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Lifestyle Interventions to Prevent Diabetes in U.S. Home Visiting Programs
Sponsor: California Polytechnic State University-San Luis Obispo
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.
Official title: Randomized Controlled Trial of Lifestyle Interventions for the Prevention of Diabetes in US Home Visiting Programs
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
978
Start Date
2026-01-15
Completion Date
2030-04-30
Last Updated
2026-03-05
Healthy Volunteers
No
Interventions
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.
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.
Locations (3)
California Polytechnic State University
San Luis Obispo, California, United States
Northwestern University
Chicago, Illinois, United States
Miriam Hospital
Providence, Rhode Island, United States