Healthy Lifestyle Education for Pregnancy Outcomes

(LEAN Trial)

Overseen By Alyssa M Hernandez, DO

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: No smartphone, Major fetal anomaly

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Healthy lifestyle education for pregnancy outcomes?

Research shows that healthy lifestyle education can improve health literacy and promote healthier behaviors, which are linked to better pregnancy outcomes. Additionally, healthier lifestyles in early pregnancy are associated with fewer complications and reduced risks for both mother and child. ^{1 2 3 4 5}

Is healthy lifestyle education safe for pregnant women?

Healthy lifestyle education, which includes guidance on diet and physical activity, is generally considered safe for pregnant women. It aims to improve health literacy and promote healthy behaviors, which can lead to better pregnancy outcomes. ^{1 3 5 6 7}

How does the treatment 'Healthy lifestyle education' differ from other treatments for pregnancy outcomes?

Healthy lifestyle education is unique because it focuses on individualized, evidence-based education to improve health literacy and promote healthy behaviors during pregnancy, rather than using medication or medical interventions. This approach aims to enhance diet quality, physical activity, and overall lifestyle choices, which can positively impact pregnancy outcomes. ^{1 3 4 5 7}

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)

Research Team

Anna Palatnik, MD

Principal Investigator

Medical College of Wisconsin

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

Exclusion Criteria

No access to a smartphone

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the LEAN Intervention arm complete five nutrition modules and receive weekly follow-up calls for three months

3 months

Weekly phone calls

Follow-up

Participants are monitored for cardiovascular health and pregnancy outcomes, including gestational diabetes and hypertensive disorders

Up to 2 years

Treatment Details

Interventions

• Healthy lifestyle education

Trial Overview 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.

Participant Groups

Group I: LEAN Intervention Experimental Treatment 1 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 Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Promoting healthy lifestyle considerations during pregnancy in Midwifery clinics in China: a best practice implementation project. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of healthy lifestyle interventions on weight gain in overweight pregnant women: A cluster-randomized controlled trial. [2021]

3. Australia pubmed.ncbi.nlm.nih.gov

A healthy lifestyle education programme for health literacy and health-promoting behaviours: A pre-implementation and post-implementation study. [2020]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Lifestyle behaviours during pregnancy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Prepare randomized clinical trial: Acceptability, engagement, and lifestyle effects of a weight loss intervention beginning in pre-pregnancy. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Health Education about Lifestyle-Related Risk Factors in Gynecological and Obstetric Care: A Qualitative Study of Healthcare Providers' Views in Germany. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Is Health Education among the Decisive Factors for the Diet Quality of Pregnant Women in Poland? [2023]