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

Primary Purpose

Diabetes, Gestational, Gestational Weight Gain, Postpartum Weight Retention

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Medically Tailored Meals

About this trial

This is an interventional other trial for Diabetes, Gestational focused on measuring Lifestyle Intervention, Weight-Loss, Self-Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Wake Forest Baptist Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Medically Tailored Meals

Usual Care Comparison Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Feasibility of Medically Tailored Meals in Postpartum Mothers: Cost per Participant

Determine an approximate cost for the medically tailored meal program per participant

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.

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.

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.

Secondary Outcome Measures

Change in Mean Glucose

Using data from the continuous glucose monitor, changes in mean glucose will be assessed

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

Change in Glycemic Variability

Using data from the continuous glucose monitor, changes in glycemic variability (percent coefficient of variation) will be assessed

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

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

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

Full Information

NCT ID

NCT04866823

First Posted

April 26, 2021

Last Updated

April 10, 2023

Sponsor

Wake Forest University Health Sciences

Collaborators

North Carolina Diabetes Research Center, University of North Carolina, Chapel Hill

1. Study Identification

Unique Protocol Identification Number

NCT04866823

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

October 20, 2021 (Actual)

Primary Completion Date

January 17, 2023 (Actual)

Study Completion Date

January 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

North Carolina Diabetes Research Center, University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Gestational, Gestational Weight Gain, Postpartum Weight Retention

Keywords

Lifestyle Intervention, Weight-Loss, Self-Care

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Medically Tailored Meals

Arm Type

Experimental

Arm Description

Arm Title

Usual Care Comparison Group

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Medically Tailored Meals

Intervention Description

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.

Primary Outcome Measure Information:

Title

Feasibility of Medically Tailored Meals in Postpartum Mothers: Percent of meals successfully Ordered and Delivered

Description

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

Time Frame

3 months

Title

Feasibility of Medically Tailored Meals in Postpartum Mothers: Cost per Participant

Description

Determine an approximate cost for the medically tailored meal program per participant

Time Frame

3 months

Title

Days of Continuous Glucose Monitoring in Postpartum Mothers

Description

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

Time Frame

Baseline

Title

Days of Continuous Glucose Monitoring in Postpartum Mothers

Description

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

Time Frame

3 months

Title

Acceptability of Study Measures

Description

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.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Change in Mean Glucose

Description

Using data from the continuous glucose monitor, changes in mean glucose will be assessed

Time Frame

Baseline and month 3

Title

Change in Glucose Management Indicator (GMI)

Description

Using data from the continuous glucose monitor, changes in GMI will be assessed as a proxy measure of hemoglobin A1c

Time Frame

Baseline and month 3

Title

Change in Glycemic Variability

Description

Using data from the continuous glucose monitor, changes in glycemic variability (percent coefficient of variation) will be assessed

Time Frame

Baseline and month 3

Title

Change in Time in Range (TIR)

Description

Using data from the continuous glucose monitor, changes in percent of time in range (70 mg/dL to 180 mg/dL) will be assessed

Time Frame

Baseline and month 3

Title

Change in Time Above Range (Hyperglycemia)

Description

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

Time Frame

Baseline and month 3

Title

Change in Time Below Range (Hypoglycemia)

Description

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

Time Frame

Baseline and month 3

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

All participants are required to be biological Females

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Morgana Mongraw-Chaffin

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest Baptist Health

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27101

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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