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

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.

NCT Number	NCT06988306
Lead Sponsor	California Polytechnic State University-San Luis Obispo Collaborators: Lifespan/ The Miriam Hospital, Northwestern University, Bradley Hospital, Patient-Centered Outcomes Research Institute
Conditions	Diabetes Mellitus, Gestational Diabetes Mellitus (GDM)
Enrollment	978 participants
Start Date	2026-01-15
Primary Completion	2030-04-30 (estimated)
Study Completion	2030-04-30 (estimated)
Updated on ClinicalTrials.gov	2026-03-05