Predictive ability of social cognitive theory in exercise research: an integrated literature review. Electronic feedback in a diet- and physical activity-based lifestyle intervention for weight loss: a randomized controlled trial A home-based nurse-coached inspiratory muscle training intervention in heart failure. Mediators of physical activity change in a behavioral modification program for type 2 diabetes patients Outcomes of a 12-Month Web-Based Intervention for Overweight and Obese Men A Randomised Trial of a Weight Loss Intervention for Overweight and Obese People Diagnosed with Coronary Heart Disease and/or Type 2 Diabetes Multiple Health Behavior Changes and Co-variation in a Telephone Counseling Trial Promoting healthy weight with "stability skills first": a randomized trial. Examining Participant Engagement in an Information Technology-Based Physical Activity and Nutrition Intervention for Men: The Manup Randomized Controlled Trial Weight management for overweight and obese men delivered through professional football clubs: a pilot randomized trial Impact of the fit and strong intervention on older adults with osteoarthritis. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials Translating the Diabetes Prevention Program lifestyle intervention for weight loss into primary care: a randomized trial. Controlled outcome evaluation of the First Step Program: a daily physical activity intervention for individuals with type II diabetes Diabetes NetPLAY: A physical activity website and linked email counselling randomized intervention for individuals with type 2 diabetes Diabetes Personal Trainer Outcomes A brief structured education programme enhances self-care practices and improves glycaemic control in Malaysians with poorly controlled diabetes. The ‘Healthy Dads, Healthy Kids’ randomized controlled trial: efficacy of a healthy lifestyle program for overweight fathers and their children A randomized controlled trial of a self-regulation intervention for older adults with asthma. Maintenance of exercise after phase II cardiac rehabilitation: a randomized controlled trial. A randomized controlled trial of self-management programme improves health-related outcomes of older people with heart failure. A 12-Week Commercial Web-Based Weight-Loss Program for Overweight and Obese Adults: Randomized Controlled Trial Comparing Basic Versus Enhanced Features PREFER study: a randomized clinical trial testing treatment preference and two dietary options in behavioral weight management--rationale, design and baseline characteristics. Randomised controlled trial of a pedometer-based telephone intervention to increase physical activity among cardiac patients not attending cardiac rehabilitation. Using the CHANGE intervention to enhance long-term exercise. A randomized trial of a self-regulation intervention for women with asthma. Testing an intervention to promote children's adherence to asthma self-management. Supervised fitness walking in patients with osteoarthritis of the knee. A randomized, controlled trial. Framework for design and evaluation of complex interventions to improve health Weight loss during the intensive intervention phase of the weight-loss maintenance trial. Evaluation of an Education Program for Elementary School Children with Asthma The SHED-IT randomized controlled trial: evaluation of an Internet-based weight-loss program for men.
The mechanisms that underlie successful initiation and adherence to physical activity regimens are not well understood . Few theoretical models have used consistent explanatory variables that are theory-driven and many findings that use extant models are equivocal . Social Cognitive Theory ( SCT ) as presented by B and ura ( 1986 , 1997 ) appears to have strong promise as a guide to underst and ing physical activity behaviors and developing clinical ly relevant interventions to promote the initiation and maintenance of physical activity . This critical systematic review of research using SCT was completed to determine the predictive ability of model constructs in explaining physical activity behavior and in identifying key intervention components found to enhance physical activity initiation and maintenance . Following review for quality and adequacy , published research during the years 1990 - 1998 contained 27 studies that examined the relationship between the construct of SCT , self-efficacy  , and physical activity .  All of the descriptive studies found a statistically significant relationship between self-efficacy and exercise behavior . Intervention studies demonstrated that participation in an exercise program promoted self-efficacy , and that programs design ed to increase outcome expectations and self-efficacy significantly increased exercise behavior . Due to the central ity of self-efficacy in many of the social psychological theories that help explain the attitude-intention-behavior triad , a strong need remains to design interventions to maximize its usefulness . Clear , generalizable , systematic and theoretically comprehensive , r and omized , controlled studies are needed to underst and the usefulness of the construct Background The SenseWear ™ Armb and ( SWA ) ( BodyMedia , Inc. Pittsburgh , PA ) is a physical activity and lifestyle monitor that objective ly and accurately measures free-living energy balance and sleep and includes software for self-monitoring of daily energy expenditure and energy intake . The real-time feedback of the SWA can improve individual self-monitoring and , therefore , enhance weight loss outcomes . Methods We recruited 197 sedentary overweight or obese adults ( age , 46.8 ± 10.8 y ; body mass index ( BMI ) , 33.3 ± 5.2 kg/m2 ; 81 % women , 32 % African-American ) from the greater Columbia , South Carolina area . Participants were r and omized into 1 of 4 groups , a self-directed weight loss program via an evidence -based weight loss manual ( St and ard Care , n = 50 ) , a group-based behavioral weight loss program ( GWL , n = 49 ) , the armb and alone ( SWA-alone , n = 49 ) , or the GWL plus the armb and ( GWL+SWA , n = 49 ) , during the 9-month intervention . The primary outcome was change in body weight and waist circumference . A mixed-model repeated- measures analysis compared change in the intervention groups to the st and ard care group on weight and waist circumference status after adjusting for age , sex , race , education , energy expenditure , and recruitment wave . Results Body weight was available for 62 % of participants at 9 months ( 52 % st and ard care , 70 % intervention ) . There was significant weight loss in all 3 intervention groups ( GWL , 1.86 kg , P = 0.05 ; SWA-alone , 3.55 kg , P = 0.0002 ; GWL+SWA , 6.59 kg , P < 0.0001 ) but not in the St and ard Care group ( 0.89 kg , P = 0.39 ) at month 9 . Only the GWL+SWA group achieved significant weight loss at month 9 compared to the St and ard Care group ( P = 0.04 ) . Significant waist circumference reductions were achieved in all 4 groups at month 9 ( St and ard Care , 3.49 cm , P = 0.0004 ; GWL , 2.42 cm , P = 0.008 ; SWA-alone , 3.59 cm , P < 0.0001 ; GWL+SWA , 6.77 cm , P < 0.0001 ) , but no intervention group had significantly reduced waist circumference compared to the St and ard Care group . Conclusions