Effectiveness of Lifestyle Intervention for Type 2 Diabetes in Primary Care: the REAL HEALTH-Diabetes Randomized Clinica
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Diabetes Unit, Department of Medicine, Massachusetts General Hospital (MGH) Diabetes Research Center, Boston, MA, USA; 2Harvard Medical School, Boston, MA, USA; 3Mongan Institute Health Policy Research Center, MGH, Boston, MA, USA; 4Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA; 5MGH Chelsea Health Center, Boston, MA, USA; 6MGH Charlestown Health Center, Boston, MA, USA; 7MGH Revere Health Center, Boston, MA, USA.
BACKGROUND: Intensive lifestyle interventions (LI) improve outcomes in obesity and type 2 diabetes but are not currently available in usual care. OBJECTIVE: To compare the effectiveness and costs of two group LI programs, in-person LI and telephone conference call (telephone LI), to medical nutrition therapy (MNT) on weight loss in primary care patients with type 2 diabetes. DESIGN: A randomized, assessor-blinded, practicebased clinical trial in three community health centers and one hospital-based practice affiliated with a single health system. PARTICIPANTS: A total of 208 primary care patients with type 2 diabetes, HbA1c 6.5 to < 11.5, and BMI > 25 kg/m2 (> 23 kg/m2 in Asians). INTERVENTIONS: Dietitian-delivered in-person or telephone group LI programs with medication management or MNT referral. MAIN MEASURES: Primary outcome: mean percent weight change. Secondary outcomes: 5% and 10% weight loss, change in HbA1c, and cost per kilogram lost. KEY RESULTS: Participants’ mean age was 62 (SD 10) years, 45% were male, and 77% were White, with BMI 35 (SD 5) kg/m2 and HbA1c 7.7 (SD 1.2). Seventy were assigned to in-person LI, 72 to telephone LI, and 69 to MNT. The mean percent weight loss (95% CI) at 6 and 12 months was 5.6% (4.4–6.8%) and 4.6% (3.1–6.1%) for in-person LI, 4.6% (3.3–6.0%) and 4.8% (3.3–6.2%) for telephone LI, and 1.1% (0.2–2.0%) and 2.0% (0.9–3.0%) for MNT, with statistically significant differences between each LI arm and MNT (P < 0.001) but not between LI arms (P = 0.63). HbA1c improved in all participants. Compared
Prior Presentations Portions of this work were presented in abstract form at the American Diabetes Association’s Scientific Sessions in June 2019. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s11606-019-05629-9) contains supplementary material, which is available to authorized users. Received November 26, 2019 Accepted December 20, 2019
with MNT, the incremental cost per kilogram lost was $789 for in-person LI and $1223 for telephone LI. CONCLUSIONS: In-person LI or telephone group LI can achieve good weight loss outcomes in primary care type 2 diabetes patients at a reasonable cost. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02320253 KEY WORDS: type 2 diabetes; lifestyle intervention; primary care; costeffectiveness; weight loss interventions. J Gen Intern Med DOI: 10.1007/s11606-019-05629-9 © Society of General Internal Medicine 2020
INTRODUCTION
Intensive, multicomponent behavioral interventions for type 2 diabetes and obesity, also known as lifestyle interventio
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