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

Contemp Clin Trials. 2018 Aug:71:9-17. doi: 10.1016/j.cct.2018.05.018. Epub 2018 May 25.

Abstract

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.

Keywords: Implementation research; Lifestyle intervention; Practice-based research; Randomized controlled trial; Research translation to practice; Telephonic intervention; Type 2 diabetes.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Ambulatory Care Facilities
  • Body Mass Index
  • Cost-Benefit Analysis
  • Diabetes Mellitus, Type 2* / epidemiology
  • Diabetes Mellitus, Type 2* / psychology
  • Diabetes Mellitus, Type 2* / therapy
  • Diet Therapy* / economics
  • Diet Therapy* / methods
  • Female
  • Humans
  • Life Style
  • Male
  • Middle Aged
  • Obesity* / epidemiology
  • Obesity* / psychology
  • Obesity* / therapy
  • Primary Health Care / methods*
  • Psychotherapy, Group* / economics
  • Psychotherapy, Group* / methods
  • Risk Reduction Behavior*
  • Treatment Outcome
  • United States
  • Weight Loss

Associated data

  • ClinicalTrials.gov/NCT02320253