Nutrition Optimization and Community Upliftment for Postpartum Recovery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJohns Hopkins University
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
MFeast ENHANCED
BehavioralIntervention 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
BehavioralThose assigned to the "MFeast Usual Care" group will receive prepared MTF delivered by MFeast and as needed MNT from 1 to 24 weeks postpartum.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: MFeast ENHANCEDExperimental treatment 1 intervention
Group B: MFeast Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Participant Enrollment Rate
Participant Enrollment Rate as assessed by the percentage of participants consented/enrolled compared to the total eligible participants
Time frame
6-8 months postpartum2
Participant Retention
Retention as assessed by the percentage of participants completing all study follow-up visits among all enrolled participants.
Time frame
6-8 months postpartum3
Adherence as assessed by self-reported food consumption scores and photographs sent to the study team via secure messaging app
Consumption scores range from 0%, 25%, 50%, 75%, or 100%, indicating the amount of food consumed the prior week (self and dependents scores reported).
Time frame
6-8 months postpartum4
Satisfaction as assessed by focus groups and the 8 item Client Satisfaction Questionnaire- (CSQ-8)
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.
Time frame
6-8 months postpartumSecondary outcomes
1
Dietary Quality as assessed by the Healthy Eating Index (HEI) 24-hour recall
The HEI uses a scoring system to evaluate a set of foods. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations and dietary patterns published in the Dietary Guidelines.
Time frame
Baseline, 3 and 6 months postpartum2
Stress assessed by the 4-item Stress Scale.
The 4-item Stress Scale consists of 4 questions. The lowest total score is 0 and the highest total score on the scale is 16. Higher scores are correlated to more stress.
Time frame
Baseline, 3 and 6 months postpartum3
Food Insecurity measured using a 6-item Food Insecurity scale.
The 6-item Food Insecurity scale uses a subset of the standard 18 item food security scale. The Scores on the scale range from 0-6 with 0-1 indicating high or marginal food security, 2-4 indicating low food security and 5-6 indicating very low food security
Time frame
Baseline, 3 and 6 months postpartum4
Postpartum Weight Retention in pounds as assessed by the difference in self-reported pre-pregnancy weight and postpartum weights
Will be assessed by calculating the difference in self reported pre-pregnancy weight (with Electronic Health Record validation) and postpartum weights (study provided scales)
Time frame
Baseline, 3 and 6 months postpartumOther outcomes
1
2 hour plasma glucose levels assessed using Oral Glucose Tolerance Test (OGTT)
Test will be done using 75 g oral glucose load with measurement of 2-hour plasma glucose levels. Obtained by electronic health records (EHR) or lab request.
Time frame
4-12 weeks postpartum2
HbA1C
HbA1C assessed by EHR or lab request
Time frame
3 and 6 months postpartum3
Percent time spent in euglycemia as assessed by participant blinded Continuous Glucose Monitor (CGM) sensor
Will be measured by % time in euglycemia (glucose 70-139)
Time frame
3 and 6 months postpartum4
Percent time spent in hyperglycemia assessed by participant blinded CGM sensor
Will be measured by % time with hyperglycemia (glucose \>140)
Time frame
3 and 6 months postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov