibrated for each country and make the estimation of CVD risk possible without using laboratory-based measurements . FUNDING National Institutes of Health IMPORTANCE Hypertension is the most important preventable cause of morbidity and mortality globally , yet there are relatively few data collected using st and ardized methods . OBJECTIVE To examine hypertension prevalence , awareness , treatment , and control in participants at baseline in the Prospect i ve Urban Rural Epidemiology ( PURE ) study . DESIGN , SETTING , AND PARTICIPANTS A cross-sectional study of 153,996 adults ( complete data for this analysis on 142,042 ) aged 35 to 70 years , recruited between January 2003 and December 2009 . Participants were from 628 communities in 3 high-income countries ( HIC ) , 10 upper-middle-income and low-middle-income countries ( UMIC and LMIC ) , and 4 low-income countries ( LIC ) . MAIN OUTCOMES AND MEASURES Hypertension was defined as individuals with self-reported treated hypertension  or with an average of 2 blood pressure measurements of at least 140/90 mm Hg using an automated digital device . Awareness was based on self-reports , treatment was based on the regular use of blood pressure-lowering medications , and control was defined as individuals with blood pressure lower than 140/90 mm Hg . RESULTS Among the 142,042 participants , 57,840 ( 40.8 % ; 95 % CI , 40.5%-41.0 % ) had hypertension and 26,877 ( 46.5 % ; 95 % CI , 46.1%-46.9 % ) were aware of the diagnosis . Of those who were aware of the diagnosis , the majority ( 23,510 [ 87.5 % ; 95 % CI , 87.1%-87.9 % ] of those who were aware ) were receiving pharmacological treatments , but only a minority of those receiving treatment were controlled ( 7634 [ 32.5 % ; 95 % CI , 31.9%-33.1 % ] ) . Overall , 30.8 % , 95 % CI , 30.2%-31.4 % of treated patients were taking 2 or more types of blood pressure-lowering medications . The percentages aware ( 49.0 % [ 95 % CI , 47.8%-50.3 % ] in HICs , 52.5 % [ 95 % CI , 51.8%-53.2 % ] in UMICs , 43.6 % [ 95 % CI , 42.9%-44.2 % ] in LMICs , and 40.8 % [ 95 % CI , 39.9%-41.8 % ] in LICs ) and treated ( 46.7 % [ 95 % CI , 45.5%-47.9 % ] in HICs , 48.3 % , [ 95 % CI , 47.6%-49.1 % ] in UMICs , 36.9 % , [ 95 % CI , 36.3%-37.6 % ] in LMICs , and 31.7 % [ 95 % CI , 30.8%-32.6 % ] in LICs ) were lower in LICs compared with all other countries for awareness ( P < .001 ) and treatment ( P < .001 ) . Awareness , treatment , and control of hypertension were higher in urban communities compared with rural ones in LICs ( urban vs rural , P < .001 ) and LMICs ( urban vs rural , P < .001 ) , but similar for other countries . Low education was associated with lower rates of awareness , treatment , and control in LICs , but not in other countries . CONCLUSIONS AND RELEVANCE Among a multinational study population , 46.5 % of participants with hypertension were aware of the diagnosis , with blood pressure control among 32.5 % of those being treated . These findings suggest substantial room for improvement in hypertension diagnosis and treatment Background . Approximately 153 million children worldwide are orphaned and vulnerable to potentially traumatic events ( PTEs ) . Gender differences in PTEs in low- and middle-income countries ( LMIC ) are not well-understood , although support services and prevention programs often primarily involve girls . Methods . The Positive Outcomes for Orphans study used a two-stage , cluster-r and omized sampling design to identify 2837 orphaned and separated children ( OSC ) in five LMIC in sub-Saharan Africa and Asia . We examined self-reported prevalence and incidence of several PTE types , including physical and sexual abuse , among 2235 children who were ≥10 years at baseline or follow-up , with a focus on gender comparisons . Results . Lifetime prevalence by age 13 of any PTE other than loss of a parent was similar in both boys [ 91.7 % ( 95 % confidence interval ( CI ) ( 85.0–95.5 ) ] and girls [ 90.3 % CI ( 84.2–94.1 ) ] in institutional-based care , and boys [ 92.0 % ( CI 89.0–94.2 ) ] and girls [ 92.9 % CI ( 89.8–95.1 ) ] in family-based care ; annual incidence was similarly comparable between institution dwelling boys [ 23.6 % CI ( 19.1,−29.3 ) ] and girls [ 23.6 % CI ( 18.6,−30.0 ) ] , as well as between family-dwelling boys [ 30.7 % CI ( 28.0,−33.6 ) ] and girls [ 29.3 % CI ( 26.8,−32.0 ) ] . Physical and sexual abuse had the highest overall annual incidence of any trauma type for institution-based OSC [ 12.9 % CI ( 9.6–17.4 ) ] and family-based OSC [ 19.4 % CI ( 14.5–26.1 ) ] , although estimates in each setting were no different between genders . Conclusion . Prevalence and annual incidence of PTEs were high among OSC in general , but gender-specific estimates were comparable . Although support services and prevention programs are essential for female OSC , programs for male OSC are equally important BACKGROUND There is a need to evaluate and implement cost-effective strategies to improve adherence to treatments in coronary heart disease . There are no studies from low- to middle income countries ( LMICs ) evaluating trained community health worker (CHW)-based interventions for the secondary prevention of coronary heart disease . METHODS We design ed a hospital-based , open r and omized trial of CHW-based interventions versus st and ard care .  