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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different meal delivery strategies can help Black women manage weight after childbirth, potentially preventing chronic high blood pressure. Participants will receive either fresh food deliveries or prepared meals to determine which approach is more effective and sustainable. The trial suits Black women who are the main meal planners in their household, eligible for WIC benefits, and experienced high blood pressure during pregnancy. Participants will provide feedback through online surveys and share basic health data, such as weight and blood pressure. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance postpartum health strategies for Black women.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the MFeast ENHANCED treatment aims to improve nutrition for recovery after childbirth. While specific safety data is not available, meals tailored by medical experts suggest it is generally well-tolerated. These programs typically meet the higher nutrient needs after childbirth, making them generally safe for most people. Additionally, similar nutrition programs have been used in other contexts with good safety records. No reports of negative effects from similar programs suggest they are likely safe for new mothers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

MFeast ENHANCED is unique because it offers a hybrid approach to postpartum recovery, combining prepared meals with fresh food delivery that users can activate themselves. This treatment stands out by incorporating structural and nutritional support specifically for lactation, which isn't a focus in most standard postpartum care options. Additionally, it is culturally adapted to enhance engagement and adherence, and it even includes food provision for dependents, addressing broader family needs. Researchers are excited about this approach because it tailors nutrition and support to the unique needs of postpartum individuals, potentially improving recovery outcomes.

What evidence suggests that this trial's treatments could be effective for postpartum weight control?

The MFeast ENHANCED program, available to participants in this trial, has been shown in studies to improve nutrition after childbirth, which is crucial for recovery. This program provides personalized nutrition plans to meet the increased nutrient needs during this period. Research indicates that these customized plans aid in weight management and overall health. Early results suggest that the MFeast ENHANCED approach might also help prevent long-term health issues like high blood pressure. By creating meal plans and supporting breastfeeding, this program aims to empower new mothers, particularly in communities with fewer resources. In contrast, the MFeast Usual Care program, another treatment arm in this trial, offers only prepared medically tailored meals. ^{1 5 6 7 8}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06445530

Study Details | NCT06445530 | Nutrition Optimization and ... This study will evaluate the feasibility, acceptability, and preliminary effectiveness of a postpartum dietary intervention for Black women with obesity and a ...

2. withpower.com withpower.com/trial/nutrition-optimization-for-postpartum-recovery-32fff

Nutrition Optimization 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 ...

3. ctv.veeva.com ctv.veeva.com/study/nutrition-optimization-and-community-upliftment-for-postpartum-recovery-intervention-to-support-hea

Intervention to Support Healing After Hypertensive Disorders ... This study will evaluate the feasibility, acceptability, and preliminary effectiveness of a postpartum ... MFeast ENHANCED (a hybrid MTF ...

4. withpower.com withpower.com/trial/phase-diabetes-gestational-8-2024-709c0

Nutrition Programs for Postpartum Recovery MFeast ENHANCED is unique because it focuses on providing comprehensive nutritional support specifically tailored for postpartum recovery, which is not commonly ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9867978/

Measuring enhanced recovery in obstetrics: a narrative ... This article provides a summary of current measures of enhanced recovery after cesarean delivery success, and optimal measures of inpatient and outpatient ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10857475/

Efficacy of an enhanced recovery nursing plan as a rooming ... The authors developed a postoperative enhanced recovery nursing plan as a rooming‐in practice for women with preeclampsia based on summarizing evidence‐based ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666577822001009

Measuring enhanced recovery in obstetrics: a narrative ... This article provides a summary of current measures of enhanced recovery after cesarean delivery success, and optimal measures of inpatient and outpatient ...

8. journals.lww.com journals.lww.com/mfm/fulltext/2023/07000/care_bundles__enhanced_recovery_after_delivery.4.aspx

Care Bundles: Enhanced Recovery After Delivery This article summarizes the current evidence, provides care recommendations, and identifies the next steps in improving obstetrics care.