Design and participant characteristics of a primary care adaptation of the Look AHEAD Lifestyle Intervention for weight loss in type 2 diabetes: The REAL HEALTH-diabetes study.

BACKGROUND/AIMS: The REAL HEALTH -Diabetes Study is a practice-based clinical trial that adapted the Look AHEAD lifestyle intervention for implementation in primary care settings. The trial will compare the effectiveness and cost-effectiveness of in-person group lifestyle intervention, telephone group lifestyle intervention, and individual medical nutrition therapy (MNT), the current recommended standard of care in type 2 diabetes. The primary outcome is percent weight loss at 6 months with outcomes also measured at 12, 18, 24 (intervention completion), and 36 months. Here, we describe the adaptation, trial design, implementation strategies, and baseline characteristics of enrolled participants. METHODS: The study is a three-arm, patient-level, randomized trial conducted in three community health centers (CHCs) and one diabetes practice affiliated with one academic medical center. RESULTS: The study used existing clinical infrastructure to recruit participants from study sites. Strategies for successful conduct of the trial included partnering with health-center based co-investigator clinicians, engaging primary care providers, and accommodating clinical workflows. Of 248 eligible patients who attended a screening visit, 211 enrolled, with 70 randomly assigned to in-person group lifestyle intervention, 72 to telephone group lifestyle intervention, and 69 to MNT. The cohort was 55% female, 29% non-white, with mean age 62 years and mean BMI 35 kg/m2. Enrollment rates were higher at CHC sites. CONCLUSIONS: A practice-based randomized trial of a complex behavioral lifestyle intervention for type 2 diabetes can be implemented in community health and usual clinical settings. Participant and provider engagement was higher at local CHC sites reflecting the study implementation focus. CLINICAL TRIAL REGISTRATION: NCT02320253.

Cost-effectiveness of SHINE: A Telephone Translation of the Diabetes Prevention Program.

BACKGROUND: The Support, Health Information, Nutrition, and Exercise (SHINE) trial recently showed that a telephone adaptation of the Diabetes Prevention Program (DPP) lifestyle intervention was effective in reducing weight among patients with metabolic syndrome. The aim of this study is to determine whether a conference call (CC) adaptation was cost effective relative to an individual call (IC) adaptation of the DPP lifestyle intervention in the primary care setting. METHODS: We performed a stochastic cost-effectiveness analysis alongside a clinical trial comparing two telephone adaptations of the DPP lifestyle intervention. The primary outcomes were incremental cost-effectiveness ratios estimated for weight loss, body mass index (BMI), waist circumference, and quality-adjusted life years (QALYs). Costs were estimated from the perspective of society and included direct medical costs, indirect costs, and intervention costs. RESULTS: After one year, participants receiving the CC intervention accumulated fewer costs ($2,831 vs. $2,933) than the IC group, lost more weight (6.2 kg vs. 5.1 kg), had greater reduction in BMI (2.1 vs. 1.9), and had greater reduction in waist circumference (6.5 cm vs. 5.9 cm). However, participants in the CC group had fewer QALYs than those in the IC group (0.635 vs. 0.646). The incremental cost-effectiveness ratio for CC vs. IC was $9,250/QALY, with a 48% probability of being cost-effective at a willingness-to-pay of $100,000/QALY. CONCLUSIONS: CC delivery of the DPP was cost effective relative to IC delivery in the first year in terms of cost per clinical measure (weight lost, BMI, and waist circumference) but not in terms of cost per QALY, most likely because of the short time horizon.

Short and long-term lifestyle coaching approaches used to address diverse participant barriers to weight loss and physical activity adherence.

BACKGROUND: Individual barriers to weight loss and physical activity goals in the Diabetes Prevention Program, a randomized trial with 3.2 years average treatment duration, have not been previously reported. Evaluating barriers and the lifestyle coaching approaches used to improve adherence in a large, diverse participant cohort can inform dissemination efforts. METHODS: Lifestyle coaches documented barriers and approaches after each session (mean session attendance = 50.3 ± 21.8). Subjects were 1076 intensive lifestyle participants (mean age = 50.6 years; mean BMI = 33.9 kg/m²; 68% female, 48% non-Caucasian). Barriers and approaches used to improve adherence were ranked by the percentage of the cohort for whom they applied. Barrier groupings were also analyzed in relation to baseline demographic characteristics. RESULTS: Top weight loss barriers reported were problems with self-monitoring (58%); social cues (58%); holidays (54%); low activity (48%); and internal cues (thought/mood) (44%). Top activity barriers were holidays (51%); time management (50%); internal cues (30%); illness (29%), and motivation (26%). The percentage of the cohort having any type of barrier increased over the long-term intervention period. A majority of the weight loss barriers were significantly associated with younger age, greater obesity, and non-Caucasian race/ethnicity (p-values vary). Physical activity barriers, particularly thought and mood cues, social cues and time management, physical injury or illness and access/weather, were most significantly associated with being female and obese (p < 0.001 for all). Lifestyle coaches used problem-solving with most participants (≥75% short-term; > 90% long term) and regularly reviewed self-monitoring skills. More costly approaches were used infrequently during the first 16 sessions (≤10%) but increased over 3.2 years. CONCLUSION: Behavioral problem solving approaches have short and long term dissemination potential for many kinds of participant barriers. Given minimal resources, increased attention to training lifestyle coaches in the consistent use of these approaches appears warranted.

Implications of the diabetes prevention program and Look AHEAD clinical trials for lifestyle interventions.

The Diabetes Prevention Program (DPP) and Look AHEAD (Action for Health in Diabetes) trials are long-term randomized clinical trials that have the potential to direct diabetes care and medical nutrition therapy for obesity, prediabetes, and type 2 diabetes both now and in the future. This article summarizes and compares the important evidence-based results of these diabetes and obesity clinical trials and reviews the similarities and differences in lifestyle interventions that were designed for these trials. Although there were many similarities in the features of the DPP and Look AHEAD interventions, the Look AHEAD lifestyle intervention was more ambitious in several ways: higher individual weight-loss goals, lower calorie and fat-gram targets based on initial body weight, more intensive intervention frequency, combining closed group and individual session format, and use of more structured nutrition intervention strategies from the outset, including meal replacements, structured menus, and combined fat and calorie counting. Evidence, knowledge, and insights gained from working on these clinical trials will be very important in determining the strategies, methods, and approaches needed to make sure that the results of these trials will be fully applied in real-world practice settings for obesity, prediabetes, and type 2 diabetes.

Research navigating the course of clinical practice in diabetes.

Three of the four largest and, arguably, most important long-term clinical trials focusing on diabetes in the past 2 decades have had medical nutrition therapy (MNT) as a major element of their experimental therapies: the Diabetes Control and Complications Trial and its follow-up study the Epidemiology of Diabetes Interventions and Complications Study, the Diabetes Prevention Program, and the Look AHEAD (Action for Health in Diabetes) study. The important features of these studies, their major results, and implications for current and future practice of MNT in the prevention and treatment of diabetes are delineated. The evidence suggests that dietetics professionals have an increasingly important role in the early initiation of MNT in the treatment and prevention of diabetes and in establishing the long-term relationships required to shape behavior and sustain the lifestyle habits that translate into significant reductions in the incidence of diabetes-related health outcomes and improved cost-effectiveness over time.