Patients after an acute coronary syndrome ( ACS ) were r and omized to an intervention group ( a CHW-based intervention package , comprising education tools to enhance self-care and adherence , and regular follow-up by the CHW ) or to st and ard care for 12 months during which study outcomes were recorded . The CHWs were trained over a period of 6 months . The primary outcome measure was medication adherence . The secondary outcomes were differences in adherence to lifestyle modification , physiological parameters ( blood pressure [ BP ] , body weight , body mass index [ BMI ] , heart rate , lipids ) , and major adverse cardiovascular events . RESULTS We recruited 806 patients stabilized after an ACS from 14 hospitals in 13 Indian cities . The mean age was 56.4 ( ± 11.32 ) years , and 17.2 % were females . A high prevalence of risk factors such as hypertension ( 43.4 % ) , diabetes ( 31.9 % ) , tobacco consumption ( 35.4 % ) , and inadequate physical activity ( 70.5 % ) was documented . A little over half had ST-elevation myocardial infa rct ion ( 53.7 % ) , and 46.3 % had non-ST-elevation myocardial infa rct ion or unstable angina . CONCLUSION The CHW interventions and training for SPREAD have been developed and adapted for local use . The results and experience of this study will be important to counter the burden of cardiovascular diseases in low- to middle income countries IMPORTANCE Women with a history of gestational diabetes mellitus ( GDM ) are at substantially increased risk of type 2 diabetes mellitus ( T2DM ) . The identification of important modifiable factors could help prevent T2DM in this high-risk population . OBJECTIVE To examine the role of physical activity and television watching and other sedentary behaviors  , and changes in these behaviors in the progression from GDM to T2DM . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study of 4554 women from the Nurses ' Health Study II who had a history of GDM , as part of the ongoing Diabetes & Women 's Health Study . These women were followed up from 1991 to 2007 . EXPOSURES Physical activity and television watching and other sedentary behaviors  were assessed in 1991 , 1997 , 2001 , and 2005 . MAIN OUTCOMES AND MEASURE Incident T2DM identified through self-report and confirmed by supplemental question naires . RESULTS We documented 635 incident T2DM cases during 59,287 person-years of follow-up . Each 5-metabolic equivalent hours per week ( MET-h/wk ) increment of total physical activity , which is equivalent to 100 minutes per week of moderate-intensity physical activity , was related to a 9 % lower risk of T2DM ( adjusted relative risk [ RR ] , 0.91 ; 95 % CI , 0.88 - 0.94 ) ; this inverse association remained significant after additional adjustment for body mass index ( BMI ) . Moreover , an increase in physical activity was associated with a lower risk of developing T2DM . Compared with women who maintained their total physical activity levels , women who increased their total physical activity levels by 7.5 MET-h/wk or more ( equivalent to 150 minutes per week of moderate-intensity physical activity ) had a 47 % lower risk of T2DM ( RR , 0.53 ; 95 % CI , 0.38 - 0.75 ) ; the association remained significant after additional adjustment for BMI . The multivariable adjusted RRs ( 95 % CIs ) for T2DM associated with television watching of 0 to 5 , 6 to 10 , 11 to 20 , and 20 or more hours per week were 1 ( reference ) , 1.28 ( 1.04 - 1.59 ) , 1.41 ( 1.11 - 1.79 ) , and 1.77 ( 1.28 - 2.45 ) , respectively ( P value for trend < .001 ) ; additional adjustment for BMI attenuated the association . CONCLUSIONS AND RELEVANCE Increasing physical activity may lower the risk of progression from GDM to T2DM . These findings suggest a hopeful message to women with a history of GDM , although they are at exceptionally high risk for T2DM , promoting an active lifestyle may lower the risk OBJECTIVE Hypertension and other noncommunicable diseases represent a growing threat to low/middle-income countries ( LMICs ) . Mobile health technologies may improve noncommunicable disease outcomes , but LMICs lack re sources to provide these services . We evaluated the efficacy of a cloud computing model using automated self-management calls plus home blood pressure ( BP ) monitoring as a strategy for improving systolic BPs ( SBPs ) and other outcomes of hypertensive patients in two LMICs . SUBJECTS AND METHODS This was a r and omized trial with a 6-week follow-up . Participants with high SBPs ( ≥140 mm Hg if nondiabetic and ≥130 mm Hg if diabetic ) were enrolled from clinics in Honduras and Mexico . Intervention patients received weekly automated monitoring and behavior change telephone calls sent from a server in the United States , plus a home BP monitor . At baseline , control patients received BP results , hypertension information , and usual healthcare . The primary outcome , SBP , was examined for all patients in addition to a preplanned subgroup with low literacy or high hypertension information needs . Secondary outcomes included perceived health status and medication-related problems . RESULTS Of the 200 patients recruited , 181 ( 90 % ) completed follow-up , and 117 of 181 had low literacy or high hypertension information needs . The median annual income was $ 2,900 USD , and average educational attainment was 6.5 years . At follow-up intervention patients ' SBPs decreased 4.2 mm Hg relative to controls ( 95 % confidence interval -9.1 , 0.7 ; p=0.09 ) . In the subgroup with high information needs , intervention patients ' average SBPs decreased 8.8 mm Hg ( -14.2 , -3.4 , p=0.002 ) . Compared with controls , intervention patients at follow-up reported fewer depressive symptoms ( p=0.004 ) , fewer medication problems ( p<0.0001 ) , better general health ( p<0.0001 ) , and greater satisfaction with care ( p≤0.004 ) . CONCLUSIONS Automated