An interventional study of MFeast ENHANCED and MFeast Usual Care in Obesity, Maternal and Gestational Diabetes, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention
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:
Participants will:
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.
60 studies on the registry are indexed under Pregnancy in Obesity; 17 are open to participants now.
This study's planned enrollment of 40 is below the median of 160 across 33 interventional studies indexed under Pregnancy in Obesity.
Browse Pregnancy in Obesity studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MFeast ENHANCED (a hybrid MTF intervention with a patient-activated transition from prepared meal to fresh food delivery, adaptations for postpartum people, structural and nutritional lactation support, cultural adaptations for engagement and adherence, and food provision for dependents)
Behavioral: MFeast ENHANCED
MFeast Usual Care (prepared medically tailored meals only).
Behavioral: MFeast Usual Care
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.
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.
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 postpartum
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 postpartum
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 postpartum
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 postpartum
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.
Time frame: 1-6 months postpartum
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 postpartum
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 postpartum
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 postpartum
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 postpartum
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 postpartum
HbA1C
HbA1C assessed by EHR or lab request
Time frame: 3 and 6 months postpartum
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 postpartum
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 postpartum
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.
Time frame: 3 and 6 months postpartum
Mean daily glucose
Mean daily glucose for 10 days in months 3 and 6 postpartum
Time frame: 3 and 6 months postpartum
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.