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Background The National Diabetes Prevention Program (National DPP) is rapidly expanding in an effort to help those at high risk of type 2 diabetes prevent or delay the disease. In 2012, the Centers for Disease Control and Prevention funded six national organizations to scale and sustain multistate delivery of the National DPP lifestyle change intervention (LCI). This study aims to describe reach, adoption, and maintenance during the 4-year funding period and to assess associations between site-level factors and program effectiveness regarding participant attendance and participation duration. Methods The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework was used to guide the evaluation from October 2012 to September 2016. Multilevel linear regressions were used to examine associations between participant-level demographics and site-level strategies and number of sessions attended, attendance in months 7–12, and duration of participation. Results The six funded national organizations increased the number of participating sites from 68 in 2012 to 164 by 2016 across 38 states and enrolled 14,876 eligible participants. By September 2016, coverage for the National DPP LCI was secured for 42 private insurers and 7 public payers. Nearly 200 employers were recruited to offer the LCI on site to their employees. Site-level strategies significantly associated with higher overall attendance, attendance in months 7–12, and longer participation duration included using self-referral or word of mouth as a recruitment strategy, providing non-monetary incentives for participation, and using cultural adaptations to address participants’ needs. Sites receiving referrals from healthcare providers or health systems also had higher attendance in months 7–12 and longer participation duration. At the participant level, better outcomes were achieved among those aged 65+ (vs. 18–44 or 45–64), those who were overweight (vs. obesity), those who were non-Hispanic white (vs. non-Hispanic black or multiracial/other races), and those eligible based on a blood test or history of gestational diabetes mellitus (vs. screening positive on a risk test). Conclusions In a time of rapid dissemination of the National DPP LCI the findings of this evaluation can be used to enhance program implementation and translate lessons learned to similar organizations and settings.

Purpose of ReviewThis article highlights foundational evidence, translation studies, and current research behind type 2 diabetes prevention efforts worldwide, with focus on high-risk populations, and whole-population approaches as catalysts to global prevention.Recent FindingsContinued focus on the goals of foundational lifestyle change program trials and their global translations, and the targeting of those at highest risk through both in-person and virtual modes of program delivery, is critical. Whole-population approaches (e.g., socioeconomic policies, healthy food promotion, environmental/systems changes) and awareness raising are essential complements to efforts aimed at high-risk populations.SummarySuccessful type 2 diabetes prevention strategies are being realized in the USA through the National Diabetes Prevention Program and elsewhere in the world. A multi-tiered approach involving appropriate risk targeting and whole-population efforts is essential to curb the global diabetes epidemic.

The Diabetes Prevention Program (DPP) randomized controlled trial demonstrated that metformin treatment reduced progression to type 2 diabetes (T2D) by 31% compared to placebo in adults with prediabetes. Circulating micro-ribonucleic acids (miRs) are promising biomarkers of T2D risk, but little is known about their associations with metformin regimens for T2D risk reduction. We compared the change in 24 circulating miRs from baseline to 2 years in a subset from DPP metformin intervention (n = 50) and placebo (n = 50) groups using Wilcoxon signed rank tests. Spearman correlations were used to evaluate associations between miR change and baseline clinical characteristics. Multiple linear regression was used to adjust for covariates. The sample was 73% female, 17% Black, 13% Hispanic, and 50 ± 11 years. Participants were obese, normotensive, prediabetic, and dyslipidemic. Change in 12 miR levels from baseline to 2 years was significantly different in the metformin group compared with placebo after adjusting for multiple comparisons: six (let-7c-5p, miR-151a-3p, miR-17-5p, miR-20b-5p, miR-29b-3p, and miR-93-5p) were significantly upregulated and six (miR-130b-3p, miR-22-3p, miR-222-3p, miR-320a-3p, miR-320c, miR-92a-3p) were significantly downregulated in the metformin group. These miRs help to explain how metformin is linked to T2D risk reduction, which may lead to novel biomarkers, therapeutics, and precision health strategies.