telephone care management plus home BP monitors can improve outcomes for hypertensive patients in LMICs . A cloud computing model within regional telecommunication centers could make these services available in areas with limited infrastructure for patient-focused informatics support 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 Introduction Diabetes self-management education ( DSME ) is a fundamental element of type 2 diabetes care . Although 75 % of adults with diabetes worldwide live in low-income and middle-income countries ( LMICs ) , limited DSME research has been conducted in LMICs . The objective of this study was to evaluate a home-based DSME intervention in rural Guatemala . Methods We conducted a prospect i ve study of a DSME intervention using a quasi-experimental , single-group pretest – posttest design . We enrolled 90 participants in the intervention , which consisted of 6 home visits ( May 2014–July 2016 ) conducted by a diabetes educator using a curriculum culturally and linguistically tailored to rural Mayan population s. Primary outcomes were changes in mean hemoglobin A1c ( HbA1c ) and mean systolic and diastolic blood pressure at baseline and at 12 months . Secondary outcomes were diabetes knowledge and self-care activities at baseline and intervention completion . Results HbA1c decreased significantly from baseline to 12 months ( absolute mean change , −1.5 % ; 95 % confidence interval [ CI ] , −1.9 % to −1.0 % ; P < .001 ) . Systolic blood pressure also improved significantly at 12 months ( −6.2 mm Hg ; 95 % CI , −10.1 to −2.2 mm Hg ; P = .002 ) ; changes in diastolic blood pressure were not significant ( −1.6 mm Hg ; 95 % CI , −3.9 to −0.7 mm Hg ; P = .17 ) . We also found significant improvements in diabetes knowledge and self-care activities from baseline to intervention completion . Conclusion DSME interventions can be successfully delivered in a setting with an underre source d health system , high poverty rate , and unique cultural characteristics like Mayan Guatemala . Our findings point to the need for more DSME research in re source -limited setting s globally BACKGROUND Periodontitis and type 2 diabetes mellitus ( T2DM ) are major health problems , especially in low-income population s with little access to dental care . Low-cost models for treatment of periodontal disease have not been tested in controlled studies in low-income population s. Dental prophylaxis , which includes removal of supragingival calculus and plaque , has been shown to arrest the progression of periodontitis . A controlled clinical trial was conducted to determine the effect of dental prophylaxis on periodontitis in T2DM . METHODS Twenty-six patients with T2DM and chronic periodontitis ( CP ) and 26 without T2DM with CP were selected .  Periodontal probing depth ( PD ) , gingival bleeding on probing ( BOP ) , clinical attachment level ( CAL ) , and surfaces with plaque were recorded at baseline and 3 , 6 , and 9 months after initial treatment . All the participants received instructions on oral hygiene and one session of dental prophylaxis at baseline and every 3 months . Glycated hemoglobin ( HbA1c ) levels were measured at baseline and every 3 months in patients with T2DM . RESULTS A significant improvement of PD , BOP , and sites with plaque was observed 3 months after treatment in patients with T2DM ( P = 0.001 ) . In controls , mean PD significantly improved after 6 months compared with baseline ( P = 0.001 ) . No significant improvement of CAL occurred in either group . No significant differences in periodontal parameters between the groups were detected , and no participant showed progression of CP during the 9-month study period . Dental prophylaxis did not influence HbA1c levels , and no association among HbA1c concentration , pretreatment metabolic status , and severity of CP was found . CONCLUSION Routine prophylaxes every 3 months significantly improve periodontal health and prevent progression of CP in both poorly controlled and well-controlled patients with T2DM BACKGROUND Physical activity has a protective effect against  cardiovascular disease ( CVD )  in high-income countries , where physical activity is mainly recreational , but it is not known if this is also observed in lower-income countries , where physical activity is mainly non-recreational . We examined whether different amounts and types of physical activity are associated with lower mortality and CVD  in countries at different economic levels . METHODS In this prospect i ve cohort study , we recruited participants from 17 countries ( Canada , Sweden , United Arab Emirates , Argentina , Brazil , Chile , Pol and , Turkey , Malaysia , South Africa , China , Colombia , Iran , Bangladesh , India , Pakistan , and Zimbabwe ) . Within each country , urban and rural areas in and around selected cities and towns were identified to reflect the geographical diversity . Within these communities , we invited individuals aged between 35 and 70 years who intended to live at their current address for at least another 4 years .  