Intervention Delivery Matters: What Mothers at High Risk for Type 2 Diabetes Want in a Diabetes Prevention Program-Results from a Comparative Effectiveness Trial.
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SUBMITTER: Palmer KNB
PROVIDER: S-EPMC7414259 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe Diabetes Prevention Program (DPP) was a randomized, 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.MethodsWe describe the resource 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.ResultsAlthough 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 randomization, 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.ConclusionsThe implementation of diabetes prevention programs in high-risk individuals will result in important health benefits and represents a good value for money.Trial registrationNCT00004992 (DPP) and NCT00038727 (DPPOS).
| S-EPMC5471886 | biostudies-literature
Project description:Diabetes Prevention Program (DPP)
| PRJNA227394 | ENA
Project description:Educational attainment is inversely associated with type 2 diabetes risk, but it is unknown whether education impacts individuals' diabetes prevention efforts. We examined the comparative efficacy of intensive lifestyle intervention and metformin by educational attainment among participants in the Diabetes Prevention Program (DPP), an ongoing U.S. multi-site trial beginning in 1996.We studied 2,910 DPP participants randomized to receive lifestyle intervention, metformin, or placebo. Stratifying by educational attainment, diabetes incidence and relative risk reductions by treatment assignment were estimated using Cox proportional hazards regression.47% of participants had completed college and 53% had not. Compared to placebo, lifestyle participants who had completed college demonstrated a 68% reduction in diabetes incidence (95% CI=56, 77), whereas those with less education experienced a 47% risk reduction (95% CI=29, 61). For metformin participants, college graduates experienced a 49% relative risk reduction (95% CI=33, 62), compared to 23% (95% CI=1, 41) among those with lower educational attainment. There was a statistically significant education-by-treatment interaction with incident diabetes (p=0.03).Intensive lifestyle intervention and metformin have greater efficacy among highly educated individuals. Future efforts to deliver these treatments and study their dissemination may be more effective if tailored to individuals' educational background.
| S-EPMC4490008 | biostudies-literature
Project description:The Centers for Disease Control and Prevention, State and Local Health Departments, and other organizations in the USA are working to increase population access to the Diabetes Prevention Program (DPP) lifestyle intervention. Delivering the DPP through telehealth videoconference may increase access to this intervention, particularly in rural communities. The purpose of this study was to compare participation, monitoring of diet and physical activity, and weight loss in participants receiving the intervention on-site and those participating virtually through telehealth. Beginning in 2008, Holy Rosary Healthcare collaborated with the Montana Department of Public Health and Human Services to provide the DPP to participants on-site in one community and simultaneously through telehealth to participants in multiple other communities. From 2008 through 2015, 894 participants were enrolled in the program (29% at telehealth sites). The mean age of participants was 51.7 years and 84% were female. Overall, participants attended 14.4, 3.9, and 15.0 weekly core, post-core, and total sessions, respectively. There were no statistically significant differences in number of intervention sessions attended by the telehealth or on-site participants. There were no statistically significant differences in the mean weight loss or reduction in BMI between the telehealth and the on-site groups. There also were no statistically significant differences in the percentage of telehealth or on-site participants who achieved ≥5% weight loss (56 vs. 57%) or the 7% weight loss goal (38 vs. 41%). Our findings suggest that participants receiving the DPP through telehealth have similar rates of participation and achieve similar weight loss as participants attending the program on-site.
| S-EPMC5526819 | biostudies-other
Project description:Identifying novel biomarkers of type 2 diabetes risk may improve prediction and prevention among individuals at high risk of the disease and elucidate new biological pathways relevant to diabetes development. We performed plasma metabolite profiling in the Diabetes Prevention Program (DPP), a completed trial that randomized high-risk individuals to lifestyle, metformin, or placebo interventions. Previously reported markers, branched-chain and aromatic amino acids and glutamine/glutamate, were associated with incident diabetes (P < 0.05 for all), but these associations were attenuated upon adjustment for clinical and biochemical measures. By contrast, baseline levels of betaine, also known as glycine betaine (hazard ratio 0.84 per SD log metabolite level, P = 0.02), and three other metabolites were associated with incident diabetes even after adjustment. Moreover, betaine was increased by the lifestyle intervention, which was the most effective approach to preventing diabetes, and increases in betaine at 2 years were also associated with lower diabetes incidence (P = 0.01). Our findings indicate betaine is a marker of diabetes risk among high-risk individuals both at baseline and during preventive interventions and they complement animal models demonstrating a direct role for betaine in modulating metabolic health.
| S-EPMC4839205 | biostudies-literature
Project description:BackgroundGestational diabetes mellitus (GDM) is an increasingly prevalent risk factor for type 2 diabetes. We evaluated the effectiveness of a group-based lifestyle modification program in mothers with prior GDM within their first postnatal year.Methods and findingsIn this study, 573 women were randomised to either the intervention (n = 284) or usual care (n = 289). At baseline, 10% had impaired glucose tolerance and 2% impaired fasting glucose. The diabetes prevention intervention comprised one individual session, five group sessions, and two telephone sessions. Primary outcomes were changes in diabetes risk factors (weight, waist circumference, and fasting blood glucose), and secondary outcomes included achievement of lifestyle modification goals and changes in depression score and cardiovascular disease risk factors. The mean changes (intention-to-treat [ITT] analysis) over 12 mo were as follows: -0.23 kg body weight in intervention group (95% CI -0.89, 0.43) compared with +0.72 kg in usual care group (95% CI 0.09, 1.35) (change difference -0.95 kg, 95% CI -1.87, -0.04; group by treatment interaction p = 0.04); -2.24 cm waist measurement in intervention group (95% CI -3.01, -1.42) compared with -1.74 cm in usual care group (95% CI -2.52, -0.96) (change difference -0.50 cm, 95% CI -1.63, 0.63; group by treatment interaction p = 0.389); and +0.18 mmol/l fasting blood glucose in intervention group (95% CI 0.11, 0.24) compared with +0.22 mmol/l in usual care group (95% CI 0.16, 0.29) (change difference -0.05 mmol/l, 95% CI -0.14, 0.05; group by treatment interaction p = 0.331). Only 10% of women attended all sessions, 53% attended one individual and at least one group session, and 34% attended no sessions. Loss to follow-up was 27% and 21% for the intervention and control groups, respectively, primarily due to subsequent pregnancies. Study limitations include low exposure to the full intervention and glucose metabolism profiles being near normal at baseline.ConclusionsAlthough a 1-kg weight difference has the potential to be significant for reducing diabetes risk, the level of engagement during the first postnatal year was low. Further research is needed to improve engagement, including participant involvement in study design; it is potentially more effective to implement annual diabetes screening until women develop prediabetes before offering an intervention.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12610000338066.
| S-EPMC4961439 | biostudies-literature
Project description:IntroductionDiabetes and obesity pose a significant burden for the U.S. military beneficiary population, creating a great need to provide evidence-based diabetes and obesity prevention services for military personnel, retirees, and their dependents. Despite increasing dissemination of the Diabetes Prevention Program (DPP) lifestyle intervention nationwide, formal evaluation of implementation of this highly successful program is limited in the military setting. The purpose of this study is to prospectively evaluate delivery of a direct adaptation of a 1-year DPP lifestyle intervention at a U.S. Air Force medical facility, Wright-Patterson Medical Center (WPMC), to determine the feasibility of delivery of the program in a group of at-risk active duty military, retirees, and family members, as well as assess effectiveness in improving weight and other risk factors for type 2 diabetes.Materials and methodsA pre/post study design was utilized to evaluate feasibility and effectiveness of the DPP Group Lifestyle Balance (GLB), an up-to-date, 22-session direct adaptation of the DPP curriculum, at WPMC. Participants chose to complete the 1-year program either in coach-led face-to-face groups or via DVD with weekly telephonic coach contact. The study was approved by the University of Pittsburgh and WPMC Institutional Review Boards.ResultsA total of 99 individuals enrolled in the study, with 83 (84%) and 77 (78%) completing 6- and 12-month follow-up assessments, respectively. The mean age of participants at baseline was 57 (range 20-85 years), with 63% being female. The group was comprised of individuals who were non-Hispanic White (73.7%), non-Hispanic Black (18.2%), and other race or Hispanic ethnicity (8.1%). Within this group, there were 10 active duty military, 37 retirees, and 52 family members. The DPP-GLB program was shown to be feasible to implement in this military healthcare setting as demonstrated by the high engagement over the course of the year-long program. Significant improvements were shown in the two main behavioral goals: mean weight (-12.8 lbs, -6.3%, P < .001) and mean physical activity (PA) (+18.9 Met-hrs/wk, P < .001). In addition, significant improvements in other diabetes and cardiovascular risk factors including low-density lipoprotein cholesterol, fasting insulin, diastolic blood pressure, and waist circumference were noted, as well as improvement in health-related quality of life.ConclusionsThese results demonstrate that the DPP-GLB program delivered via face-to-face groups or DVD was feasible and effective in improving weight, PA levels, and diabetes and cardiovascular risk factors in this group of active and retired military personnel and their family members. The program was well received by the program participants as well as the WPMC team. These findings offer a model for provision of the DPP-GLB program throughout the Military Health System.
