Healthy eating and active living to reverse diabetes (HEAL Diabetes-USA): a randomized controlled pilot study protocol to assess the feasibility of a weight loss intervention for diabetes remission.

BACKGROUND

Intensive lifestyle programs promoting weight loss have been shown to induce long-term remission of early Type 2 diabetes (T2D). Further, multicomponent weight loss interventions are recommended for all patients with obesity, but these programs are largely unavailable for people living in low-income and medically underserved areas in the United States (US) and little is known about the benefits, feasibility, and costs of such interventions in community settings.

OBJECTIVE

To assess the feasibility, preliminary effectiveness, and costs of a multicomponent intensive healthy eating and weight-loss program designed to support diabetes remission.

STUDY

DESIGN

The US-based Healthy Eating and Active Living to reverse diabetes (HEAL Diabetes-USA) is a pragmatic randomized controlled pilot study conducted in Memphis, Tennessee (data collection: August 2023-August 2025), independent of and not affiliated with the UK-based HEAL-D program. Adults (≥18 years) with early T2D (<6 years), HbA1c ≥ 6.5%, and overweight/obesity (n = 60) are randomized to either Enhanced Care (EC) or Intensive Care (IC). EC includes printed materials and standard health coaching. IC is the multi-component intervention arm which includes grocery delivery, nutrition education, biweekly group sessions, and ongoing health coaching. Primary outcomes include changes in body weight and HbA1c, and proportion of patients who achieved diabetes remission at 6 and 12 months. Secondary outcomes include changes in random blood glucose, self-efficacy, diabetes self-care activities and program cost analyses.

CONCLUSIONS

This protocol describes the design of HEAL Diabetes-USA, a community-based intensive lifestyle intervention for early T2D. Findings will inform the feasibility and cost-effectiveness of delivering multicomponent diabetes-remission programs in medically underserved US settings.