Total physical activity  was assessed using the  International Physical Activity Question naire ( IPQA ) . Participants with pre-existing CVD were excluded from the analyses . Mortality and CVD were recorded during a mean of 6·9 years of follow-up . Primary clinical outcomes during follow-up were mortality plus major CVD ( CVD mortality , incident myocardial infa rct ion , stroke , or heart failure ) , either as a composite or separately . The effects of physical activity on mortality and CVD were adjusted for sociodemographic factors and other risk factors taking into account household , community , and country clustering . FINDINGS Between Jan 1 , 2003 , and Dec 31 , 2010 , 168 916 participants were enrolled , of whom 141 945 completed the IPAQ . Analyses were limited to the 130 843 participants without pre-existing CVD . Compared with low physical activity ( < 600 metabolic equivalents [ MET ] × minutes per week or < 150 minutes per week of moderate intensity physical activity ) , moderate ( 600 - 3000 MET × minutes or 150 - 750 minutes per week ) and high physical activity ( > 3000 MET × minutes or > 750 minutes per week ) were associated with grade d reduction in mortality ( hazard ratio 0·80 , 95 % CI 0·74 - 0·87 and 0·65 , 0·60 - 0·71 ; p<0·0001 for trend ) , and major CVD ( 0·86 , 0·78 - 0·93 ; p<0·001 for trend  ) . Higher physical activity was associated with lower risk of CVD and mortality  in high-income , middle-income , and low-income countries . The adjusted population attributable fraction for not meeting the physical activity guidelines was 8·0 % for mortality and 4·6 % for major CVD , and for not meeting high physical activity was 13·0 % for mortality and 9·5 % for major CVD . Both recreational and non-recreational physical activity were associated with benefits . INTERPRETATION Higher recreational and non-recreational physical activity was associated with a lower risk of mortality and CVD events in individuals from low-income , middle-income , and high-income countries . Increasing physical activity is a simple , widely applicable , low cost global strategy that could reduce deaths and CVD in middle age . FUNDING Population Health Research Institute , the Canadian Institutes of Health Research , Heart and Stroke Foundation of Ontario , Ontario SPOR Support Unit , Ontario Ministry of Health and Long-Term Care , AstraZeneca , Sanofi-Aventis , Boehringer Ingelheim , Servier , GSK , Novartis , King Pharma , and national and local organisations in participating countries that are listed at the end of the Article Inadequate knowledge of the influence of lifestyle on clinical outcomes contributes to the difficulties many African Americans experience with type 2 diabetes mellitus ( T2DM ) . This pilot study examined a 12-week church-based culturally targeted diabetes self-management education ( DSME ) intervention for middle-aged and older African Americans with T2DM . Quantitative data were collected at baseline and at 12 weeks and included question naires and anthropometric measures . There were significant increases in medication adherence ( p = .006 ) , healthy eating ( p = .009 ) , and foot care adherence ( p = .003 ) . The intervention had a clinical ly significant effect on systolic blood pressure , blood lipids , physical activity , and waist circumference . Church-based culturally targeted DSME interventions may result in improved outcomes for African-American adults with T2DM . The authors discuss the value of community-based interventions that target behavioural changes in population s of chronically ill patients , particularly those who historically have been disenfranchised and /or underserved This paper describes the Common Elements Treatment Approach ( CETA ) for adults presenting with mood or anxiety problems developed specifically for use with lay counselors in low- and middle-income countries ( LMIC ) . Details of the intervention development , training , supervision , and decision-making process are presented . Case vignettes are used as examples throughout . Preliminary findings are presented on counselor/supervisor performance and client outcomes from practice cases completed prior to r and omized controlled trials ( RCT ) conducted at two sites for adult survivors of torture and /or systematic violence in ( a ) southern Iraq and ( b ) Thail and -Burma border . Data suggest that local supervisors and lay counselors with little prior mental health training or experience maintained fidelity to the model . The majority of pilot clients were retained in treatment , suggesting acceptability . Using the Reliable Change Index ( RCI ) for each individual we examined the number of clients above a minimal threshold ( z > 1.96 ) for each outcome . In Iraq 100 % of clients had RCIs above the threshold for depression and posttraumatic stress , and 81.8 % for impaired function . In Thail and , 81.3 % of clients had RCIs above minimum threshold for depression , 68.8 % for posttraumatic stress , and 37.5 % for impaired function . Implementation of CETA is discussed in relation to cultural issues within LMIC . These findings , combined with US-based evidence , suggest that a common elements approach warrants further development and testing as a means for addressing the treatment gap for mental health problems in LMIC Background Tobacco use kills half a million people every month , most in low – middle income countries ( LMICs ) . There is an urgent need to identify potentially low-cost , scalable tobacco cessation interventions for these countries . Objective To evaluate a brief community outreach intervention delivered by health workers to promote tobacco cessation in India . Design Cluster-r and omised controlled trial . Setting 32 low-income administrative blocks in Delhi , half government authorised ( ‘ resettlement colony ’ ) and half unauthorised ( ‘ J.J. cluster ’ ) communities . Participants 1213 adult tobacco users . Interventions Administrative blocks were computer r and omised in a 1:1 ratio , to the intervention ( 16 clusters ; n=611 ) or control treatment ( 16 clusters ; n=602 ) , delivered and assessed at individual