Clinical trial NCT06879054: Lifestyle, Education, Activity, Nutrition (LEAN) Into Pregnancy
Official title: Lifestyle, Education, Activity, Nutrition (LEAN) Into Pregnancy: A Randomized Controlled Trial Investigating the Impact of Healthy Lifestyle Education During Preconception and Early Pregnancy on Cardiovascular and Pregnancy Outcomes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy
Preconception Education
Preconception Care, Preconception Risk
Adverse Pregnancy Outcomes
Keywords: Preconception education
Cardiovascular health
Pregnancy
Lifestyle intervention
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Feasibility of the LEAN into Pregnancy Study
timeFrame: From enrollment through the end of intervention at 3 months.
Secondary outcomes:
measure: Life's Essential 8
timeFrame: At enrollment and after intervention at 3 months.
measure: Incident rate of gestational diabetes among participants who become pregnant.
timeFrame: Up to 2 years after enrollment
measure: Acceptability of the LEAN into Pregnancy Study
timeFrame: 3 months from enrollment (end of intervention)
measure: Incident rate of hypertensive disorders of pregnancy in participants who become pregnant
timeFrame: Up to 2 years after enrollment
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Anna Palatnik, MD
role: PRINCIPAL_INVESTIGATOR
References: