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Purpose: Our objective is to evaluate the "reach" component of the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework by comparing prediabetics who were and were not interested in enrolling in a free work site diabetes prevention program (DPP) during the first year of the program. Reach is defined as the proportion of eligible participants who enroll in a health program., Design: A cross-sectional study design was used., Setting: The setting was a large health system in the Midwest., Participants: Prediabetic health plan enrollees and spouses (N = 2158)., Measures: An online health survey, annual voluntary biometric screenings delivered by a trained health-care professional using standardized protocols via point-of-care testing, and records from the DPP office were the sources of data for this study., Analysis: Health behaviors and biometric screening results were simultaneously compared using multivariable logistic regression., Results: The study population was 63% female, 79% white, and 16% black, and the mean age was 50.2 years (SD = 10.2). The reach of this program was 10%. Prediabetics were more likely to express interest in the DPP, if they were female (adjusted odds ratio [AOR]: 2.4; 95% confidence interval [95% CI]: 1.55-3.72; P < .001), black (AOR = 2.23; 95% CI: 1.43-3.47; P < .001), older in age (AOR: 1.08; 95% CI: 0.99-1.17; P = .05), or had a high-risk waist circumference (AOR = 1.44; 95% CI: 0.98-2.13; P = .07), lower self-efficacy to make healthy changes (AOR = 0.48; 95% CI: 0.26-0.91; P = .03), and 5 or more doctor visits in the last year (AOR = 2.13; 95% CI: 0.99-4.57; P = .05), after controlling for other covariates., Conclusion: Current recruitment and implementation strategies are reaching only a small group of individuals who are not representative of the larger prediabetic population. These findings inform future engagement strategies, and we recommend that public health practitioners evaluate reach to ensure that health promotion programs are of high value.

Objective: To examine the outcomes of a Medicare population who participated in a program combining digital health with human coaching for diabetes risk reduction., Method: People at risk for diabetes enrolled in a program combining digital health with human coaching. Participation and health outcomes were examined at 16 weeks and 6 and 12 months., Results: A total of 501 participants enrolled; 92% completed at least nine of 16 core lessons. Participants averaged 19 of 31 possible opportunities for weekly program engagement. At 12 months, participants lost 7.5% ( SD = 7.8%) of initial body weight; among participants with clinical data, glucose control improved (glycosylated hemoglobin [HbA1c] change = -0.14%, p = .001) and total cholesterol decreased (-7.08 mg/dL, p = .008). Self-reported well-being, depression, and self-care improved ( p < .0001)., Discussion: This Medicare population demonstrated sustained program engagement and improved weight, health, and well-being. The findings support digital programs with human coaching for reducing chronic disease risk among older adults.

Background: Half of Mexican-American women are under-active and nearly 78% are overweight/obese. The high lifetime risk of developing type 2 diabetes necessitates a culturally appropriate lifestyle intervention., Purpose: Unidas por la Vida is a novel dyadic intervention that capitalizes on the centrality of family in Latino culture to mobilize an existing family dyad as a resource for health behavior change. The intervention aims to improve health behaviors and promote weight loss in two at-risk members of the same family: mothers with type 2 diabetes and their overweight/obese adult daughters who are at risk for developing diabetes., Methods: Participants (N = 460 mother-adult daughter dyads) will be randomized into one of three conditions: 1) dyadic participation (mothers-daughters) in a lifestyle intervention; 2) individual participation (mothers alone; unrelated daughters alone) in a lifestyle intervention; and 3) mother-daughter dyads in a minimal intervention control group., Results: The primary outcome is weight loss. Secondary outcomes include physical activity, dietary intake, physiological measures (e.g. HbA1c), and body composition. Both the dyadic and individual interventions are expected to produce greater weight loss at 6, 12, and 18 months than those in minimal intervention control group, with women assigned to the dyadic intervention expected to lose more weight and to maintain the weight loss longer than women assigned to the individual intervention., Conclusion: Because health risks are often shared by multiple members of at-risk families, culturally appropriate, dyadic interventions have the potential to increase the success of behavior change efforts and to extend their reach to multiple family members., Trial Registration: ClinicalTrials.gov identifier NCT02741037., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Aim: To investigate changes in dietary intake following a 6-mo randomised controlled trial of the self-directed, gender-tailored type 2 diabetes mellitus (T2DM) Prevention Using LifeStyle Education (PULSE) program in men., Methods: Men aged 18-65 years, with a body mass index (BMI) 25-40 kg/m 2 , and at high risk for developing T2DM were recruited from the Hunter Region of New South Wales, Australia. Eligible participants were randomised into one of two groups: (1) waitlist control; or (2) PULSE intervention. Dietary intake was assessed at baseline and immediately post-program using the Australian Eating Survey food frequency questionnaire and diet quality measured using the Australian Recommended Food Score (ARFS)., Results: One hundred and one participants ( n = 48, control; n = 53, intervention, mean age 52.3 ± 9.7 years, BMI of 32.6 ± 3.3 kg/m 2 ) commenced the study. Following the active phase, differences between groups were observed for proportion of total energy consumed from healthful (core) foods (+7.6%EI, P < 0.001), energy-dense, nutrient-poor foods (-7.6%EI, P < 0.001), sodium (-369 mg, P = 0.047), and diet quality (ARFS) (+4.3, P = 0.004), including sub-scales for fruit (+1.1, P = 0.03), meat (+0.9, P = 0.004) and non-meat protein (+0.5, P = 0.03)., Conclusion: The PULSE prevention program's nutrition messages led to significant improvements in dietary intake in men at risk of T2DM., Competing Interests: Conflict-of-interest statement: All authors declare no conflict of interest.

Background: The Diabetes Prevention Program (DPP) is an effective lifestyle intervention to reduce incidence of type 2 diabetes. However, there are gaps in knowledge about how to implement DPP. The aim of this study was to evaluate implementation of DPP via assessment of a clinical demonstration in the Veterans Health Administration (VHA)., Methods: A 12-month pragmatic clinical trial compared weight outcomes between the Veterans Affairs Diabetes Prevention Program (VA-DPP) and the usual care MOVE!® weight management program (MOVE!). Eligible participants had a body mass index (BMI) ≥30 kg/m 2 (or BMI ≥ 25 kg/m 2 with one obesity-related condition), prediabetes (glycosylated hemoglobin (HbA1c) 5.7-6.5% or fasting plasma glucose (FPG) 100-125 mg/dL), lived within 60 min of their VA site, and had not participated in a weight management program within the last year. Established evaluation and implementation frameworks were used to guide the implementation evaluation. Implementation barriers and facilitators, delivery fidelity, participant satisfaction, and implementation costs were assessed. Using micro-costing methods, costs for assessment of eligibility and scheduling and maintaining adherence per participant, as well as cost of delivery per session, were also assessed., Results: Several barriers and facilitators to Reach, Adoption, Implementation, Effectiveness and Maintenance were identified; barriers related to Reach were the largest challenge encountered by site teams. Fidelity was higher for VA-DPP delivery compared to MOVE! for five of seven domains assessed. Participant satisfaction was high in both programs, but higher in VA-DPP for most items. Based on micro-costing methods, cost of assessment for eligibility was $68/individual assessed, cost of scheduling and maintaining adherence was $328/participant, and cost of delivery was $101/session., Conclusions: Multi-faceted strategies are needed to reach targeted participants and successfully implement DPP. Costs for assessing patients for eligibility need to be carefully considered while still maximizing reach to the targeted population.

Background: One of the fastest growing risk groups for early onset of diabetes is women with a recent pregnancy complicated by gestational diabetes, and for this group, Latinas are the largest at-risk group in the USA. Although evidence-based interventions, such as the Diabetes Prevention Program (DPP), which focuses on low-cost changes in eating, physical activity and weight management can lower diabetes risk and delay onset, these programs have yet to be tailored to postpartum Latina women. This study aims to tailor a IT-enabled health communication program to promote DPP-concordant behavior change among postpartum Latina women with recent gestational diabetes. The COM-B model (incorporating Capability, Opportunity, and Motivational behavioral barriers and enablers) and the Behavior Change Wheel (BCW) framework, convey a theoretically based approach for intervention development. We combined a health literacy-tailored health IT tool for reaching ethnic minority patients with diabetes with a BCW-based approach to develop a health coaching intervention targeted to postpartum Latina women with recent gestational diabetes. Current evidence, four focus groups (n = 22 participants), and input from a Regional Consortium of health care providers, diabetes experts, and health literacy practitioners informed the intervention development. Thematic analysis of focus group data used the COM-B model to determine content. Relevant cultural, theoretical, and technological components that underpin the design and development of the intervention were selected using the BCW framework., Results: STAR MAMA delivers DPP content in Spanish and English using health communication strategies to: (1) validate the emotions and experiences postpartum women struggle with; (2) encourage integration of prevention strategies into family life through mothers becoming intergenerational custodians of health; and (3) increase social and material supports through referral to social networks, health coaches, and community resources. Feasibility, acceptability, and health-related outcomes (weight loss, physical activity, consumption of healthy foods, breastfeeding, and glucose screening) will be evaluated at 9 months postpartum using a randomized controlled trial design., Conclusions: STAR MAMA provides a DPP-based intervention that integrates theory-based design steps. Through systematic use of behavioral theory to inform intervention development, STAR MAMA may represent a strategy to develop health IT intervention tools to meet the needs of diverse populations., Trial Registration: ClinicalTrials.gov NCT02240420.

A telephone delivered translation of the DPP weight loss program, delivered by trained primary care staff over 2 years, resulted in significant weight loss for patients with metabolic syndrome. Participants in groups (conference calls) continued to lose weight a full year after the program ended, while those called individually regained. [ABSTRACT FROM AUTHOR]

Strategies for management of pre-diabetes within the community setting are needed. An adaptation of the successful Diabetes Prevention Program lifestyle intervention delivered by trained diabetes educators was evaluated. Results indicate that trained diabetes educators offer an important community resource for health care providers for their patients with pre-diabetes. [ABSTRACT FROM AUTHOR]

Background: 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., Objective: 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., Methods: 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., Results: 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., Conclusions: 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.

