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

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.

Author information

1
Massachusetts General Hospital (MGH) Diabetes Research Center, Diabetes Unit, Department of Medicine, Boston, MA, United States; Harvard Medical School, Boston, MA, United States. Electronic address: ldelahanty@partners.org.
2
Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, United States.
3
Harvard Medical School, Boston, MA, United States; Mongan Institute Health Policy Center, MGH, Boston, MA, United States.
4
Massachusetts General Hospital (MGH) Diabetes Research Center, Diabetes Unit, Department of Medicine, Boston, MA, United States.
5
Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, United States; MGH Chelsea Health Center, Boston, MA, United States.
6
Harvard Medical School, Boston, MA, United States; Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, United States; MGH Charlestown Health Center, Boston, MA, United States.
7
Harvard Medical School, Boston, MA, United States; Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, United States; MGH Revere Health Center, Boston, MA, United States.
8
Massachusetts General Hospital (MGH) Diabetes Research Center, Diabetes Unit, Department of Medicine, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.

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

PMID:
29803816
PMCID:
PMC6067988
[Available on 2019-08-01]
DOI:
10.1016/j.cct.2018.05.018

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