Lifestyle, Education, Activity, Nutrition (LEAN) Into Pregnancy

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)

NCT Number	NCT06879054
Lead Sponsor	Medical College of Wisconsin
Conditions	Pregnancy, Preconception Education, Preconception Care, Preconception Risk, Adverse Pregnancy Outcomes
Enrollment	200 participants
Start Date	2026-07-01
Primary Completion	2029-05 (estimated)
Study Completion	2029-09 (estimated)
Updated on ClinicalTrials.gov	2026-03-12