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Behavioral Intervention

Medically Tailored Meals for Pregnancy Weight Gain

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
Demographics: Women 18 years of age and older who reside in Forsyth County, NC
Pregnancy: Currently 24 or more weeks into a singleton pregnancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing whether medically tailored meals can help reduce high blood sugar after delivery in post-partum women with a history of gestational diabetes.

Eligible Conditions
  • Pregnancy Weight Gain
  • Gestational Diabetes
  • Gestational Weight Gain
  • Postpartum Weight Retention

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of Study Measures
Days of Continuous Glucose Monitoring in Postpartum Mothers
Feasibility of Medically Tailored Meals in Postpartum Mothers: Cost per Participant
+1 more
Secondary outcome measures
Change in Glucose Management Indicator (GMI)
Change in Glycemic Variability
Change in Mean Glucose
+3 more

Awards & 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?

University of North Carolina, Chapel HillOTHER
1,481 Previous Clinical Trials
4,143,146 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,225 Previous Clinical Trials
998,392 Total Patients Enrolled
North Carolina Diabetes Research CenterUNKNOWN
1 Previous Clinical Trials
14 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Feb 2025