NCT06320054

Preventing Obstetric Complications With Dietary Intervention

Preventing Common Obstetric Complications Through an Immersive, Medically Tailored Meal Program

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to learn whether access to healthy and fresh food, health coaching, and nutrition support intervention can reduce adverse birth outcomes in pregnant women. The main questions it aims to answer are: * Does access to healthy and fresh food, health coaching and nutrition support reduce the risk of gestational diabetes or preeclampsia and ultimately improve health outcomes for mothers and their newborns? * Are participants able to successfully utilize the health program? Are participants satisfied and self-equipped to apply the teachings of the program within their lives following their participation in the study? Participants will be randomly assigned to one of two groups. Participants in the standard of care will be asked to: * Complete surveys * Biometric screenings Participants in the intervention group will be asked to: * Complete surveys * Biometric screenings * Participate in weekly personal health coaching * Receive and consume provided weekly meals. Researchers will compare the standard of care to those who receive the intervention to see the impact of the intervention on clinical outcomes including: gestational weight gain, blood pressure, diagnosis of gestational diabetes, diagnosis of gestational hypertension or preeclampsia, and gestational age at birth.

Conditions

• Gestational Diabetes
• Gestational Hypertension
• High Risk Pregnancy
• Preeclampsia

Interventions

Type	Name	Description
BEHAVIORAL	Maternal Health Management Program	Program participants will receive 10 fresh, local meals each week, delivered to their homes, health coaching including cooking and physical activity, biometrics screenings, and educational support to enable sustainable lifestyle change.

Timeline

• Start date: 2024-06-12
• Primary completion: 2026-02-28
• Completion: 2026-12-31
• First posted: 2024-03-20
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States