Meals for Moms: Medically-Tailored Meals for Women Who Had Gestational Diabetes

NCT04866823 | Completed Results

• 2 other identifiers: IRB0007271540010554
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to test whether delivery of medically tailored meals (meals designed specifically to be healthy) can be used to help reduce high blood sugar after delivery of a baby. Participants will be recruited and consented during the third trimester of pregnancy but will begin study activities after delivery. Participants will complete a series of questionnaires on demographics, health history, home environment, overall and financial stress, plans for weight loss and infant feeding, and food insecurity. Participants will also be asked to wear continuous glucose monitors for two separate 14-day periods (within 2 weeks of delivery and at 3 months). All participants will receive weekly emails with educational videos and 3 virtual visits with a member of the study team and will also be randomly assigned to an intervention or comparison group. In the intervention, participants will receive weekly meal deliveries of 10 pre-prepared meals from Providence Community Kitchen (local company in Winston-Salem, NC) that are calorically restricted and appropriate for post-partum women with a history of gestational diabetes and who may be breast-feeding. Women in the control condition will receive written resources on self-care, nutrition, and physical activity appropriate for post-partum women who had gestational diabetes.

Conditions

Diabetes, Gestational; Gestational Weight Gain; Postpartum Weight Retention

Keywords

Lifestyle Intervention; Weight-Loss; Self-Care

Outcome Measures

Primary Outcomes (4)

• Number of Meals Successfully Ordered and Delivered

  Determine the percent of meals successfully ordered \& delivered in the intervention group

  3 months

• Number of Dollars Cost

  Determine the total cost across all participants for the medically tailored meal program per participant assuming 20 meals per week provided to each participant for 12 weeks.

  3 months

• Days of Continuous Glucose Monitoring in Postpartum Mothers

  Tracking the number of days the continuous glucose monitors were worn (of 14 total possible) at baseline.

  14 day period assessed at baseline

• Days of Continuous Glucose Monitoring in Postpartum Mothers

  Tracking the number of days the continuous glucose monitors were worn (of 14 total possible) at 3 months.

  3 months

Study Arms (2)

Medically Tailored Meals

EXPERIMENTAL

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.

Behavioral: Medically Tailored Meals

Usual Care Comparison Group

NO 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.

Interventions

Medically Tailored Meals BEHAVIORAL

Participants will receive weekly meals (20 per week) prepared by a local community kitchen and catering group. Each week, 10 dinners and 10 lunches will be delivered to the participant's home with instructions for storage, re-heating, recipes, and nutritional information.

Medically Tailored Meals

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All participants are required to be biological Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Demographics: Women 18 years of age and older who reside in Forsyth County, NC
• Pregnancy: Currently 24 or more weeks into a singleton pregnancy
• Clinical evidence of gestational diabetes mellitus (GDM) defined as either 3-hour oral glucose tolerance test (OGTT) results obtained in the second trimester of pregnancy that show at least 2 abnormal values or a diagnosis of "gestational diabetes" included on the Problem List in medical record during current pregnancy, regardless of OGTT values
• Excessive gestational weight gain: Most recent weight exceeds predicted weight gain for current weeks gestational age defined as pre-pregnancy Body mass index (BMI) of 30 kg/m2 or more and weight at most recent clinical visit 20+ pounds over pre-pregnancy weight or pre-pregnancy BMI of 25-29.9 kg/m2 and weight at most recent clinical visit 25+ pounds over pre-pregnancy weight
• English Proficiency: Able to read/understand English at or above a level sufficient to comprehend recruitment, informed consent, and intervention materials.
• Access to a smart phone/tablet/computer capable of connecting to video calls or teleconferencing software.
• Willingness to Accept Randomization: Prospective participants must be willing to accept randomization to either the medically tailored meal intervention or the comparison intervention condition.

You may not qualify if:

• Clinical history of diabetes (type 1 or 2) pre-pregnancy
• Non-singleton pregnancy
• Other chronic diseases or medical conditions that would increase risk or make participation otherwise unsafe, including special dietary needs. A clinician investigator will review the medical record for all potential participants to determine if any such conditions exist.
• Known food allergies of sensitivities. Potential participants who report special dietary requirements including vegetarians, vegans, those who follow kosher or other specialized diets will be excluded due to the small nature of this pilot study.
• History of allergic skin reaction to adhesive tape
• Unable or unwilling to wear a continuous glucose monitor (CGM) device
• Is scheduled for an MRI during the study weeks, making use of the CGM device unsafe
• Other: Conditions/criteria likely to interfere with participation and acceptance of randomized assignment, including the following: inability/unwillingness to give informed consent, major psychiatric or cognitive problems (schizophrenia, dementia, self-reported substance or alcohol abuse), participation in another research study that would interfere with Meals for Moms

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• North Carolina Diabetes Research Center: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27101, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Gestational Weight Gain; Weight Loss

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Morgana Mongraw-Chaffin
• Organization: Wake Forest School of Medicine

mmongraw@wakehealth.edu

13367133108

Study Officials

• Morgana Mongraw-Chaffin

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 30, 2021
• Study Start: October 20, 2021
• Primary Completion: January 17, 2023
• Study Completion: January 17, 2023
• Last Updated: April 29, 2025
• Results First Posted: February 10, 2025

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)