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

NCT ID: NCT06879054

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2029-09-30

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:

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)

Detailed Description

Studies investigating adverse pregnancy outcomes have shown contributing effects from increased rates of diabetes, hypertension, and abnormal cholesterol and cardiovascular disease events. Previous studies have additionally shown that lifestyle modifications such as the DASH diet, regular exercise, and reduction in stress can lower blood pressure, lower LDL cholesterol levels, and decrease poor health behaviors that are linked to cardiovascular disease. However, studies have failed to quantify the effects of lifestyle modifications on more short-term cardiovascular health that may increase adverse pregnancy outcomes. By shifting the focus from cardiovascular disease treatment to positive health promotion, it promotes a paradigm shift to focus on prevention of disease and improved societal health overall. Preliminary data from our group showed significant correlations between preeclampsia and lower availability of healthy food, which is one of the factors quantified in Life's Essential 8. A major gap in the literature remains lifestyle interventions that can lead to risk factors for cardiovascular health in pregnant populations during gestation and also in the preconception period. We believe that lifestyle interventions preconception or during pregnancy can improve cardiovascular health during gestation and reduce adverse pregnancy outcomes.

We hypothesize that the implementation of specific educational modules surrounding diet and exercise and repeated patient interaction will improve Life's Essential 8 cardiovascular score and, in those who are pregnant, potentially reduce the risk for gestational diabetes and preeclampsia.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

LEAN Intervention

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.

Group Type: EXPERIMENTAL

Healthy lifestyle education

Intervention Type: OTHER

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

Standard of Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Healthy lifestyle education

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

Intervention Type: OTHER

Other Intervention Names

Health lifestyle education

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Anna Palatnik, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Palatnik, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Central Contacts

Alyssa M Hernandez, DO

Role: CONTACT

alyhernandez@mcw.edu

4148055285

Facility Contacts

Alyssa Hernandez, DO

Role: primary

alyhernandez@mcw.edu

414-805-5285

Other Identifiers

PRO48098

Identifier Type: -

Identifier Source: org_study_id