Clinical trial NCT06320054: Preventing Obstetric Complications With Dietary Intervention
Official title: Preventing Common Obstetric Complications Through an Immersive, Medically Tailored Meal Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Gestational Hypertension
High Risk Pregnancy
Preeclampsia
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Advancing a Healthier Wisconsin Endowment
name: Food for Health, Inc.
First posted: 2024-03-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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

Primary outcomes:
measure: Clinical Outcomes
timeFrame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
measure: Clinical Outcomes
timeFrame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
measure: Clinical Outcomes
timeFrame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
measure: Clinical Outcomes
timeFrame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
measure: Clinical Outcomes
timeFrame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Secondary outcomes:
measure: Patient Reported Outcomes
timeFrame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
measure: Patient Reported Outcomes
timeFrame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
measure: Patient Reported Outcomes
timeFrame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
measure: Patient Reported Outcomes
timeFrame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
measure: Patient Reported Outcomes
timeFrame: End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks)
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedert & The Medical College of Wiscosin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Anna Palatnik, MD
role: PRINCIPAL_INVESTIGATOR
References: