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LEAN Into Pregnancy Study: Healthy Lifestyle Education for Pregnancy Outcomes

This study, called LEAN (Lifestyle, Education, Activity, Nutrition) Into Pregnancy, is looking at whether healthy lifestyle education can improve heart health and reduce problems during pregnancy. You might be able to join if you are a woman between 18 and 35 years old, planning to get pregnant within two years, or are in your first trimester of pregnancy. You also need to be at risk for preeclampsia (a serious blood pressure condition during pregnancy) based on certain criteria. The study will give some participants healthy lifestyle education using materials from the Gaples Institute, while others will receive routine care. Researchers want to see if this education is practical, improves your cardiovascular (heart and blood vessel) health, and lowers the risk of problems like gestational diabetes (diabetes during pregnancy) and preeclampsia. A total of 200 participants will be involved. The current status of this study is unclear.

Study design
This is an interventional study with 200 participants. Participants will be randomly assigned to receive either healthy lifestyle education plus routine care, or routine care alone.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The feasibility of the study will be measured from enrollment through the end of the intervention at 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06879054

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

Not Yet Recruiting
NAAges 18–35InterventionalPrevention
Medical College of Wisconsin
~200 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:Healthy lifestyle education

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of the LEAN into Pregnancy Study
Measured over From enrollment through the end of intervention at 3 months.

Conditions

Pregnancy
Preconception Education
Preconception Care, Preconception Risk
Adverse Pregnancy Outcomes

Explore related trials

PreconceptionPregnancy

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Anna Palatnik, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin

Who to contact

Alyssa M Hernandez, DO
[email protected]
4148055285
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Feasibility of the LEAN into Pregnancy StudyFrom enrollment through the end of intervention at 3 months.

    Determine feasibility (as measured by recruitment, completion of all modules and surveys, and retention in the study for three months) of the LEAN into Pregnancy study.