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

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT06879054
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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)

Key Dates

Start date
Jul 1, 2026
Status verified
Mar 2026
Primary completion
May 31, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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.
  • No Intervention: Standard of Care
    Participants randomized to the Standard of Care arm will receive routine prenatal or gynecologic care.

Primary Outcome Measure

Feasibility of the LEAN into Pregnancy Study [ Time Frame: From enrollment through the end of intervention at 3 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical College of WisconsinMilwaukeeWisconsin53226
Alyssa Hernandez, DO
[email protected]
4148055285
Anna Palatnik, MD (PRINCIPAL_INVESTIGATOR)

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