Clinical trial NCT06445530: Nutrition Optimization and Community Upliftment for Postpartum Recovery
Official title: Nutrition Optimization and Community Upliftment for Postpartum Recovery: Interventions to Support Healing After Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity, Maternal
Gestational Diabetes
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-06-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design is a two parallel-arm pilot randomized controlled trial. The investigators will be applying the principles of a hybrid type 1 implementation-effectiveness randomized controlled trial.
Primary purpose: PREVENTION

Brief summary: 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)

Detailed description: 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.

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

Primary outcomes:
measure: Participant Enrollment Rate
timeFrame: 6-8 months postpartum
measure: Participant Retention
timeFrame: 6-8 months postpartum
measure: Adherence as assessed by self-reported food consumption scores and photographs sent to the study team via secure messaging app
timeFrame: 6-8 months postpartum
measure: Satisfaction as assessed by focus groups and the 8 item Client Satisfaction Questionnaire- (CSQ-8)
timeFrame: 6-8 months postpartum
measure: Participant Engagement assessed by frequency and quality of meal discussions
timeFrame: 1-6 months postpartum
Secondary outcomes:
measure: Dietary Quality as assessed by the Healthy Eating Index (HEI) 24-hour recall
timeFrame: Baseline, 3 and 6 months postpartum
measure: Stress assessed by the 4-item Stress Scale.
timeFrame: Baseline, 3 and 6 months postpartum
measure: Food Insecurity measured using a 6-item Food Insecurity scale.
timeFrame: Baseline, 3 and 6 months postpartum
measure: Postpartum Weight Retention in pounds as assessed by the difference in self-reported pre-pregnancy weight and postpartum weights
timeFrame: Baseline, 3 and 6 months postpartum
Other outcomes:
measure: 2 hour plasma glucose levels assessed using Oral Glucose Tolerance Test (OGTT)
timeFrame: 4-12 weeks postpartum
measure: HbA1C
timeFrame: 3 and 6 months postpartum
measure: Percent time spent in euglycemia as assessed by participant blinded Continuous Glucose Monitor (CGM) sensor
timeFrame: 3 and 6 months postpartum
measure: Percent time spent in hyperglycemia assessed by participant blinded CGM sensor
timeFrame: 3 and 6 months postpartum
measure: Postprandial glucose excursions assessed by participant blinded CGM sensor
timeFrame: 3 and 6 months postpartum
measure: Mean daily glucose
timeFrame: 3 and 6 months postpartum
Locations:
city: Baltimore
country: United States
facility: East Baltimore Medical Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Michelle S Ogunwole, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: