Preventing Obstetric Complications With Dietary Intervention

Launched by MEDICAL COLLEGE OF WISCONSIN · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether providing pregnant women with access to healthy food, health coaching, and nutrition support can help prevent complications like gestational diabetes and preeclampsia, which can affect both mothers and their babies. The researchers want to find out if this program can improve health outcomes for both groups and if participants feel satisfied and capable of using what they learn once the study is over.

To be eligible for the trial, women must be at least 18 years old, receiving prenatal care, and in the early stages of pregnancy (up to about 16 weeks). They should also be at risk for certain complications due to previous health issues or specific medical history. Participants will be randomly placed in one of two groups: one group will receive standard care, while the other will take part in the nutrition intervention, which includes weekly health coaching and meals provided by the study. Participants can expect to complete surveys and health screenings throughout the trial. This study is currently recruiting women in Milwaukee County, and it aims to learn how these different approaches can lead to healthier pregnancies and babies.

Gender

FEMALE

Eligibility criteria

• 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