| S-EPMC10187478 | biostudies-literature
Project description:IntroductionOnline Diabetes Prevention Programs (DPPs) can be scaled up and delivered broadly. However, little is known about real-world effectiveness and how outcomes compare with in-person DPP. This study examined online DPP weight loss and participation outcomes and secondarily compared outcomes among participating individuals with parallel in-person interventions.Study designA large non-randomized trial supplemented by a comparative analysis of participating individuals from a concurrent trial of two parallel in-person programs: in-person DPP and the Veterans Administration's standard of care weight loss program (MOVE!).Setting/participantsObese/overweight Veterans with prediabetes enrolled in online DPP (n = 268) between 2013 and 2014. Similar eligibility criteria were used to enroll in-person participants between 2012 and 2014 (n = 273 in-person DPP, n = 114 MOVE!) within a separate trial.InterventionOnline DPP included a virtual group format, live e-coach, weekly modules delivered asynchronously, and wireless home scales. In-person programs included eight to 22 group-based, face-to-face sessions.Main outcomes measuresWeight change at 6 and 12 months using wirelessly uploaded home scale data or electronic medical record weights from clinical in-person visits. Outcomes were analyzed between 2015 and 2017.ResultsFrom 1,182 invitations, 268 (23%) participants enrolled in online DPP. Among these, 158 (56%) completed eight or more modules; mean weight change was -4.7kg at 6 months and -4.0kg at 12 months. In a supplemental analysis of participants completing one or more sessions/modules, online DPP participants were most likely to complete eight or more sessions/modules (87% online DPP vs 59% in-person DPP vs 55% MOVE!, p < 0.001). Online and in-person DPP participants lost significantly more weight than MOVE! participants at 6 and 12 months; there was no significant difference in weight change between online and in-person DPP.ConclusionsAn intensive, multifaceted online DPP intervention had higher participation but similar weight loss compared to in-person DPP. An intensive, multifaceted online DPP intervention may be as effective as in-person DPP and help expand reach to those at risk.
| S-EPMC6699502 | biostudies-literature
Project description:The largest and longest clinical trial of metformin for the prevention of diabetes is the Diabetes Prevention Program/Diabetes Prevention Program Outcomes Study (DPP/DPPOS). In this review, we summarise data from the DPP/DPPOS, focusing on metformin for diabetes prevention, as well as its long-term glycaemic and cardiometabolic effects and safety in people at high-risk of developing diabetes. The DPP (1996-2001) was a RCT of 3234 adults who, at baseline, were at high-risk of developing diabetes. Participants were assigned to masked placebo (n = 1082) or metformin (n = 1073) 850 mg twice daily, or intensive lifestyle intervention (n = 1079). The masked metformin/placebo intervention phase ended approximately 1 year ahead of schedule because of demonstrated efficacy. Primary outcome was reported at 2.8 years. At the end of the DPP, all participants were offered lifestyle education and 88% (n = 2776) of the surviving DPP cohort continued follow-up in the DPPOS. Participants originally assigned to metformin continued to receive metformin, unmasked. The DPP/DPPOS cohort has now been followed for over 15 years with prospective assessment of glycaemic, cardiometabolic, health economic and safety outcomes. After an average follow-up of 2.8 years, metformin reduced the incidence of diabetes by 31% compared with placebo, with a greater effect in those who were more obese, had a higher fasting glucose or a history of gestational diabetes. The DPPOS addressed the longer-term effects of metformin, showing a risk reduction of 18% over 10 and 15 years post-randomisation. Metformin treatment for diabetes prevention was estimated to be cost-saving. At 15 years, lack of progression to diabetes was associated with a 28% lower risk of microvascular complications across treatment arms, a reduction that was no different among treatment groups. Recent findings suggest metformin may reduce atherosclerosis development in men. Originally used for the treatment of type 2 diabetes, metformin, now proven to prevent or delay diabetes, may serve as an important tool in battling the growing diabetes epidemic. Long-term follow-up, currently underway in the DPP/DPPOS, is now evaluating metformin's potential role, when started early in the spectrum of dysglycaemia, on later-stage comorbidities, including cardiovascular disease and cancer.ClinicalTrials.gov NCT00038727 and NCT00004992.
| S-EPMC5709233 | biostudies-literature
Project description:Pacific Islander populations, including Marshallese, face a disproportionately high burden of health disparities relative to the general population.A community-based participatory research (CBPR) approach was utilized to engage Marshallese participants in a comparative effectiveness trial testing 2 Diabetes Prevention Program (DPP) interventions designed to reduce participant's weight, lower HbA1c, encourage healthy eating, and increase physical activity.To compare the effectiveness of the faith-based (WORD) DPP to the culturally adapted (Pacific Culturally Adapted Diabetes Prevention Program [PILI]) DPP, a clustered randomized controlled trial (RCT) with 384 Marshallese participants will be implemented in 32 churches located in Arkansas, Kansas, Missouri, and Oklahoma. Churches will be randomly assigned to WORD DPP arm or to PILI DPP arm.WORD DPP focuses on connecting faith and health to attain a healthy weight, eat healthy, and be more physically active. In contrast, PILI DPP is a family and community focused DPP curriculum specifically adapted for implementation in Pacific Islander communities. PILI focuses on engaging social support networks to maintain a healthy weight, eat healthy, and be more physically active. All participants are assessed at baseline, immediate post intervention, and 12 months post intervention.Both interventions aim to cause weight loss through improving physical activity and healthy eating, with the goal of preventing the development of T2D. The clustered RCT will determine which intervention is most effective with the Marshallese population. The utilization of a CBPR approach that involves local stakeholders and engages faith-based institutions in Marshallese communities will increase the potential for success and sustainability. This study is registered at clinicaltrials.gov (NCT03270436).
| S-EPMC5959435 | biostudies-literature