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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if healthy lifestyle education can enhance heart health and reduce pregnancy complications such as gestational diabetes (a type of diabetes that develops during pregnancy) and preeclampsia (a condition causing high blood pressure and potential organ damage). Participants will be divided into two groups: one will receive routine care, while the other will receive additional education on nutrition and healthy living. Ideal candidates are women planning to become pregnant within two years or in their first trimester, who are at risk for conditions like preeclampsia or gestational diabetes. Participants will engage in activities such as blood tests and lifestyle surveys. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could improve maternal health outcomes.

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 prior data suggests that healthy lifestyle education is safe for improving pregnancy outcomes?

Research has shown that learning about healthy lifestyles is generally safe and well-received by participants. Studies have found that lifestyle changes can help manage healthy weight gain during pregnancy and lead to better pregnancy outcomes. Various studies indicate no strong evidence of harmful effects from these educational programs.

Participants in similar programs have reported positive experiences without major issues. The focus on nutrition and exercise is typically safe and beneficial. Based on past research, learning about healthy lifestyles appears to be a safe option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Healthy Lifestyle Education for Pregnancy Outcomes trial because it takes a novel approach to improving pregnancy outcomes by focusing on education rather than medication. Unlike standard prenatal care, which traditionally involves regular check-ups and monitoring, this trial emphasizes empowering pregnant individuals with knowledge about nutrition through short, engaging modules. This educational strategy aims to enhance understanding of healthy eating, which could lead to better health for both mothers and their babies. Additionally, the trial includes personalized follow-up through weekly phone calls, providing ongoing support and encouragement, which is a unique and supportive feature not typically found in standard prenatal care.

What evidence suggests that healthy lifestyle education is effective for improving pregnancy outcomes?

Research has shown that learning about healthy lifestyles can improve pregnancy outcomes. For example, one study found that this education helped prevent excessive weight gain during pregnancy. Another study demonstrated that programs focused on nutrition helped women understand healthy eating early in pregnancy. A review of dietary programs also indicated they were effective in improving diet quality and lifestyle choices, positively affecting pregnancy results. In this trial, participants in the LEAN Intervention arm will receive education on nutrition and healthy habits, which studies suggest can help reduce complications like gestational diabetes and preeclampsia. ^{1 6 7 8 9}

Who Is on the Research Team?

Anna Palatnik, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11667471/

a protocol for a systematic review and meta-analysis - PMC To systematically collect, review and summarise available evidence on the pooled effect of the nutrition education to pregnant women on birth outcomes in sub- ...

2. ysph.yale.edu ysph.yale.edu/news-article/group-prenatal-care-intervention-shows-promising-results-in-reducing-adverse-pregnancy-outcomes/

Group Prenatal Care Intervention Shows Promising Results in ... A group prenatal care intervention focused on healthy lifestyle choices and weight management significantly reduced their risk of excess pregnancy weight gain ...

3. nature.com nature.com/articles/s41598-025-07979-3

Effectiveness of nutrition literacy intervention on pregnancy ... The comprehensive nutritional literacy intervention implemented in early pregnancy significantly improved pregnant women's nutritional literacy levels.

4. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07185-z

Effective dietary interventions during pregnancy: a systematic ... The primary aims of this systematic review and meta-analysis were to summarise the effectiveness of dietary interventions for pregnant woman.

5. withpower.com withpower.com/trial/phase-preconception-education-4-2025-f7184

Healthy Lifestyle Education for Pregnancy Outcomes ... This approach aims to enhance diet quality, physical activity, and overall lifestyle choices, which can positively impact pregnancy outcomes. Show more.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11649848/

Impact of health literacy on pregnancy outcomes in ... However, this review identified no significant impact of current health education interventions on the risk of stillbirth, or neonatal or ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00486629?tab=table

Impact of Diet and Exercise Activity on Pregnancy Outcomes The general goal of the present study is to assess the impact of a community-based exercise and dietary intervention in pregnant women living in urban areas ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2797034

Implementation of Antenatal Lifestyle Interventions Into ... Lifestyle interventions optimize healthy GWG and substantially improve pregnancy outcomes, with demonstrated cost-effectiveness. As ...

9. odphp.health.gov odphp.health.gov/healthypeople/objectives-and-data/browse-objectives/pregnancy-and-childbirth

Pregnancy and Childbirth - Healthy People 2030 Healthy People 2030 focuses on preventing pregnancy complications and maternal deaths and helping women stay healthy before, during, and after pregnancy.