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

Recruiting now · Not applicable

Conditions studied: Diabetes Mellitus, Gestational Diabetes Mellitus (GDM)

In brief

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.

Key facts

Study ID: NCT06988306
Run by: California Polytechnic State University-San Luis Obispo
People needed: 978
Starts: 2026-01-15
Expected to finish: 2030-04-30
Last updated by the study team: 2026-03-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Currently in home visiting
Pregnant or < 3 months (13 weeks) postpartum
Gestational Diabetes Mellitus diagnosis in most recent pregnancy (based on self-report)
Aged 18 years or older
English- or Spanish-speaking.
Not currently being given medically tailored meals
Willing to receive randomization to either group

You may not qualify if…

Pre-existing diabetes (based on self-report)

Where it is running

California Polytechnic State University — San Luis Obispo, California, United States (enrolling)
Northwestern University — Chicago, Illinois, United States
Miriam Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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