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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ABSTRACT:
SUBMITTER: Palmer KNB
PROVIDER: S-EPMC7414259 | biostudies-literature | 2020 Oct
REPOSITORIES: biostudies-literature
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Intervention Delivery Matters: What Mothers at High Risk for Type 2 Diabetes Want in a Diabetes Prevention Program-Results from a Comparative Effectiveness Trial.
Palmer Kelly N B KNB Garr Barry Valene E VE Marrero David G DG McKinney Brett M BM Graves Anne N AN Winters Chelsy K CK Hannon Tamara S TS
Diabetes therapy : research, treatment and education of diabetes and related disorders 20200808 10
Participants in the ENCOURAGE Healthy Families Study, a family-focused, modified Diabetes Prevention Program, reported challenges to and preferences for engaging in a diabetes prevention program. Challenges with flexible intervention delivery, accessibility, the traditional group-based format, and Coronavirus Disease 2019 (COVID-19) exposure risk can be mitigated by participant preferences for one-on-one, virtual/online intervention delivery.Trial Registration: ClinicalTrials.gov identifier, NCT ...[more]
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Project description:The U.S. Cooperative Extension Service (CE) has potential to deliver the National Diabetes Prevention Program (NDPP) to rural residents with prediabetes. However, the CE remains underutilized for the delivery of NDPP. We compared the feasibility/effectiveness of the NDPP (0-6 mos.) delivered by CE personnel to rural residents with prediabetes using Zoom® (CE-Zoom®) or by our research staff using Facebook® (FB). Adults (n = 31, age ~55 years) were enrolled (CE-Zoom® n = 16, FB n = 15). Attendance did not differ significantly between groups (CE Zoom® = 69%, FB = 83%, p = 0.15). Participant retention was similar in the CE Zoom® (88%) and FB groups (87%). CE-Zoom® and FB® groups provided weekly, self-monitoring data for 83% and 84% of the 24 potential weeks, respectively. Six-month weight loss was not different between groups (CE-Zoom® = -5.99 ± 8.0 kg, -5.4%, FB = -1.68 ± 3.3 kg, -1.6% p = 0.13). Participants achieving ≥5% weight loss was greater in the CE-Zoom® (44%) compared with the FB group (7%, p = 0.04). Participants achieving the NDPP program goal for physical activity (≥150 min/week) did not differ (CE-Zoom® = 75%, FB = 67%, p = 0.91). This pilot trial demonstrated the potential feasibility and effectiveness of the NDPP delivered by CE personnel in a group remote format (Zoom®) to adults with prediabetes living in rural areas.
| S-EPMC9408158 | biostudies-literature
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:Introduction: Based on previously published US Diabetes Prevention Program (DPP) cost-effectiveness analyses (CEAs), metformin continues to be promoted as "cost-effective." We reviewed a 10-year CEA to assess this. Treatment alternatives included placebo, branded metformin and individual lifestyle modification. Following the original CEA, we added group lifestyle as a modeled alternative. Methods: Original published data were taken as given and re-analyzed according to accepted principles for calculating incremental cost-effectiveness ratios (ICERs). With more than 2 treatments, these require attention to the rankings of interventions according to cost or effect prior to stipulating appropriate ICERs to calculate. Results: With appropriate ICER calculations, metformin was not cost-effective. Net Loss calculations indicated substantial costs/health losses to using metformin instead of the optimal lifestyle alternative in response to metformin having been confusingly labeled "cost-saving" in the original CEA. Conclusions: The original DPP CEA, subsequent analyses and citations of such analyses continue to conclude that both metformin and lifestyle modification are cost-effective in diabetes prevention. However, using metformin implies substantial costs and health losses compared to the cost-effective lifestyle modification. It may be that metformin has a role in cost-effective diabetes prevention, but this has yet to be shown based on DPP data.
| S-EPMC11752154 | biostudies-literature
Project description:Diabetes Prevention Program (DPP)
| PRJNA227394 | ENA
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:ObjectiveEducational 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.MethodsWe 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.Results47% 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).ConclusionsIntensive 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: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:BackgroundAmong people with abdominal obesity, women are more likely to develop diabetes than men. Mobile health (mHealth)-based technologies provide the flexibility and resource-saving opportunities to improve lifestyles in an individualized way. However, mHealth-based diabetes prevention programs tailored for busy mothers with abdominal obesity have not been reported yet.ObjectiveThe aim of this study is to evaluate the feasibility and acceptability of an mHealth-based diabetes prevention program and its preliminary efficacy in reducing weight-related variables, behavioral variables, psychological variables, and diabetes risk among Chinese mothers with abdominal obesity over 6 months.MethodsA randomized controlled trial was conducted at health management centers in 2 tertiary hospitals in Changsha, China. The mHealth group (n=40) received 12 weekly web-based lifestyle modification modules for diabetes prevention, 6 biweekly individualized health education messages based on their goal settings, and a Fitbit tracker. The control group (n=40) received 12 weekly web-based general health education modules, 6 biweekly general health education messages, and a Fitbit tracker. Data were collected at baseline, 3 months, and 6 months on the feasibility and acceptability outcomes, weight-related variables (waist circumference and BMI), diabetes risk scores, glycemic levels, behavioral variables (daily step count, active minutes, fruit and vegetable intake, calorie consumption, and sleep duration), and psychological variables (self-efficacy and social support for physical activity and diet, perceived stress, and quality of life). Generalized estimating equations were used for data analysis.ResultsApproximately 85% (68/80) of the participants completed 6 months of follow-up assessments. Regarding the feasibility and acceptance of the program in the mHealth group, the average number of modules reviewed was 7.9 out of 12, and the satisfaction score was 4.37 out of 5. Significant improvements at 6 months between the intervention and control groups were found in waist circumference (β=-2.24, 95% CI -4.12 to -0.36; P=.02), modifiable diabetes risk scores (β=-2.5, 95% CI -4.57 to -0.44; P=.02), daily steps (β=1.67, 95% CI 0.06-3.29; P=.04), self-efficacy for physical activity (β=1.93, 95% CI 0.44-3.43; P=.01), social support for physical activity (β=2.27, 95% CI 0.80-3.74; P=.002), and physical health satisfaction (β=0.82, 95% CI 0.08-1.55; P=.03). No differences were found in BMI, total diabetes risk score, daily active minutes, daily intake of fruits and vegetables, sleep duration, daily calorie consumption, self-efficacy, and social support for diet (P>.05).ConclusionsThis study addresses the potential role of tailored lifestyle interventions based on mHealth technology by offering tailored web-based health modules and health information in managing diabetes risk among mothers with abdominal obesity. The mHealth diabetes prevention program provides a flexible, customized, and resource-saving model for busy mothers. Future research could further explore the efficacy improvement on dietary behaviors to better serve the health care needs of this population.Trial registrationChinese Clinical Trial Registry ChiCTR2400090554; https://www.chictr.org.cn/showproj.html?proj=226411.
| S-EPMC11806265 | 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