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. Prevention of type 2 diabetes - where is the evidence? The Sydney Diabetes Prevention Program: A community-based translational study A large-scale diabetes prevention program in real-life settings in Qingdao of China (2006-2012). Examination of costs for a lay health educator-delivered translation of the Diabetes Prevention Program in senior centers. A model of translational research for diabetes prevention in low and middle-income countries: The Diabetes Community Lifestyle Improvement Program (D-CLIP) trial. Reducing obesity among employees of a manufacturing plant: translating the Diabetes Prevention Program to the workplace. Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol Translating the Diabetes Prevention Program into an Online Social Network Ngāti and healthy: translating diabetes prevention evidence into community action Translating the Diabetes Prevention Program to Primary Care: A Pilot Study Lay health educators translate a weight-loss intervention in senior centers: a randomized controlled trial. One-Year Results of a Community-Based Translation of the Diabetes Prevention Program Japan Diabetes Outcome Intervention Trial-1(J-DOIT1), a nationwide cluster randomized trial of type 2 diabetes prevention by telephone-delivered lifestyle support for high-risk subjects detected at health checkups: rationale, design, and recruitment Community-Based Translation of the Diabetes Prevention Program’s Lifestyle Intervention in an Underserved Latino Population Translating the Diabetes Prevention Program: a comprehensive model for prevention training and program delivery. Description of an Academic Community Partnership Lifestyle Program for Lower Income Minority Adults at Risk for Diabetes Cost of a group translation of the Diabetes Prevention Program: Healthy Living Partnerships to Prevent Diabetes. Culturally adapting the prevention of diabetes and obesity in South Asians (PODOSA) trial. Examining the Psychological Pathways to Behavior Change in a Group-Based Lifestyle Program to Prevent Type 2 Diabetes The healthy living partnerships to prevent diabetes and the diabetes prevention program: a comparison of year 1 and 2 intervention results Walking away from type 2 diabetes: trial protocol of a cluster randomised controlled trial evaluating a structured education programme in those at high risk of developing type 2 diabetes PREVENT-DM Comparative Effectiveness Trial of Lifestyle Intervention and Metformin.
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 Diabetes is an “ old disease ” . The first description of diabetes written on papyrus about 3500 years ago is found in the Ebers papyrus  , which was discovered in Egypt in 1873 by the German archeologist Georg Ebers . Humans , like most mammals , may develop diabetes , if sufficient environmental exposure to physical inactivity , unhealthy diet and obesity are present . Genetic effects are important for the individual risk of type 2 diabetes ( T2D ) but twin studies have shown that the genetic effects combined explain less than 50 % of the risk of T2D ( 1 ) . Today we know almost 100 susceptibility genes associated with T2D but the relative importance of each of these genes is low ( 2 ) , and together they explain only a small part of the disease risk . Thus , genetic screening can not be used for the prediction of T2D for individuals . On the other h and , healthy lifestyle can also prevent T2D in people who are genetically at high risk , e.g. those with positive family history ( 3 ) . Thus , the importance of lifestyle factors for the development and prevention of T2D is overwhelming . The strongest evidence in medicine is considered to come from r and omized controlled trials ( RCTs ) . They are also important in providing the link to causal inference that in most observational studies can not be derived . At the same time , observational studies are necessary for the identification of factors associated with an increased or decreased risk of a disease , and for generation of hypotheses on potential means for prevention based on modifiable risk factors . Observational studies have by now identified a large number of factors that are associated with the development of T2D or with the protection against it . Most of them are related to physical activity , diet and obesity . It has also been shown unequivocally that exposures ( poor nutrition , infections , smoking , etc . ) during fetal life and early infancy result ing in insufficient development ( often shown as low birth weight ) also predict T2D later in life ( 4 ) . Traditionally , T2D has been considered to be a disease of the elderly . However , with increasing obesity and sedentary lifestyle in children , there are increasing numbers of cases of T2D already occurring at a young age in many population s ( 5 ) . In the past two decades several innovative RCTs have repeatedly shown that interventions on modifiable risk factors can reduce the incidence of diabetes in high-risk groups . The evidence has been summarized in several systematic review s and meta-analyses ( 6,7 ) . There is compelling scientific evidence from RCTs that T2D can be prevented or its onset delayed . The key for prevention is a multimodal package of lifestyle changes that is a sum outcome of dietary and physical activity behaviours . The power of lifestyle was dramatically illustrated by the Finnish Diabetes Prevention Study ( DPS ) that explicitly showed that when the study