Continuous self-monitoring from wearable technology with real-time feedback may be particularly useful to enhance lifestyle changes that promote weight loss in sedentary overweight or obese adults . This strategy , combined with a group-based behavioral intervention , may yield optimal weight loss . Trial Registration Clinical Trials.gov : People with heart failure ( HF ) are living longer but with disabling dyspnea that erodes quality of life ( QOL ) . Decreased strength of inspiratory muscles ( IMs ) may contribute to dyspnea in HF , and inspiratory muscle training ( IMT ) has been shown to improve the strength of IMs . The purpose of this study was to determine the effects of a 3-month nurse-coached IMT program . B and ura 's Self-Efficacy Theory directed nursing interventions . This r and omized controlled trial employed an experimental group ( IMT ) and a control group ( education ) . Data were collected during six home visits . Outcome measures included maximal inspiratory pressure , perceived dyspnea , self-efficacy , and health-related QOL . Significant differences in PI(max ) , dyspnea , and respiratory rate were found . Implication s for further research and practice are discussed Background Many studies have reported significant behavioral impact of physical activity interventions . However , few have examined changes in potential mediators of change preceding behavioral changes , result ing in a lack of information concerning how the intervention worked . Our purpose was to examine mediation effects of changes in psychosocial variables on changes in physical activity in type 2 diabetes patients . Methods Ninety-two patients ( 62 ± 9 years , 30 , 0 ± 2.5 kg/m2 , 69 % males ) participated in a r and omized controlled trial . The 24-week intervention was based on social-cognitive constructs and consisted of a face-to-face session , telephone follow-ups , and the use of a pedometer .  Social-cognitive variables and physical activity  ( device-based and self-reported ) were collected at baseline , after the 24-week intervention and at one year post-baseline . PA was measured by pedometer , accelerometer and question naire . Results Post-intervention physical activity changes were mediated by coping with relapse , changes in social norm , and social modeling from family members ( p ≤ 0.05 ) . One-year physical activity changes were mediated by coping with relapse , changes in social support from family and self-efficacy towards physical activity barriers ( p ≤ 0.05 ) Conclusions For patients with type 2 diabetes , initiatives to increase their physical activity could usefully focus on strategies for resuming regular patterns of activity , on engaging family social support and on building confidence about dealing with actual and perceived barriers to activity . Trial Registration NCT00903500 , Clinical Trials.gov Background This study assessed the effect of a 1-year internet-based weight loss intervention  for men . Methods Four hundred forty-one overweight and obese men were r and omized to intervention or delayed treatment . Participants completed a Web-based assessment of diet and physical activity behaviors and weekly tailored Web modules addressing weight-related behaviors . Results At 12 months compared to controls , intervention men decreased percent of energy from saturated fat and increased grams of fiber and fruit/vegetable servings per 1.000 kcal ( p values < 0.001 ) and walked 16 min more per day ( p < 0.05 ) . No between-group differences in body mass index ( BMI ) , weight , or waist circumference were seen , but among completers , men in the highest tertile of intervention participation had lower weight ( 98.74 vs. 102.37 kg ) , BMI ( 32.38 vs. 33.46 ) , and waist circumference ( 42.17 vs. 43.47 cm ) compared to men who participated less often . Conclusions The intervention improved diet and activity behaviors , but weight loss occurred only for those with the highest adherence Background Weight reduction limits disease progression in obese people with coronary heart disease ( CHD ) and /or type 2 diabetes mellitus ( T2DM ) . Purpose To test a 16-week group-based weight reduction intervention combining exercise , diet and behaviour change strategies aim ed to increase self-efficacy  ( Healthy Eating and Exercise Lifestyle Program — HEELP ) on weight , body mass index ( BMI ) , waist circumference and exercise . Methods Participants with CHD and /or T2DM and BMI between 27 to 39 kg/m2 were r and omised to HEELP  ( n = 83 ) or usual care ( n = 65 ) . Results Participants were aged a mean 63.47 years ( SD 8.9 ) , male ( 58 % ) and Caucasian ( 79 % ) . HEELP participants lost significantly more weight , BMI and waist circumference and exercised more days/week for a longer duration /week than usual care . Clinical ly significant weight loss ( ≥5 % ) was more common in HEELP than usual care . Conclusion The HEELP result ed in weight loss and improved exercise behaviour in obese people with CHD and T2DM Background Delivering effective multiple health behavior interventions to large numbers of adults with chronic conditions via primary care setting s is a public health priority . Purpose Within a 12-month , telephone-delivered diet and physical activity intervention with multiple behavioral outcomes , we examined the extent and co-variation of multiple health behavior change . Methods A cluster-r and omized trial with 434 patients with type 2 diabetes or hypertension were recruited from 10 general practice s , which were r and omized to receive telephone counseling or usual care .  Results Those receiving telephone counseling were significantly more likely than those in usual care to make greater reductions in multiple behaviors after adjusting for baseline risk behaviors ( OR 2.42 ; 95%CI 1.43 , 4.11 ) . Controlling for baseline risk and group allocation , making changes to either physical activity , fat , vegetable , or fiber intake was associated with making significantly more improvements in other behaviors . Conclusions For patients with chronic conditions , telephone counseling can significantly improve multiple health behaviors , with behavioral changes tending to co-vary OBJECTIVE Although behavioral weight-loss interventions produce short-term weight loss , long-term maintenance remains elusive . This r and omized trial examined whether learning a novel set of " stability skills " before losing weight improved long-term weight management . Stability skills were design ed to optimize individuals ' current satisfaction with lifestyle and self-regulatory habits while requiring the minimum effort and attention necessary . METHOD Overweight/obese women ( N = 267 ) were r and omly assigned to one of two 6-month interventions and assessed at baseline and at 6 , 12 , and 18 months . Maintenance First women participated first in an 8-week stability skills maintenance module and then in a st and ard 20-week behavioral weight-loss program . Weight Loss First women participated first in a st and ard 20-week behavioral weight-loss program and then in a st and ard 8-week problem-solving skills maintenance module . There was no intervention staff contact during the 12-month follow-up period ( 6 - 18 months ) . RESULTS As design ed , Maintenance First participants lost the same percentage of initial weight during the 6-month intervention period as Weight Loss First participants ( M = -8.6 % , SD = 5.7 , vs. M = -9.1 % , SD = 6.9 ; t = -0.6 , p = .52 ) . However , Maintenance First participants regained significantly less weight during the 12-month follow-up period ( 6 - 18 months ) than Weight Loss First participants ( M = 3.2 lb , SD = 10.4 , vs. M = 7.3 lb , SD = 9.9 [ M = 1.4 kg , SD = 4.7 , vs. M = 3.3 kg , SD = 4.5 ] ; t = 3.3 , p = .001 , d = 0.4 ) . CONCLUSION Learning stability skills before losing weight was successful in helping women to maintain weight loss without intervention staff contact during follow-up . These results can inform the study design of future innovative interventions Background Males experience a shorter life expectancy and higher rates of chronic diseases compared to their female counterparts . To improve health outcomes among males , interventions specifically developed for males that target their health behaviors are needed . Information technology (IT)-based interventions may be a promising intervention approach in this population group , however , little is known about how to maximize engagement and retention in Web-based programs . Objective The current study sought to explore attributes hypothesized to influence user engagement among a sub sample of participants from the ManUp study , a r and omized controlled trial testing the efficacy of an interactive Web-based intervention for promoting physical activity and nutrition among middle-aged males . Methods Semistructured interviews were conducted and audiotaped with 20 of the ManUp participants . Interview questions were based on a conceptual model of engagement and centered on why participants took part in the study , what they liked and did not like about the intervention they received , and how they think the intervention could be improved . Interview recordings were transcribed and coded into themes . Results There were five themes that were identified in the study . These themes were : ( 1 ) users ’ motives , ( 2 ) users ’ desired outcomes , ( 3 ) users ’ positive experiences , ( 4 ) users ’ negative emotions , and ( 5 ) attributes desired by user . Conclusions There is little research in the field that has explored user experiences in human-computer interactions and how such experiences may relate to engagement , especially among males . Although not conclusive , the current study provides some insight into what personal attributes of middle-aged males ( such as their key motives and goals for participating ) and attributes of the intervention material s ( such as usability , control , and interactivity ) may impact on user engagement in this group . These findings will be helpful for informing the design and implementation of future health behavior interventions for males . Trial Registration Australian New Zeal and Clinical Trials Registry : ACTRN12611000081910 ; https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?ACTRN=12611000081910 ( Archived by WebCite at http://www.webcitation.org/6M4lBlvCA ) Background The prevalence of male obesity is increasing , but men are less likely than women to attend existing weight management programmes . We have taken a novel approach to reducing perceived barriers to weight loss for men by using professional football ( soccer ) clubs to encourage participation in a weight management group programme , gender-sensitised in content and style of delivery .  Football Fans in Training ( FFIT ) provides 12 weeks of weight loss , physical activity and healthy eating advice at top professional football clubs in Scotl and . This pilot r and omized trial explored the feasibility of using these clubs as a setting for a r and omized controlled trial of 12 month weight loss following men ’s participation in FFIT . Methods A two-arm pilot trial at two Scottish Premier League football clubs ( one large , one smaller ) , with 103 men ( aged 35–65 , body mass index ( BMI ) ≥27 kg/m2 ) individually r and omized to  the intervention ( n=51 , received the pilot programme ( p-FFIT ) immediately ) and waitlist comparison ( n=52 , received p-FFIT after four months ) groups . Feasibility of recruitment , r and omization , data collection and retention were assessed . Objective physical measurements ( weight , waist circumference , blood pressure , body composition ) and question naires ( self-reported physical activity , diet , alcohol consumption , psychological outcomes ) were obtained from both groups by fieldworkers trained to st and ard protocol s at baseline and 12 weeks , and from the intervention group at 6 and 12 months . Qualitative methods elicited men ’s experiences of participation in the pilot trial . Results Following a short recruitment period , the recruitment target was achieved at the large , but not smaller , club . Participants ’ mean age was 47.1±8.4 years ; mean BMI 34.5±5.0 kg/m2 . Retention through the trial was good ( > 80 % at 12 weeks and 6 months ; > 75 % at 12 months ) , and 76 % attended at least 80 % of available programme delivery sessions . At 12 weeks , the intervention group lost significantly more weight than the comparison group ( 4.6 % c.f . -0.6 % , p<.001 ) and many maintained this to 12 months ( intervention group baseline-12 month weight loss : 3.5 % , p<.001 ) . There were also improvements in self-reported physical activity and diet , many sustained long term . Conclusions The results demonstrated the feasibility of trial procedures and the potential of FFIT to engage men in sustained weight loss and positive lifestyle change . They supported the conduct of a fully-powered r and omized controlled trial PURPOSE This study assessed the impact of a low cost , multicomponent physical activity intervention for older adults with lower extremity osteoarthritis . DESIGN AND METHODS A r and omized controlled trial compared the effects of a facility-based multiple-component training program followed by home-based adherence  ( n = 80 ) to a  wait list control group ( n = 70 ) . Assessment s were conducted at baseline and at 2 and 6 months following r and omization . The training program consisted of range of motion , resistance training , aerobic walking , and education-group problem solving regarding self-efficacy for exercise and exercise adherence . All training group participants developed individualized plans for posttraining adherence . RESULTS Relative to the persons in the control group , individuals who participated in the exercise program experienced a statistically significant improvement in exercise efficacy , a 48.5 % increase in exercise adherence , and a 13.3 % increase in 6-min distance walk that were accompanied by significant decreases in lower extremity stiffness at 2 and 6 months . Program participants also experienced a significant decrease in lower extremity pain and a borderline significant improvement in efficacy to adhere to exercise over time at 6 months ( p = .052 ) . In contrast , persons in the control group deteriorated over time on the efficacy and adherence measures and showed no change on the other measures . No adverse health effects were encountered . IMPLICATION S These benefits indicate that this low-cost intervention may hold great promise as one of a growing number of public health intervention strategies for older adults in the United States with osteoarthritis Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more BACKGROUND The Diabetes Prevention Program ( DPP ) lifestyle intervention reduced the incidence of type 2 diabetes mellitus ( DM ) among high-risk adults by 58 % , with weight loss as the dominant predictor . However , it has not been adequately translated into primary care . METHODS We evaluated 2 adapted DPP lifestyle interventions  among overweight or obese adults who were recruited from 1 primary care clinic and had pre-DM and /or metabolic syndrome . Participants were r and omized to ( 1 ) a coach-led group intervention ( n = 79 ) , ( 2 ) a self-directed DVD intervention ( n = 81 ) , or ( 3 ) usual care ( n = 81 ) . During a 3-month intensive intervention phase , the DPP-based behavioral weight-loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD . During the maintenance phase , participants in both interventions received lifestyle change coaching and support remotely-through secure email within an electronic health record system and the American Heart Association Heart360 website for weight and physical activity goal setting and self-monitoring . The primary outcome was change in body mass index ( BMI ) ( calculated as weight in kilograms divided by height in meters squared ) from baseline to 15 months . RESULTS At baseline , participants had a mean ( SD ) age of 52.9 ( 10.6 ) years and a mean BMI of 32.0 ( 5.4 ) ; 47 % were female ; 78 % , non-Hispanic white ; and 17 % , Asian/Pacific Isl and er . At month 15 , the mean ± SE change in BMI from baseline was -2.2 ± 0.3 in the coach-led group vs -0.9 ± 0.3 in the usual care group ( P < .001 ) and -1.6 ± 0.3 in the self-directed group vs usual care ( P = .02 ) . The percentages of participants who achieved the 7 % DPP-based weight-loss goal were 37.0 % ( P = .003 ) and 35.9 % ( P = .004 ) in the coach-led and self-directed groups , respectively , vs 14.4 % in the usual care group . Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose level . CONCLUSION Proven effective in a primary care setting , the 2 DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00842426 OBJECTIVE : To conduct a r and omised trial of a physical activity ( PA ) intervention , The First Step Program ( FSP ) for adults with type II diabetes . DESIGN : A 16-week intervention study and 24-week follow-up assessment . PARTICIPANTS : A total of 47 overweight/obese , sedentary individuals ( age=52.7±5.2 y ; BMI = 33.3±5.6 kg/m2 ) recruited through a diabetes education centre . MEASUREMENTS : Primary outcome :  daily PA assessed by pedometer ( steps/day ) . Secondary outcomes : anthropometric measures ( weight , BMI , waist girth , hip girth ) ; indicators of cardiovascular health ( resting heart rate and blood pressure ) ; glycemic control ( fasting glucose , insulin , HbA1c , glucose concentration 120 min postglucose load ) ; plasma lipid status ( total cholesterol , HDL cholesterol , LDL cholesterol , and triglycerides ) . RESULTS : Relative to the CONTROL group , FSP participants increased  their PA > 3000 steps/day ( approximately 30 min/day ) during the intervention ( P<0.0001 ) . Waist and hip girth decreased ( approximately 2–3 cm ) , but did not differ significantly between groups . Significant changes did not emerge for any of the other variables . CONCLUSIONS : The FSP is a practical intervention that elicits an immediate and profound change in walking behaviour . Such change is an important ‘ first step ’ towards increasing the volume and /or intensity of PA necessary to improve long-term health outcomes in this largely sedentary and overweight or obese population . Relapse by 24 weeks indicates that other strategies such as booster sessions are needed to maintain lifestyle change . Further research must determine realistic and responsive health outcomes for this population that are achievable through practical , real-world programming Background -This pilot study evaluated the feasibility ( recruitment , retention , adherence and satisfaction ) and preliminary efficacy of a 12-week website and email-linked counselling intervention on physical activity behaviour change in individuals with type 2 diabetes . Methods -A total of 49 individuals with type 2 diabetes ( 59 % female , average age 54.1 years ) were r and omized to the Diabetes NetPLAY intervention or control condition . The intervention condition received information grounded in the Social Cognitive Theory ( SCT ) , personalized weekly emails , an on-line logbook and message board . Key outcomes included physical activity behaviour and related cognition changes . The control condition was provided links to the Canadian Diabetes Association 's Clinical Practice Guidelines for Physical Activity and Canada 's Guide to Physical Activity . Results -Intervention participants indicated high levels of satisfaction for this mode of delivery and study results demonstrated the feasibility of web-based mediums for the delivery of physical activity information in this population . The intervention group demonstrated a significant improvement in total vigorous and moderate minutes of physical activity ( p = 0.05 ) compared to the control group over the 12-week study . Among the SCT variables , behavioural capacity , showed a significant increase ( p < 0.001 ) among intervention participants . Conclusion -Web-based interventions for individuals with type 2 diabetes are feasible and show promise for improving positive physical activity outcomes OBJECTIVE —To assess the social-cognitive , behavioral , and physiological outcomes of a self-management intervention for youth with type 1 diabetes . RESEARCH DESIGN AND METHODS —A total of 81 youth with type 1 diabetes aged 11–16 years were r and  omized  to usual care versus a “ diabetes personal trainer ” intervention , consisting of six self-monitoring , goal - setting , and problem-solving sessions with trained nonprofessionals . Assessment s were completed at baseline and multiple follow-up intervals . A1C data were obtained from medical records . ANCOVA adjusting for age and baseline values were conducted for each outcome . RESULTS —At both short-term and 1-year follow-up , there was a trend for an overall intervention effect on A1C ( short-term F = 3.71 , P = 0.06 ; 1-year F = 3.79 , P = 0.06 ) and a significant intervention-by-age interaction , indicating a great effect among older than younger youth ( short-term F = 4.78 , P = 0.03 ; 1-year F = 4.53 , P = 0.04 ) . Subgroup analyses demonstrated no treatment group difference among younger youth but a significant difference among the older youth . No treatment group differences in parent or youth report of adherence were observed . CONCLUSIONS —The diabetes personal trainer intervention demonstrated significant effects in A1C among middle adolescents We assessed the effectiveness of a brief structured diabetes education programme based on the concept of self-efficacy on self-care and glycaemic control using single-blind study design . One hundred and sixty-four participants with poorly controlled diabetes from two setting s were r and omized using computer-generated list into control ( n = 82 ) and intervention ( n = 82 ) groups , of which 151 completed the study . Monthly interventions over 12 weeks addressed the self-care practice s of diet , physical activity , medication adherence and self-monitoring of blood glucose ( SMBG ) . These self-care practice s were assessed at Weeks 0 and 12 using pre- and post- question naires in both groups together with glycated haemoglobin A1c ( HbA1c ) and diabetes knowledge . In the intention-to-treat analysis ( n = 164 ) , the intervention group improved their SMBG ( P = < 0.001 ) , physical activity ( P = 0.001 ) , HbA1c ( P = 0.03 ) , diabetes knowledge ( P = < 0.001 ) and medication adherence . At Week 12 , HbA1c difference adjusted for SMBG frequency , medication adherence and weight change remained significant ( P = 0.03 ) compared with control group . For within group comparisons , diabetes knowledge ( P = < 0.001 ) , HbA1c level ( P = < 0.001 ) , SMBG ( P = < 0.001 ) and medication adherence ( P = 0.008 ) improved from baseline in the intervention group . In the control group , only diabetes knowledge improved ( P = < 0.001 ) . These findings can contribute to the development of self-management diabetes education in Malaysia Objective : To evaluate the feasibility and efficacy of the ‘ Healthy Dads , Healthy Kids ’ ( HDHK ) program , which was design ed to help overweight fathers lose weight and be a role model of positive health behaviors for their children . Design : R and omized controlled trial . Participants : A total of 53 overweight/obese men ( mean ( s.d . ) age=40.6 ( 7.1 ) years ; body mass index ( BMI ) = 33.2 ( 3.9 ) ) and their primary school-aged children ( n=71 , 54 % boys ; mean ( s.d . ) age=8.2 ( 2.0 ) years ) were r and omly assigned ( family unit ) to either ( i )  the HDHK program ( n=27 fathers , n=39 children ) or ( ii ) a wait-list control group ( n=26 fathers , n=32 children).Intervention : Fathers in the 3-month program attended eight face-to-face education sessions . Children attended three of these sessions . Outcomes : The primary outcome was fathers ’ weight .  Fathers and their children were assessed at baseline , and at 3- and 6-month follow-up , for weight , waist circumference , BMI , blood pressure , resting heart rate ( RHR ) , objective ly measured physical activity and self-reported dietary intake . Results : Intention-to-treat analysis revealed significant between-group differences at 6 months for weight loss ( P<0.001 ) , with HDHK fathers  losing more weight ( −7.6 kg ; 95 % confidence interval ( CI ) −9.2 , −6.0 ; d=0.54 ) than control group fathers ( 0.0 kg ; 95 % CI −1.4 , 1.6 ) . Significant treatment effects ( P<0.05 ) were also found for waist circumference ( d=0.62 ) , BMI ( d=0.53 ) , systolic blood pressure ( d=0.92 ) , RHR ( d=0.66 ) and physical activity ( d=0.91 ) , but not for dietary intake . In children , significant treatment effects ( P<0.05 ) were found for physical activity ( d=0.74 ) , RHR ( d=0.51 ) and dietary intake ( d=0.84 ) . Conclusion : The HDHK program result ed in significant weight loss and improved health-related outcomes in fathers and improved eating and physical activity among children . Targeting fathers is a novel and efficacious approach to improving health behavior in their children OBJECTIVES To evaluate a self-regulation intervention for asthma for older adults . DESIGN A blinded r and omized controlled trial . SETTING Single-center tertiary care academic center . PARTICIPANTS Seventy older adults aged 65 and older with persistent asthma r and omized to an intervention or control group . INTERVENTION Participants participate in a six-session program conducted over the telephone and in group sessions . Participants selected an asthma-specific goal , identified problems , and addressed potential barriers . MEASUREMENTS Outcomes were assessed at 1 , 6 , and 12 months and included the mini-Asthma Quality of Life Question naire ( mAQLQ ) , Asthma Control Question naire ( ACQ ) , healthcare utilization , exhaled nitric oxide ( FENO ) , and percentage of predicted forced expiratory volume in 1 second ( FEV1 % ) . RESULTS The mAQLQ score was significantly higher in the intervention group at 1 , 6 , and 12 months , even after controlling for confounding factors . The between-group difference decreased over time , although at 12 months , it remained greater than 0.5 points . The ACQ was better in the intervention group than in the control group at 1 , 6 , and 12 months . At 12 months , those in the intervention group were 4.2 times as likely as those in the control group to have an ACQ score in the controlled range . Healthcare utilization was lower in the intervention group , although no difference was observed in FENO or predicted FEV1 % . CONCLUSION A self-regulation intervention can improve asthma control , quality of life , and healthcare utilization in older adults BACKGROUND Patients who have completed Phase II cardiac rehabilitation have low rates of maintenance of exercise after program completion , despite the importance of sustaining regular exercise to prevent future cardiac events . PURPOSE The efficacy of a home-based intervention to support exercise maintenance among patients who had completed Phase II cardiac rehabilitation versus contact control was evaluated . DESIGN An RCT was used to evaluate the intervention . Data were collected in 2005 - 2010 and analyzed in 2010 . SETTING / PARTICIPANTS One hundred thirty patients ( mean age=63.6 years [ SD=9.7 ] , 20.8 % female ) were r and omized to exercise counseling ( Maintenance Counseling group , n=64 ) or contact control ( Contact Control group , n=66 ) . INTERVENTION Maintenance Counseling group participants received a 6-month program of exercise counseling ( based on the transtheoretical model and social cognitive theory ) delivered via telephone , as well as print material s and feedback reports . MAIN OUTCOME MEASURES Assessment s of physical activity ( 7-Day Physical Activity Recall ) , motivational readiness for exercise , lipids , and physical functioning were conducted at baseline , 6 months , and 12 months . Objective accelerometer data were collected at the same time points . Fitness was assessed via maximal exercise stress tests at baseline and 6 months . RESULTS The Maintenance Counseling group reported significantly higher exercise participation than the Contact Control group at 12 months ( difference of 80 minutes , 95 % CI=22 , 137 ) . Group differences in exercise at 6 months were nonsignificant . The intervention significantly increased the probability of participants ' exercising at or above physical activity guidelines and attenuated regression in motivational readiness versus the Contact Control Group at 6 and 12 months . Self-reported physical functioning was significantly higher in the Maintenance Counseling group at 12 months . No group differences were seen in fitness at 6 months or lipid measures at 6 and 12 months . CONCLUSIONS A telephone-based intervention can help maintain exercise , prevent regression in motivational readiness for exercise , and improve physical functioning in this patient population AIMS This paper is a report on the effectiveness of a self-management programme based on the self-efficacy construct , in older people with heart failure . BACKGROUND Heart failure is a major health problem worldwide , with high mortality and morbidity , making it a leading cause of hospitalization . Heart failure is associated with a complex set of symptoms that arise from problems in fluid and sodium retention . Hence , managing salt and fluid intake is important and can be enhanced by improving patients ' self-efficacy in changing their behaviour . DESIGN R and omized controlled trial . METHODS Heart failure patients attending cardiac clinics in northern Taiwan from October 2006-May 2007 were r and omly assigned to two groups : control ( n = 46 ) and intervention ( n = 47 ) . The intervention group received a 12-week self-management programme that emphasized self-monitoring of salt/fluid intake and heart failure-related symptoms . Data were collected at baseline as well as 4 and 12 weeks later . Data analysis to test the hypotheses used repeated- measures anova models . RESULTS Participants who received the intervention programme had significantly better self-efficacy for salt and fluid control , self-management behaviour and their heart failure-related symptoms were significantly lower than participants in the control group . However , the two groups did not differ significantly in health service use . CONCLUSION The self-management programme improved self-efficacy for salt and fluid control , self-management behaviours , and decreased heart failure-related symptoms in older Taiwanese out patients with heart failure . Nursing interventions to improve health-related outcomes for patients with heart failure should emphasize self-efficacy in the self-management of their disease Background The development and use of Web-based programs for weight loss is increasing rapidly , yet they have rarely been evaluated using r and omized controlled trials ( RCTs ) . Interestingly , most people who attempt weight loss use commercially available programs , yet it is very uncommon for commercial programs to be evaluated independently or rigorously . Objective To compare the efficacy of a st and ard commercial Web-based weight-loss program ( basic ) versus an enhanced version of this Web program that provided additional personalized e-feedback and contact from the provider ( enhanced ) versus a wait-list control group ( control ) on weight outcomes in overweight and obese adults . Methods This purely Web-based trial using a closed online user group was an assessor-blinded RCT with participants r and omly allocated to the basic or enhanced 12-week Web-based program , based on social cognitive theory , or the control , with body mass index ( BMI ) as the primary outcome . Results We enrolled 309 adults ( 129/309 , 41.8 % male , BMI mean 32.3 , SD 4 kg/m2 ) with 84.1 % ( 260/309 ) retention at 12 weeks . Intention-to-treat analysis showed that both intervention groups reduced their BMI compared with the controls ( basic : –0.72 , SD 1.1 kg/m2 , enhanced : –1.0 , SD 1.4 , control : 0.15 , SD 0.82 ; P < .001 ) and lost significant weight ( basic : –2.1 , SD 3.3 kg , enhanced : –3.0 , SD 4.1 , control : 0.4 , SD 2.3 ; P < .001 ) with changes in waist circumference ( basic : –2.0 , SD 3.5 cm , enhanced : –3.2 , SD 4.7 , control : 0.5 , SD 3.0 ; P < .001 ) and waist-to-height ratio ( basic : –0.01 , SD 0.02 , enhanced : –0.02 , SD 0.03 , control : 0.0 , SD 0.02 ; P < .001 ) , but no differences were observed between the basic and enhanced groups . The addition of personalized e-feedback and contact provided limited additional benefits compared with the basic program . Conclusions A commercial Web-based weight-loss program can be efficacious across a range of weight-related outcomes and lifestyle behaviors and achieve clinical ly important weight loss . Although the provision of additional personalized feedback did not facilitate greater weight loss after 12 weeks , the impact of superior participant retention on longer-term outcomes requires further study . Further research is required to determine the optimal mix of program features that lead to the biggest treatment impact over time . Trial Registration Australian New Zeal and Clinical Trials Registry ( ANZCTR ) : 12610000197033 ; http://www.anzctr.org.au/trial_view.aspx?id=335159 ( Archived by WebCite at http://www.webcitation.org/66Wq0Yb7U BACKGROUND Obesity , a disorder associated with a myriad of comorbidities , is increasing at an alarming rate around the world . Given that pharmacotherapy has limited available options and that bariatric surgery is reserved for those who are morbidly obese or who have significant comorbidities , the most common approach to the treatment of obesity is st and ard behavioral treatment . This approach includes behavior modification related to eating and activity habits . The purpose of this paper is to describe the rationale , design , methods and baseline sample characteristics of a r and omized controlled trial of a behavioral intervention in weight loss management , referred to as the PREFER study . METHODS The PREFER study , using a four-group design , includes : ( 1 ) a r and omization scheme that permits participants to indicate a preferred dietary treatment approach , and ( 2 ) two dietary options , one of which is a lacto-ovo-vegetarian diet that has demonstrated potential for long-term adherence . The intervention ( 32 treatment sessions ) is delivered over 12 months and is followed by a 6-month maintenance phase ; final assessment occurs at 18 months . RESULTS We screened 932 individuals and r and omized 197 to the study : Treatment Preference-Yes ( n=84 ) and Treatment Preference-No ( n=98 ) . To maintain a balance across the four treatment groups , 15 subjects who preferred the st and ard diet had to be discarded from the Treatment Preference-Yes group . Retention at 18 months for the first of three cohorts was 82 % . CONCLUSIONS The PREFER study is a single center study and is the first r and omized controlled trial examining a lacto-ovo-vegetarian diet as part of weight loss treatment . The ethnically diverse sample includes males and females with a body mass index of 27 to 43 . The study has the potential to make a contribution to underst and ing the role of treatment preference and the potential of a lacto-ovo-vegetarian diet for long-term weight loss OBJECTIVE To determine the effectiveness of a pedometer-based telephone intervention on the physical activity levels of cardiac patients who did not attend a CRP . METHODS A r and omised controlled trial was conducted with 215 patients referred to a CRP but who could not or chose not to attend . The 6-week intervention included self-monitoring of physical activity using a pedometer and step calendar ; and behavioural counselling and goal setting sessions . Data were collected at baseline , 6 weeks and 6 months . RESULTS Study groups did not differ significantly at baseline . After 6 weeks , improvements in total physical activity time ( p=0.027 ) , total physical activity sessions ( p=0.003 ) , walking time ( p=0.013 ) and walking sessions ( p=0.002 ) in the intervention group were significantly greater than the control group after adjusting for baseline differences , and remained significant at 6 months . CONCLUSION The findings that the pedometer-based telephone intervention was successful in increasing physical activity levels in cardiac patients who did not attend a CRP could result in major health benefits for this group of people . PRACTICAL IMPLICATION S The pedometer-based telephone intervention could be offered as an effective and accessible option for patients not attending a CRP to increase and maintain their physical activity levels after hospitalisation Although Phase II Cardiac Rehabilitation ( CR ) is effective at reconditioning people following cardiac events , it has had limited effectiveness in assisting participants to maintain the long-term exercise necessary for secondary prevention of cardiovascular events . This article describes a promising new intervention , CHANGE ( Change Habits by Applying New Goals and Experiences ) , design ed to enhance individuals ' problem solving , self-efficacy , and relapse prevention skills regarding long-term exercise . Five small-group ,  nurse-led sessions  are used to provide the intervention during the last three weeks of the formal CR program , and at one and two months following CR . Pilot data indicate that the CHANGE intervention has a positive effect on number and length of exercise sessions , number of minutes exercised , and time spent in target heart rate ( HR ) zone as measured by wristwatch HR monitors for three months following CR . The CHANGE intervention was found to be acceptable to clients and feasible to clinicians BACKGROUND Women with asthma have greater  mortality and morbidity than men in the United States . To date , there has been no rigorous evaluation of an intervention focused on the particular problems in asthma management faced by women . This study was a r and omized clinical trial of a self-regulation , telephone counseling intervention emphasizing women 's concerns , and sex and gender role factors in their management of asthma . METHODS A total of 808 women with diagnosed asthma were r and omly assigned to the intervention group or a usual-care control group , including conventional asthma education . Interviews and medical record data were collected to assess psychosocial factors , and the behavioral factors of functioning , quality of life , symptoms , and health-care use at baseline and the subsequent 1 year . Generalized estimating equations , identity link , logit link , and log link were employed to analyze the data . RESULTS Compared to control subjects , the women receiving treatment had greater annual reductions in the average number of nights with asthma symptoms ( p = 0.04 ) , days of missed work/school ( p = 0.03 ) , emergency department visits ( p = 0.04 ) , unscheduled office visits ( p = 0.01 ) , and scheduled office visits ( p = 0.04 ) . They had greater recognition of asthma symptoms during the menstrual cycle ( p = 0.0003 ) , had decreased asthma symptoms with sexual activity ( p = 0.008 ) , and had greater improvement in quality of life ( p = 0.0005 ) , self-regulation ( p = 0.03 ) , and self-confidence to manage asthma ( p = 0.001 ) . CONCLUSION The intervention improved women 's clinical status , functioning , quality of life , and health-care use . A program with a focus on asthma management problems particular to women can significantly assist female asthma patients PURPOSE To test the hypothesis that compared with the control group , 7 through 11-year-old children with persistent asthma who received asthma education plus a contingency management behavioral protocol  would show higher adherence to peak expiratory flow ( PEF ) monitoring for asthma self-management and would report fewer asthma episodes . DESIGN AND METHODS A r and omized , controlled trial was conducted with 77 children with persistent asthma in a southeastern U.S. state . Both the intervention and control groups received instruction on PEF monitoring . Only the intervention group received asthma education plus contingency management , based on cognitive social learning theory , including self-monitoring , a contingency contract , tailoring , cueing , and reinforcement . At-home adherence to daily PEF monitoring during the 16-week study was assessed with the AccuTrax Personal Diary Spirometer  , a computerized h and -held meter . Adherence was measured as a percentage of prescribed daily PEF uses at Weeks 4 ( baseline ) , 8 ( postintervention ) , and 16 ( maintenance ) . RESULTS At the end of the baseline period , the groups did not differ in adherence to daily PEF monitoring nor at Week 8 . At Week 16 , the intervention group 's adherence for daily electronically monitored PEF was higher than that of the control group . Children in either group who were > or= 80 % adherent to at least once-daily PEF monitoring during the last week of the maintenance period ( weeks 8 to 16 ) were less likely to have an asthma episode during this period compared with those who were less adherent . CONCLUSIONS The intervention to teach children to adhere to the recommended regimen for managing their asthma at home was effective OBJECTIVE To assess the effect of a program of supervised fitness walking and patient education on functional status , pain , and use of medication in patients with osteoarthritis of the knee . DESIGN An 8-week r and omized , controlled trial . SETTING Inpatient and outpatient services of an orthopedic hospital in an academic medical center . PATIENTS A total of 102 patients with a documented diagnosis of primary osteoarthritis of one or both knees participated in the study . Data were obtained on 47 of 51 intervention patients and 45 of 51 control patients . INTERVENTIONS An 8-week program of supervised fitness walking and patient education or st and ard routine medical care . MEASUREMENTS Patients were evaluated and outcomes assessed before and after the intervention using a 6-minute test of walking distance and scores on the physical activity , arthritis impact , pain , and medication subscales of the Arthritis Impact Measurement Scale ( AIMS ) . RESULTS Patients r and omly assigned to the walking program had a 70-meter increase in walking distance relative to their baseline assessment , which represents an improvement of 18.4 % ( 95 % Cl , 9.8 % to 27.0 % ) . In contrast , controls showed a 17-meter decrease in walking distance relative to their baseline assessment ( P less than 0.001 ) . Improvements in functional status as measured by the AIMS physical activity subscale were also observed in the walking group but not in the control group ( P less than 0.001 ) ; patients assigned to the walking program improved 39 % ( Cl , 15.6 % to 60.4 % ) . Although changes in scores on the arthritis impact subscale were similar in the two groups ( P = 0.093 ) , the walking group experienced a decrease in arthritis pain of 27 % ( Cl , 9.6 % to 41.4 % ) ( P = 0.003 ) . Medication use was less frequent in the walking group than in the control group at the post-test ( P = 0.08 ) . CONCLUSIONS A program of supervised fitness walking and patient education can improve functional status without worsening pain or exacerbating arthritis-related symptoms in patients with osteoarthritis of the knee R and omised controlled trials are widely accepted as the most reliable method of determining effectiveness , but most trials have evaluated the effects of a single intervention such as a drug . Recognition is increasing that other , non-pharmacological interventions should also be rigorously evaluated.1 - 3 This paper examines the design and execution of research required to address the additional problems result ing from evaluation of complex interventions —that is , those “ made up of various interconnecting parts.”4 The issues dealt with are discussed in a longer Medical Research Council paper ( www.mrc.ac.uk/complex_packages.html ) . We focus on r and omised trials but believe that this approach could be adapted to other design s when they are more appropriate . # # # # Summary points Complex interventions are those that include several components The evaluation of complex interventions is difficult because of problems of developing , identifying , documenting , and reproducing the intervention A phased approach to the development and evaluation of complex interventions is proposed to help research ers define clearly where they are in the research process Evaluation of complex interventions requires use of qualitative and quantitative evidence There are specific difficulties in defining , developing , documenting , and reproducing complex interventions that are subject to more variation than a drug . A typical example would be the design of a trial to evaluate the  benefits of specialist stroke units .  Such a trial would have to consider the expertise of various health professionals as well as investigations , drugs , treatment guidelines , and arrangements for discharge and follow up . Stroke units may also vary in terms of organisation , management , and skill mix . The active components of the stroke unit may be difficult to specify , making it difficult to replicate the intervention . The box gives other examples of complex interventions . # # # # Examples of complex interventions Service delivery and organisation : Stroke units Hospital at home Interventions directed at health professionals ' behaviour : Strategies for implementing guidelines Computerised decision support Community interventions : Community BACKGROUND To improve methods for long-term weight management , the Weight Loss Maintenance ( WLM ) trial , a four-center r and omized trial , was conducted to compare alternative strategies for maintaining weight loss over a 30-month period . This paper describes methods and results for the initial 6-month weight-loss program ( Phase I ) . METHODS Eligible adults were aged > or = 25 , overweight or obese ( BMI = 25 - 45 kg/m2 ) , and on medications for hypertension and /or dyslipidemia . Anthropomorphic , demographic , and psychosocial measures were collected at baseline and 6 months . Participants ( n=1685 ) attended 20 weekly group sessions to encourage calorie restriction , moderate-intensity physical activity , and the DASH ( dietary approaches to stop hypertension ) dietary pattern . Weight-loss predictors with missing data were replaced by multiple imputation . RESULTS Participants were 44 % African American and 67 % women ; 79 % were obese ( BMI > or = 30 ) , 87 % were taking anti-hypertensive medications , and 38 % were taking antidyslipidemia medications . Participants attended an average of 72 % of 20 group sessions . They self-reported 117 minutes of moderate-intensity physical activity per week , kept 3.7 daily food records per week , and consumed 2.9 servings of fruits and vegetables per day . The Phase-I follow-up rate was 92 % . Mean ( SD ) weight change was -5.8 kg ( 4.4 ) , and 69 % lost at least 4 kg . All race-gender subgroups lost substantial weight :  African-American men ( -5.4 kg + /- 7.7 ) ; African-American women ( -4.1 kg + /- 2.9 ) ; non-African-American men ( -8.5 kg + /- 12.9 ) ; and non-African-American women ( -5.8 kg + /- 6.1 ) . Behavioral measures ( e.g. , diet records and physical activity ) accounted for most of the weight-loss variation , although the association between behavioral measures and weight loss differed by race and gender groups . CONCLUSIONS The WLM behavioral intervention successfully achieved clinical ly significant short-term weight loss in a diverse population of high-risk patients To evaluate the effectiveness of a comprehensive asthma management education program for 7- to 12-year-old children with asthma , entitled Roaring Adventures of Puff ( RAP ) , 18 elementary schools in Edmonton were r and omized to intervention and control groups . Participating in the program were 76 students with asthma in the intervention schools and 86 in the control schools . Children in the intervention schools had statistically significant improvements in unscheduled doctor visits , missed school days , moderate-to-severe parent rating of severity , severity of shortness of breath , limitations in the kind of play , and correct use of medications . Unscheduled doctor visits and missed school days were the only significant improvements in the control group ; however , improvements were about half that of the intervention group . The results showed that a comprehensive , school-based asthma education program is feasible and improves outcomes The aim of this study was to evaluate the efficacy of an Internet-based weight-loss program  for men in an assessor blinded r and omized controlled trial . In total , 65 overweight/obese male staff and students at the University of Newcastle ( mean ( s.d . ) age = 35.9 ( 11.1 ) years ; BMI = 30.6 ( 2.8 ) ) were r and omly assigned to either ( i ) Internet group ( n = 34 ) or ( ii ) control group ( information only ) ( n = 31 ) . Both groups received one face-to-face information session and a program booklet . Internet group participants used the study website to self-monitor diet and activity with feedback provided based on participants ' online entries on seven occasions over 3 months . Participants were assessed at baseline , 3- , and 6-month follow-up for weight , waist circumference , BMI , blood pressure , resting heart rate , objective ly measured physical activity , and self-reported total daily kilojoules . Intention-to-treat analysis revealed significant weight loss of 5.3 kg ( 95 % confidence interval ( CI ) : -7.3 , -3.3 ) at 6 months for the Internet group and 3.5 kg ( 95 % CI : -5.5 , -1.4 ) for the control group . A significant time effect was found for all outcomes but no between-group differences . Per- protocol analysis revealed a significant group-by-time interaction ( P < 0.001 ) , with compliers losing more weight at 6 months ( -9.1 kg ; 95 % CI -11.8 , -6.5 ) than noncompliers ( -2.7 kg ; 95 % CI -5.3 , -0.01 ) and the control group ( -4.2 kg ; 95 % CI -6.2 , -2.2 ) . Simple weight-loss interventions can be effective in achieving statistically and clinical ly significant weight loss in men . The Internet is a feasible and effective medium for weight loss in men but strategies need to be explored to improve engagement in online programs
BACKGROUND Theory is often recommended as a framework for guiding hypothesized mechanisms of treatment effect .
However , there is limited guidance about how to use theory in intervention development .
METHODS We conducted a systematic review to provide an exemplar review evaluating the extent to which use of theory is identified and incorporated within existing interventions .