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

Summary

The study is examining the health effects of gestational diabetes mellitus (GDM) intervention and medically tailored meals within home visiting. A large study is proposed that will include nearly a thousand pregnant or recently pregnant adults with recent GDM and who are from different regions and backgrounds. Two treatment approaches are compared, and both are in home visiting. One treatment group is receiving enhanced lifestyle support for GDM along with meals, and the other is receiving just the enhanced lifestyle support. The study will examine whether these interventions help reduce diabetes and pre-diabetes through 12 months postpartum, as well as other health factors like weight and blood pressure.

Conditions

• Diabetes Mellitus
• Gestational Diabetes Mellitus (GDM)

Interventions

BEHAVIORAL

GDM Enhanced

The GDM Enhanced intervention is comprised of HV-delivered, evidence-based modules (10-20 minutes) with facilitator guides. The content prioritizes management and prevention of diabetes through healthy eating, physical activity, and stigma-informed weight management strategies.

BEHAVIORAL

Meals

The Meal intervention includes medically tailored meals being provided to participants starting after randomization and tailored to their individual dietary preferences and cultural considerations.

Sponsors & Collaborators

• Lifespan/ The Miriam Hospital

  collaborator UNKNOWN

• Northwestern University

  collaborator OTHER

• Bradley Hospital

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• California Polytechnic State University-San Luis Obispo

  lead OTHER

Principal Investigators

• Suzanne Phelan, PhD · California Polytechnic State University-San Luis Obispo

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-15

Primary Completion

2030-04-30

Completion

2030-04-30

Countries

• United States

Study Locations