Improving pregnancy outcomes with healthy food and coaching
Preventing Common Obstetric Complications Through an Immersive, Medically Tailored Meal Program
This study is testing if giving pregnant women healthy food and coaching can help lower their chances of developing gestational diabetes and preeclampsia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT06320054 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if providing access to healthy food, health coaching, and nutrition support can reduce the risk of gestational diabetes and preeclampsia in pregnant women. Participants will be randomly assigned to either a standard care group or an intervention group that receives weekly health coaching and meals. The study will assess both the effectiveness of the intervention in improving health outcomes for mothers and newborns, as well as participant satisfaction and ability to apply the program teachings in their lives. Surveys and biometric screenings will be conducted for all participants.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older, at risk for preeclampsia or gestational diabetes, with a pre-pregnancy BMI of 25 or higher, and residing in Milwaukee County.
Not a fit: Patients with diagnosed Type I or Type II diabetes, end-stage renal disease, or those using weight-increasing psychotropic agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to healthier pregnancies and improved outcomes for mothers and their newborns.
How similar studies have performed: Other studies have shown promising results with dietary interventions in managing pregnancy-related complications, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milwaukee, Wisconsin
- Froedert & The Medical College of Wiscosin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Anna Palatnik, MD — Medical College of Wisconsin
- Study coordinator: Anna Palatnik, MD
- Email: apalatnik@mcw.edu
- Phone: 414-805-6624
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.