Home visiting support with medically tailored meals to prevent diabetes after gestational diabetes
Official title: Randomized Controlled Trial of Lifestyle Interventions for the Prevention of Diabetes in US Home Visiting Programs
Run by California Polytechnic State University-San Luis Obispo · NCT06988306 · Data updated 2026-11-12
This project will test whether adding medically tailored meals to enhanced lifestyle support delivered through home visiting helps pregnant or recently pregnant adults with recent gestational diabetes avoid diabetes or prediabetes in the year after birth.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 978 (estimated) |
| Sponsor | California Polytechnic State University-San Luis Obispo Academic / other |
| Locations | 3 sites (San Luis Obispo, California and 2 other locations) |
| Status | Recruiting |
| Started | January 15, 2026 |
| Main results expected | April 30, 2030 |
| Study ends | April 30, 2030 |
| Registry record updated | March 5, 2026 |
| Trial ID | NCT06988306 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant or within 13 weeks postpartum adults enrolled in a home visiting program who are 18 or older, English- or Spanish-speaking, and had gestational diabetes in their most recent pregnancy and are not already receiving medically tailored meals.
✕Probably not a fit
People with pre-existing diabetes, those already receiving medically tailored meals, not enrolled in home visiting, or unwilling to be randomized are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The randomized interventional study will enroll nearly 1,000 pregnant or up to 13 weeks postpartum adults with a recent diagnosis of gestational diabetes across multiple U.S. sites. Participants already enrolled in home visiting will be randomized to receive either enhanced lifestyle support plus medically tailored meals or enhanced lifestyle support alone, with both interventions delivered within home visiting visits. Primary outcomes include development of type 2 diabetes or pre-diabetes through 12 months postpartum, and secondary outcomes include weight, blood pressure, dietary quality, and food insecurity. The trial emphasizes brief, scalable interventions that build on existing home visiting content and will collect data in English and Spanish.
Why it matters
Potential benefit: If successful, this approach could lower postpartum rates of type 2 diabetes and improve weight, blood pressure, and food security among people with gestational diabetes.
How similar studies have gone: Medically tailored meals have been shown in other populations to improve glucose control, weight, dietary quality, and food security, but integrating them into home visiting to prevent postpartum diabetes is a novel application.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
California Polytechnic State University
San Luis Obispo, California, United States Recruiting -
Northwestern University
Chicago, Illinois, United States Not yet recruiting -
Miriam Hospital
Providence, Rhode Island, United States Not yet recruiting
Study contacts
- Principal investigator: Suzanne Phelan, PhD — California Polytechnic State University-San Luis Obispo
- Study coordinator: Brooke Latzke-Davis, BS
- Email: blatzked@calpoly.edu
- Phone: 805-756-5694
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.