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

Diabetes, Gestational Clinical Trial

Official title:

Meals for Moms: A Postpartum Medically-Tailored Meal Program to Promote Weight Loss and Blood Glucose Control Among Women With Hyperglycemia in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04866823
• Other study ID #: IRB00072715
• Status: Completed
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: January 17, 2023

Study information

• Verified date: February 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Pregnancy and delivery can function as a "stress test" for future development of cardiovascular disease and metabolic disorders, with gestational diabetes and excessive weight gain during pregnancy leading to worse outcomes later in a mother's life. The prevalence of both conditions continues to increase with the obesity epidemic, highlighting the urgent need for successful interventions to reverse maternal weight gain and promote normal blood sugars. The early postpartum period provides a critical opportunity to address diet behaviors that are related to both weight and diabetes. Postpartum medically-tailored meal delivery is a novel approach that may allow for improved blood sugar control and weight loss in a traditionally hard-to-engage patient population. There is currently no available data on the cost, feasibility, or effectiveness of providing medically-tailored meals to postpartum women. This is a pilot study of medically-tailored meals for new mothers whose pregnancies were complicated by gestational diabetes, and whose total gestational weight gain exceeded recommendations. Study will enroll 30 women with gestational diabetes and excessive gestational weight gain late in the third trimester of a singleton pregnancy. Data collection and intervention activities will begin after delivery. All participants will wear a continuous glucose monitor for baseline (first 2 weeks after delivery) and at follow up (after 3 months). Participants will also completed self-administered questionnaires, receive weekly informational videos by email, and have 3 monthly in-person check-ins with a member of the study team. Twenty participants will be randomly assigned to a medically-tailored meals intervention and 10 to a usual-care comparison group. A local community-based program will prepare and deliver 10 medically-tailored meals per week to intervention participants for their first 3 months postpartum.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 17, 2023
• Est. primary completion date: January 17, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Body Weight
• Diabetes, Gestational
• Gestational Weight Gain
• Postpartum Weight Retention
• Weight Gain

Intervention

Behavioral:
• Medically Tailored Meals
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.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	North Carolina Diabetes Research Center, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Medically Tailored Meals in Postpartum Mothers: Percent of meals successfully Ordered and Delivered	Determine the percent of meals successfully ordered & delivered in the intervention group	3 months
Primary	Feasibility of Medically Tailored Meals in Postpartum Mothers: Cost per Participant	Determine an approximate cost for the medically tailored meal program per participant	3 months
Primary	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.	Baseline
Primary	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
Primary	Acceptability of Study Measures	Using qualitative interviews, assess how acceptable the target population found the proposed data collection measures to be - collecting feedback from subjects to plan for a larger trial.	3 months
Secondary	Change in Mean Glucose	Using data from the continuous glucose monitor, changes in mean glucose will be assessed	Baseline and month 3
Secondary	Change in Glucose Management Indicator (GMI)	Using data from the continuous glucose monitor, changes in GMI will be assessed as a proxy measure of hemoglobin A1c	Baseline and month 3
Secondary	Change in Glycemic Variability	Using data from the continuous glucose monitor, changes in glycemic variability (percent coefficient of variation) will be assessed	Baseline and month 3
Secondary	Change in Time in Range (TIR)	Using data from the continuous glucose monitor, changes in percent of time in range (70 mg/dL to 180 mg/dL) will be assessed	Baseline and month 3
Secondary	Change in Time Above Range (Hyperglycemia)	Using data from the continuous glucose monitor, changes in percent of time above the target range (70 mg/dL to 180 mg/dL) will be assessed	Baseline and month 3
Secondary	Change in Time Below Range (Hypoglycemia)	Using data from the continuous glucose monitor, changes in percent of time below the target range (70 mg/dL to 180 mg/dL) will be assessed	Baseline and month 3