Nutrition Optimization and Community Upliftment for Postpartum Recovery
Recruiting · NCT06445530 · Interventional (participants receive a specific treatment) · Lead sponsor: Johns Hopkins University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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)
Who can take part
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 is running
1 location listed across 1 US state.
- East Baltimore Medical Campus - Baltimore, Maryland, United States