Abstract: This pilot project evaluated the Group Lifestyle Balance program (GLB), an adaptation of the DPP lifestyle intervention, delivered via DVD with remote participant support provided by the University of Pittsburgh Diabetes Prevention Support Center. Results suggest that GLB-DVD with remote support may provide an effective alternative for GLB delivery. [ABSTRACT FROM AUTHOR]

Objective: It is unclear how lipids change in response to lifestyle modification or metformin among postmenopausal glucose intolerant women using and not using hormone therapy (HT). We examined the one-year changes in lipids among postmenopausal, prediabetic women in the Diabetes Prevention Program (DPP), and whether changes were mediated by sex hormones., Materials/methods: We performed a secondary analysis of a randomized controlled trial of 342 women who used HT at baseline and year 1 and 382 women who did not use HT at either time point. Interventions included intensive lifestyle (ILS) with goals of weight reduction of at least 7% of initial weight and 150 minutes per week of moderate intensity exercise, or metformin or placebo administered 850 mg up to twice a day. Women were not randomized to HT. Main outcome measures were changes between baseline and study year 1 in low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides., Results: Compared to placebo, both ILS and metformin significantly reduced LDL-C and raised HDL-C among HT users, changes partially explained by change in estradiol and testosterone but independent of changes in waist circumference and 1/fasting insulin. In contrast, DPP interventions had no effect on LDL-C and HDL-C among non-HT users. ILS significantly lowered triglycerides among non-users but did not significantly change triglycerides among HT users. Metformin did not significantly change triglycerides among non-users but increased triglycerides among HT users., Conclusions: The beneficial effects of ILS and metformin on lowering LDL-C and raising HDL-C differ depending upon concurrent HT use., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: Coronary flow reserve (CFR) provides independent prognostic information in diabetic patients with known or suspected coronary artery disease. However, there have been no substantial data to evaluate CFR in prediabetics. Accordingly, we aimed to evaluate CFR in subjects with prediabetes using second harmonic transthoracic Doppler echocardiography., Methods and Results: We measured CFR of 65 subjects with prediabetes, 45 patients with overt type 2 diabetes, and 43 sex and age matched normoglycemic healthy subjects with normal glucose tolerance. Ages, gender, existence of hypertension or hypercholesterolemia, smoking status were similar among the groups. CFR was significantly lower in diabetics (2.15 ± 0.39) than in prediabetics (2.39 ± 0.45) and controls (2.75 ± 0.35); in addition, it was significantly lower in prediabetics than controls. Only 2 (5%) of control subjects had abnormal CFR (<2) but 11 (17%) prediabetic subjects and 19 (42%) diabetic patients had abnormal CFR. We found that only age (β=-0.31, P<0.01) and presence of the diabetes (β=-0.57, P<0.01) were significant predictors of lower CFR in a multivariable model that adjusted for other variables. CFR was significantly and inversely correlated with age (r=-0.15, P=0.04), fasting glucose level (r=-0.27, P=0.001), postprandial glucose level (r=0.43, P<0.001), hemoglobin A1C level (r=-0.34, P<0.001), LDL cholesterol level (r=0.22, P=0.009), mitral A velocity (r=-0.27, P=0.001) and Tei index (r=-0.19, P=0.02), whereas mitral E/A ratio, mitral Em (r=0.18, P=0.02), mitral Em/Am ratio (r=0.23, P=0.004) were significantly and positively correlated with CFR., Conclusion: CFR is impaired in subjects with prediabetics, but this impairment is not as severe as that in diabetics., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Objective: To assess associations and genotype × treatment interactions for melanocortin 4 receptor (MC4R) locus variants and obesity-related traits. Design and Methods Diabetes Prevention Program (DPP) participants (N=3,819, of whom 3,356 were genotyped for baseline and 3,234 for longitudinal analyses) were randomized into intensive lifestyle modification (diet, exercise, weight loss), metformin or placebo control. Adiposity was assessed in a subgroup (n=909) using computed tomography. All analyses were adjusted for age, sex, ethnicity and treatment. Results: The rs1943218 minor allele was nominally associated with short-term (6 month; P=0.032) and long-term (2 year; P=0.038) weight change. Eight SNPs modified response to treatment on short-term (rs17066856, rs9966412, rs17066859, rs8091237, rs17066866, rs7240064) or long-term (rs12970134, rs17066866) reduction in body weight, or diabetes incidence (rs17066829) (all Pinteraction <0.05). Conclusion: This is the first study to comprehensively assess the role of MC4R variants and weight regulation in a weight loss intervention trial. One MC4R variant was directly associated with obesity-related traits or diabetes; numerous other variants appear to influence body weight and diabetes risk by modifying the protective effects of the DPP interventions.