Nutrition Optimization and Community Upliftment for Postpartum Recovery: Hypertension

NCT ID: NCT06445543

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-09-30
• Study Completion Date: 2027-06-30

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 chronic hypertension-a potent contributor to disparate mortality among Black women.

• To conduct a pilot randomized control trial to test the feasibility, acceptability, and effectiveness of a multi-component Medically Tailored Food (MTF) intervention, MFeast 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 and 6 months post-delivery after the baseline survey.
• Submit anthropometric data (e.g. weight and blood pressure)

Detailed Description

This study will evaluate the feasibility, acceptability, and preliminary effectiveness of a postpartum dietary intervention for Black women with obesity and a recent pregnancy complicated by hypertensive disorders of pregnancy (HDP). The investigators will recruit women through Medicaid insurance plans (Priority Partners), clinical obstetric practice (Johns Hopkins Outpatient Center, Women's Health Center), perinatal community-based organizations (MOM Cares and Bloom Collective), and home-visiting locations (The Family Tree of Maryland)-all of which can verify clinical outcomes for participants.

At 37 weeks gestation, participants are contacted by the study team for consent, baseline data collection (baseline visit 1), and randomization 1:1 to receive the intervention vs. usual care (which begins in the first postpartum week). 3-7 days after randomization, the remainder of baseline visit information (baseline visit 2) is collected including information for prepared MTF food supplier Moveable Feast Baltimore. The intervention group will initially receive 10 weekly prepared heart-healthy meals from MFeast; Lactation nutritional 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 (medically tailored via study team-crafted virtual grocery store) for 16 more weeks. Those assigned to the "MFeast Usual Care" group will receive 10 weekly prepared heart-healthy meals from Moveable Feast (MFeast).

Conditions

Obesity, Maternal; Pre-Eclampsia; Complicating Pregnancy; Gestational Hypertension; Eclampsia; Complicating Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

MFeast ENHANCED

Intervention Type: BEHAVIORAL

The intervention group will initially receive 10 weekly prepared heart-healthy meals from MFeast; Lactation nutritional 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 (medically tailored via study team-crafted virtual grocery store) for 16 more weeks.

MFeast Usual Care

MFeast Usual Care (prepared medically tailored meals only).

Group Type: ACTIVE_COMPARATOR

MFeast Usual Care

Intervention Type: BEHAVIORAL

Those assigned to the "MFeast Usual Care" group will receive 10 weekly prepared heart-healthy meals from MFeast.

Interventions

MFeast ENHANCED

The intervention group will initially receive 10 weekly prepared heart-healthy meals from MFeast; Lactation nutritional 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 (medically tailored via study team-crafted virtual grocery store) for 16 more weeks.

Intervention Type: BEHAVIORAL

MFeast Usual Care

Those assigned to the "MFeast Usual Care" group will receive 10 weekly prepared heart-healthy meals from MFeast.

Intervention Type: BEHAVIORAL

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
• Hypertensive disorder of pregnancy, defined as one of the following: Gestational Hypertension, Preeclampsia, Eclampsia
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Ogunwole, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

East Baltimore Medical Campus

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00445487

Identifier Type: -

Identifier Source: org_study_id