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)
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.
No access to a smartphone
Major fetal anomaly diagnosed during current pregnancy, if pregnant at consent
Parallel
Healthy lifestyle education
Other interventionHealthy lifestyle education via nutritional educational modules from the Gaples Institute.
Feasibility of the LEAN into Pregnancy Study
Determine feasibility (as measured by recruitment, completion of all modules and surveys, and retention in the study for three months) of the LEAN into Pregnancy study.
Life's Essential 8
Determine the impact of healthy lifestyle education on Life's Essential 8 cardiovascular score pre- and post-intervention.
Incident rate of gestational diabetes among participants who become pregnant.
Determine the impact of healthy lifestyle education on adverse pregnancy outcomes among participants who become pregnant, specifically the rate of gestational diabetes.
Acceptability of the LEAN into Pregnancy Study
Acceptability will be measured by surveys distributed to participants in the intervention arm at the final study visit.
Incident rate of hypertensive disorders of pregnancy in participants who become pregnant
Determine the impact of healthy lifestyle education on adverse pregnancy outcomes among participants who become pregnant, specifically the rate of hypertensive disorders of pregnancy.
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This trial is not recruiting at the moment. You can still explore other options:
