Your session is about to expire
← Back to Search
Behavioral Intervention
Meals for Moms: Medically-Tailored Meals for Women Who Had Gestational Diabetes
N/A
Waitlist Available
Led By Morgana Mongraw-Chaffin
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if delivering healthy meals to new mothers can help manage their blood sugar after giving birth. It targets women who had gestational diabetes and gained too much weight during pregnancy. The meals are designed to be low in calories and suitable for breastfeeding, aiming to keep blood sugar stable and support weight loss.
Eligible Conditions
- Gestational Weight Gain
- Diabetes
- Gestational Diabetes
- Postpartum Weight Retention
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability of Study Measures
Days of Continuous Glucose Monitoring in Postpartum Mothers
Feasibility of Medically Tailored Meals in Postpartum Mothers: Cost per Participant
+1 moreSecondary study objectives
Change in Glucose Management Indicator (GMI)
Change in Glycemic Variability
Change in Mean Glucose
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Medically Tailored MealsExperimental Treatment1 Intervention
A series of medically tailored meals appropriate for women with gestational diabetes will be developed in partnership with chefs from a local community kitchen and catering company. Meals will create a slight caloric deficit in order to promote gradual weight loss, but with sufficient energy intake and macronutrient balance to allow breastfeeding. These meals will be roughly 40% carbohydrate, 30% protein, and 30% fat in composition. Study Team will plan up to 20 unique lunch and dinner meals for the series. Each meal will be prepared to be between 450-600 kcal and to contain 6 ounces of protein, 4 ounces of vegetable and I cup of whole grain (at a minimum). Participants will receive detailed recipe cards and nutrition information with each meal. In addition to receiving the medically tailored meals, participants will be advised to supplement their own breakfast +/- snacks to reach a total daily calorie goal determined by starting BMI category.
Group II: Usual Care Comparison GroupActive Control1 Intervention
Participants in this group will receive written materials on self-care, nutrition, and physical activity in the postpartum period and community resources for healthy living.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medically Tailored Meals
2020
N/A
~700
Find a Location
Who is running the clinical trial?
North Carolina Diabetes Research CenterUNKNOWN
1 Previous Clinical Trials
14 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,561 Previous Clinical Trials
4,298,729 Total Patients Enrolled
1 Trials studying Gestational Weight Gain
371 Patients Enrolled for Gestational Weight Gain
Wake Forest University Health SciencesLead Sponsor
1,397 Previous Clinical Trials
2,460,117 Total Patients Enrolled
1 Trials studying Gestational Weight Gain
60 Patients Enrolled for Gestational Weight Gain
Morgana Mongraw-ChaffinPrincipal InvestigatorWake Forest University Health Sciences