Nutrition and community food support for postpartum recovery after gestational diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized pilot compares an enhanced medically tailored food program (MFeast ENHANCED) that begins with prepared meals and can shift to fresh food delivery, includes dietitian-led nutrition coaching and lactation snack bundles, versus usual prepared medically tailored meals (MFeast Usual Care). Eligible participants are low-income, English-speaking Black women age 18 or older with BMI >30 and recent gestational diabetes recruited through Medicaid plans, obstetric clinics, and community partners in Baltimore. Enrollment and baseline data collection begin around 37 weeks gestation with randomization 1:1 and the intervention starting in the first postpartum week, with follow-up via online surveys and clinical outcome verification. The trial is designed to test feasibility, acceptability, preliminary effectiveness, and the potential for sustainability and scalability in a community setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years
* Self-identify as Black or African American
* Low-income (defined as eligible for Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) benefits)
* Speak English as a primary language
* Identify as a primary meal planner/preparer
* Gestational diabetes
* Gestational age \>37 weeks
* Have a BMI \> 30 (calculated based on chart review of height and weight measurement)
* Willing to take part in the intervention and data collection procedures through online surveys

Exclusion Criteria:

* Mothers who have social support i.e. have family members preparing meals for the mother
* Mothers who are unlikely to be at the primary residence in the postpartum period
* Mothers with very specific dietary needs, i.e, food allergies, picky eaters, vegetarian / vegan
* Mothers whose birth outcome is a stillborn
* Mothers who have serious mental illness

Where it's running

• East Baltimore Medical Campus
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Michelle S Ogunwole, MD, PhD — Johns Hopkins School of Medicine
• Study coordinator: Michelle S Ogunwole, MD PhD
• Email: sogunwo1@jhmi.edu
• Phone: 2143154936

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.