NCT06879054

Brief 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:

  • Blood draws to test hemoglobin A1c and lipids
  • Surveys about diet, physical activity, sleep, and tobacco use
  • Gaples Nutritional Education Modules (if applicable)

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
39mo left

Started Jul 2026

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

February 14, 2025

Last Update Submit

March 11, 2026

Conditions

PregnancyPreconception EducationPreconception Care, Preconception RiskAdverse Pregnancy Outcomes

Keywords

Preconception educationCardiovascular healthPregnancyLifestyle intervention

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the LEAN into Pregnancy Study

    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.

    From enrollment through the end of intervention at 3 months.

Secondary Outcomes (4)

  • Life's Essential 8

    At enrollment and after intervention at 3 months.

  • Incident rate of gestational diabetes among participants who become pregnant.

    Up to 2 years after enrollment

  • Acceptability of the LEAN into Pregnancy Study

    3 months from enrollment (end of intervention)

  • Incident rate of hypertensive disorders of pregnancy in participants who become pregnant

    Up to 2 years after enrollment

Study Arms (2)

LEAN Intervention

EXPERIMENTAL

Participants randomized to the LEAN Intervention arm will complete five modules on nutrition for optimal health and submit their completed certificates. The Gaples Institute is a free website that provides free educational modules regarding nutrition education. Each module is 10-15 minutes long and covers the power of a healthy diet, the truth about dietary fat, information about carbohydrates, facts about protein, calcium, and sodium, and simple strategies for healthy eating. Participants will also receive weekly phone calls to follow up with the progress of the implementation of the lifestyle intervention for the next three months.

Other: Healthy lifestyle education

Standard of Care

NO INTERVENTION

Participants randomized to the Standard of Care arm will receive routine prenatal or gynecologic care.

Interventions

Healthy lifestyle educationOTHER

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

Also known as: Health lifestyle education
LEAN Intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Study Officials

  • Anna Palatnik, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyssa M Hernandez, DO

CONTACT

4148055285alyhernandez@mcw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 14, 2025

First Posted

March 17, 2025

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)