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

NCT06879054 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-12

No results posted yet for this study

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)

Conditions

  • Pregnancy
  • Preconception Education
  • Preconception Care, Preconception Risk
  • Adverse Pregnancy Outcomes

Interventions

OTHER

Healthy lifestyle education

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

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Anna Palatnik, MD · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2029-05-31
Completion
2029-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06879054 on ClinicalTrials.gov