Nutrition Optimization for Postpartum Recovery

(NOURISH-HDP Trial)

Overseen By Michelle S Ogunwole, MD PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Social support, Dietary needs, Stillborn, Mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 24 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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)

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on nutrition and food delivery for postpartum recovery.

Is the Nutrition Optimization for Postpartum Recovery treatment safe for humans?

The research on balanced energy protein supplements, which are similar to the treatment in question, shows high compliance and acceptability among pregnant women, suggesting they are generally safe for human use. ^{1 2 3 4 5}

How is the treatment MFeast ENHANCED unique for postpartum recovery?

MFeast ENHANCED is unique for postpartum recovery as it likely focuses on optimizing nutrition to meet the increased nutrient needs during this period, which are often difficult to fulfill through diet alone. This treatment may include specific supplements or dietary adjustments to address common deficiencies like iron and folic acid, which are crucial for recovery and overall health after childbirth. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment MFeast ENHANCED and MFeast Usual Care for postpartum recovery?

Research highlights the importance of personalized nutrition approaches for maternal health, suggesting that tailored nutrition strategies can improve health outcomes for mothers and their babies. While specific data on MFeast ENHANCED and MFeast Usual Care is not provided, the emphasis on personalized nutrition aligns with the potential benefits of these treatments in optimizing postpartum recovery. ^{1 5 6 11 12}

Who Is on the Research Team?

Michelle Ogunwole, MD, PhD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for postpartum individuals who have experienced hypertensive disorders like eclampsia or pre-eclampsia. It aims to help Black women, in particular, manage postpartum weight and prevent chronic hypertension. Participants need to be able to respond to online surveys and submit data on their weight and blood pressure.

Inclusion Criteria

I am eligible for WIC benefits due to low income.

Have a BMI > 30 (calculated based on chart review of height and weight measurement)

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

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline

Baseline data collection and randomization to intervention or usual care

1 week

2 visits (in-person)

Treatment

Participants receive medically tailored food interventions, with a transition from prepared meals to fresh food delivery

24 weeks

Monthly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

6-8 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• MFeast ENHANCED
• MFeast Usual Care

Trial Overview The study compares two types of Medically Tailored Food (MTF) interventions: MFeast ENHANCED (a customizable program with prepared meals transitioning to fresh food delivery including dependents' food provision) versus MFeast Usual Care (prepared medically tailored foods only).

How Is the Trial Designed?

Group I: MFeast ENHANCED Experimental Treatment 1 Intervention

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 II: MFeast Usual Care Active Control 1 Intervention

MFeast Usual Care (prepared medically tailored meals only).

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

Breastfeeding women on special diets, such as weight-loss or vegetarian diets, as well as those with eating disorders like anorexia or bulimia, require nutritional counseling to mitigate dietary risks.

Current research is insufficient to fully understand how a lactating woman's nutrition impacts both her health and her child's health, highlighting the need for further studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diets and eating disorders: implications for the breastfeeding mother. Weekly, SJ.[2015]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Addressing barriers to maternal nutrition in low- and middle-income countries: A review of the evidence and programme implications. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Optimizing Maternal Nutrition: The Importance of a Tailored Approach. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Assessment of maternal nutrition. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Pregnancy and lactation: physiological adjustments, nutritional requirements and the role of dietary supplements. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Maternal nutrition and birth outcomes. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Compliance with and acceptability of two fortified balanced energy protein supplements among pregnant women in rural Nepal. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Diets and eating disorders: implications for the breastfeeding mother. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Position of the American Dietetic Association: promoting and supporting breastfeeding. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The relationship between diet, activity, and other factors, and postpartum weight change by race. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Nutritional support during pregnancy and lactation. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Comparison of dietary intake of overweight postpartum mothers practicing breastfeeding or formula feeding. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Key issues in nutrition. From conception through infancy. [2019]