An interventional study of Medically Tailored Meals in Diabetes, Gestational, Gestational Weight Gain and Postpartum Weight Retention, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Other
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.
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.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's enrollment of 12 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
Number of Meals Successfully Ordered and Delivered
Determine the percent of meals successfully ordered \& delivered in the intervention group
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
Due to recruitment limitations, we did not include a comparison group.
| Milestone | Medically Tailored Meals | Usual Care Comparison Group |
|---|---|---|
| Started | 12 | 0 |
| Completed | 9 | 0 |
| Not completed | 3 | 0 |
Determine the percent of meals successfully ordered \& delivered in the intervention group
| meals | Medically Tailored Meals | Usual Care Comparison Group |
|---|---|---|
| Number of Meals Successfully Ordered and Delivered | 2880 | — |
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.
| Number of dollars cost | Medically Tailored Meals | Usual Care Comparison Group |
|---|---|---|
| Number of Dollars Cost | 1800.0 | — |
Tracking the number of days the continuous glucose monitors were worn (of 14 total possible) at baseline.
| Number of Days | Medically Tailored Meals | Usual Care Comparison Group |
|---|---|---|
| Days of Continuous Glucose Monitoring in Postpartum Mothers | 13 (6 to 14) | — |
Tracking the number of days the continuous glucose monitors were worn (of 14 total possible) at 3 months.
| days | Medically Tailored Meals | Usual Care Comparison Group |
|---|---|---|
| Days of Continuous Glucose Monitoring in Postpartum Mothers | 11.43 (1 to 14) | — |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Medically Tailored Meals | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Usual Care Comparison Group | — | — | — |
Due to recruitment limitations, we did not inlcude a comparison group.
| Age, Categorical(Participants) | Medically Tailored Meals | Usual Care Comparison Group | Total |
|---|---|---|---|
| <=18 years | 0 | — | 0 |
| Between 18 and 65 years | 12 | — | 12 |
| >=65 years | 0 | — | 0 |
| Age, Continuous(years) | Medically Tailored Meals | Usual Care Comparison Group | Total |
|---|---|---|---|
| Mean | 35 ± 5 | — | 35 ± 5 |
| Sex: Female, Male(Participants) | Medically Tailored Meals | Usual Care Comparison Group | Total |
|---|---|---|---|
| Female | 12 | — | 12 |
| Male | 0 | — | 0 |
| Ethnicity (NIH/OMB)(Participants) | Medically Tailored Meals | Usual Care Comparison Group | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | — | 6 |
| Not Hispanic or Latino | 6 | — | 6 |
| Unknown or Not Reported | 0 | — | 0 |
| Race (NIH/OMB)(Participants) | Medically Tailored Meals | Usual Care Comparison Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | — | 0 |
| Asian | 2 | — | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | — | 0 |
| Black or African American | 5 | — | 5 |
| White | 3 | — | 3 |
| More than one race | 2 | — | 2 |
| Unknown or Not Reported | 0 | — | 0 |
| Region of Enrollment(participants) | Medically Tailored Meals | Usual Care Comparison Group | Total |
|---|---|---|---|
| United States | 12 | — | 12 |
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Wake Forest University Health Sciences