Clinical Trials Logo

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04866823
Study type Interventional
Source Wake Forest University Health Sciences
Contact Beatriz Ospino-Sanchez
Phone 3367166498
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date July 2021
Completion date April 2022

See also
  Status Clinical Trial Phase
Recruiting NCT02577536 - PregSource: Crowdsourcing to Understand Pregnancy
Completed NCT01940003 - Effects of an Aquatic Physical Exercise Program on Glycaemic Control and Perinatal Outcomes of Gestational Diabetes: Study Protocol for a Randomized Controlled Trial N/A
Completed NCT02960295 - The Virtual Visit for Women With Gestational Diabetes N/A
Completed NCT01919476 - Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women N/A
Enrolling by invitation NCT03307486 - Gestational Diabetes: a Cohort Study N/A
Recruiting NCT04417452 - Long-term Outcome After Gestational Diabetes and Diabetes in Pregnancy
Completed NCT02968628 - Effect of Maternal Diabetes on Brain Development, as Measured by Neonatal Electroencephalogram (EEG)
Active, not recruiting NCT04222348 - MeDiGes Study: Metformine Use in Gestational Diabetes Phase 3
Completed NCT03007186 - Glucose Monitoring During Threatening Preterm Birth in Patients With and Without Gestational Diabetes Mellitus
Completed NCT00069576 - Gestational Diabetes Mellitus Trial (GDM) N/A
Recruiting NCT02893072 - Medical Nutrition Therapy Intervention Program for Women With Gestational Diabetes--a Prospective Study N/A
Completed NCT02770079 - Insulin Sensitivity and Secretion During Pregnancy and Post Partum in Women With Gestational Diabetes.
Completed NCT00681460 - Metformin in Gestational Diabetes Mellitus N/A
Not yet recruiting NCT04198857 - Development and Testing of a Mobile Health Application for Management of Gestational Diabetes N/A
Recruiting NCT03117543 - Diagnostic Approaches in Gestational Diabetes and Impact of Ethnicity
Completed NCT02931656 - Acute Effects of an Aquatic Physical Exercise on Glycemic Control of Gestational Diabetes N/A
Completed NCT01837680 - Glycemic Control Using Insulin Levemir Versus Insulin NPH for Diabetes in Pregnancy N/A
Completed NCT01105455 - The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Pregnant Women at Risk for Gestational Diabetes N/A
Terminated NCT00514618 - Outpatient Cervical Ripening With Orally Administered Misoprostol in Diabetics N/A
Active, not recruiting NCT03607799 - A Culturally-tailored Personalized Nutrition Intervention in South Asian Women at Risk of Gestational Diabetes N/A