Nutrition Optimization and Community Upliftment for Postpartum Recovery

Официальное название

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

Обзор

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)

Подробное описание

This study will evaluate the feasibility, acceptability, and preliminary effectiveness of a postpartum dietary intervention for Black women with obesity and a recent pregnancy complicated by gestational diabetes mellitus (GDM). The investigators will recruit women through Medicaid insurance plans (Priority Partners), clinical obstetric practice (Johns Hopkins Outpatient Center, Women's Health Center), perinatal community-based organizations (MOM Cares and Bloom Collective), and home-visiting locations (The Family Tree of Maryland)-all of which can verify clinical outcomes for participants.

At 37 weeks gestation, participants are contacted by the study team for consent, baseline data collection (baseline visit 1), and randomization 1:1 to receive the intervention vs. usual care (which begins in the first postpartum week). 3-7 days after randomization, the remainder of baseline visit information (baseline visit 2) is collected including information for the prepared MTF vendor (Moveable Feast Baltimore)

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

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.

Вмешательства

• Поведенческое MFeast ENHANCED
  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 consultan
• Поведенческое MFeast Usual Care
  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.

Первичные конечные точки

• Participant Enrollment Rate [Срок оценки: 6-8 months postpartum]
• Participant Retention [Срок оценки: 6-8 months postpartum]
• Adherence as assessed by self-reported food consumption scores and photographs sent to the study team via secure messaging app [Срок оценки: 6-8 months postpartum]
• Satisfaction as assessed by focus groups and the 8 item Client Satisfaction Questionnaire- (CSQ-8) [Срок оценки: 6-8 months postpartum]
• Participant Engagement assessed by frequency and quality of meal discussions [Срок оценки: 1-6 months postpartum]

Вторичные конечные точки (4)

• Dietary Quality as assessed by the Healthy Eating Index (HEI) 24-hour recall [Срок оценки: Baseline, 3 and 6 months postpartum]
• Stress assessed by the 4-item Stress Scale. [Срок оценки: Baseline, 3 and 6 months postpartum]
• Food Insecurity measured using a 6-item Food Insecurity scale. [Срок оценки: Baseline, 3 and 6 months postpartum]
• Postpartum Weight Retention in pounds as assessed by the difference in self-reported pre-pregnancy weight and postpartum weights [Срок оценки: Baseline, 3 and 6 months postpartum]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• East Baltimore Medical Campus — Baltimore

Идентификаторы

NCT: NCT06445530 · IRB00350743 · U24DK132733 · K12AR084229

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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