Preventing Obstetric Complications With Dietary Intervention

Last updated: November 6, 2025
Sponsor: Medical College of Wisconsin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes (Pediatric)

Pregnancy Complications

High Blood Pressure (Hypertension - Pediatric)

Treatment

Maternal Health Management Program

Clinical Study ID

NCT06320054
PRO00049771
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion criteria:

  1. Age at enrollment ≥ 18 years of age

  2. Receiving prenatal care at Froedtert

  3. ≤ 16 weeks and 6 days of gestation

  4. At risk of preeclampsia, defined as being eligible for low dose aspirin treatmentAND/OR at risk for gestational diabetes defined as having a history of gestationaldiabetes, OR previously given birth to an infant weighing ≥ 4000 g, OR has adiagnosis of PCOS

  5. Pre-pregnancy Body Mass Index ≥ 25 kg/m^2

  6. Resides in Milwaukee County at time of consent

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

  8. Able to read and communicate in English

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

  10. Has access to a working refrigerator

  11. Viable singleton pregnancy

Exclusion

Exclusion criteria:

  1. Diagnosed with Type I or Type II Diabetes or Hemoglobin A1C ≥ 6.5%

  2. Diagnosed with End Stage Renal Disease

  3. Use of weight-increasing psychotropic agents

  4. Active inflammatory bowel disease, or history of bowel resection or malabsorptivesyndrome, or history of bariatric surgery

  5. Significant food allergies, preferences or dietary requirements that would interferewith diet adherence

  6. Multifetal gestation

  7. Active substance use that would preclude program adherence

  8. Chronic use of oral corticosteroids

  9. Unable to provide informed consent

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Maternal Health Management Program
Phase:
Study Start date:
June 12, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Froedert & The Medical College of Wiscosin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Froedert & The Medical College of Wiscosin

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Active - Recruiting

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