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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different food delivery programs can help new mothers manage weight after childbirth and prevent type 2 diabetes, with a focus on Black women. It compares two approaches: MFeast ENHANCED, which provides prepared meals, and MFeast Usual Care, which offers a switch to fresh food. Both options are tailored to cultural preferences and family needs. The study seeks participants who are Black or African American, have had gestational diabetes, are low-income, and are the main meal planners in their household. Participants will complete online surveys and share weight and health data. As an unphased trial, this study offers a unique opportunity to contribute to research that could lead to healthier outcomes for new mothers.

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.

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

Research has shown that the MFeast ENHANCED program aims to improve nutrition for recovery after childbirth by meeting higher nutrient needs during this crucial time. While specific safety data for this exact program is unavailable, nutrition-focused programs are generally considered low-risk. The program's goal is to provide complete nutritional support, which is usually well-tolerated.

Regarding safety, these programs rarely report serious side effects, as they focus on diet and lifestyle changes. The trial is labeled "Not Applicable" for phase, indicating minimal safety concerns and a focus on the program's effectiveness and ease of use. Participants can generally expect a safe experience when joining this type of nutritional support program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MFeast ENHANCED program for postpartum recovery because it offers a unique approach compared to current options like meal delivery services or traditional dietary advice. Unlike these standard methods, MFeast ENHANCED combines the convenience of medically tailored meals with a transition to fresh food delivery, providing structural and nutritional lactation support tailored specifically for postpartum individuals. It also includes cultural adaptations to improve engagement and adherence, and even addresses food provision for dependents. This comprehensive support system aims to enhance recovery by addressing not just nutrition, but also cultural and family needs.

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

In this trial, participants will join one of two programs: MFeast ENHANCED or MFeast Usual Care. Research has shown that the MFeast ENHANCED program, which delivers fresh food and culturally tailored support, can improve nutrition for new mothers. Early results suggest this approach helps meet the increased nutrient needs during recovery after childbirth. By providing personalized meals and support, the program may aid in better weight management, potentially lowering the risk of type 2 diabetes. Studies have shown that meeting nutritional needs during this time is important for long-term health. Meanwhile, MFeast Usual Care, which focuses on prepared meals, also helps maintain a balanced diet, but the ENHANCED approach offers additional personalized and community-focused benefits. ^{1 5 6 7 8}

Who Is on the Research Team?

Michelle S 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 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

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

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 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

What Are the Treatments Tested in This Trial?

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.

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+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

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]

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]

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]

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.