Trial Outcomes & Findings for Meals for Moms: Medically-Tailored Meals for Women Who Had Gestational Diabetes (NCT NCT04866823)

NCT ID: NCT04866823

Last Updated: 2025-04-29

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

3 months

Results posted on

2025-04-29

Participant Flow

Due to recruitment limitations, we did not include a comparison group.

Participant milestones

Participant milestones
Measure	Medically Tailored Meals 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. 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.	Usual Care Comparison Group 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.
Overall Study STARTED	12	0
Overall Study COMPLETED	9	0
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 3 months

Population: No comparison group was included due to limited recruitment numbers.

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

Outcome measures

Outcome measures
Measure	Medically Tailored Meals n=2880 meals 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. 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.	Usual Care Comparison Group 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.
Number of Meals Successfully Ordered and Delivered	2880 meals	—

PRIMARY outcome

Timeframe: 3 months

Population: No comparison group was included.

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.

Outcome measures

Outcome measures
Measure	Medically Tailored Meals n=12 Participants 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. 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.	Usual Care Comparison Group 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.
Number of Dollars Cost	1800.0 Number of dollars cost	—

PRIMARY outcome

Timeframe: 14 day period assessed at baseline

Population: No comparison group was included.

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

Outcome measures

Outcome measures
Measure	Medically Tailored Meals n=12 Participants 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. 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.	Usual Care Comparison Group 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.
Days of Continuous Glucose Monitoring in Postpartum Mothers	13 Number of Days Interval 6.0 to 14.0	—

PRIMARY outcome

Timeframe: 3 months

Population: No comparison group was included due to limited recruitment numbers.

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

Outcome measures

Outcome measures
Measure	Medically Tailored Meals n=7 Participants 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. 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.	Usual Care Comparison Group 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.
Days of Continuous Glucose Monitoring in Postpartum Mothers	11.43 days Interval 1.0 to 14.0	—

Adverse Events

Medically Tailored Meals

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Comparison Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Morgana Mongraw-Chaffin

Wake Forest School of Medicine

Phone: 13367133108

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Medically Tailored Meals n=12 Participants 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. 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.	Usual Care Comparison Group 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.	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	—	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Continuous	35 years STANDARD_DEVIATION 5 • n=5 Participants	—	35 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	—	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	—	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	—	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	—	5 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	—	12 participants n=5 Participants