Actively Recruiting
Preventing Obstetric Complications With Dietary Intervention
Led by Medical College of Wisconsin · Updated on 2025-11-10
100
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
Sponsors
M
Medical College of Wisconsin
Lead Sponsor
A
Advancing a Healthier Wisconsin Endowment
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Preventing Obstetric Complications With Dietary Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at enrollment
- Receiving prenatal care at Froedtert
- Pregnant with gestation less than or equal to 16 weeks and 6 days
- At risk of preeclampsia (eligible for low dose aspirin) or at risk for gestational diabetes (history of gestational diabetes, previous infant weighing 4000 g or more, or diagnosis of PCOS)
- Pre-pregnancy Body Mass Index of 25 kg/m^2 or higher
- Resides in Milwaukee County at time of consent
- Low socio-economic status (less than 200% of Federal Poverty Level, defined as receiving Medicaid)
- Able to read and communicate in English
- Has access to a smart device or computer with reliable internet connection
- Has access to a working refrigerator
- Viable singleton pregnancy
You will not qualify if you...
- Diagnosed with Type I or Type II Diabetes or Hemoglobin A1C of 6.5% or higher
- Diagnosed with End Stage Renal Disease
- Use of weight-increasing psychotropic agents
- Active inflammatory bowel disease, history of bowel resection or malabsorptive syndrome, or history of bariatric surgery
- Significant food allergies, preferences, or dietary requirements interfering with diet adherence
- Multifetal gestation
- Active substance use interfering with program adherence
- Chronic use of oral corticosteroids
- Unable to provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Froedert & The Medical College of Wiscosin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
A
Anna Palatnik, MD
CONTACT
A
Amandla Stanley, MSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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