Clinical trial

Nutrition Optimization and Community Upliftment for Postpartum Recovery

Recruiting now · Not applicable · 1 countries · Registry ID NCT06445530

Recruiting nowNot applicableInterventional

What this study is about

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)

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexFemale

Healthy volunteersNot accepted

ConditionObesity, Maternal, Gestational Diabetes

Full registry criteria

Inclusion Criteria: * 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 * Gestational diabetes * 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 Exclusion Criteria: * 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

Treatments and study arms

MFeast ENHANCED

Behavioral

Intervention group will initially receive prepared MTF (low carbohydrate, low-fat meals, which have been shown to improve glycemia in people with prediabetes) delivered by MFeast (10 meals weekly); Tailored Medical Nutrition Therapy (MNT) delivered by dieticians from MFeast via monthly phone calls and focused on only: ↓sugar-sweetened beverages and ↑fruit and vegetable consumption; Lactation 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 (via study team-crafted virtual grocery store) for 16 more weeks.

MFeast Usual Care

Behavioral

Those assigned to the "MFeast Usual Care" group will receive prepared MTF delivered by MFeast and as needed MNT from 1 to 24 weeks postpartum.

Primary outcomes

Participant Enrollment Rate6-8 months postpartum

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

Participant Retention6-8 months postpartum

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

Adherence as assessed by self-reported food consumption scores and photographs sent to the study team via secure messaging app6-8 months postpartum

Consumption scores range from 0%, 25%, 50%, 75%, or 100%, indicating the amount of food consumed the prior week (self and dependents scores reported).

Satisfaction as assessed by focus groups and the 8 item Client Satisfaction Questionnaire- (CSQ-8)6-8 months postpartum

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.

Participant Engagement assessed by frequency and quality of meal discussions1-6 months postpartum

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

East Baltimore Medical Campus🇺🇸 Baltimore, Maryland, United States

Open map