Aims/hypothesis Although the Diabetes Prevention Program (DPP) established lifestyle changes (diet, exercise and weight loss) as the ‘gold standard’ preventive therapy for diabetes, the relative contribution of exercise alone to the overall utility of the combined diet and exercise effect of DPP is unknown; furthermore, the optimal intensity of exercise for preventing progression to diabetes remains very controversial. To establish clinical efficacy, we undertook a study (2009 to 2013) to determine: how much of the effect on measures of glucose homeostasis of a 6 month programme modelled after the first 6 months of the DPP is due to exercise alone; whether moderate- or vigorous-intensity exercise is better for improving glucose homeostasis; and to what extent amount of exercise is a contributor to improving glucose control. The primary outcome was improvement in fasting plasma glucose, with improvement in plasma glucose AUC response to an OGTT as the major secondary outcome. Methods The trial was a parallel clinical trial. Sedentary, non-smokers who were 45–75 year old adults ( n  = 237) with elevated fasting glucose (5.28–6.94 mmol/l) but without cardiovascular disease, uncontrolled hypertension, or diabetes, from the Durham area, were studied at Duke University. They were randomised into one of four 6 month interventions: (1) low amount (42 kJ kg body weight −1 week −1 [KKW])/moderate intensity: equivalent of expending 42 KKW (e.g. walking ∼16 km [8.6 miles] per week) with moderate-intensity (50% V . O 2 reserve ) exercise; (2) high amount (67 KKW)/moderate intensity: equivalent of expending 67 KKW (∼22.3 km [13.8 miles] per week) with moderate-intensity exercise; (3) high amount (67 KKW)/vigorous intensity: equivalent to group 2, but with vigorous-intensity exercise (75% V . O 2 reserve ); and (4) diet + 42 KKW moderate intensity: same as group 1 but with diet and weight loss (7%) to mimic the first 6 months of the DPP. Computer-generated randomisation lists were provided by our statistician (G. P. Samsa). The randomisation list was maintained by L. H. Willis and C. A. Slentz with no knowledge of or input into the scheduling, whereas all scheduling was done by L. A. Bateman, with no knowledge of the randomisation list. Subjects were automatically assigned to the next group listed on the randomisation sheet (with no ability to manipulate the list order) on the day that they came in for the OGTT, by L. H. Willis. All plasma analysis was done blinded by the individuals doing the measurements (i.e. lipids, glucose, insulin). Subjects and research staff (other than individuals analysing the blood) were not blinded to the group assignments. Results Number randomised, completers and number analysed with complete OGTT data for each group were: low-amount/moderate-intensity (61, 43, 35); high-amount/moderate-intensity (61, 44, 40); high-amount/vigorous-intensity (61, 43, 38); diet/exercise (54, 45, 37), respectively. Only the diet and exercise group experienced a decrease in fasting glucose ( p  < 0.001). The means and 95% CIs for changes in fasting glucose (mmol/l) for each group were: high-amount/moderate-intensity −0.07 (−0.20, 0.06); high-amount/vigorous 0.06 (−0.07, 0.19); low-amount/moderate 0.05 (−0.05, 0.15); and diet/exercise −0.32 (−0.46, −0.18). The effects sizes for each group (in the same order) were: 0.17, 0.15, 0.18 and 0.71, respecively. For glucose tolerance (glucose AUC of OGTT), similar improvements were observed for the diet and exercise (8.2% improvement, effect size 0.73) and the 67 KKW moderate-intensity exercise (6.4% improvement, effect size 0.60) groups; moderate-intensity exercise was significantly more effective than the same amount of vigorous-intensity exercise ( p  < 0.0207). The equivalent amount of vigorous-intensity exercise alone did not significantly improve glucose tolerance (1.2% improvement, effect size 0.21). Changes in insulin AUC, fasting plasma glucose and insulin did not differ among the exercise groups and were numerically inferior to the diet and exercise group. Conclusions/interpretation In the present clinical efficacy trial we found that a high amount of moderate-intensity exercise alone was very effective at improving oral glucose tolerance despite a relatively modest 2 kg change in body fat mass. These data, combined with numerous published observations of the strong independent relation between postprandial glucose concentrations and prediction of future diabetes, suggest that walking ∼18.2 km (22.3 km prescribed with 81.6% adherence in the 67 KKW moderate-intensity group) per week may be nearly as effective as a more intensive multicomponent approach involving diet, exercise and weight loss for preventing the progression to diabetes in prediabetic individuals. These findings have important implications for the choice of clinical intervention to prevent progression to type 2 diabetes for those at high risk. Trial registration : ClinicalTrials.gov NCT00962962 Funding : The study was funded by National Institutes for Health National Institute of Diabetes and Digestive and Kidney Diseases (NIH-NDDK) (R01DK081559)

Approximately 8.3% of the US population has diabetes and estimates indicate that 79 million adults have prediabetes and 33.8% are obese, increasing their risk of diabetes. The national Diabetes Prevention Program (DPP) and subsequent translation studies have demonstrated the efficacy of the DPP lifestyle intervention (DPPLI) on lowering weight and reducing risk of type 2 diabetes over 10 years. Innovative strategies are needed to translate the DPPLI to reach people at risk of diabetes. Community health workers represent a group of individuals poised to play a role in supporting the translation of the DPPLI, especially in underserved populations. This article aims to 1) describe community health workers in general; 2) describe their role and impact on diabetes care in general; and 3) provide a detailed overview of studies involving community health workers in the translation of the DPPLI.

