NCT06320054Active, not recruiting
Preventing Obstetric Complications With Dietary Intervention
Preventing Common Obstetric Complications Through an Immersive, Medically Tailored Meal Program
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 69 (actual)
- First submitted
- 5 Mar 2024
- Start date
- 12 Jun 2024
- Primary completion date
- 28 May 2026
- Lead sponsor
- Medical College of Wisconsin
- Diseases
- High blood pressure
- NCT number
- NCT06320054
What you commit to
- Study type: Interventional
- Participants enrolled: 69
- From 12 Jun 2024 to the primary completion date, 28 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic use of oral corticosteroids
Other illness
- Diagnosed with End Stage Renal Disease
- Active inflammatory bowel disease, or history of bowel resection or malabsorptive syndrome, or history of bariatric surgery
- Significant food allergies, preferences or dietary requirements that would interfere with diet adherence
Lab values
- Diagnosed with Type I or Type II Diabetes or Hemoglobin A1C ≥ 6.5%
Other
- Use of weight-increasing psychotropic agents
- Multifetal gestation
- Active substance use that would preclude program adherence
- Unable to provide informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Froedert & The Medical College of Wiscosin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.