Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06445530
Other study ID # IRB00424214
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2024
Est. completion date June 2026

Study information

Verified date May 2024
Source Johns Hopkins University
Contact Michelle S Ogunwole, MD PhD
Phone 2143154936
Email sogunwo1@jhmi.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date June 2026
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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 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
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.

Locations

Country Name City State
United States East Baltimore Medical Campus Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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. 4-12 weeks postpartum
Other HbA1C HbA1C assessed by EHR or lab request 3 and 6 months postpartum
Other 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) 3 and 6 months postpartum
Other Percent time spent in hyperglycemia assessed by participant blinded CGM sensor Will be measured by % time with hyperglycemia (glucose >140) 3 and 6 months postpartum
Other Postprandial glucose excursions assessed by participant blinded CGM sensor Postprandial glucose is calculated using the incremental area under the curve (AUCi) of blood glucose (mg/dL) over a period of time. The AUCi will be calculated for 1 hour (AUCi 0-60) after a meal. The participants will have the sensors on for 10 days, and will be asked to document their meals to correlate with calculated AUCi's. 3 and 6 months postpartum
Other Mean daily glucose Mean daily glucose for 10 days in months 3 and 6 postpartum 3 and 6 months postpartum
Primary Participant Enrollment Rate Participant Enrollment Rate as assessed by the percentage of participants consented/enrolled compared to the total eligible participants 6-8 months postpartum
Primary Participant Retention Retention as assessed by the percentage of participants completing all study follow-up visits among all enrolled participants. 6-8 months postpartum
Primary 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). 6-8 months postpartum
Primary 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. 6-8 months postpartum
Primary Participant Engagement assessed by frequency and quality of meal discussions Analyze the messaging app and Slack Channel to determine the frequency and quality of discussions about meals and recipes. 1-6 months postpartum
Secondary 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. Baseline, 3 and 6 months postpartum
Secondary 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. Baseline, 3 and 6 months postpartum
Secondary 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 Baseline, 3 and 6 months postpartum
Secondary 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) Baseline, 3 and 6 months postpartum
See also
  Status Clinical Trial Phase
Recruiting NCT05081037 - Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS) N/A
Active, not recruiting NCT03249896 - Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes N/A
Terminated NCT03749889 - Low Carb vs Normal Carb in Pregnancy N/A
Completed NCT03859193 - Education Nutritional Video for Gestational Diabetics N/A
Recruiting NCT05037526 - Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes N/A
Completed NCT06178250 - Placenta, Fetal Liver, Sectional Ductus Venosus Volumes Examined by Three-dimensional Ultrasound in the Second Trimester N/A
Not yet recruiting NCT06310356 - Continuous Glucose Monitoring for Women With Gestational Diabetes N/A
Recruiting NCT02590016 - Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: A Randomized Controlled Trial Phase 4
Withdrawn NCT01947699 - Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide Phase 4
Not yet recruiting NCT00883259 - Metformin and Gestational Diabetes in High-risk Patients: a RCTs Phase 4
Recruiting NCT03008824 - Micronutrients in Pregnancy as a Risk Factor for Diabetes and Effects on Mother and Baby N/A
Active, not recruiting NCT01340924 - Relationship Between Gestational Diabetes and Type 2 Diabetes
Completed NCT00534105 - Lipid Metabolism in Gestational Diabetes N/A
Recruiting NCT00371306 - Comparison of Glucovance to Insulin for Diabetes During Pregnancy N/A
Completed NCT03388723 - Intergenerational Programming of Diabesity in Offspring of Women With Gestational Diabetes Mellitus
Recruiting NCT04521712 - Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia N/A
Enrolling by invitation NCT03307486 - Gestational Diabetes: a Cohort Study N/A
Active, not recruiting NCT03301792 - Group Versus Traditional Prenatal Care for Diabetes N/A
Enrolling by invitation NCT05603793 - YoUng Adolescents' behaViour, musculoskeletAl heAlth, Growth & Nutrition
Completed NCT03669887 - Lifestyle Modification to Improve Diet in Women With GDM N/A