Nutrition Optimization and Community Upliftment for Postpartum Recovery: Hypertension
NCT06445543 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2025-10-10
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)
Conditions
- Obesity, Maternal
- Pre-Eclampsia; Complicating Pregnancy
- Gestational Hypertension
- Eclampsia; Complicating Pregnancy
Interventions
- BEHAVIORAL
-
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.
- BEHAVIORAL
-
MFeast Usual Care
Those assigned to the "MFeast Usual Care" group will receive 10 weekly prepared heart-healthy meals from MFeast.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Michelle Ogunwole, MD, PhD · Johns Hopkins School of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2027-03-31
- Completion
- 2027-06-30
Countries
- United States
Study Locations
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