Nutrition Programs for Postpartum Recovery

(NOURISH-GDM 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

Trial Summary

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 type 2 diabetes-a potent contributor to disparate mortality among Black women. The main aims of the study are: * To conduct a pilot randomized control trial to test the feasibility, acceptability, and effectiveness of a multi-component Medically Tailored Food (MTF) intervention, Moveable Feast 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, 6 months post-delivery after the baseline survey. * Submit anthropometric data (i.e, weight) and information about laboratory results ( e.g. HgbA1C)

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

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

The research highlights the importance of adequate nutrition during pregnancy and postpartum for improving health outcomes. While specific data on MFeast ENHANCED and MFeast Usual Care is not provided, studies suggest that tailored nutrition education and counseling can support healthy maternal diet and weight management, which are crucial for postpartum recovery. ^{1 2 3 4 5}

Is the nutrition program for postpartum recovery safe for humans?

Research on early oral feeding after cesarean delivery suggests it is generally safe, with studies comparing immediate and on-demand feeding showing no significant safety concerns. ^{6 7 8 9 10}

How is the treatment MFeast ENHANCED different from other postpartum recovery treatments?

MFeast ENHANCED is unique because it focuses on providing comprehensive nutritional support specifically tailored for postpartum recovery, which is not commonly addressed by standard postpartum care. This treatment may include specific dietary plans or supplements to help new mothers recover more effectively after childbirth, addressing nutritional needs that are often overlooked in usual care. ^{2 11 12 13 14}

Research Team

Michelle S Ogunwole, MD, PhD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

This trial is for postpartum individuals who had gestational diabetes or obesity during pregnancy. They should be willing to receive and use medically tailored food deliveries, respond to online surveys, and submit health data like weight and HgbA1C levels.

Inclusion Criteria

Willing to take part in the intervention and data collection procedures through online surveys

Self-identify as Black or African American

Diagnosed with gestational diabetes

Exclusion Criteria

Mothers who have serious mental illness

I have family support, including meal preparation.

Mothers who are unlikely to be at the primary residence in the postpartum period

Timeline

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 either MFeast ENHANCED or MFeast Usual Care intervention

24 weeks

Monthly phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

6-8 months postpartum

Treatment Details

Interventions

• MFeast ENHANCED
• MFeast Usual Care

Trial Overview The study compares two approaches: 'MFeast Usual Care' with prepared meals only, versus 'MFeast ENHANCED', which includes a switch from prepared meals to fresh food delivery, cultural customization, and providing food for dependents.

Participant Groups

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+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

A randomized trial involving 264 women with overweight or obesity found that a prenatal behavioral intervention using meal replacements did not significantly help women return to their prepregnancy weight or reduce postpartum weight retention after 12 months.

Despite the intervention reducing excess gestational weight gain, it did not lead to lasting changes in weight control behaviors after delivery, indicating that simply reducing weight gain during pregnancy may not be enough to prevent postpartum weight retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Partial Meal Replacement During Pregnancy Reduce 12-Month Postpartum Weight Retention? Phelan, S., Wing, RR., Brannen, A., et al.[2021]

Adequate nutrition during the periconceptional and prenatal periods is crucial for reducing the risk of pregnancy complications and improving birth outcomes, highlighting the importance of maternal nutritional status.

Evidence-based tools and recommendations can help healthcare providers assess and optimize the diets of pregnant women, ultimately supporting healthier pregnancies and reducing the risk of chronic diseases in their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal nutrition: a practical guide for assessment and counseling. Widen, E., Siega-Riz, AM.[2021]

The Healthy & Home postpartum community nursing program effectively supports new mothers and their families through home visits and various resources, helping to bridge the gap between hospital discharge and community care.

This program, which includes services like breastfeeding support and mental health resources, has evolved over 25 years and demonstrates the importance of comprehensive follow-up care to prevent hospital readmissions and promote maternal and infant wellbeing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Going home with baby: innovative and comprehensive support for new mothers. Olson, T., Bowen, A., Smith-Fehr, J., et al.[2023]

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]

References

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

Does Partial Meal Replacement During Pregnancy Reduce 12-Month Postpartum Weight Retention? [2021]

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

Prenatal nutrition: a practical guide for assessment and counseling. [2021]

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

Assessment of maternal nutrition. [2016]

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

Nutritional assessment of the pregnant woman. [2019]

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

Immediate compared with on-demand maternal full feeding after planned caesarean delivery: a randomised trial. [2022]

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

A randomized comparative trial of early initiation of oral maternal feeding versus conventional oral feeding after cesarean delivery. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of early initiation of oral feeding after cesarean section. [2022]

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

Providing Equitable Postpartum Breastfeeding Support at an Urban Academic Hospital. [2022]

10. India pubmed.ncbi.nlm.nih.gov

Comparison of early and on-demand maternal feeding after Caesarean delivery: a prospective randomised trial. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Going home with baby: innovative and comprehensive support for new mothers. [2023]

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

Integrating Obstetrical Care and WIC Nutritional Services to Address Maternal Obesity and Postpartum Weight Retention. [2018]

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

Nutritional support during pregnancy and lactation. [2013]

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

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