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Behavioral Intervention

Medically Tailored Meals for Gestational 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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

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 more

Secondary study objectives

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

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