Nutrition Optimization and Community Upliftment for Postpartum Recovery: Interventions to Support Healing After Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Participant Retention
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention, blinding of participants or MFeast staff is not possible, but data collectors will be blinded to arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Participant Retention
时间窗: 6-8 months postpartum
Retention as assessed by the percentage of participants completing all study follow-up visits among all enrolled participants.
Satisfaction as assessed by focus groups and the 8 item Client Satisfaction Questionnaire- (CSQ-8)
时间窗: 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 discussions
时间窗: 1-6 months postpartum
Analyze the messaging app and Slack Channel to determine the frequency and quality of discussions about meals and recipes.
Participant Enrollment Rate
时间窗: 6-8 months postpartum
Participant Enrollment Rate as assessed by the percentage of participants consented/enrolled compared to the total eligible participants
Adherence as assessed by self-reported food consumption scores and photographs sent to the study team via secure messaging app
时间窗: 6-8 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).
次要结局
- Dietary Quality as assessed by the Healthy Eating Index (HEI) 24-hour recall(Baseline, 3 and 6 months postpartum)
- Stress assessed by the 4-item Stress Scale.(Baseline, 3 and 6 months postpartum)
- Food Insecurity measured using a 6-item Food Insecurity scale.(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(Baseline, 3 and 6 months postpartum)