level between 07/2012 and 11/2013 . The intervention was single session quit advice ( 15 min ) plus a single training session in yogic breathing exercises ; the control condition comprised very brief quit advice ( 1 min ) alone . Both were delivered via outreach , with contact made though household visits . Measurements The primary outcome was 6-month sustained abstinence from all tobacco , assessed 7 months post intervention delivery , biochemically verified with salivary cotinine . Results The smoking cessation rate was higher in the intervention group ( 2.6 % ( 16/611 ) ) than in the control group ( 0.5 % ( 3/602 ) ) ( relative risk=5.32 , 95 % CI 1.43 to 19.74 , p=0.013 ) . There was no interaction with type of tobacco use ( smoked vs smokeless ) . Results did not change material ly in adjusted analyses , controlling for participant characteristics . Conclusions A single session community outreach intervention can increase tobacco cessation in LMIC . The effect size , while small , could impact public health if scaled up with high coverage . Trial registration number IS RCT CN23362894 BACKGROUND Patients ' engagement in mobile health ( m-health ) interventions using interactive voice response ( IVR ) calls is less in low- and middle-income countries ( LMICs ) than in industrialized ones . We conducted a study to determine whether automated telephone feedback to informal caregivers ( " CarePartners " ) increased engagement in m-health support among diabetes and hypertension patients in Bolivia . MATERIAL S AND METHODS Patients with diabetes and /or hypertension were identified through ambulatory clinics affiliated with four hospitals . All patients enrolled with a CarePartner . Patients were r and omized to weekly IVR calls including self-management questions and self-care education either alone ( " st and ard m-health " ) or with automated feedback about health and self-care needs sent to their CarePartner after each IVR call ( " m-health+CP " ) . RESULTS The 72 participants included 39 with diabetes and 53 with hypertension , of whom 19 had ≤6 years of education . After 1,225 patient-weeks of attempted IVR assessment s , the call completion rate was higher among patients r and omized to m-health+CP compared with st and ard m-health ( 62.0 % versus 44.9 % ; p < 0.047 ) . CarePartner feedback more than tripled call completion rates among indigenous patients and patients with low literacy ( p < 0.001 for both ) . M-health+CP patients were more likely to report excellent health via IVR ( adjusted odds ratio [ AOR ] = 2.60 ; 95 % confidence interval [ CI ] , 1.07 , 6.32 ) and less likely to report days in bed due to illness ( AOR = 0.42 ; 95 % CI , 0.19 , 0.91 ) . CONCLUSIONS In this study we found that caregiver feedback increased engagement in m-health and may improve patients ' health status relative to st and ard approaches . M-health+CP represents a scalable strategy for increasing the reach of self-management support in LMICs OBJECTIVES To analyze data from recent Demographic and Health Surveys ( DHS ) conducted in 21 low- and middle-income countries ( LMICs ) to examine patterns of interpregnancy intervals , unmet need , pregnancy risk and family planning method use and method mix among women 0 - 23 months postpartum . STUDY DESIGN Secondary analysis of postpartum women aged 15 - 49 years in 22 DHS surveys from 21 LMICs conducted between 2005 and 2012 . We applied an adapted unmet need definition for postpartum women to look at prospect i ve fertility preferences . We also constructed a new composite pregnancy risk indicator for postpartum women who have been sexually active since their last birth . RESULTS In 9 of 22 surveys , 50 % or more of nonfirst births occur at interpregnancy intervals that are too short . Overall prospect i ve unmet need for family planning by postpartum women has not changed demonstrably since a 2001 analysis and is universally high : 61 % of all postpartum women across the 21 countries have an unmet need for family planning . In 10 of 22 surveys , pregnancy risk rises steadily throughout the 2 years after birth . In the remaining 12 surveys , the risk of pregnancy peaks at 6 - 11 months after birth . Even when postpartum women are using family planning , they rely overwhelmingly on short-acting methods ( 51 - 96 % in 21 of 22 surveys ) . CONCLUSION Our approach of estimating pregnancy risk by postpartum timing confirms a high probability for pregnancies to be less than optimally spaced within 2 years of a prior birth and suggests that special consideration is needed to effectively reach this population with the right messages and services . IMPLICATION S Using recent , multicountry data for women within 2 years postpartum in LMICs , this paper up date s existing estimates of high prospect i ve unmet need for family planning and presents a new composite pregnancy risk analysis based on postpartum women 's actual practice s to demonstrate the magnitude of missed opportunities for programmatic intervention for the postpartum population Background Therapeutic hypothermia reduces death and disability after moderate or severe neonatal encephalopathy in high-income countries and is used as st and ard therapy in these setting s. However , the safety and efficacy of cooling therapy in low- and middle-income countries ( LMICs ) , where 99 % of the disease burden occurs , remains unclear . We will examine whether whole body cooling reduces death or neurodisability at 18–22 months after neonatal encephalopathy , in LMICs . Methods We will r and omly allocate 408 term or near-term babies ( aged ≤ 6 h ) with moderate or severe neonatal encephalopathy admitted to public sector neonatal units in LMIC countries ( India , Bangladesh or Sri Lanka ) , to either usual care alone or whole-body cooling with usual care . Babies allocated to the cooling arm will have core body temperature maintained at 33.5 ° C using a servo-controlled cooling device for 72 h , followed by re-warming at 0.5 ° C per hour . All babies will have detailed infection screening at the time of recruitment and 3 Telsa cerebral magnetic resonance imaging and spectroscopy at 1–2 weeks after birth . Our primary endpoint is death or moderate or severe disability at the age of 18 months . Discussion Upon completion , HELIX will be the largest cooling trial in neonatal encephalopathy and will provide a definitive answer regarding the safety and efficacy of cooling therapy for neonatal encephalopathy in LMICs . The trial will also provide important data about the influence of co-existent perinatal infection on the efficacy of hypothermic neuroprotection . Trial registration Clinical Trials.gov , NCT02387385 . Registered on 27 February 2015 CONTEXT Polycystic ovary syndrome ( PCOS ) affects 6%-21 % of women . PCOS has been associated with an increased risk of dysglycemia including gestational diabetes mellitus ( GDM ) and type 2 diabetes mellitus ( T2DM ) . OBJECTIVE The objective of the study was to assess the prevalence of dysglycemia and the impact of obesity in young reproductive-aged women with and without PCOS in a community-based cohort . DESIGN This was a cross-sectional analysis of data from a large longitudinal study ( the Australian Longitudinal Study on Women 's Health ) . SETTING The setting for the study was the general community . PARTICIPANTS Women were r and omly selected from the national health insurance data base . St and ardized data collection occurred at five survey time points ( years 1996 , 2000 , 2003 , 2006 , and 2009 ) . Data from survey 4 ( 2006 , n = 9145 , 62 % of original cohort aged 18 - 23 y ) were examined for this study . MAIN OUTCOME MEASURES Self-reported PCOS , GDM , and T2DM were measured . RESULTS In women aged 28 - 33 years , PCOS prevalence was 5.8 % [ 95 % confidence interval ( CI ) 5.3%-6.4 % ] . The prevalence of GDM ( in women reporting prior pregnancy ) and T2DM was 11.2 % and 5.1 % in women with PCOS and 3.8 % and 0.3 % in women without PCOS , respectively ( P for both < .001 ) . PCOS was associated with an increased odds of GDM and T2DM . After adjusting for age , body mass index , hypertension , smoking , and demographic factors , the odds of GDM ( odds ratio 2.1 , 95 % CI 1.1 - 3.9 , P = .02 ) and T2DM ( odds ratio 8.8 , 95 % CI 3.9 - 20.1 , P < .001 ) remained increased in women reporting PCOS . CONCLUSIONS In a large community-based cohort of reproductive-aged women , PCOS was independently associated with a higher risk of GDM and T2DM , independent of body mass index . Aggressive screening , prevention , and management of dysglycemia is clearly warranted in women with PCOS Purpose The purpose of this study was to test the impact of distributing coupons redeemable at farmers markets plus an educational intervention on fruit and vegetable ( F&V ) purchase and consumption in overweight patients with type 2 diabetes ( T2DM ) . Methods Seventy-eight participants with T2DM being followed at Jacobi Medical Center , a large public hospital in the Bronx , New York , were r and omized to receive the st and ard of care or a 1-hour session focused on benefits of F&V consumption and $ 6 in coupons . Question naires assessed demographics , F&V intake , and farmers market purchasing at baseline and 12 weeks . Clinical parameters were obtained through chart review at baseline and at 12 weeks . Results Participants were predominantly Latino , females , and low income . At 12 weeks , there was a statistically significant increase in the number of participants in the intervention arm who reported purchasing from a farmers market . In addition , there was a minimal increase in fresh fruit intake in the intervention arm at 12 weeks . Conclusion Focused education combined with a small economic incentive result ed in an increase in purchasing behavior and fresh fruit intake per day . A more intense behavioral intervention combined with increased access may result in a significant impact on obesity and diabetes , particularly among low-income and racially diverse communities BACKGROUND Several international guidelines recommend the consumption of two servings of fruits and three servings of vegetables per day , but their intake is thought to be low worldwide . We aim ed to determine the extent to which such low intake is related to availability and affordability . METHODS We assessed  fruit and vegetable consumption  using data from country-specific , vali date d semi-quantitative food frequency question naires in the Prospect i ve Urban Rural Epidemiology ( PURE ) study , which enrolled participants from communities in 18 countries between Jan 1 , 2003 , and Dec 31 , 2013 . We documented household income data from participants in these communities ; we also recorded the diversity and non-sale prices of fruits and vegetables from grocery stores and market places between Jan 1 , 2009 , and Dec 31 , 2013 . We determined the cost of fruits and vegetables relative to income per household member . Linear r and om effects models , adjusting for the clustering of households within communities , were used to assess mean fruit and vegetable intake by their relative cost . FINDINGS Of 143 305 participants who reported plausible energy intake in the