RecruitingNot applicable

Nutrition Optimization and Community Upliftment for Postpartum Recovery

Nutrition Optimization and Community Upliftment for Postpartum Recovery: Interventions to Support Healing After Gestational Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two food delivery programs for Black adults with low income who have diabetes during pregnancy. One program offers prepared meals only; the other lets people switch to fresh food and also provides food for their dependents. The goal is to help people manage weight after giving birth and prevent type 2 diabetes.

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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are age 18 or older and identify as Black or African American.
  • Have low income and qualify for WIC, a food support program.
  • Speak English as your main language.
  • Are the main person who plans or prepares meals.
  • Have gestational diabetes, which is diabetes during pregnancy.
  • Have a pregnancy lasting more than 37 weeks.
  • Have a BMI over 30. BMI is a measure based on height and weight.
  • Are willing to take part in the food program and share study information through online surveys.

Who can't join

  • Have family members who prepare meals for you.
  • Are unlikely to stay at your main home after giving birth.
  • Have specific food needs, such as food allergies, picky eating, or a vegetarian or vegan diet.
  • Have a baby who is stillborn.
  • Have a serious mental illness.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

MD