Background Type 2 diabetes (T2D) is a global health concern affecting 10.5% of the adult population and is projected to rise significantly in the coming decades. Lifestyle modification programs, such as the Diabetes Prevention Program (DPP), can effectively reduce T2D risk among individuals with prediabetes. However, their implementation in real-world healthcare settings remains poor, particularly in Spain, where T2D prevalence is the highest in Europe. The ALADIM study aims to evaluate the effectiveness and implementation of an adapted DPP in Spanish Primary Care Centers (PCCs). The primary effectiveness outcome is weight, the co-primary implementation outcome is implementation fidelity. We will also assess the effect of DPP implementation on overall prediabetes management within the PCCs (spillover) by measuring the percentage of people with prediabetes receiving lifestyle advice. Methods The ALADIM trial is a hybrid type II effectiveness-implementation cluster-randomized controlled trial involving 10 PCCs of Mallorca (Balearic Islands, Spain). PCCs will be randomized to the intervention (5 PCCs) or control (5 PCCs) group in a 1:1 ratio. The intervention group will receive training and materials to implement and deliver the adapted DPP over 12 months. The control group will continue providing usual care. The DPP will be culturally adapted using the Intervention Mapping-ADAPT (IM-ADAPT) approach. The implementation strategy will be designed using Implementation Mapping. Measures of effectiveness will be assessed at the participant level at baseline, 6 and 12 months during the intervention period, and 18 months after baseline. Implementation outcomes will be assessed at the PCC level at multiple time-points throughout the study period. Spillover will be assessed at PCC level at months -1, 6 and 18. An intention-to-treat analysis will assess effectiveness and spillover effect using generalized estimating equations. Implementation outcomes will be evaluated using a mixed-methods approach. Discussion The ALADIM study has the potential to address the gap between research and practice by employing implementation science for evaluation, adaptation and implementation of an evidence-based diabetes intervention. The findings will contribute to the development of a sustainable and scalable implementation strategy for T2D prevention, with potential implications for policy and practice at regional and national levels. Trial registration ClinicalTrials.gov, NCT06871059. Registered 10 March 2025, https://clinicaltrials.gov/study/NCT06871059

Aims/hypothesis The Diabetes Prevention Program (DPP) lifestyle intervention successfully achieved its goal of increasing leisure physical activity levels. This current study examines whether the lifestyle intervention also changed time spent being sedentary and the impact of sedentary time on diabetes development in this cohort. Methods 3,232 DPP participants provided baseline data. Sedentary behaviour was assessed via an interviewer-administered questionnaire and reported as time spent watching television specifically (or combined with sitting at work). Mean change in sedentary time was examined using repeated measures ANCOVA. The relationship between sedentary time and diabetes incidence was determined using Cox proportional hazards models. Results During the DPP follow-up (mean: 3.2 years), sedentary time declined more in the lifestyle than the metformin or placebo participants ( p  < 0.05). For the lifestyle group, the decrease in reported mean television watching time (22 [95% CI 26, 17] min/day) was greater than in the metformin or placebo groups ( p  < 0.001). Combining all participants together, there was a significantly increased risk of developing diabetes with increased television watching (3.4% per hour spent watching television), after controlling for age, sex, treatment arm and leisure physical activity ( p  < 0.01), which was attenuated when time-dependent weight was added to the model. Conclusions/interpretation In the DPP, the lifestyle intervention was effective at reducing sedentary time, which was not a primary goal. In addition, in all treatment arms, individuals with lower levels of sedentary time had a lower risk of developing diabetes. Future lifestyle intervention programmes should emphasise reducing television watching and other sedentary behaviours in addition to increasing physical activity. Trial registration: ClinicalTrials.gov NCT00004992

Digital therapeutics are evidence-based behavioral treatments delivered online that can increase accessibility and effectiveness of health care. However, few studies have examined long-term clinical outcomes of digital therapeutics. The objective of this study was to conduct a 2-year follow-up on participants in the Internet-based Prevent diabetes prevention program pilot study, specifically examining the effects on body weight and A1c, which are risk factors for diabetes development. A quasi-experimental research design was used, including a single-arm pre- and post-intervention assessment of outcomes. Participants underwent a 16-week weight loss intervention and an ongoing weight maintenance intervention. As part of the program, participants received a wireless scale, which was used to collect body weight data on an ongoing basis. Participants also received A1c test kits at baseline, 0.5 year, 1 year, and 2-year time points. Participants previously diagnosed with prediabetes (n=220) were originally enrolled in the pilot study. A subset of participants (n=187) met Centers for Disease Control and Prevention (CDC) criteria for starting the program (starters), and a further subset (n=155) met CDC criteria for completing the program (completers) and were both included in analyses. Program starters lost an average of 4.7% (SD 0.4) of baseline body weight after 1 year and 4.2% (SD 0.8) after 2 years, and reduced A1c by mean 0.38% (SD 0.07) after 1 year and 0.43% (SD 0.08) after 2 years. Program completers lost mean 4.9% (SD 0.5) of baseline body weight after 1 year and 4.3% (SD 0.8) after 2 years, and reduced A1c by 0.40% (SD 0.07) after 1 year and 0.46% (SD 0.08) after 2 years. For both groups, neither 2-year weight loss nor A1c results were significantly different from 1-year results. Users of the Prevent program experienced significant reductions in body weight and A1c that are maintained after 2 years. Contrary to the expected progression from prediabetes to diabetes over time, average A1c levels continued to show an average regression from within the prediabetic range (5.7%-6.4%) initially to the normal range (<5.7%) after 2 years. Further investigation is warranted to test digital therapeutics as a scalable solution to address national diabetes and cardiovascular disease prevention efforts.