food frequency question naire  , mean fruit and vegetable intake was 3·76 servings ( 95 % CI 3·66 - 3·86 ) per day . Mean daily consumption was 2·14 servings ( 1·93 - 2·36 ) in low-income countries ( LICs ) , 3·17 servings ( 2·99 - 3·35 ) in lower-middle-income countries ( LMICs ) , 4·31 servings ( 4·09 - 4·53 ) in upper-middle-income countries ( UMICs ) , and 5·42 servings ( 5·13 - 5·71 ) in high-income countries ( HICs ) . In 130 402 participants who had household income data available , the cost of two servings of fruits and three servings of vegetables per day per individual accounted for 51·97 % ( 95 % CI 46·06 - 57·88 ) of household income in LICs , 18·10 % ( 14·53 - 21·68 ) in LMICs , 15·87 % ( 11·51 - 20·23 ) in UMICs , and 1·85 % ( -3·90 to 7·59 ) in HICs ( ptrend=0·0001 ) . In all regions , a higher percentage of income to meet the guidelines was required in rural areas than in urban areas ( p<0·0001 for each pairwise comparison ) . Fruit and vegetable consumption among individuals decreased as the relative cost increased ( ptrend=0·00040 ) . INTERPRETATION The consumption of fruit and vegetables is low worldwide , particularly in LICs , and this is associated with low affordability . Policies worldwide should enhance the availability and affordability of fruits and vegetables . FUNDING Population Health Research Institute , the Canadian Institutes of Health Research , Heart and Stroke Foundation of Ontario , AstraZeneca ( Canada ) , Sanofi-Aventis ( France and Canada ) , Boehringer Ingelheim ( Germany and Canada ) , Servier , GlaxoSmithKline , Novartis , King Pharma , and national or local organisations in participating countries Background — Sugar-sweetened beverages ( SSBs ) are consumed globally and contribute to adiposity . However , the worldwide impact of SSBs on burdens of adiposity-related cardiovascular diseases ( CVDs ) , cancers , and diabetes mellitus has not been assessed by nation , age , and sex . Methods and Results — We modeled global , regional , and national burdens of disease associated with SSB consumption by age/sex in 2010 . Data on SSB consumption levels were pooled from national dietary surveys worldwide . The effects of SSB intake on body mass index and diabetes mellitus , and of elevated body mass index on CVD , diabetes mellitus , and cancers were derived from large prospect i ve cohort pooling studies . Disease-specific mortality/morbidity data were obtained from Global Burden of Diseases , Injuries , and Risk Factors 2010 Study . We computed cause-specific population -attributable fractions for SSB consumption , which were multiplied by cause-specific mortality/morbidity to compute estimates of SSB-attributable death/disability . Analyses were done by country/age/sex ; uncertainties of all input data were propagated into final estimates . Worldwide , the model estimated 184 000 ( 95 % uncertainty interval , 161 000–208 000 ) deaths/y attributable to SSB consumption : 133 000 ( 126 000–139 000 ) from diabetes mellitus , 45 000 ( 26 000–61 000 ) from CVD , and 6450 ( 4300–8600 ) from cancers . Five percent of  SSB-related deaths occurred in low-income , 70.9 % in middle-income , and 24.1 % in high-income countries . Proportional mortality attributable to SSBs ranged from < 1 % in Japanese > 65 years if age to 30 % in Mexicans < 45 years of age . Among the 20 most populous countries , Mexico had largest absolute ( 405 deaths/million adults ) and proportional ( 12.1 % ) deaths from SSBs . A total of 8.5 ( 2.8 , 19.2 ) million disability-adjusted life years were related to SSB intake ( 4.5 % of diabetes mellitus – related disability-adjusted life years ) . Conclusions — SSBs are a single , modifiable component of diet that can impact preventable death/disability in adults in high- , middle- , and low-income countries , indicating an urgent need for strong global prevention programs BACKGROUND : The comorbidity of type 2 diabetes mellitus ( T2DM ) and depression is associated with poor glycemic control .  Exercise has been shown to improve mood and glycemic control , but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise . Behavioral activation , an evidence -based depression psychotherapy , was design ed to help people with depression make gradual behavior changes , and may be helpful to build exercise adherence in sedentary population s. This pilot r and omized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression . METHODS / DESIGN : Sedentary women with inadequately controlled T2DM and depression ( N=60 ) will be r and omly assigned to one of two conditions : exercise or usual care .  Participants r and omized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care . Participants r and omized to the  usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity . Assessment s will occur at baseline and 3- , 6- , and 9-months following r and omization . The goals of this pilot study are to demonstrate feasibility and intervention acceptability , estimate the re sources and costs required to deliver the intervention and to estimate the st and ard deviation of continuous outcomes ( e.g. , depressive symptoms and glycosylated hemoglobin ) in preparation for a fully-powered r and omized clinical trial . DISCUSSION : A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression . TRIAL REGISTRATION : NCT01024790 Background Prediabetes is an asymptomatic condition in which patients ’ blood glucose levels are higher than normal but do not meet diagnostic criteria for type 2 diabetes mellitus ( T2DM ) . A key window of opportunity to increase engagement of patients with prediabetes in