Gestational Diabetes, Gestational Hypertension, High Risk Pregnancy, Preeclampsia
Conditions
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.
Interventions
BEHAVIORALMaternal Health Management Program
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.
Sponsors
Medical College of Wisconsin
Advancing a Healthier Wisconsin Endowment
Food for Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcomes | End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks) | gestational weight gain (BMI early pregnancy in comparison to BMI at delivery) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes | End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks) | program utilization (measured by percentage of weekly coaching attended and number of meals consumed) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnna Palatnik, MD
Medical College of Wisconsin
Outcome results
None listed