Preventing Obstetric Complications With Dietary Intervention (PLATE)

Medical College of Wisconsin

Status: Enrolling

Conditions: Gestational Diabetes; Preeclampsia; Gestational Hypertension; High Risk Pregnancy

Treatments: Behavioral: Maternal Health Management Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06320054

PRO00049771

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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 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
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 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 malabsorptive syndrome, or history of bariatric surgery
5. Significant food allergies, preferences or dietary requirements that would interfere with 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Standard Prenatal Care

No Intervention group

Description:

Standard Prenatal Care, biometric screenings, and surveys (baseline, 4-12 weeks postpartum).

Maternal Health Management Program

Experimental group

Description:

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.

Treatment:

Behavioral: Maternal Health Management Program