participants with impaired glucose tolerance reached all five modest lifestyle intervention targets , none of them progressed to T2D ( 8) . Importantly , lifestyle intervention lasting for 3–6 years has been shown to have a carry-over effect on T2D incidence that lasts for several years ; up to 15 in the Finnish Diabetes Prevention Study ( 9 ) and 20 years in the China Da Qing Diabetes Prevention Study ( 10 ) . The observed sustained risk reduction seems to be a result of sustained lifestyle changes , but the legacy effect of improved glycaemia during the early intervention may also have contributed to the long-term effect . The follow-up data from the Chinese study indicate moreover that vascular risks are also reduced by lifestyle management . Several prognostic question naires exist for detecting people at risk of T2D ( 11 ) . One of the screening tools with an adequately high sensitivity and specificity is the Finnish Diabetes Risk Score ( FINDRISC ) developed in Finl and ( 12 ) . The FINDRISC has been successfully implemented in the Finnish primary health care system and used also in many other countries . The FINDRISC was also tested in the Omani population and as a result a slightly modified Omani Diabetes Risk Score was developed ( 13 ) which may be a suitable screening tool for the Arab population s in the Middle East . Lifestyle interventions aim ing at translating evidence from efficacy RCTs on T2D prevention into “ real world ” intervention programmes have also been carried out in various population s. Such data were recently combined in a meta- analysis considering the relationship between intervention effectiveness and adherence to guidelines ( 14 ) . The primary meta- analysis included 22 studies with outcome data for weight loss at 12 months . The pooled result of the direct pairwise meta- analysis shows that Background Type 2 diabetes is a major public health problem in Australia with prevalence increasing in parallel with increasing obesity . Prevention is an essential component of strategies to reduce the diabetes burden . There is strong and consistent evidence from r and omised controlled trials that type 2 diabetes can be prevented or delayed through lifestyle modification which improves diet , increases physical activity and achieves weight loss in at risk people . The current challenge is to translate this evidence into routine community setting s , determine feasible and effective ways of delivering the intervention and providing on-going support to sustain successful behavioural changes . Methods / Design The Sydney Diabetes Prevention Program ( SDPP ) is a translational study which will be conducted in 1,550 participants aged 50 - 65 years ( including 100 indigenous people aged 18 years and older ) at high risk of future development of diabetes . Participants will be identified through a screening and recruitment program delivered through primary care and will be offered a community-based lifestyle modification intervention . The intervention comprises an initial individual session and three group sessions based on behaviour change principles and focuses on five goals : 5 % weight loss , 210 min/week physical activity ( aerobic and strength training exercise ) , limit dietary fat and saturated fat to less than 30 % and 10 % of energy intake respectively , and at least 15 g/1000 kcal dietary fibre . This is followed by 3-monthly contact with participants to review progress and offer ongoing lifestyle advice for 12 months . The effectiveness and costs of the program on diabetes-related risk factors will be evaluated . Main outcomes include changes in weight , physical activity , and dietary changes ( fat , saturated fat and fibre intake ) . Secondary outcomes include changes in waist circumference , fasting plasma glucose , blood pressure , lipids , quality of life , psychological well being , medication use and health service utilization . Discussion This translational study will ascertain the reach , feasibility , effectiveness and cost-effectiveness of a lifestyle modification program delivered in a community setting through primary health care . If demonstrated to be effective , it will result in recommendations for policy change and practical methods for a wider community program for preventing or delaying the onset of type 2 diabetes in high risk people AIMS Qingdao Diabetes Prevention Program aims to translate the trial experience to real-life setting s with goals to : ( 1 ) raise the public awareness of diabetes and diabetes risk factors , and promote healthy diet and physical activity ; ( 2 ) reduce the number of high-risk people developing diabetes through lifestyle counselling ; ( 3 ) early diagnosis of diabetes ; ( 4 ) evaluate the effectiveness , cost-effectiveness , feasibility , acceptability and sustainability of the programs . PROGRAM DESIGN The project 's first phase ( 2006 - 2009 ) was focused on health promotion targeting at the entire population of 1.94 million , and training of professionals ; and the second phase ( 2009 - 2012 ) on  lifestyle counselling targeting at individuals with a diabetes risk score of > or=14 . The effectiveness of the intervention and the cost-effectiveness of the program between the intervention arm ( n=8000 ) and the control arm ( n=4000 ) who are r and omly selected from the project targeting and not-targeting areas will be evaluated with the diabetes incidence as the primary outcome . Milestone achieved from 2006 to 2009 : 3993 health professionals