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

Starting soon · Not applicable

Conditions studied: Pregnancy, Preconception Education, Preconception Care, Preconception Risk, Adverse Pregnancy Outcomes

In brief

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)

Key facts

Study ID

NCT06879054

Run by

Medical College of Wisconsin

People needed

200

Starts

2026-07-01

Expected to finish

2029-09-01

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• No access to a smartphone
• Major fetal anomaly diagnosed during current pregnancy, if pregnant at consent

Where it is running

• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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