Healthy Lifestyle Education for Pregnancy Outcomes
(LEAN Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAnna Palatnik, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medical College of Wisconsin

No Placebo Group

Trial Summary

What is the purpose of this trial?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)

Eligibility Criteria

This trial is for women who are planning to become pregnant or are in early pregnancy, aiming to improve their cardiovascular health and reduce complications like gestational diabetes and preeclampsia. Participants will be involved in activities such as blood tests and lifestyle surveys.

Inclusion Criteria

I plan to become pregnant soon or am in my first trimester.

English-speaking

At risk for preeclampsia based on specified ACOG criteria

+1 more

Exclusion Criteria

No access to a smartphone

Major fetal anomaly diagnosed during current pregnancy, if pregnant at consent

Participant Groups

The LEAN into Pregnancy study is testing whether healthy lifestyle education can boost cardiovascular health scores and lower the risk of pregnancy issues. Women will either receive this education plus routine care or just routine care, with a total of 200 participants.

2Treatment groups

Experimental Treatment

Active Control

Group I: LEAN InterventionExperimental Treatment1 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 II: Standard of CareActive Control1 Intervention

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