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NOT YET RECRUITING
NCT06879054
NA

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

Sponsor: Medical College of Wisconsin

View on ClinicalTrials.gov

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

Interventions

OTHER

Healthy lifestyle education

Healthy lifestyle education via nutritional educational modules from the Gaples Institute.

Locations (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, United States