finished training courses ; 724,130 educational booklets were distributed to families and 318,284 high-risk individuals recorded and 130,164 underwent at least one follow-up counselling session 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 AIMS The Diabetes Community Lifestyle Improvement Program ( D-CLIP ) aims to implement and evaluate in a controlled , r and omized trial the effectiveness , cost-effectiveness , and sustainability of a culturally appropriate , low-cost , and sustainable lifestyle intervention for the prevention of type 2 diabetes mellitus in India . METHODS D-CLIP , a translational research project adapted from the methods and curriculum developed and tested for efficacy in the Diabetes Prevention Program , utilizes innovated methods ( a step-wise model of diabetes prevention with lifestyle and metformin added when needed ; inclusion of individuals with isolated glucose tolerance , impaired fasting glucose , and both ; classes team-taught by professionals and trained community educators ) with the goals of increasing diabetes prevention , community acceptability , and long-term dissemination and sustainability of the program . The study outcomes are : diabetes incidence ( primary measure of effectiveness ) , cost-effectiveness , changes in anthropometric measures , plasma lipids , blood pressure , blood glucose , and HbA(1c , ) Program acceptability and sustainability will be assessed using a mixed methods approach . CONCLUSION D-CLIP , a low-cost , community-based , research program , addresses the key components of translational research and can be used as a model for prevention of chronic diseases in other low and middle-income country setting Obesity affects individuals physically and emotionally , contributing to direct and indirect employer costs . Targeted obesity interventions through the Diabetes Prevention Program Lifestyle Core Curriculum offered at the worksite could promote healthy lifestyle decisions result ing in weight improvement among overweight and obese employees . A pretest-posttest cohort design was used to evaluate changes in weight and body mass index among 35 Diabetes Prevention Program participants ; they achieved statistically significant changes in body weight ( p < .001 ) and body mass index ( p < .001 ) . As a process measure , Diabetes Prevention Program session attendance moderately correlated with weight loss ( r = .51 ; p = .002 ) . Many health care professionals , including occupational health nurses , can implement evidence -based worksite obesity interventions to support employee weight loss Background Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency . After a r and omized controlled trial of a multilingual automated telephone self-management support program ( ATSM ) improved patient-centered dimensions of diabetes care in safety net clinics , we collaborated with a nonprofit Medicaid managed care plan to translate research into practice , offering ATSM as a covered benefit and augmenting ATSM to promote medication activation . This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project ( SMARTSteps ) . Methods / Design This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English , Cantonese , or Spanish and receive care at 4 publicly-funded clinics . Through language -stratified r and omization , participants were assigned to four intervention statuses : SMARTSteps-ONLY , SMARTSteps-PLUS , or wait-list for either intervention . In addition to usual primary care , intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care , medication adherence , safety concerns , psychological issues , and preventive services . Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning . SMARTSteps-PLUS also included health coach calls to promote medication activation , adherence and intensification , if triggered by ATSM-reported non-adherence , refill non-adherence from pharmacy cl aims , or suboptimal cardiometabolic indicators . Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months . For participants who agreed to structured telephone interviews at baseline and 6 months ( n = 252 ) , primary outcomes will be changes in quality of life and functional status with secondary outcomes of 6-month changes in self-management behaviors/efficacy and patient-centered processes of care . We will also evaluate 6-month changes in cardiometabolic ( HbA1c , blood pressure , and LDL ) and utilization indicators for all participants . Discussion Outcomes will provide evidence regarding real-world implementation of ATSM within a Medicaid managed care plan serving safety net setting s. The evaluation trial will provide insight into translating and scaling up health information technology interventions for linguistically and culturally diverse vulnerable population s with chronic disease . Trial Registration Clinical Trials.gov : Purpose The purpose of this study was to evaluate the efficacy of Prevent , an online social network-based translation of the Diabetes Prevention Program ( DPP ) lifestyle intervention , against the Centers for Disease Control and Prevention ( CDC ) Diabetes Prevention and Recognition Program ( DPRP ) outcome st and ards and weight loss outcomes of other DPP translations . Methods Two hundred twenty participants previously diagnosed with prediabetes were recruited online and enrolled in Prevent , a DPP-based group lifestyle intervention that integrates a private online social network , weekly lessons , health coaching , and a wireless scale and