strategies to prevent T2DM is when they are screened for T2DM and found to have prediabetes , yet the effects of this screening and brief counseling are unknown . Methods In this parallel- design r and omized controlled trial we will recruit 315 non-diabetic patients from the Ann Arbor VA Medical Center ( AAVA ) who have one or major risk factors for T2DM and an upcoming primary care appointment at the AAVA , but have not had a hemoglobin A1c ( HbA1c ) test to screen for T2DM in the previous 12 months . After informed consent , participants will complete a baseline survey and be r and omly assigned to , at the time of their next primary care appointment , one of two arms : ( 1 ) to have a hemoglobin A1c ( HbA1c ) test to screen for T2DM and receive brief , st and ardized counseling about these results or ( 2 ) to review a brochure about clinical preventive services . Participants will complete surveys 2 weeks , 3 months , and 12 months after their primary care appointment , and a weight measurement 12 months after their primary care appointment . The primary outcome is weight change after 12 months . The secondary outcomes are changes in perception of risk for T2DM ; knowledge of T2DM prevention ; self-efficacy and motivation to prevent T2DM ; use of pharmacotherapy for T2DM prevention ; physical activity ; participation in weight management programs ; and mental health . Quantitative analyses will compare outcomes among participants in the HbA1c test arm found to have prediabetes with participants in the brochure arm . Among participants in the HbA1c test arm found to have prediabetes we will conduct semi-structured interviews about their underst and ing of and reactions to receiving a prediabetes diagnosis . Discussion This trial will generate foundational data on the effects of a prediabetes diagnosis and brief counseling on patients ’ preventive behaviors and mediators of these behaviors that will enable the development of novel strategies to improve patient engagement in T2DM prevention . Trial registration Clinical Trials.gov , NCT02747108 . Registered on 18 April 2016 Background India currently has more than 60 million people with Type 2 Diabetes Mellitus ( T2DM ) and this is predicted to increase by nearly two-thirds by 2030 . While management of those with T2DM is important , preventing or delaying the onset of the disease , especially in those individuals at ‘ high risk ’ of developing T2DM , is urgently needed , particularly in re source -constrained setting s. This paper describes the protocol for a cluster r and omised controlled trial of a peer-led lifestyle intervention program to prevent diabetes in Kerala , India . Methods / design A total of 60 polling booths are r and omised to the intervention arm or control arm in rural Kerala , India . Data collection is conducted in two steps . Step 1 ( Home screening ) : Participants aged 30–60 years are administered a screening question naire . Those having no history of T2DM and other chronic illnesses with an Indian Diabetes Risk Score value of ≥60 are invited to attend a mobile clinic ( Step 2 ) . At the mobile clinic , participants complete question naires , undergo physical measurements , and provide blood sample s for biochemical analysis . Participants identified with T2DM at Step 2 are excluded from further study participation . Participants in the control arm are provided with a health education booklet containing information on symptoms , complications , and risk factors of T2DM with the recommended levels for primary prevention . Participants in the intervention arm receive : ( 1 ) eleven peer-led small group sessions to motivate , guide and support in planning , initiation and maintenance of lifestyle changes ; ( 2 ) two diabetes prevention education sessions led by experts to raise awareness on T2DM risk factors , prevention and management ; ( 3 ) a participant h and book containing information primarily on peer support and its role in assisting with lifestyle modification ; ( 4 ) a participant workbook to guide self-monitoring of lifestyle behaviours , goal setting and goal review ; ( 5 ) the health education booklet that is given to the control arm . Follow-up assessment s are conducted at 12 and 24 months . The primary outcome is incidence of T2DM . Secondary outcomes include behavioural , psychosocial , clinical , and biochemical measures . An economic evaluation is planned . Discussion Results from this trial will contribute to improved policy and practice regarding lifestyle intervention programs to prevent diabetes in India and other re source -constrained setting s . Trial registration Australia and New Zeal and Clinical Trials Registry : ACTRN12611000262909
Conclusion Based on available literature , evidence suggests that community-based interventions may reduce the incidence rate of T2DM and may positively affect anthropometric indices and HbA1C .
Due to the heterogeneity observed between trials we recommend more well- design ed RCTs with longer follow-up duration s be executed , to confirm whether community-based interventions lead to reduced T2DM events in the at-risk population of LMIC setting
Background The increasing prevalence of type 2 diabetes mellitus ( T2DM ) can have a substantial impact in low- and middle-income countries ( LMICs ) .
Community-based programs addressing diet , physical activity , and health behaviors have shown significant benefits on the prevention and management of T2DM , mainly in high-income countries .
However , their effects on preventing T2DM in the at-risk population of LMICs have not been thoroughly evaluated .