Preventing Obstetric Complications With Dietary Intervention

Not Applicable

Recruiting

• Conditions: Gestational Hypertension; High Risk Pregnancy; Preeclampsia; Gestational Diabetes
• Interventions: Behavioral: Maternal Health Management Program

• Registration Number: NCT06320054
• Lead Sponsor: Medical College of Wisconsin

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-20
• Study Start: 2024-06-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-06-30
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maternal Health Management Program	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.

Primary Outcome Measures

Name	Time	Method
Clinical Outcomes	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)	Gestational age at birth (Weeks and Days)

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes	End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)	Self-Efficacy (as measure by Self-Efficacy survey)

Trial Locations

Locations (1)

Froedert & The Medical College of Wiscosin; 🇺🇸 Milwaukee, Wisconsin, United States