NCT06445530 Nutrition Optimization and Community Upliftment for Postpartum Recovery
| NCT ID | NCT06445530 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Obesity, Maternal |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-09-15 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to better understand how different strategies, timing, and enhancements to medically tailored food delivery will address structural inequities in the food environment, empower communities to sustain behavior change, and ultimately improve postpartum weight control to prevent type 2 diabetes-a potent contributor to disparate mortality among Black women. The main aims of the study are: * To conduct a pilot randomized control trial to test the feasibility, acceptability, and effectiveness of a multi-component Medically Tailored Food (MTF) intervention, Moveable Feast ENHANCED (a hybrid MTF intervention with a patient-activated change from prepared meals to fresh food delivery, customized for postpartum people, culturally customized for engagement and adherence, and food provision for dependents) versus MFeast Usual Care (prepared medically tailored foods only) * To test sustainability and scalability. Participants will: * Respond to online surveys (supported by study team members via scheduled phone calls) via REDCap links shared before each study visit at baseline, 3, 6 months post-delivery after the baseline survey. * Submit anthropometric data (i.e, weight) and information about laboratory results ( e.g. HgbA1C)
Eligibility Criteria
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
Contact & Investigator
Michelle S Ogunwole, MD, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins School of Medicine
Frequently Asked Questions
Who can join the NCT06445530 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Obesity, Maternal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06445530 currently recruiting?
Yes, NCT06445530 is actively recruiting participants. Contact the research team at sogunwo1@jhmi.edu for enrollment information.
Where is the NCT06445530 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06445530 clinical trial?
NCT06445530 is sponsored by Johns Hopkins University. The principal investigator is Michelle S Ogunwole, MD, PhD at Johns Hopkins School of Medicine. The trial plans to enroll 40 participants.
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