RecruitingNot ApplicableNCT06445530

Nutrition Optimization and Community Upliftment for Postpartum Recovery

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


Sponsor

Johns Hopkins University

Enrollment

40 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria9

  • 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 Criteria5

  • 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

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Interventions

BEHAVIORALMFeast ENHANCED

Intervention group will initially receive prepared MTF (low carbohydrate, low-fat meals, which have been shown to improve glycemia in people with prediabetes) delivered by MFeast (10 meals weekly); Tailored Medical Nutrition Therapy (MNT) delivered by dieticians from MFeast via monthly phone calls and focused on only: ↓sugar-sweetened beverages and ↑fruit and vegetable consumption; Lactation snack bundles to boost milk supply + structural support for breastfeeding/pumping via lactation consultants and pumping supply subsidization; culturally-adapted seasoning bundles; and dependent meal boxes for children in the household (i.e., will include 10 developmentally appropriate snack and small meal bundles, for up to 24 weeks. At postpartum week 8 participants will be offered a transition from prepared medically tailored meals to Instacart fresh food delivery (via study team-crafted virtual grocery store) for 16 more weeks.

BEHAVIORALMFeast Usual Care

Those assigned to the "MFeast Usual Care" group will receive prepared MTF delivered by MFeast and as needed MNT from 1 to 24 weeks postpartum.


Locations(1)

East Baltimore Medical Campus

Baltimore, Maryland, United States

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NCT06445530


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