An interventional study of Healthy lifestyle education in Pregnancy, Preconception Education and Preconception Care, Preconception Risk, sponsored by Medical College of Wisconsin. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Prevention
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:
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:
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.
Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Healthy lifestyle education
Participants randomized to the Standard of Care arm will receive routine prenatal or gynecologic care.
Healthy lifestyle education via nutritional educational modules from the Gaples Institute.
Also known as: Health lifestyle education
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.
Time frame: From enrollment through the end of intervention at 3 months.
Life's Essential 8
Determine the impact of healthy lifestyle education on Life's Essential 8 cardiovascular score pre- and post-intervention.
Time frame: At enrollment and after intervention at 3 months.
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.
Time frame: Up to 2 years after enrollment
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.
Time frame: 3 months from enrollment (end of intervention)
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.
Time frame: Up to 2 years after enrollment
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Medical College of Wisconsin