Translating the Diabetes Prevention Program: a comprehensive model for prevention training and program delivery. Baseline reach and adoption characteristics in a randomized controlled trial of two weight loss interventions translated into primary care: a structured report of real-world applicability. Implementing a diabetes prevention program in a rural African-American church. Sex Differences in Diabetes Risk and the Effect of Intensive Lifestyle Modification in the Diabetes Prevention Program A High-Carbohydrate, High-Fiber, Low-Fat Diet Results in Weight Loss among Adults at High Risk of Type 2 Diabetes. The healthy living partnerships to prevent diabetes and the diabetes prevention program: a comparison of year 1 and 2 intervention results Examination of costs for a lay health educator-delivered translation of the Diabetes Prevention Program in senior centers. Translating the Diabetes Prevention Program lifestyle intervention for weight loss into primary care: a randomized trial. The Cost-Effectiveness of Lifestyle Modification or Metformin in Preventing Type 2 Diabetes in Adults with Impaired Glucose Tolerance The cost-effectiveness of diabetes prevention: results from the Diabetes Prevention Program and the Diabetes Prevention Program Outcomes Study 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Healthy Living Partnerships to Prevent Diabetes (HELP PD): design and methods. Design of a cluster-randomized controlled trial of a diabetes prevention program within African-American churches: The Fit Body and Soul study. Two-year weight-loss maintenance in primary care-based Diabetes Prevention Program lifestyle interventions Genetic Predisposition to Weight Loss and Regain With Lifestyle Intervention: Analyses From the Diabetes Prevention Program and the Look AHEAD Randomized Controlled Trials Long-Term Weight Loss With Metformin or Lifestyle Intervention in the Diabetes Prevention Program Outcomes Study The 2 x 2 factorial design: its application to a randomized trial of aspirin and carotene in U.S. physicians. Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial Achieving weight and activity goals among diabetes prevention program lifestyle participants. Methodology of a diabetes prevention translational research project utilizing a community-academic partnership for implementation in an underserved Latino community Effective Translation of an Intensive Lifestyle Intervention for Hispanic Women With Prediabetes in a Community Health Center Setting Regression From Pre-Diabetes to Normal Glucose Regulation in the Diabetes Prevention Program Long-term Effects of Lifestyle Intervention or Metformin on Diabetes Development and Microvascular Complications: the DPP Outcomes Study
BACKGROUND The Diabetes Prevention Program ( DPP ) demonstrated that lifestyle intervention reduces risk for type 2 diabetes and the metabolic syndrome . A universal framework for translation of multiple aspects of the DPP intervention , including training , support , and evaluation is needed to enhance treatment fidelity in a variety of setting s. PURPOSE This study aims to develop a comprehensive model for diabetes prevention translation using a modified DPP lifestyle intervention . METHODS The DPP lifestyle intervention was adapted to a 12-session group-based program called Group Lifestyle Balance for implementation in the community setting . A model for training and support mirroring that of the DPP was developed for prevention professionals administering the program . The process of training/support and program implementation was evaluated for feasibility and effectiveness using a nonr and omized prospect i ve design in two phases ( N=51 , Phase 1 : 2005 - 2006 ; N=42 , Phase 2 : 2007 - 2009 ; data analysis completed 2008 - 2009 ) . A total of 93 nondiabetic individuals with BMI > or=25 kg/m(2 ) and the metabolic syndrome or prediabetes participated . Measures were collected at baseline and post-intervention for all and 6 and 12 months post-intervention for Phase 2 . RESULTS Significant decreases in weight , waist circumference , and BMI were noted in both phases from baseline . Participants in Phase 2 also demonstrated decreases in total cholesterol , non-HDL cholesterol , and systolic and diastolic blood pressure that were maintained at 12 months . Average combined weight loss for both groups over the course of the 3-month intervention was 7.4 pounds ( 3.5 % relative loss , p<0.001 ) ; 23.8 % and 52.2 % of those who completed the program reached 7 % and 5 % weight loss , respectively . More than 80 % of those achieving 7 % weight loss in the Phase-2 group maintained their weight loss at 6 months . CONCLUSIONS A comprehensive diabetes prevention model for training , intervention delivery , and support was shown to be successful and was effective in reducing diabetes and cardiovascular disease risk factors in this group of high-risk individuals BACKGROUND Although the Diabetes Prevention Program ( DPP ) lifestyle intervention reduced type 2 diabetes incidence by 58 % among high-risk adults at academic centers , it requires translation into typical primary care setting s. Using baseline data from the Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care ( E-LITE ) r and omized controlled trial , we evaluated the potential of its two DPP-based interventions to reach their target population s and be adopted into routine use . METHODS Overweight/obese adults with increased cardiometabolic risk enrolled from one primary care clinic . Using the RE- AIM ( Reach , Effectiveness , Adoption , Implementation , Maintenance ) model , we assessed reach with data on patient identification , participation , and representativeness , and adoption with data on intervention feasibility and potential for organizational diffusion . RESULTS The target population was identified by search ing electronic health records . Contact was attempted for 2391 patients who completed initial screening by phone ( 56 % uptake ) or online ( 44 % ) . Most ( 88 % ) of those screened ineligible were not within the target population ; 12 % were excluded because of research requirements . Conservatively estimated participation rate was 44 % . Participants ( n=241 ) included 54 % men and had a mean ( SD ) age of 52.9 years ( 10.6 ) and body mass index of 32 kg/m(2 ) ( 5.4 ) . Regarding adoption , all clinic physicians agreed to participate . The feasibility of intervention implementation and dissemination was enhanced by leveraging existing intervention , training , and primary care re sources . CONCLUSIONS E-LITE 's lifestyle interventions had fair-to-good potential for primary care reach and adoption . Our trial evidence and structured reporting may inform real-world implementation of translational trials by health networks , physicians , and payers OBJECTIVES The purpose of this study was to determine the feasibility of implementing a diabetes prevention program ( DPP ) in a rural African-American church . METHODS A six-session DPP , modeled after the successful National Institutes of Health ( NIH ) DPP , was implemented in a rural African-American church . Adult members of the church identified as high risk for diabetes , based on results of a risk question naire , were screened with a fasting glucose . Persons with prediabetes , a fasting glucose of 100 - 125 mg/dL , participated in the six-session , Lifestyle Balance Church DPP . The primary outcomes were attendance rates and changes in fasting glucose , weight and body mass index measured at baseline , six- and 12-month follow-up . RESULTS Ninety-nine adult church members were screened for diabetes risk . Eleven had impaired fasting glucose .  Ten of 11 participated in the six-session intervention , for an attendance rate of 78 % . After the intervention and 12-month follow-up , there was a mean weight loss of 7.9 lbs and 10.6 lbs , respectively . CONCLUSIONS This pilot project suggests that a modified six-session DPP can be translated to a group format and successfully implemented in a church setting . Further r and omized studies are needed to determine the effectiveness of such an intervention OBJECTIVE —In participants of the Diabetes Prevention Program ( DPP ) r and omized to intensive lifestyle modification ( ILS ) , meeting ILS goals strongly correlated with prevention of diabetes in the group as a whole . Men met significantly more ILS goals than women but had a similar incidence of diabetes . Therefore , we explored sex differences in risk factors for diabetes and the effect of ILS on risk factors . RESEARCH DESIGN AND METHODS —Baseline risk factors for diabetes and percent change in risk factors over the first year in men versus women were compared using Wilcoxon 's rank-sum tests . RESULTS —At baseline , men were older and had a larger waist circumference ; higher fasting plasma glucose concentration , caloric intake , and blood pressure ; and lower HDL cholesterol and corrected insulin response than women , who were less physically active and had a higher BMI ( P < 0.01 for all comparisons ) . Over the first year of the DPP , no sex difference in risk factors for diabetes was observed for those who lost <3 % body weight . Weight loss of 3–7 % body weight yielded greater decreases in 2-h glucose ( P < 0.01 ) , insulin concentration ( P < 0.04 ) , and insulin resistance ( P < 0.03 ) in men than in women . Weight loss of > 7 % body weight result ed in greater decreases in 2-h glucose ( P < 0.01 ) , triglyceride level ( P < 0.01 ) , and A1C ( P < 0.03 ) in men than in women . CONCLUSIONS —Weight loss > 3 % body weight yielded greater reduction in risk factors for diabetes in men than in women . Despite the more favorable effects of ILS in men , baseline risk factors were more numerous in men and likely obscured any sex difference in incident diabetes Background : Weight loss is a key factor in reducing diabetes risk . The Diabetes Prevention Program ( DPP ) is a completed clinical trial that r and omly assigned individuals at high risk of diabetes to a placebo ( PLBO ) , metformin ( MET ) , or intensive lifestyle intervention ( ILS ) group , which included physical activity ( PA ) and reduced dietary fat intake . Objective : We aim ed to evaluate the associations between diet and weight at baseline and to identify specific dietary factors that predicted weight loss among DPP participants . Methods : Diet was assessed by a food frequency question naire . The associations between intakes of macronutrients and various food groups and body weight among DPP participants at baseline were assessed by linear regression , adjusted for race/ethnicity , age , sex , calorie intake , and PA . Models that predicted weight loss at year 1 were adjusted for baseline weight , change in calorie intake , and change in PA and stratified by treatment allocation ( MET , ILS , and PLBO ) . All results are presented as estimates ± SEs . Results : A total of 3234 participants were enrolled in the DPP ; 2924 had completed dietary data ( 67.5 % women ; mean age : 50.6 ± 10.7 y ) . Adjusted for calorie intake , baseline weight was negatively associated with carbohydrate intake ( -1.14 ± 0.18 kg body weight/100 kcal carbohydrate , P < 0.0001 ) and , specifically , dietary fiber ( -1.26 ± 0.28 kg/5 g fiber , P < 0.0001 ) . Baseline weight was positively associated with total fat ( 1.25 ± 0.21 kg/100 kcal , P < 0.0001 ) , saturated fat ( 1.96 ± 0.46 kg/100 kcal , P < 0.0001 ) , and protein ( 0.21 ± 0.05 kg/100 kcal , P < 0.0001 ) . For all groups , weight loss after 1 y was associated with increases in carbohydrate intake , specifically dietary fiber , and decreases in total fat and saturated fat intake . Conclusions : Higher carbohydrate consumption among DPP participants , specifically high-fiber carbohydrates , and lower total and saturated fat intake best predicted weight loss when adjusted for changes in calorie intake . Our results support the benefits of a high-carbohydrate , high-fiber , low-fat diet in the context of overall calorie reduction leading to weight loss , which may prevent diabetes in high-risk individuals . This trial was registered at clinical trials.gov as NCT00004992 A number of research studies have attempted to translate the behavioral lifestyle intervention delivered in the Diabetes Prevention Program ( DPP ) . To compare the active interventions of two trials , Diabetes Prevention Program DPP and Healthy Living Partnerships to Prevent Diabetes ( HELP PD ) , after 1 and 2 years of intervention . DPP included 3234 adults with prediabetes r and omized to intensive lifestyle intervention , metformin , troglitazone , or placebo .  The lifestyle intervention , professionally delivered to individuals in a clinical setting , focused on diet and increased physical activity . HELP PD , a community-based translation of DPP , included 301 adults r and omized to receive intensive lifestyle intervention or enhanced usual care .  Mean weight-losses at 1 year ( 6.9 kg in DPP , 6.4 kg in HELP PD ) and 2 years ( 5.5 kg in DPP , 4.4 kg in HELP PD ) were similar across studies . Reductions in glucose were also similar across studies at both time points ( 5.2 mg/dL in DPP and 4.1 mg/dL in HELP PD at 1 year ; 1.8 mg/dL and 1.6 mg/dL at 2 years ) . HELP PD participants achieved larger reductions in triglycerides at 1 and 2 years ( 38.4 mg/dL and 34.9 mg/dL , respectively ) than DPP participants ( 24.8 mg/dL and 22.4 mg/dL ) . High-density lipoprotein decreased in HELP PD participants at year 1 ( −0.6 mg/dL ) and increased in DPP ( 1.2 mg/dL ) but there were no significant differences in year 2 . HELP PD , a community model for diabetes prevention , was similar to DPP in reducing body weight and lowering blood glucose , both important risk factors that should be controlled to reduce risk for developing type 2 diabetes OBJECTIVE Older adults in the U.S. have high rates of obesity . Despite the demonstrated efficacy of lifestyle interventions among older adults , lifestyle interventions are not widely implemented in community setting s. Program delivery by lay health educators ( LHEs ) might support greater dissemination because of lower delivery cost and greater accessibility . We examined the costs of a LHE-delivered translation of the Diabetes Prevention Program ( DPP ) evidence -based lifestyle intervention for older adults in Arkansas senior centers . METHODS This examination of costs used data from a cluster r and omized control trial ( conducted 2008 - 2010 ) in which 7 senior centers ( 116 participants ) were r and omized to implement a LHE-delivered 12-session translation of the DPP lifestyle intervention . We compiled direct lifestyle intervention  implementation costs , including training , recruitment , material s , and ongoing intervention implementation support . Weight loss data ( at 4-month follow-up ) were collected from participants . RESULTS Participant weight loss averaged 3.7 kg at 4-months . The total estimated cost to implement the lifestyle intervention is $ 2731 per senior center , or $ 165 per participant . The implementation cost per kilogram lost is $ 45 . CONCLUSIONS A LHE-delivered DPP translation in senior centers is effective in achieving weight loss at low cost and offers promise for the dissemination of this evidence -based intervention 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 Context The Diabetes Prevention Program ( DPP ) showed that lifestyle changes or metformin effectively decreased the development of  type 2 diabetes in adults with impaired glucose tolerance . The economics of these interventions is important to policymakers . Contribution This cost-effectiveness model estimates that the DPP life-style intervention would cost society about $ 8800 and metformin would cost about $ 29900 per quality -adjusted life-year saved . While lifestyle intervention had a favorable cost-effectiveness profile at any adult age , metformin was not cost-effective after age 65 years . Implication s The cost-effectiveness of lifestyle intervention to prevent type 2 diabetes  in high-risk individuals is within the range that American society typically finds acceptable for health care interventions . The Editors During the past half century , the number of persons with diagnosed diabetes in the United States has increased 4- to 6-fold ( 1 ) . Recent large clinical trials from Asia , Europe , and North America have demonstrated that behavioral and medication interventions can delay or prevent the development of type 2 diabetes in persons with impaired glucose tolerance , which is defined by a plasma glucose level between 7.77 mmol/L ( 140 mg/dL ) and 11.04 mmol/L ( 199 mg/dL ) 2 hours after a 75-g oral glucose load ( 2 - 6 ) . The Diabetes Prevention Program ( DPP ) r and omly assigned 3234 nondiabetic persons 25 years of age or older with impaired glucose tolerance and fasting glucose levels between 5.27 mmol/L ( 95 mg/dL ) and 6.94 mmol/L ( 125 mg/dL ) to placebo ; a lifestyle-modification program with the goals of at least a 7 % weight loss and 150 minutes of physical activity per week ; or metformin , 850 mg twice daily ( 4 ) . The mean age of participants was 51 years , and the mean body mass index was 34.0 kg/m2 ; 68 % were women and 45 % were members of minority groups ( 4 ) . The average follow-up was 2.8 years . Compared with the placebo intervention , the lifestyle intervention reduced the incidence of type 2 diabetes by 58 % and the metformin intervention reduced the incidence of type 2 diabetes by 31 % ( 4 ) . We have previously described the costs of the DPP interventions and their cost-effectiveness within the 3-year trial period ( 7 , 8) . In this analysis , we project the costs , health outcomes , and cost-effectiveness of the DPP lifestyle and metformin interventions over a lifetime relative to the placebo intervention . Methods Clinical Trial The lifestyle intervention involved a healthy , low-calorie , low-fat diet and moderate physical activity , such as brisk walking . The lifestyle intervention was implemented with a 16-lesson core curriculum covering diet , exercise , and behavior modification that was taught by case managers on a one-on-one basis , followed by individual sessions ( usually monthly ) and group sessions with case managers ( 9 ) . At the end of the study , 38 % of participants in the lifestyle intervention group had lost at least 7 % of their initial body weight .  The metformin and placebo interventions were initiated at a dosage of 850 mg once a day . At 1 month , the dosage of metformin or placebo was increased to 850 mg twice daily . Case managers reinforced adherence during individual quarterly sessions ( 10 ) . At the end of the study , 72 % of participants in the metformin intervention group and 77 % of participants in the placebo intervention group took at least 80 % of the prescribed dose . All participants received st and ard lifestyle recommendations through written information and an annual 20- to 30-minute individual session that emphasized the importance of a healthy lifestyle ( 10 ) . Simulation Model We assessed the progression from impaired glucose tolerance to onset of diabetes to clinical ly diagnosed diabetes to diabetes with complications and death by using a lifetime simulation model originally developed by the Centers for Disease Control and Prevention and Research Triangle Institute International . The model has a Markov structure and includes annual transition probabilities between disease states ( 11 ) . In addition to disease progression , the model tracks costs and quality -adjusted life-years ( QALYs ) . The model has been described elsewhere ( 11 ) . For our analyses , we modified the model to include data from the DPP on progression , costs , and quality of life associated with impaired glucose tolerance , data from the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) on diabetes progression and complications , and new data on cost and quality of life associated with diabetes . A technical report describing the model is available . Supplement . Technical Report Disease Progression , Complications , and Comorbid Conditions Impaired Glucose Tolerance to Onset of Type 2 Diabetes We analyzed data from the DPP to assess the annual hazard of diabetes onset in the lifestyle , metformin , and placebo intervention groups . For patients receiving the placebo intervention , the annual hazard of diabetes onset was 10.8 per 100 person-years . At 3 years of follow-up , the risk reductions for the lifestyle and metformin interventions were 55.8 % and 29.9 % , respectively . In the base-case analysis , we assumed that the lifestyle and metformin interventions would be applied until diabetes onset and that the health and quality -of-life benefits associated with the interventions persisted until diabetes onset . Complications and Comorbid Conditions Associated with Impaired Glucose Tolerance We analyzed data from the DPP and other published sources to assess the prevalence of complications and comorbid conditions in participants with impaired glucose tolerance . At baseline , 6.0 % of DPP participants had microalbuminuria and 0.4 % had nephropathy .  The DPP did not measure peripheral neuropathy , but previous studies found that the prevalence of neuropathy in persons with impaired glucose tolerance was 74 % of that in persons with newly diagnosed type 2 diabetes ( 12 ) and 12.3 % of persons with newly diagnosed type 2 diabetes have neuropathy ( 13 ) . Therefore , we assumed that at baseline , 8.5 % of DPP participants had clinical neuropathy . At baseline , 28 % of DPP participants had hypertension , 45 % had dyslipidemia , 7 % were smokers , 1.1 % had a history of cerebrovascular disease , and 2.0 % had a history of myocardial infa rct ion . No other complications were present . We assumed that during impaired glucose tolerance , microvascular or neuropathic complications would not progress . We assumed that hypertension and dyslipidemia developed at the rates observed in the DPP . On the basis of 2 large studies ( 14 , 15 ) , we assumed that the incidences of coronary heart disease and cerebrovascular disease in patients with impaired glucose tolerance were 58 % and 56 % , respectively , of those observed in patients with type 2 diabetes . We further assumed that nondiabetes-related mortality for persons with impaired glucose tolerance was the same as for persons with diabetes ( 16 ) . Onset of Type 2 Diabetes to Clinical Diagnosis of Type 2 Diabetes In the DPP , participants were tested for diabetes every 6 months ; diabetes was diagnosed at onset . In routine clinical practice , type 2 diabetes is estimated to develop 8 to 12 years before its clinical diagnosis ( 17 , 18 ) . In our base-case analysis , we therefore assumed that a 10-year delay occurred between the onset and clinical diagnosis of diabetes . Participants in the DPP  had a mean hemoglobin A1c level of 6.4 % at the onset of diabetes . Participants in the UKPDS had a mean hemoglobin A1c of 7.1 % after a dietary run-in period but before r and omization ( 13 ) . Both DPP placebo participants and UKPDS participants received st and ard lifestyle recommendations . Accordingly , we assumed that during the 10-year interval between onset and clinical diagnosis of diabetes , patients were treated for type 2 diabetes and that hemoglobin A1c level increased at 0.07 % per year from 6.4 % to 7.1 % . Complications and Comorbid Conditions Associated with Undiagnosed Diabetes We further assumed that between onset and clinical diagnosis of diabetes , microvascular and neuropathic complications progressed slowly , such that by clinical diagnosis of type 2 diabetes , their prevalence reached the level observed in the UKPDS cohort at r and omization ( 13 , 19 , 20 ) . We assumed that blood pressure and lipid levels progressed as they did in DPP participants and that cardiovascular complications occurred as they would in type 2 diabetes according to risk factors and hemglobin A1c level ( 21 , 22 ) . Clinical Diagnosis of Type 2 Diabetes to Diabetes with Complications and Death We assumed that after clinical diagnosis , all persons with type 2 diabetes received intensive glycemic management as described in the UKPDS ( 13 ) . We modeled changes in hemoglobin A1c and diabetes treatments to reflect those observed in the UKPDS intensive therapy group . We based risk for retinopathy progression on UKPDS 38 ( 23 ) , risk for nephropathy progression on UKPDS 64 ( 20 ) , and risk for neuropathy progression on UKPDS 33 ( 13 ) . We based risk for cerebrovascular disease on UKPDS 60 ( 22 ) and risk for coronary heart disease on UKPDS 56 ( 21 ) . Costs Costs of Impaired Glucose Tolerance To estimate the total direct medical costs of impaired glucose tolerance , we considered the costs of the DPP interventions ( the cost of identifying participants , implementing and maintaining the interventions , and monitoring and treating the side effects of the interventions ) and the costs of the medical care outside the DPP ( 7 ) . In analyses from the perspective of society , we included both direct medical costs and direct nonmedical costs . We did not include indirect costs because they are captured in the assessment of QALYs ( 24 ) . Table 1 shows the total direct medical costs by treatment group , sex , and year in the DPP ( 7 ) . Costs were higher in the lifestyle and metformin interventions than in the placebo intervention and higher in women than in men . Costs decreased over time in all 3 intervention groups but after year 1 tended to decrease more in the lifestyle than Background The Diabetes Prevention Program ( DPP ) was a r and omized , controlled clinical trial . It demonstrated that among high-risk individuals with impaired glucose tolerance , diabetes incidence was reduced by 58 % with lifestyle intervention and 31 % with metformin compared to placebo . During the Diabetes Prevention Program Outcomes Study ( DPPOS ) , all DPP participants were unmasked to their treatment assignments , the original lifestyle intervention group was offered additional lifestyle support , the metformin group continued metformin , and all three groups were offered a group-implemented lifestyle intervention . Over the 10 years of combined DPP/DPPOS follow-up , diabetes incidence was reduced by 34 % in the lifestyle group and 18 % in the metformin group compared to placebo . The purpose of this article is to review and synthesize analyses published by the DPP/DPPOS Research Group that have described the cost-effectiveness of diabetes prevention . Methods We describe the re source utilization and costs of the DPP and DPPOS interventions , the costs of non-intervention-related medical care , the impact of the interventions on diabetes progression and quality -of-life , and the cost-effectiveness of the interventions from health system and societal perspectives . Cost-effectiveness analyses were performed with a 3-year time horizon using DPP data , a lifetime time horizon that simulated 3-year DPP data , and a 10-year time horizon using combined DPP/DPPOS data . Results Although more expensive than the placebo intervention , the greater costs of the lifestyle and metformin interventions were offset by reductions in the costs of nonintervention-related medical care . Every year after r and omization , quality -of-life was better for participants in the lifestyle intervention compared to those in the metformin or placebo intervention . In both the simulated lifetime analysis and the 10-year within trial economic analysis , lifestyle and metformin were extremely cost-effective ( that is , improved outcomes at a low incremental cost ) or even cost-saving ( that is , improved outcomes and reduced total costs ) compared to the placebo intervention . Conclusions The implementation of diabetes prevention programs in high-risk individuals will result in important health benefits and represents a good value for money . Trial registration NCT00004992 ( DPP ) and NCT00038727 ( DPPOS ) BACKGROUND In the 2.8 years of the Diabetes Prevention Program ( DPP ) r and omised clinical trial ,  diabetes incidence  in high-risk adults was reduced by 58 % with intensive lifestyle intervention and by 31 % with metformin , compared with placebo . We investigated the persistence of these effects in the long term . METHODS All active DPP participants were eligible for continued follow-up . 2766 of 3150 ( 88 % ) enrolled for a median additional follow-up of 5.7 years ( IQR 5.5 - 5.8 ) . 910 participants were from the lifestyle , 924 from the metformin , and 932 were from the original placebo groups .  On the basis of the benefits from the intensive lifestyle intervention in the DPP , all three groups were offered group-implemented lifestyle intervention . Metformin treatment was continued in the original metformin group ( 850 mg twice daily as tolerated ) , with participants unmasked to assignment , and the original lifestyle intervention group was offered additional lifestyle support . The primary outcome was development of diabetes according to American Diabetes Association criteria . Analysis was by intention-to-treat . This study is registered with Clinical Trials.gov , number NCT00038727 . FINDINGS During the 10.0-year ( IQR 9.0 - 10.5 ) follow-up since r and omisation to DPP , the original lifestyle group lost , then partly regained weight . The modest weight loss with metformin was maintained . Diabetes incidence rates during the DPP were 4.8 cases per 100 person-years ( 95 % CI 4.1 - 5.7 ) in the intensive lifestyle intervention group , 7.8 ( 6.8 - 8.8 ) in the metformin group , and 11.0 ( 9.8 - 12.3 ) in the placebo group . Diabetes incidence rates in this follow-up study were similar between treatment groups : 5.9 per 100 person-years ( 5.1 - 6.8 ) for lifestyle , 4.9 ( 4.2 - 5.7 ) for metformin , and 5.6 ( 4.8 - 6.5 ) for placebo . Diabetes incidence in the 10 years since DPP r and omisation was reduced by 34 % ( 24 - 42 ) in the lifestyle group and 18 % ( 7 - 28 ) in the metformin group compared with placebo . INTERPRETATION During follow-up after DPP , incidences in the former placebo and metformin groups fell to equal those in the former lifestyle group , but the cumulative incidence of diabetes remained lowest in the lifestyle group . Prevention or delay of diabetes with lifestyle intervention or metformin can persist for at least 10 years . FUNDING National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) Although the Diabetes Prevention Program ( DPP ) developed a lifestyle weight loss intervention that has been demonstrated to prevent type 2 diabetes in high-risk individuals , it has yet to be widely adopted at the community level . The Healthy Living Partnership to Prevent Diabetes study ( HELP PD ) was design ed to translate the DPP approach for use in community setting s as a cost-effective intervention led by Community Health Workers ( CHW 's ) and administered through a Diabetes Care Center ( DCC ) . Approximately 300 overweight and obese ( BMI 25 - 40 kg/m(2 ) ) individuals with prediabetes ( fasting blood glucose 95 - 124 mg/dl ) were r and omly assigned to either a lifestyle weight loss intervention ( LW ) or an enhanced usual care comparison condition ( UC ) . The goal of LW is > or=7 % weight loss achieved through increases in physical activity ( 180 min/wk ) and decreases in caloric intake ( approximately 1500 kcal/day ) . The intervention consists of CHW-led group-mediated cognitive behavioral meetings that occur weekly for 6 months and monthly thereafter for 18 months . UC consists of 2 individual meetings with a registered dietitian and a monthly newsletter . The primary outcome is change in fasting blood glucose . Secondary outcomes include cardiovascular risk factors , health-related quality of life , and social cognitive variables . Outcomes are masked and are collected every 6 months . The cost-effectiveness of the program will also be assessed . A community-based program that is administered through local DCC 's and that harnesses the experience of community members ( CHW 's ) may be a promising strategy for the widespread dissemination of interventions effective at preventing type 2 diabetes in high risk individuals Evidence from varied community setting s has shown that the Group Lifestyle Balance ( GLB ) Program and other adaptations of the Diabetes Prevention Program ( DPP ) intervention are effective in lowering diabetes risk . Most DPP data originated from studies of pre-diabetic whites , with only sparse evidence of the effect of DPP in African Americans ( AAs ) in community setting s. This paper describes the design , methods , baseline characteristics and cost effective measures , of a single-blinded , cluster-r and omized trial of a faith-based adaptation of the GLB program , Fit Body and Soul ( FBAS ) . The major aims are to test efficacy and cost utility of FBAS in twenty AA churches . R and omization occurred at the church level and 604 AA overweight/obese ( BMI ≥25kg/m(2 ) ) adults with fasting plasma glucose range from normal to pre-diabetic received either FBAS or a health-education comparison program . FBAS is a group-based , multi-level intervention delivered by trained church health advisors ( health professionals from within the church ) , with the goal of ≥7 % weight loss , achieved through increasing physical activity , healthy eating and behavior modification . The primary outcome is weight change at 12weeks post intervention . Secondary outcomes include hemoglobin A1C , fasting plasma glucose , waist circumference , blood pressure , physical activity level , quality of life measures , and cost-effectiveness . FBAS is the largest known cohort of AAs enrolled in a faith-based DPP translation . Reliance on health professionals from within the church for program implementation and the cost analysis are unique aspects of this trial . The design provides a model for faith-based DPPs and holds promise for program sustainability and widespread dissemination Objective : To investigate whether the effects on weight loss and cardiometabolic risk factor reduction of two technology-mediated lifestyle interventions for 15 months in a primary care-based translation trial sustained at 24 months ( that is , 9 months after the end of intervention ) . Design : This study analyzed data from an extended follow-up of participants in the original ‘ E-LITE ’ ( Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care)-r and omized controlled trial , which demonstrated the effectiveness of two adapted Diabetes Prevention Program ( DPP ) lifestyle interventions compared with usual primary care . Subjects : E-LITE r and omized 241 overweight or obese participants with pre-diabetes and /or metabolic syndrome to receive usual care alone  ( n=81 ) or usual care plus a coach-led ( n=79 ) or self-directed intervention ( n=81 ) . The interventions provided coach-led group behavioral weight-loss treatment or a take-home , self-directed DVD using the same 12-week curriculum , followed by 12 additional months of technology-mediated coach contact and self-monitoring support . Participants received no further intervention after month 15 . A blinded assessor conducted 24-month visits by following the measurement protocol s of the original trial . Measurements include weight and cardiometabolic risk factors ( waist circumference , fasting plasma glucose , resting blood pressure , triglycerides , high- and low-density lipoprotein cholesterol , total cholesterol and triglyceride to high-density lipoprotein cholesterol ratio ) . Results : At month 24 , mean±s.e . changes in body mass index ( trial primary outcome ) and weight ( kg ) from baseline were –1.9±0.3 ( P=0.001 ) and –5.4±0.9 ( P<0.001 ) in the coach-led intervention , and –1.6±0.3 ( P=0.03 ) and –4.5±0.9 ( P=0.001 ) in the self-directed intervention , compared with –0.9±0.3 and 2.4±0.9 in the usual care group . In addition , both interventions led to a greater percentage of participants maintaining ⩾7 % weight loss and sustained improvements in waist circumference and fasting plasma glucose levels than usual care . Conclusion : This study shows sustained benefits of the two primary care-based , technology-mediated DPP lifestyle interventions . The findings warrant replication in long-term studies involving diverse population Clinical ly relevant weight loss is achievable through lifestyle modification , but unintentional weight regain is common . We investigated whether recently discovered genetic variants affect weight loss and /or weight regain during behavioral intervention .  Participants at high-risk of type 2 diabetes ( Diabetes Prevention Program [ DPP ] ; N = 917/907 intervention/comparison ) or with type 2 diabetes ( Look AHEAD [ Action for Health in Diabetes ] ; N = 2,014/1,892 intervention/comparison ) were from two parallel arm ( lifestyle vs. comparison ) r and omized controlled trials . The associations of 91 established obesity-predisposing loci with weight loss across 4 years and with weight regain across years 2–4 after a minimum of 3 % weight loss were tested . Each copy of the minor G allele of MTIF3 rs1885988 was consistently associated with greater weight loss  following lifestyle intervention over 4 years across the DPP and Look AHEAD . No such effect was observed across comparison arms , leading to a nominally significant single nucleotide polymorphism × treatment interaction ( P = 4.3 × 10−3 ) . However , this effect was not significant at a study -wise significance level ( Bonferroni threshold P < 5.8 × 10−4 ) . Most obesity-predisposing gene variants were not associated with weight loss or regain within the DPP and Look AHEAD trials , directly or via interactions with lifestyle Overweight and obesity are strong and potentially modifiable risk factors for type 2 diabetes ( T2D ) . Prevention of T2D among persons with prediabetes is a public health priority , and weight loss plays a central role in efforts to prevent or delay the disease . Whereas excess body weight is strongly associated with insulin resistance and hyperglycemia , improved glycemia is readily noticeable when persons with overweight or obesity lose weight ; however , the health benefits of weight loss may last only when the initial weight loss persists over the long term ( 1 ) . There is clinical impetus to examine whether baseline demographic , psychosocial , or physiologic factors can help to identify more favorable long-term weight loss ( LTWL ) patterns , especially in the context of available treatments for diabetes prevention . R and omized controlled trials ( RCTs ) have shown efficacy of metformin , intensive lifestyle intervention ( ILS ) , or both in preventing or delaying onset of T2D among high-risk persons with overweight and obesity ( 2 , 3 ) . In the DPP ( Diabetes Prevention Program ) , metformin and ILS reduced risk for diabetes relative to placebo by 31 % and 58 % , respectively , over an average follow-up of 2.8 years ( 2 ) . Metformin and ILS were associated with average weight losses at 2.8 years of 2.1 and 5.6 kg , respectively , versus 0.1 kg with placebo ( 2 ) , and weight loss was the primary driver of diabetes prevention ( 4 , 5 ) . During long-term follow-up of DPP participants in its Outcomes Study ( DPPOS ) , weight changes differed among treatment groups at 10 and 15 years ( 6 , 7 ) . After achieving significantly greater initial weight loss than participants in the other groups , those in the ILS group regained about 3.5 kg over time , with a net loss of about 2 kg relative to baseline at 10 years . However , those in the metformin group achieved and maintained an average loss of about 2.5 kg , and the average weight of those in the placebo group changed by 1 kg or less during the same period ( 6 ) . The DPP and the DPPOS make up the largest and longest clinical trial of metformin for prevention of T2D . In the DPP , weight loss explained 64 % of the beneficial effect of metformin on T2D risk ( 4 ) . The primary aims of the current study were to compare differences in LTWL maintenance by original intervention group among participants who achieved clinical ly significant weight loss of at least 5 % at 1 year and to examine baseline factors that predicted maintenance of weight loss for up to 15 years . We also evaluated the effect of postbaseline factors , such as degree of initial weight loss and adherence to the r and omized interventions . Methods The DPP ( July 1996 to July 2001 ) was an RCT that compared the efficacy of ILS , metformin , and placebo in prevention of T2D among 3234 participants with elevated glucose levels and overweight or obesity . The 1997 diagnostic criteria of the American Diabetes Association ( 8) were used to establish the primary outcome of diabetes , defined as a fasting plasma glucose level of 7.0 mmol/L ( 126 mg/dL ) or higher measured semiannually or a 2-hour plasma glucose level of 11.1 mmol/L ( 200 mg/dL ) or higher after a 75-g oral glucose load measured annually , with confirmation within 6 weeks . The protocol , baseline characteristics of the sample , and primary outcomes ( including all clinical and physiologic variables examined in these analyses ) have been described previously ( 2 , 9 , 10 ) , along with minor variations in eligibility criteria . Participants were r and omly assigned to receive an individually administered ILS ( a 16-session behavior modification intervention implemented over approximately 6 to 8 months , with a goal of achieving 7 % weight loss through healthy dietary changes , reductions in intake of calories and fat , and 150 minutes of moderate-intensity physical activity [ mostly walking ] per week ) , metformin ( 850 mg twice daily ) , or placebo ( 11 ) . Both medication interventions were masked ( double-blind ) , but the ILS was not . After 6 months , participants in the ILS group continued to receive individual and group reinforcement of the behavioral intervention at least every 2 months , regardless of diabetes status , but they were referred to their primary care provider ( PCP ) for diabetes management . Those in the metformin and placebo groups continued to receive the study drug until their plasma glucose level increased to 7.8 mmol/L ( 140 mg/dL ) or higher , at which time use of the study drug was discontinued and diabetes management was transferred to their PCP . The DPP study protocol was modified in July 2001 after an average follow-up of 3.2 years . Participants were informed of the main results , and there was a 1- to 2-week metformin and placebo washout period to identify whether a short-term drug effect accounted for the diabetes risk reduction with metformin ( 12 ) . The bridge protocol ( 1 August 2001 to 31 August 2002 ) was the 13-month period between the end of the DPP and the start of long-term follow-up ( DPPOS ) . Because efficacy was established for ILS compared with metformin and placebo in the cumulative reduction in diabetes incidence during the first 3.2 years , participants in all 3 groups were offered a group-administered version of the 16-session ILS . The group intervention , which had similar content but did not include individualized problem-solving and behavior changesupport components , was implemented over a 6-month period and was usually administered by the original staff . Rates of attendance at 1 or more sessions varied by group ( 58 % in the metformin group , 40 % in the ILS group , and 57 % in the placebo group ) ( 13 ) . The DPPOS began in September 2002 and examined 2779 ( 88.5 % ) of the remaining DPP participants for diabetes incidence and development of diabetes-related complications . Although the DPPOS is ongoing , the current analysis is based on average follow-up of 15 years from baseline of the DPP using data collected annually through 2013 ( Appendix Figure 1 ) . Similar proportions of the 3 r and omized DPP groups enrolled in the DPPOS ( 6 ) . During the DPPOS , metformin was provided to the group originally assigned to it , but without masking . In addition , when hemoglobin A1c levels reached 7 % or higher , use of study metformin was discontinued and diabetes care and medication management were transferred to the participant 's PCP ( this often included prescription of metformin by the PCP ) . In the ILS and placebo groups , all diabetes care and medication management were provided by the participant 's PCP .  Metformin  use was recorded at all visits for all participants during the DPP and the DPPOS . During the DPPOS , all 3 groups were offered educational lifestyle classes 4 times per year . Twice a year , the original ILS group was offered 2 to 4 booster sessions design ed to reinforce self-management behaviors for weight and activity . Lifestyle class attendance among the groups did not exceed 20 % for any of the sessions offered during the DPPOS ( data not shown ) . In all trial phases , written informed consent was obtained from all participants and studies were approved by each center 's institutional review board . An independent data and safety monitoring board appointed by the study sponsor ( the National Institute of Diabetes and Digestive and Kidney Diseases ) oversaw the studies . Appendix Figure 1 . DPP and DPPOS study design . DPP = Diabetes Prevention Program ; DPPOS = Diabetes Prevention Program Outcomes Study . Statistical Analysis Long-term weight loss was defined at each annual examination after the first year as weight loss of at least 5 % relative to baseline . We used fixed-effects models with the assumption of normally distributed errors to estimate the percentage of weight lost over time ( SAS Proc MIXED ) and generalized estimating equation ( GEE ) models to estimate the percentage of participants with LTWL ( SAS Proc GENMOD ) among those who lost at least 5 % in the first year ( 14 ) . The fixed-effects models used a compound symmetry correlation , and the GEE models used a logit link with an exchangeable correlation structure . The primary aim was to evaluate baseline and postr and omization predictors of maintenance of weight loss among participants who achieved clinical ly significant weight loss of at least 5 % at 1 year after r and omization . Potential predictors of LTWL include the baseline variables listed in the Appendix Table as well as postr and omization measures of percentage of weight lost in the first year , meeting the ILS exercise goal at the end of the core 16-session curriculum , meeting the ILS weight loss goal of 7 % at the end of the core curriculum , total number of ILS sessions , use of PCP-prescribed metformin or study metformin at the annual visit , and diabetes status at the annual visit . Appendix Table . Baseline Characteristics of Participants With < 5 % Versus 5 % Weight Loss in the First Year Two statistical methods were used to examine predictors of LTWL . First , we used logistic regression models to evaluate potential predictors of medium-term ( 5 years ) , long-term ( 10 years ) , and very-long-term ( 15 years ) weight loss ( SAS Proc LOGISTIC ) . Second , we used GEE models ( 15 , 16 ) to examine potential predictors of LTWL across all follow-up years . The GEE models provided an average estimate of the effect of the predictor on LTWL over the course of the study ( SAS Proc GENMOD ) and used a logit link and an independent correlation to ensure proper parameter estimation ( 17 ) . For both approaches , univariate models were developed separately for each predictor variable . Multivariate models included variables that were significant ( P < 0.05 ) predictors of LTWL in the univariate analyses . Final models included only measures that remained significant in the multivariate model . Given the wide variation in the numbers of participants achieving and maintaining weight loss of at least 5 % among the intervention groups , analyses were performed within groups . The incidence of diabetes diagnosed at any time in the DPP and the DPPOS was compared between participants The 2 x 2 factorial design calls for r and omizing each participant to treatment A or B to address one question and further assignment at r and om within each group to treatment C or D to examine a second issue , permitting the simultaneous test of two different hypotheses . This design can increase the efficiency of large-scale clinical trials . The Physicians ' Health Study , a r and omized trial of  aspirin and beta-carotene among U.S. physicians , illustrates some features and potential problems in the design and analysis of a factorial trial . The most common concern , interaction between treatments , is generally an advantage rather than a limitation of this design . Although such interactions are relatively uncommon , this design provides a means to measure an effect which otherwise might not be apparent . If the interaction is sufficiently severe , however , then loss of power is possible Background Gestational diabetes mellitus ( GDM ) is defined as glucose intolerance with its onset or first recognition during pregnancy . Post-GDM women have a life-time risk exceeding 70 % of developing type 2 diabetes mellitus ( T2DM ) . Lifestyle modifications reduce the incidence of T2DM by up to 58 % for high-risk individuals . Methods / Design The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program ( MAGDA-DPP ) is a r and omized controlled trial aim ing to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women . This trial has an intervention group participating in a diabetes prevention program ( DPP ) , and a control group receiving usual care from their general practitioners during the same time period . The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals , and two follow-up telephone calls .  A total of 574 women will be recruited , with 287 in each arm . The women will undergo blood tests , anthropometric measurements , and self-reported health status , diet , physical activity , quality of life , depression , risk perception and healthcare service usage , at baseline and 12 months . At completion , primary outcome ( changes in diabetes risk ) and secondary outcome ( changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors ) will be assessed in both groups . Discussion This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women . The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population .Trial registration Australian New Zeal and Clinical Trials Registry ANZCTRN OBJECTIVE The Diabetes Prevention Program ( DPP ) showed that intensive lifestyle intervention reduced the risk of diabetes by 58 % . This paper examines demographic , psychosocial , and behavioral factors related to achieving weight loss and physical activity goals in the DPP lifestyle participants . RESEARCH METHODS AND PROCEDURES Lifestyle participants ( n = 1079 ; mean age = 50.6 , BMI = 33.9 , 68 % female , and 46 % from minority groups ) had goals of 7 % weight loss and 150 min/wk of physical activity . Goal achievement was assessed at the end of the 16-session core curriculum ( approximately week 24 ) and the final intervention visit ( mean = 3.2 years ) as a function of demographic , psychosocial , and behavioral variables . RESULTS Forty-nine percent met the weight loss goal and 74 % met the activity goal initially , while 37 % and 67 % , respectively , met these goals long-term . Men and those with lower initial BMI were more likely to meet activity but not weight loss goals .  Hispanic , Asian , and Native Americans were more likely to meet the long-term activity goals , and whites were more likely to meet the initial weight loss goal . In multivariate analyses , meeting the long-term weight loss goal and both activity goals increased with age , while psychosocial and depression measures were unrelated to goal achievement .  Dietary self-monitoring  was positively related to meeting both weight loss and activity goals , and meeting the activity goal was positively related to meeting the weight loss goal . Participants who met initial goals were 1.5 to 3.0 times more likely to meet these goals long-term . DISCUSSION Success at meeting the weight loss and activity goals increased with age . Initial success predicted long-term success . Self-monitoring and meeting activity goals were related to achieving and sustaining weight loss Background Latinos comprise the largest racial/ethnic group in the United States and have 2–3 times the prevalence of type 2 diabetes mellitus as Caucasians . Methods and design The Lawrence Latino Diabetes Prevention Project ( LLDPP ) is a community-based translational research study which aims to reduce the risk of diabetes among Latinos who have a ≥ 30 % probability of developing diabetes in the next 7.5 years per a predictive equation . The project was conducted in Lawrence , Massachusetts , a predominantly Caribbean-origin urban Latino community . Individuals were identified primarily from a community health center 's patient panel , screened for study eligibility , r and omized to either a usual care or a lifestyle intervention condition , and followed for one year . Like the efficacious Diabetes Prevention Program ( DPP ) , the LLDPP intervention targeted weight loss through dietary change and increased physical activity . However , unlike the DPP , the LLDPP intervention was less intensive , tailored to literacy needs and cultural preferences , and delivered in Spanish . The group format of the intervention ( 13 group sessions over 1 year ) was complemented by 3 individual home visits and was implemented by individuals from the community with training and supervision by a clinical research nutritionist and a behavioral psychologist . Study measures included demographics , Stern predictive equation components ( age , gender , ethnicity , fasting glucose , systolic blood pressure , HDL-cholesterol , body mass index , and family history of diabetes ) , glycosylated hemoglobin , dietary intake , physical activity , depressive symptoms , social support , quality of life , and medication use . Body weight was measured at baseline , 6-months , and one-year ; all other measures were assessed at baseline and one-year . All surveys were orally administered in Spanish . Results A community-academic partnership enabled the successful recruitment , intervention , and assessment of Latinos at risk of diabetes with a one-year study retention rate of 93%.Trial registration OBJECTIVE The Diabetes Prevention Program ( DPP ) demonstrated that weight loss from intensive lifestyle intervention ( ILI ) in adults with prediabetes could decrease progression to type 2 diabetes . Inner-city , low-income Hispanic women are at high risk for developing type 2 diabetes ; however , this type of intervention is not well established in this group . We hypothesized that a DPP intervention modified for a community health center ( CHC ) setting would decrease weight and improve metabolic measures in Hispanic women with prediabetes . RESEARCH DESIGN AND METHODS Women diagnosed with prediabetes on a screening oral glucose tolerance test were recruited from a CHC . Participants ( 90 % of whom were Hispanic ) were r and omized to either usual care ( age 43 ± 9.7 years , BMI 35.2 ± 7.3 kg/m2 ) or ILI ( age 43.8 ± 10.8 years , BMI 35.4 ± 8.5 kg/m2 ) , structured as 14 weeks of group sessions focused on food choices , behavior change , physical activity , and weight loss . One year after enrollment , 122 women repeated baseline measures . RESULTS Groups had similar baseline weight , BMI , and fasting and 2-h glucose . One year later , the ILI group had lost 3.8 kg ( 4.4 % ) , while the usual care group had gained 1.4 kg ( 1.6 % , P < 0.0001 ) . Two-hour glucose excursion decreased 15 mg/dL ( 0.85 mmol/L ) in the ILI and 1 mg/dL ( 0.07 mmol/L ) in the usual care group ( P = 0.03 ) . Significant decreases favoring the ILI group were noted in BMI , percent body fat , waist circumference , and fasting insulin . CONCLUSIONS A 14-week ILI program based on the DPP can effectively be translated into a predominantly Hispanic CHC setting , result ing in decreased weight , improved fasting insulin , and smaller glucose excursions 1 year after enrolling in the program OBJECTIVE Participants in the Diabetes Prevention Program ( DPP ) r and omized to intensive lifestyle modification  ( ILS ) or metformin had a significantly reduced incidence of diabetes compared with those r and omized to placebo , yet most were still at risk because they had pre-diabetes . We explored the effect of baseline characteristics , weight change , ILS , and metformin on regression from pre-diabetes to the lowest-risk state of normal glucose regulation ( NGR ) defined by American Diabetes Association criteria . RESEARCH DESIGN AND METHODS The DPP was a prospect i ve r and omized trial . Cox proportional hazards modeling was used to identify predictors of regression from pre-diabetes to NGR over 3 years of follow-up . RESULTS Lower baseline fasting ( hazard ratio 1.52 , P < 0.01 ) and 2-h ( 1.24 , P < 0.01 ) glucose predicted regression to NGR , as did younger age ( 1.07 , P < 0.01 ) and greater insulin secretion ( 1.09 , P = 0.04 ) .  ILS  ( 2.05 , P < 0.01 ) and weight loss ( 1.34 , P < 0.01 ) had significant and independent effects on regression . A nonsignificant trend for regression was also observed for metformin ( 1.25 , P = 0.06 ) , male sex ( 1.17 , P = 0.08 ) , and insulin sensitivity ( 1.07 , P = 0.09 ) . In those entering the study with both impaired fasting glucose ( IFG ) and impaired glucose tolerance ( IGT ) , male sex and insulin sensitivity predicted regression to isolated IFG , whereas ILS , metformin , female sex , and greater insulin secretion predicted regression to isolated IGT . CONCLUSIONS Insulin secretion , and other biologic processes retained with younger age , are key in restoring NGR in people with pre-diabetes . However , NGR may also be attained through weight loss and additional aspects of ILS Background The worldwide epidemic of type 2 diabetes requires effective prevention . We determined the long-term extent of beneficial effects of lifestyle intervention and metformin on diabetes prevention , originally demonstrated during the 3-year Diabetes Prevention Program ( DPP ) , and whether diabetes-associated microvascular complications are reduced . Methods The DPP ( 1996–2001 ) was a r and omized trial comparing an intensive lifestyle intervention or masked metformin with placebo in a cohort selected to be at very high risk to develop diabetes . All participants were offered lifestyle training at DPP-end . 2776 ( 88 % ) of the surviving DPP cohort were followed in the DPP Outcome Study ( DPPOS 2002–2013 ) and analyzed by intention-to-treat based on original DPP assignment . During DPPOS , the lifestyle group was offered lifestyle reinforcement semi-annually and the metformin group received unmasked metformin . Findings During 15 years of average follow-up , lifestyle intervention and metformin  reduced diabetes incidence rates by 27 % ( p<0.0001 ) and 18 % ( p=0.001 ) , respectively , compared with the placebo group , with declining between group differences over time . At year 15 , the cumulative incidences of diabetes were 55 , 56 and 62 % , respectively . The prevalences at study -end of the aggregate microvascular outcome , composed of nephropathy , neuropathy , and retinopathy , were not significantly different among the treatment groups ( 11–13 % ) in the total cohort . However , in women ( n=1887 ) lifestyle intervention was associated with a lower prevalence ( 8.7 % ) than in the placebo ( 11 % ) and metformin ( 11.2 % ) groups , with 21 % ( p=0.03 ) and 22 % ( p=0.02 ) reductions with lifestyle compared with placebo and metformin , respectively . Compared with participants who progressed to diabetes , those who did n’t progress had a 28 % lower prevalence of microvascular complications ( p<0.0001 ) . Interpretation Lifestyle intervention or metformin significantly reduce diabetes development over 15 years . There were no overall differences in the aggregate microvascular outcome among treatment groups ; however , those who did not progress to diabetes had a lower prevalence of microvascular complications than those who progressed . Funding National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK
Findings are subject to incomplete reporting and heterogeneity of studies included , and confounding because most included studies used pre-post study design s. CONCLUSIONS DPP lifestyle modification programs achieved clinical ly meaningful weight and cardiometabolic health improvements .
Together , these data suggest that additional value is gained from these programs , reinforcing that they are likely very cost-effective
BACKGROUND The Diabetes Prevention Program ( DPP ) study showed that weight loss in high-risk adults lowered diabetes incidence and cardiovascular disease risk .
No prior analyses have aggregated weight and cardiometabolic risk factor changes observed in studies implementing DPP interventions in non research setting s in the United States .