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Recruiting NCT06988306

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

Trial Parameters

Condition Diabetes Mellitus
Sponsor California Polytechnic State University-San Luis Obispo
Study Type INTERVENTIONAL
Phase N/A
Enrollment 978
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2026-01-15
Completion 2030-04-30
Interventions
GDM EnhancedMeals

Brief 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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: • Pre-existing diabetes (based on self-report)

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