Recruiting

MTF vs. MFeast

Sponsor:

Johns Hopkins University

Code:

NCT06445530

Conditions

Obesity, Maternal

Gestational Diabetes

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MFeast ENHANCED

MFeast Usual Care

Study Details

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)

Conditions

Obesity, Maternal

Gestational Diabetes

Study ID

NCT06445530

Start date

Sep 15, 2025

Status verified date

Sep, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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).

Interventions

MFeast 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.

MFeast 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.

Primary outcome measure

  • Participant Enrollment Rate [ Time Frame: 6-8 months postpartum ]
  • Participant Retention [ Time Frame: 6-8 months postpartum ]
  • Adherence as assessed by self-reported food consumption scores and photographs sent to the study team via secure messaging app [ Time Frame: 6-8 months postpartum ]
  • Satisfaction as assessed by focus groups and the 8 item Client Satisfaction Questionnaire- (CSQ-8) [ Time Frame: 6-8 months postpartum ]
  • Participant Engagement assessed by frequency and quality of meal discussions [ Time Frame: 1-6 months postpartum ]

Central Contacts and Locations

Central contacts

Michelle S Ogunwole, MD PhD

2143154936sogunwo1@jhmi.edu

Locations

East Baltimore Medical Campus

Recruiting

Baltimore, Maryland, United States, 21205

More Information

Sponsor

Johns Hopkins University

Last update posted

Oct 3, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-10-03.