Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
NCT Number: NCT06879054
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)
Trial opening soon.
Get Notified18 year–35 year
Female
Interventional
Not applicable
Milwaukee, Wisconsin, 53226, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Healthy lifestyle education via nutritional educational modules from the Gaples Institute.
Other names: Health lifestyle education
Time frame: From enrollment through the end of intervention at 3 months.
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: At enrollment and after intervention at 3 months.
Determine the impact of healthy lifestyle education on Life's Essential 8 cardiovascular score pre- and post-intervention.
Time frame: Up to 2 years after enrollment
Determine the impact of healthy lifestyle education on adverse pregnancy outcomes among participants who become pregnant, specifically the rate of gestational diabetes.
Time frame: 3 months from enrollment (end of intervention)
Acceptability will be measured by surveys distributed to participants in the intervention arm at the final study visit.
Time frame: Up to 2 years after enrollment
Determine the impact of healthy lifestyle education on adverse pregnancy outcomes among participants who become pregnant, specifically the rate of hypertensive disorders of pregnancy.
Contact information is provided by the study sponsor or research team.
Medical College of Wisconsin
Other
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
Acronym: LEAN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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