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Lifestyle, Education, Activity, Nutrition (LEAN) Into Pregnancy
Sponsor: Medical College of Wisconsin
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 preconception period or early pregnancy. The main aims include: 1. Determine the feasibility and acceptability of the LEAN into pregnancy study. 2. Determine the impact of healthy lifestyle education on Life's Essential 8 cardiovascular health score. 3. Determine the impact of health lifestyle education on adverse pregnancy outcomes, specifically gestational diabetes and preeclampsia. A total of 200 participants will be randomly assigned to receive healthy lifestyle education in addition to routine care, or routine care alone. Participants will be asked to participate in the following activities: * Blood draws to test hemoglobin A1c and lipids * Surveys about diet, physical activity, sleep, and tobacco use * Gaples Nutritional Education Modules (if applicable)
Official title: Lifestyle, Education, Activity, Nutrition (LEAN) Into Pregnancy: A Randomized Controlled Trial Investigating the Impact of Healthy Lifestyle Education During Preconception and Early Pregnancy on Cardiovascular and Pregnancy Outcomes
Key Details
Gender
FEMALE
Age Range
18 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-07-01
Completion Date
2029-09
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
Healthy lifestyle education
Healthy lifestyle education via nutritional educational modules from the Gaples Institute.
Locations (1)
Medical College of Wisconsin
Milwaukee, Wisconsin, United States