Nutrition Optimization and Community Upliftment for Postpartum Recovery: Interventions to Support Healing After Gestational Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Maryland
East Baltimore Medical Campus
RECRUITING
Baltimore
Contact Information
Primary
Michelle S Ogunwole, MD PhD
sogunwo1@jhmi.edu
2143154936
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2027-06
Participants
Target number of participants: 40
Treatments
Experimental: MFeast ENHANCED
MFeast ENHANCED (a hybrid MTF intervention with a patient-activated transition from prepared meal to fresh food delivery, adaptations for postpartum people, structural and nutritional lactation support, cultural adaptations for engagement and adherence, and food provision for dependents)
Active_comparator: MFeast Usual Care
MFeast Usual Care (prepared medically tailored meals only).
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov