Status:
NOT_YET_RECRUITING
Lifestyle, Education, Activity, Nutrition (LEAN) Into Pregnancy
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Pregnancy
Preconception Education
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief Summary
The goal of this randomized controlled clinical trial is to determine if healthy lifestyle education can help improve cardiovascular health and reduce pregnancy complications in women during the preco...
Detailed Description
Studies investigating adverse pregnancy outcomes have shown contributing effects from increased rates of diabetes, hypertension, and abnormal cholesterol and cardiovascular disease events. Previous st...
Eligibility Criteria
Inclusion
- Patients in a period of preconception who want to become pregnant within 2 years, or patients in their first trimester of pregnancy
- English-speaking
- At risk for preeclampsia based on the following ACOG criteria: ≥1 high-risk factor: history of preeclampsia, multifetal gestation, chronic hypertension, gestational hypertension, pregestational diabetes, renal disease, or autoimmune disease, OR ≥2 moderate-risk factors: nulliparity, obesity (BMI\>30 kg/m2), family history of preeclampsia, Black or African American race, age ≥35 years, or personal history factors (previous pregnancy low birth weight, previous stillbirth, previous preterm birth, \>10-year pregnancy interval).
- At risk for gestational diabetes, defined by ACOG as a BMI \> 25 plus one or more of the following risk factors: physical inactivity, first-degree relative with diabetes, high-risk race/ethnicity (African American, Latino, Native American, Asian American, Pacific Islander), previous infant weight \>4,000g, previous GDM, chronic hypertension, HDL \<35, triglyceride \>250, PCOS, A1c ≥ 5.7, prepregnancy BMI \>40.
Exclusion
- No access to a smartphone
- Major fetal anomaly diagnosed during current pregnancy, if pregnant at consent
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06879054
Start Date
December 1 2025
End Date
September 1 2029
Last Update
October 22 2025
Active Locations (1)
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1
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226