Status:
NOT_YET_RECRUITING
Lifestyle Interventions to Prevent Diabetes in U.S. Home Visiting Programs
Lead Sponsor:
California Polytechnic State University-San Luis Obispo
Collaborating Sponsors:
Lifespan/ The Miriam Hospital
Northwestern University
Conditions:
Diabetes Mellitus
Gestational Diabetes Mellitus (GDM)
Eligibility:
FEMALE
18+ years
Phase:
NA
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 th...
Detailed Description
Gestational diabetes mellitus (GDM) is rapidly rising in prevalence and has been linked with several short and long-term adverse maternal health outcomes, including type 2 diabetes (T2DM) and cardiova...
Eligibility Criteria
Inclusion
- 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
- • Pre-existing diabetes (based on self-report)
Key Trial Info
Start Date :
January 31 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2030
Estimated Enrollment :
978 Patients enrolled
Trial Details
Trial ID
NCT06988306
Start Date
January 31 2026
End Date
April 30 2030
Last Update
July 14 2025
Active Locations (3)
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1
California Polytechnic State University
San Luis Obispo, California, United States, 93401
2
Northwestern University
Chicago, Illinois, United States, 60611
3
Miriam Hospital
Providence, Rhode Island, United States, 02906