Nutrition Optimization and Community Upliftment for Postpartum Recovery: Hypertension

NCT06445543 | Withdrawn DMC

• 1 other identifier: IRB00445487
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Participant Enrollment Rate

  Participant Enrollment Rate as assessed by the percentage of participants consented/enrolled compared to the total eligible participants.

  6-8 months postpartum

• Participant Retention

  Participant Retention as assessed by the percentage of participants completing all study follow-up visits among all enrolled participants.

  6-8 months postpartum

• Adherence as assessed by self-reported food consumption scores and photographs

  Adherence as assessed by self-reported food consumption scores and photographs sent to the study team via secure messaging app. Food Consumption scores range from 0%, 25%, 50%, 75%, or 100%, indicating the amount of food consumed the prior week (self and dependents scores reported).

  6-8 months postpartum

• Satisfaction as assessed by focus groups and the 8 item Client Satisfaction Questionnaire- (CSQ-8)

  Participants rate satisfaction with the intervention's meal quality, delivery service, and likelihood of recommending the service to others at study completion, to assess the extent to which the intervention met their needs and preferences. Scores range from 8 to 32, with higher values indicating higher satisfaction.

  6-8 months postpartum

• Participant Engagement assessed by frequency and quality of meal discussions

  Analyze the messaging app and Slack Channel to determine the frequency and quality of discussions about meals and recipes.

  1-6 months postpartum

Secondary Outcomes (4)

• Dietary Quality as assessed by the Healthy Eating Index (HEI) 24-hour recall

  Baseline, 3 and 6 months postpartum

• Stress assessed by the 4-item Stress Scale

  Baseline, 3 and 6 months postpartum

• Food Insecurity measured using a 6-item Food Insecurity Scale

  Baseline, 3 and 6 months postpartum

• Postpartum Weight (pounds) Retention as assessed by the difference in self-reported pre-pregnancy weight and postpartum weights

  Baseline, 3 and 6 months postpartum

Other Outcomes (1)

• Blood Pressure as assessed by Bluetooth blood pressure cuff

  Baseline, 3 and 6 months postpartum

Study Arms (2)

MFeast ENHANCED

EXPERIMENTAL

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)

Behavioral: MFeast ENHANCED

MFeast Usual Care

ACTIVE COMPARATOR

MFeast Usual Care (prepared medically tailored meals only).

Behavioral: MFeast Usual Care

Interventions

MFeast ENHANCED 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 ENHANCED

MFeast Usual Care BEHAVIORAL

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

MFeast Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

East Baltimore Medical Campus

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Pregnancy in Obesity; Pre-Eclampsia; Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michelle Ogunwole, MD, PhD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, blinding of participants or MFeast staff is not possible, but data collectors will be blinded to arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design is a two parallel-arm pilot randomized controlled trial. The investigators will be applying the principles of a hybrid type 1 implementation-effectiveness randomized controlled trial.

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 10, 2025

Record last verified: 2025-10

Locations

US (1)