Background COVID-19 lockdowns in March 2020 forced National Diabetes Prevention Programs (DPPs) to pause, cancel or reformulate. This qualitative study sought to (a) document if/how New York City(NYC) DPPs adapted and served participants during lockdowns, and (b) identify successes and challenges to operating programs during the lockdowns and restrictions on social gathering. Methods Researchers contacted 47 CDC-registered DPPs in NYC. Eleven DPP directors, lifestyle coaches, and coordinators involved in program implementation completed 1-hour semi-structured virtual interviews and received a $50 gift card. Interviews were recorded, transcribed, and analyzed using Grounded Theory (Dedoose, Version 9). Results Interviewees represented 7 organization types: public hospitals, weight loss programs, healthcare centers, community-based organizations, health insurance companies, faith-based DPPs, and federally qualified health centers. DPPs served participants in 4 of 5 NYC boroughs. Six organizations provided DPP services during lockdowns by going virtual. Successes and challenges related to staffing, resource allocation, virtual data tracking, and participant engagement. Most programs were successful due to resilient, dedicated, and extraordinarily innovative staff. Conclusion The pandemic highlighted opportunities for successful virtual DPPs in urban settings, and the need for more robust funding, staff support, and technical assistance for sustainability and scalability of the DPP.

Background Prediabetes is a highly prevalent condition that heralds an increased risk of progression to type 2 diabetes, along with associated microvascular and macrovascular complications. The Diabetes Prevention Program (DPP) is an established effective intervention for diabetes prevention. However, participation in this 12-month lifestyle change program has historically been low. Digital DPPs have emerged as a scalable alternative, accessible asynchronously and recognized by the Centers for Disease Control and Prevention (CDC). Yet, most digital programs still incorporate human coaching, potentially limiting scalability. Furthermore, existing effectiveness results of digital DPPs are primarily derived from per protocol, longitudinal non-randomized studies, or comparisons to control groups that do not represent the standard of care DPP. The potential of an AI-powered DPP as an alternative to the DPP is yet to be investigated. We propose a randomized controlled trial (RCT) to directly compare these two approaches. Methods This open-label, multicenter, non-inferiority RCT will compare the effectiveness of a fully automated AI-powered digital DPP (ai-DPP) with a standard of care human coach-based DPP (h-DPP). A total of 368 participants with elevated body mass index (BMI) and prediabetes will be randomized equally to the ai-DPP (smartphone app and Bluetooth-enabled body weight scale) or h-DPP (referral to a CDC recognized DPP). The primary endpoint, assessed at 12 months, is the achievement of the CDC’s benchmark for type 2 diabetes risk reduction, defined as any of the following: at least 5% weight loss, at least 4% weight loss and at least 150 min per week on average of physical activity, or at least a 0.2-point reduction in hemoglobin A1C. Physical activity will be objectively measured using serial actigraphy at baseline and at 1-month intervals throughout the trial. Secondary endpoints, evaluated at 6 and 12 months, will include changes in A1C, weight, physical activity measures, program engagement, and cost-effectiveness. Participants include adults aged 18–75 years with laboratory confirmed prediabetes, a BMI of ≥ 25 kg/m 2 (≥ 23 kg/m 2 for Asians), English proficiency, and smartphone users. This U.S. study is conducted at Johns Hopkins Medicine in Baltimore, MD, and Reading Hospital (Tower Health) in Reading, PA. Discussion Prediabetes is a significant public health issue, necessitating scalable interventions for the millions affected. Our pragmatic clinical trial is unique in directly comparing a fully automated AI-powered approach without direct human coach interaction. If proven effective, it could be a scalable, cost-effective strategy. This trial will offer vital insights into both AI and human coach-based behavioral change strategies in real-world clinical settings. Trial registration ClinicalTrials.gov NCT05056376. Registered on September 24, 2021, https://clinicaltrials.gov/study/NCT05056376