pedometer . Participants underwent a core 16-week intensive lifestyle change intervention and were then offered to continue with a post-core lifestyle change maintenance intervention , with the entire intervention ( core plus post-core ) totaling 12 months . Results One hundred eighty-seven participants met inclusion criteria for the core program and achieved an average of 5.0 % and 4.8 % weight loss at 16 weeks and 12 months , respectively . They also had a 0.37 % reduction in their A1C level at final measurement . One hundred forty-four of these same participants also met inclusion criteria for the post-core program and achieved an average of 5.4 % and 5.2 % weight loss at 16 weeks and 12 months , respectively , and a 0.40 % reduction in A1C at final measurement . Conclusion Results indicate that Prevent meets CDC DPRP outcome st and ards for diabetes prevention programs and performs favorably to other DPP translations . Considering national initiatives to address the obesity and diabetes epidemics , online delivery platforms like Prevent offer an effective and scalable solution Introduction : Type 2 diabetes mellitus ( T2DM ) is a major health issue in New Zeal and Māori . Clinical trials have demonstrated potential for the prevention of T2DM , but whether community public health programmes aim ing to prevent diabetes are effective is untested . Objective : To describe the planning and design of an intervention aim ing to translate T2DM prevention clinical trial evidence into a community-wide population health intervention in a high risk predominantly Māori community . Approach : Community concerns about the diabetes burden were heard by the local diabetes nurse , herself a tribal member , and discussed with a locally raised academic . Project planning ensued . The intervention and its evaluation were design ed using a participatory community development model . The planned intervention had three components : community-wide health promotion initiatives conveying healthy lifestyle messages , community education and monitoring for identified high-risk individuals and their extended families , and a structural strategy aim ed at adapting local environments to support lifestyle changes . The evaluation plan involved interrupted time series surveys coupled with formative and process evaluations rather than a r and omised control trial design . Discussion : Consulting communities , validating community concerns and prioritising cultural and ethical issues were key steps . Time spent developing good relationships amongst the health provider and academic research team members at the outset proved invaluable , as the team were united in addressing the project planning and implementation challenges , such as funding obstacles that arose because of our ethically and culturally appropriate non-r and omised control trial evaluation design . The pre-intervention survey demonstrated high rates of diabetes ( 13 % ) , insulin resistance ( 33 % ) and risk factors , and provided evidence for positive , as opposed to negative , lifestyle intervention messages . Conclusion : Community-wide lifestyle interventions have the potential to reduce rates of type 2 diabetes and other chronic diseases in high-risk communities , but require a high level of commitment from the health sector and buy-in from the community . Adequate commitment , leadership , planning and re sources are essential Background : Research on the translation of efficacious lifestyle change programs to prevent type 2 diabetes into community or clinical setting s is needed . Objective : The objective of this study was to examine the reach , implementation , and efficacy of a 6-month lifestyle program implemented in primary care by nurse practitioners ( NPs ) for adults at risk of type 2 diabetes . Methods : The NP sites ( n = 4 ) were r and omized to an enhanced st and ard care program ( one  NP  and one  nutrition session ) or a lifestyle program ( enhanced st and ard care and six NP sessions ) . These NPs recruited adults at risk of diabetes from their practice ( n = 58 ) , with an acceptance rate of 70 % . Results : The program reached a diverse , obese , and moderately low income sample . The NPs were able to successfully implement the protocol s. The average length of the program was 9.3 months . Attendance was high ( 98 % ) , and attrition was low ( 12 % ) . The NPs were able to adopt the educational , behavioral , and psychosocial strategies of the intervention easily . Motivational interviewing was more difficult for NPs . Mixed-model repeated- measures analysis indicated significant trends or improvement in both groups for nutrition and exercise behavior . Participants of the lifestyle program demonstrated trends for better high-density lipoprotein ( HDL ) and exercise behavior compared with the enhanced st and ard care participants . Twenty-five percent of lifestyle participants met treatment goals of 5 % weight loss compared with 11 % of st and ard care participants . Discussion : A lifestyle program can be implemented in primary care by NPs , reach the targeted population , and be modestly successful . Further research is indicated BACKGROUND Older adults have high obesity rates and respond well to evidence -based weight-loss programs , such as the Diabetes Prevention Program ( DPP ) Lifestyle intervention . The goal of this study was to determine whether a translation of the DPP Lifestyle program delivered by lay health educators and conducted in senior centers