Randomized Controlled Trial of Lifestyle Interventions for the Prevention of Diabetes in US Home Visiting Programs

What this Trial Is About

This research aims to evaluate the health effects of two lifestyle interventions for pregnant or recently pregnant adults diagnosed with gestational diabetes mellitus (GDM). The study focuses on reducing the risk of developing type 2 diabetes or pre-diabetes during the critical postpartum year. It is a large-scale, randomized controlled trial involving nearly a thousand participants from diverse backgrounds and regions in the US. The study also seeks to understand how these interventions impact other health factors like weight and blood pressure. Participants are randomly assigned to one of two groups receiving home visiting services. One group receives an enhanced lifestyle support program for managing GDM, which includes brief, evidence-based modules on healthy eating, physical activity, and weight management. The other group receives the same enhanced lifestyle program plus medically tailored meals designed to meet individual dietary needs and cultural preferences. These meals are provided starting after randomization. During the study, participants will be followed from enrollment through 12 months postpartum. Researchers will assess the incidence of type 2 diabetes or pre-diabetes and measure other outcomes such as blood sugar control (HbA1c), blood pressure, body weight, diet quality, physical activity, food security, quality of life, and mood at 3, 6, and 12 months postpartum. The study includes a detailed evaluation of how well the interventions are implemented and their reach among diverse populations. This comprehensive monitoring aims to support the long-term success and sustainability of these programs in home visiting settings.

Lifestyle Interventions to Prevent Diabetes in U.S. Home Visiting Programs