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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• Age at enrollment ≥ 18 years of age

• Receiving prenatal care at Froedtert

• ≤ 16 weeks and 6 days of gestation

• At risk of preeclampsia, defined as being eligible for low dose aspirin treatment AND/OR at risk for gestational diabetes defined as having a history of gestational diabetes, OR previously given birth to an infant weighing ≥ 4000 g, OR has a diagnosis of PCOS

• Pre-pregnancy Body Mass Index ≥ 25 kg/m\^2

• Resides in Milwaukee County at time of consent

• Low socio-economic status (\<200% of FPL defined as receiving Medicaid)

• Able to read and communicate in English

• Has access to a smart device/computer with reliable internet connection

⁃ Has access to a working refrigerator

⁃ Viable singleton pregnancy

Locations
United States
Wisconsin
Froedert & The Medical College of Wiscosin
RECRUITING
Milwaukee
Contact Information
Primary
Anna Palatnik, MD
apalatnik@mcw.edu
414-805-6624
Backup
Amandla Stanley, MSN
akstanley@mcw.edu
414-805-6691
Time Frame
Start Date: 2024-06-12
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 100
Treatments
No_intervention: Standard Prenatal Care
Standard Prenatal Care, biometric screenings, and surveys (baseline, 4-12 weeks postpartum).
Experimental: 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.
Sponsors
Collaborators: Food for Health, Inc., Advancing a Healthier Wisconsin Endowment
Leads: Medical College of Wisconsin

This content was sourced from clinicaltrials.gov