is effective in promoting weight loss among older adults . DESIGN An RCT with older adults nested within senior centers . Senior centers identified lay health educators to receive training and deliver the intervention program at the senior center . Senior centers were r and omized to DPP Lifestyle program or an attention control intervention ( cognitive training ) . SETTING / PARTICIPANTS Senior centers ( N=15 ) located throughout Arkansas . Participants ( N=228 ) were obese ( BMI = 34.5±4.9 ) older ( aged 71.2±6.6 years ) adults able to engage in moderate exercise . Follow-up data were collected at 4 months on 93 % of the original cohort between February 2009 and July 2010 . INTERVENTIONS A 12-session translation of the Diabetes Prevention Program Lifestyle behavioral weight-control program delivered in group sessions by trained lay health educators . MAIN OUTCOME MEASURES Body weight was assessed by digital scale . Percentage weight loss from baseline and proportion achieving ≥5 % and ≥7 % weight loss were examined . Analyses were completed in March 2011 . RESULTS Participants attending senior centers r and omized to Lifestyle lost a significantly greater percentage of baseline weight ( 3.8 % , 95 % CI=2.9 % , 4.6 % ) than those in the control senior centers ( 0.2 % , 95 % CI= -0.6 % , -0.9 % ) after adjusting for baseline BMI and gender ( p<0.001 ) . Among participants attending senior centers offering the Lifestyle program , 38 % lost ≥5 % of baseline weight compared with 5 % in the control arm ( p<0.001 ) . Similarly , significantly more participants ( 24 % ) in Lifestyle senior centers lost ≥7 % than did control participants ( 3 % , p=0.001 ) . CONCLUSIONS A behavioral lifestyle weight-loss intervention delivered by a lay health educator offers a promising vehicle for translation of evidence -based obesity treatment programs in underserved areas . TRIAL REGISTRATION This study is registered at Clinical trials.govNCT01377506 OBJECTIVE Although the Diabetes Prevention Program ( DPP ) and the Finnish Diabetes Prevention Study ( FDPS ) demonstrated that weight loss from lifestyle change reduces type 2 diabetes incidence in patients with prediabetes , the translation into community setting s has been difficult . The objective of this study is to report the first-year results of a community-based translation of the DPP lifestyle weight loss ( LWL ) intervention on fasting glucose , insulin resistance , and adiposity . RESEARCH DESIGN AND METHODS We r and omly assigned 301 overweight and obese volunteers ( BMI 25–40 kg/m2 ) with fasting blood glucose values between 95 and 125 mg/dL to a group-based translation of the DPP LWL intervention administered through a diabetes education program ( DEP ) and delivered by community health workers ( CHWs ) or to an enhanced usual-care condition . CHWs were volunteers with well-controlled type 2 diabetes . A total of 42.5 % of participants were male , mean age was 57.9 years , 26 % were of a race/ethnicity other than white , and 80 % reported having an education beyond high school . The primary outcome is mean fasting glucose over 12 months of follow-up , adjusting for baseline glucose . RESULTS Compared with usual-care participants , LWL intervention participants experienced significantly greater decreases in blood glucose ( −4.3 vs. −0.4 mg/dL ; P < 0.001 ) , insulin ( −6.5 vs. −2.7 μU/mL ; P < 0.001 ) , homeostasis model assessment of insulin resistance ( −1.9 vs. −0.8 ; P < 0.001 ) , weight ( −7.1 vs. −1.4 kg ; P < 0.001 ) , BMI ( −2.1 vs. −0.3 kg/m2 ; P < 0.001 ) , and waist circumference ( −5.9 vs. −0.8 cm ; P < 0.001 ) . CONCLUSIONS This translation of the DPP intervention conducted in community setting s , administered through a DEP , and delivered by CHWs holds great promise for the prevention of diabetes by significantly decreasing glucose , insulin , and adiposity Background Lifestyle modifications are considered the most effective means of delaying or preventing the development of type 2 diabetes ( T2DM ) . To contain the growing population of T2DM , it is critical to clarify effective and efficient setting s for intervention and modalities for intervention delivery with a wide population reach . The Japan Diabetes Outcome Intervention Trial-1 ( J-DOIT1 ) is a cluster r and omized controlled trial to test whether goal -focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting . This paper describes the study design and recruitment of the study subjects . Methods For the recruitment of study subjects and their follow-up annually over 3 years , we employed health checkups conducted annually at communities and worksites . Health care divisions recruited from communities and companies across Japan formed groups as a cluster r and omization unit . C and i date s for the study , aged 20 - 65 years with fasting plasma glucose ( FPG ) of 5.6 - 6.9 mmol/l , were recruited from each group using health checkups results in 2006 .  Goal -focused lifestyle support is delivered by healthcare providers via telephone over a one-year period . Study subjects will be followed-up for three years by annual health checkups . Primary outcome is the development of diabetes defined as FPG≥7.0 mmol/l on annual health checkup or based on self-report , which is confirmed by referring to medical cards . Results Forty-three groups ( clusters ) , formed from 17 health care divisions , were r and omly assigned to an intervention arm ( 22 groups ) or control arm ( 21 clusters ) between March 2007 and February 2008 . A total of 2840 participants , 1336 from the intervention and 1504 from the control arm , were recruited .  Consent rate was about 20 % , with no difference between the intervention and control arms . There were no differences in cluster size and characteristics of cluster between the groups . There were no differences in individual characteristics between the study arms . Conclusion We have launched J-DOIT1 , a nation-wide trial to prevent the development of T2DM in high-risk individuals using telephone-delivered intervention . This trial is expected to contribute to evidence -based real-world preventive practice s . Trial registration UMIN000000662 Purpose The objective was to take prevention from the clinic to the community by including a high-risk group and working with the community to tailor , enhance , deliver , and evaluate a community-based version of the Diabetes Prevention Program ’s ( DPP ) clinic-based lifestyle intervention . Methods This was a nonr and omized prospect i ve study using a single-group design . Study eligibility included a screening glucose value in the normal to prediabetes range with no current diagnosis of diabetes , overweight , not pregnant nor planning to become pregnant during study period , aged 18 to 65 , Latino , living in the study target communities , and no reported medical restrictions related to the program goals . A total of 69 individuals participated . The Healthy Living Program ( HLP ) was based on the DPP ’s 1-year intensive lifestyle program , was tailored and enhanced for a Latino community , and was delivered by community health workers . Anthropometric and paper and pencil measures were administered to examine program outcome at 6 months and 12 months . Results In general , results indicate statistically significant improvements in anthropometrics and many behavioral outcomes , particularly at 6 months . Participants demonstrated forward movement through the stages of change during the program . Conclusions Results support the effectiveness of the intervention and show that delivery of the translated version of the DPP ’s lifestyle intervention in the community by community residents holds promise as one strategy to reach people at increased risk of developing diabetes . Use of this translation model , including collaboration with community health workers , offers diabetes educators an opportunity to extend their reach into underserved communities BACKGROUND The Diabetes Prevention Program ( DPP ) demonstrated that lifestyle intervention reduces risk for type 2 diabetes and the metabolic syndrome . A universal framework for translation of multiple aspects of the DPP intervention , including training , support , and evaluation is needed to enhance treatment fidelity in a variety of setting s. PURPOSE This study aims to develop a comprehensive model for diabetes prevention translation using a modified DPP lifestyle intervention . METHODS The DPP lifestyle intervention was adapted to a 12-session group-based program called Group Lifestyle Balance for implementation in the community setting . A model for training and support mirroring that of the DPP was developed for prevention professionals administering the program . The process of training/support and program implementation was evaluated for feasibility and effectiveness using a nonr and omized prospect i ve design in two phases ( N=51 , Phase 1 : 2005 - 2006 ; N=42 , Phase 2 : 2007 - 2009 ; data analysis completed 2008 - 2009 ) . A total of 93 nondiabetic individuals with BMI > or=25 kg/m(2 ) and the metabolic syndrome or prediabetes participated . Measures were collected at baseline and post-intervention for all and 6 and 12 months post-intervention for Phase 2 . RESULTS Significant decreases in weight , waist circumference , and BMI were noted in both phases from baseline . Participants in Phase 2 also demonstrated decreases in total cholesterol , non-HDL cholesterol , and systolic and diastolic blood pressure that were maintained at 12 months . Average combined weight loss for both groups over the course of the 3-month intervention was 7.4 pounds ( 3.5 % relative loss , p<0.001 ) ; 23.8 % and 52.2 % of those who completed the program reached 7 % and 5 % weight loss , respectively . More than 80 % of those achieving 7 % weight loss in the Phase-2 group maintained their weight loss at 6 months . CONCLUSIONS A comprehensive diabetes prevention model for training , intervention delivery , and support was shown to be successful and was effective in reducing diabetes and cardiovascular disease risk factors in this group of high-risk individuals Purpose Translating strategies and approaches from the successful clinical ly based Diabetes Prevention Program ’s lifestyle intervention to community setting s is a key next step . This article describes a lifestyle program developed in partnership by research ers at a major university and public health professionals at a local health department . Methods The Live Well , Be Well ( LWBW ) program was design ed to meet the needs of lower income , minority , and low-literacy adults at risk for diabetes . It was adapted from interventions with demonstrated efficacy and delivered in Spanish and English by health department staff . The program consisted of a 6-month active phase and a 6-month maintenance phase and was primarily telephone based , with one in-person planning session and several group workshops . In-person and group sessions were held in convenient community-based setting s. Counselors provided education and skills training to modify diet and increase physical activity . Self-selected and attainable goal - setting and action plans were emphasized to enhance self-efficacy . LWBW is the intervention component of a r and omized trial with primary outcomes of fasting glucose , weight , and other clinical measures . Conclusions The program provides a unique translational model for implementing diabetes risk reduction programs for underserved population s. Individually tailored and non-prescriptive , it utilized existing health department infrastructure , focused on telephone counseling , used culturally appropriate , low-literacy material s , and was delivered in local , community-based facilities BACKGROUND Although numerous studies have translated the Diabetes Prevention Program lifestyle intervention into various setting s , no study to date has reported a formal cost analysis . PURPOSE To describe costs associated with the Healthy Living Partnerships to Prevent Diabetes ( HELP PD ) trial . DESIGN HELP PD was a 24-month RCT testing the impact of a lifestyle weight-loss intervention administered through a diabetes education program and delivered by community health workers ( CHWs ) on blood glucose and body weight among prediabetics . SETTING / PARTICIPANTS In all , 301 participants with prediabetes were r and omized in Forsyth County NC . Data reported in these analyses were collected in 2007 - 2011 and analyzed in 2011 - 2012 . INTERVENTION The lifestyle weight-loss group had a 7 % weight loss goal achieved and maintained by caloric restriction and increased physical activity . The usual care group received two visits with a registered dietitian and monthly newsletters . MAIN OUTCOME MEASURES Measures are direct medical costs , direct nonmedical costs , and indirect costs over the 2-year study period . Research costs are excluded . RESULTS The direct medical cost ( in 2010 dollars ) to identify one participant was $ 16.85 . Direct medical costs per capita for participants in the usual care group were $ 142 and $ 850 for lifestyle weight-loss participants . Per capita direct costs of care outside the study were $ 7454 for the usual care group and $ 5177 for the lifestyle weight-loss group . Per capita direct nonmedical costs were $ 12,881 for the usual care group and $ 13,836 for the lifestyle weight-loss group . The lifestyle weight-loss group in HELP PD cost $ 850 in direct medical costs for 2 years , compared to $ 2631 in direct medical costs for the first 2 years of DPP . CONCLUSIONS A community-based translation of the DPP can be delivered effectively and with reduced costs Type 2 diabetes is extremely common in South Asians , e.g. in men from Pakistani and Indian population s it is about three times as likely as in the general population in Engl and , despite similarities in body mass index . Lifestyle interventions reduce the incidence of diabetes . Trials in Europe and North America have not , however , reported on the impact on South Asian population s separately or provided the details of their cross-cultural adaptation processes . Prevention of diabetes and obesity in South Asians ( PODOSA ) is a r and omized , controlled trial in Scotl and of an adapted , lifestyle intervention aim ed at reducing weight and increasing physical activity to reduce type 2 diabetes in Indians and Pakistanis . The trial was adapted from the Finnish Diabetes Prevention Study . We describe , reflect on and discuss the following key issues : The core adaptations to the trial design , particularly the delivery of the intervention in homes by dietitians rather than in clinics . The use of both a multilingual panel and professional translators to help translate and /or develop material s. The processes and challenges of phonetic translation . How intervention re sources were adapted , modified , newly developed and translated into Urdu and Gurmukhi ( written Punjabi ) . The insights gained in PODOSA ( including time pressures on investigators , imperfections in the adaptation process , the power of verbal rather than written information , the utilization of English and the mother-tongue language s simultaneously by participants and the costs ) might help the research community , given the challenge of health promotion in multi-ethnic , urban societies OBJECTIVE To examine the psychological process of lifestyle change among adults at risk for type 2 diabetes . RESEARCH DESIGN AND METHODS A r and omized control trial in which 307 volunteers ( intervention , n = 208 ; wait control , n = 99 ) diagnosed with prediabetes completed a  six-session group-based intervention to promote healthier living . Participants ’ motivation to change , diet and exercise self-efficacy , mood , knowledge about diabetes , activity levels , healthy eating , waist circumference , and weight were assessed before and after the program . RESULTS Participation in the program was associated with significant increases in healthy eating and physical activity , reductions in waist and weight , and improvements in motivation , positive mood , self-efficacy , and knowledge . Examination of the pathways to lifestyle change showed that the educational aspect of the program increased activity levels because it increased diabetes knowledge and improved mood . Eating behavior was not mediated by any of the psychological variables . Improvements in diet and physical activity were , in turn , directly associated with changes in weight and waist circumference . CONCLUSIONS Although the program significantly improved motivation , self-efficacy , and mood , its impact on knowledge uniquely explained the increase in physical activity .  Group-based programs that are tailored to lifestyle behaviors may provide a cost-effective method of diabetes prevention , but more research is needed to explain why they improve healthy eating 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 Background The prevention of  type 2 diabetes  is a recognised health care priority globally . Within the United Kingdom , there is a lack of research investigating optimal methods of translating diabetes prevention programmes , based on the promotion of a healthy lifestyle , into routine primary care . This study aims to establish the behavioural and clinical effectiveness of a structured educational programme design ed to target perceptions and knowledge of diabetes risk and promote a healthily lifestyle , particularly increased walking activity , in a multi-ethnic population at a high risk of developing type 2 diabetes . Design Cluster r and omised controlled trial undertaken at the level of primary care practice s. Follow-up will be conducted at 12 , 24 and 36 months . The primary outcome is change in objective ly measured ambulatory activity . Secondary outcomes include progression to type 2 diabetes , biochemical variables ( including fasting glucose , 2-h glucose , HbA1c and lipids ) , anthropometric variables , quality of life and depression . Methods 10 primary care practice s will be recruited to the study ( 5 intervention , 5 control ) . Within each practice , individuals at high risk of impaired glucose regulation will be identified using an automated version of the Leicester Risk Assessment tool . Individuals scoring within the 90th percentile in each practice will be invited to take part in the study . Practice s will be assigned to either the control group ( advice leaflet ) or the intervention group , in which participants will be invited to attend a 3 hour structured educational programme design ed to promote physical activity and a healthy lifestyle . Participants in the intervention practice s will also be invited to attend annual group-based maintenance workshops and will receive telephone contact halfway between annual sessions . The study will run from 2010–2014 . Discussion This study will provide new evidence surrounding the long-term effectiveness of a diabetes prevention programme run within routine primary care in the United Kingdom . Trial Registration Clinical Trials . Gov identifier : INTRODUCTION Although the Diabetes Prevention Program and other clinical trials demonstrated the efficacy of intensive lifestyle interventions ( ILI ) and metformin to prevent type 2 diabetes , no studies have tested their comparative effects in pragmatic setting s. This study was design ed to compare the real-world effectiveness of ILI , metformin , and st and ard care among Hispanic women ( Latinas ) with prediabetes . STUDY DESIGN RCT . SETTING / PARTICIPANTS Ninety-two Latinas , who had a mean hemoglobin A1c of 5.9 % , BMI of 33.3 kg/m2 , and waist circumference of 97.4 cm ( 38.3 inches ) , were recruited from an urban community and r and omly assigned to ILI , metformin , or st and ard care using 1:1:1 allocation . Data were collected from 2013 - 2015 and analyzed in 2016 . INTERVENTION The 12-month ILI was adapted from the Diabetes Prevention Program 's ILI and delivered by community health workers ( promotoras ) over 24 sessions . Metformin participants received 850 mg twice daily . Those r and omized to st and ard care continued their regular medical care . MAIN OUTCOME MEASURES Weight and secondary outcomes ( waist circumference , blood pressure , hemoglobin A1c , fasting plasma glucose , insulin , and lipids ) were assessed at baseline and 12 months . RESULTS ILI participants demonstrated significantly greater mean weight loss ( -4.0 kg , 5.0 % ) than metformin ( -0.9 kg , 1.1 % ) and st and ard care participants ( + 0.8 kg , 0.9 % ) ( p<0.001 ) . The difference in weight loss between metformin and st and ard care was not significant . The ILI group experienced a greater reduction in waist circumference than st and ard care ( p=0.001 ) , and a marginal improvement in hemoglobin A1c compared with metformin and st and ard care ( p=0.063 ) . CONCLUSIONS In the first comparative effectiveness trial of diabetes prevention treatments , a 12-month ILI produced significantly greater weight loss than metformin and st and ard care among Latinas with prediabetes . These data suggest that ILI delivered by promotoras is an effective strategy for preventing diabetes in this high-risk group , which may be superior to metformin . Future pragmatic trials involving larger sample s should examine differences in diabetes incidence associated with these treatments
Evidence suggests that pragmatic diabetes prevention programs are effective .
Effectiveness varies substantially between programs but can be improved by maximizing guideline adherence .
OBJECTIVE To summarize the evidence on effectiveness of translational diabetes prevention programs , based on promoting lifestyle change to prevent type 2 diabetes in real-world setting s and to examine whether adherence to international guideline recommendations is associated with effectiveness .
Lifestyle interventions aim ed to translate evidence from previous efficacy trials of diabetes prevention into real-world intervention programs .