An interventional study of Cardiovascular risk screening and Follow-up of cardiovascular risk factors in Cardiovascular (CV) Risk, Metabolic Health and Primary Prevention, sponsored by Laval University. Recruiting at 1 site in Canada. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Laval University · Not applicable, Interventional, and Prevention
Indigenous people living in Canada face significant healthcare inequities, particularly in basic, primary, and secondary prevention, leading to higher rates of cardiovascular disease and mortality. This program aims to develop a comprehensive understanding of the contextual and individual determinants influencing Indigenous health, and to address health disparities by using tailored community-led participatory research and care initiatives. The investigator and research team use a Mobile Healthcare Unit travelling to Indigenous communities, providing customized, impactful, and sustainable preventive care that adapts dynamically to the evolving needs of each community. The initiative places a strong emphasis on equity and inclusivity, aiming to generate original data in Indigenous and remote underrepresented/underserved populations. This proposal will improve opportunities of identifying facilitators and barriers to preventive care in Indigenous and remote communities. This focus is vital for reducing health disparities and aligns with the Truth and Reconciliation Calls to Action. To maximize knowledge mobilization and ensure culturally appropriate initiatives align with community needs and priorities, this research program collaborates with the Indigenous University Hub at Laval University, local community members and leaders, and Indigenous peoples with lived experience. Existing national and international collaborations with Indigenous communities further enhance the initiative's potential impact and foster knowledge mobilization on a global scale. The ultimate goal is to empower Indigenous peoples and communities to advocate for systemic changes to fight inequities in healthcare in accordance with appropriated truth and reconciliation efforts.
This pilot study will take place in the Mobile Healthcare Unit (motorized vehicle) that will travel to 10 Indigenous and/or remote communities.This study aims at collecting cardiovascular (CV) data and delivering culturally appropriate research and care in underserved/underrepresented populations. Collaborating members of the communities visited will be involve in the mobile care service and will assist as translators. Recruitment and data collection will be carried out by the investigator at the IUCPQ-ULaval in collaboration with the participating communities. This study was co-designed and accepted by health departments and participating communities. Each participant will undergo a comprehensive assessment of CV risk factors and CV conditions at the beginning of the study. This assessment will be standardized and will include the following elements:
5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.
This study's planned enrollment of 500 is above the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Laval University is the lead sponsor of 380 studies on the registry; 70 are open to participants now.
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Exclusion Criteria:
Other: Cardiovascular risk screening · Other: Follow-up of cardiovascular risk factors
Extensive cardiovascular risk screening offered locally in underserved/ underrepresented communities (see Study Description for more details)
Measure changes in cardiovascular risk factors among participants who took place in the screening phase.
Height in meters
Measured using a stadiometer
Time frame: Once, at baseline.
Weight in kilograms
Measured using an electronic body scale
Time frame: At baseline and at 1 year
Body mass index in kg/(m^2)
BMI will be calculated by dividing the weight in kilograms by the square of the height in meters
Time frame: At baseline and at 1 year
Waist circumference in centimeters
Waist circumference will be measured using an ergonomic circumference measuring tape
Time frame: At baseline and at 1 year
Blood pressure
In mm Hg, using a digital blood pressure device
Time frame: At baseline and at one-year follow-up
Lipid profile
Assessment of hypercholesterolemia (LDL-C, HDL-C, triglycerides, non-HDL-C in mmol/L) and apoB levels in g/L.
Time frame: At baseline and at one-year follow-up
Physical activity measure
Using the International Physical Activity Questionnaire (IPAQ)
Time frame: At baseline and at one-year follow-up
Glycated hemoglobin (HbA1c)
Blood test, expressed as %
Time frame: At baseline and at one-year follow-up
Dietary habits
Frequency of intake per month of fruits, vegetables, whole grains, lean proteins, saturated fats and added sugars, using the Canadian Food Intake Screener.
Time frame: At baseline and at one-year follow-up
Smoking habits
Self-reported smoking habits as current smoker, former smoker or never smoked, as well as frequency of smoking
Time frame: At baseline and at one-year follow-up
Framingham risk score
Estimated 10-year cardiovascular risk, expressed as a percentage (%)
Time frame: At baseline and at one-year follow-up
Participant feedback on intervention
Questionnaire on participant satisfaction and areas of improvement in health equity.
Time frame: At baseline and at one-year follow-up
Body fat distribution
Percentage and kilograms, using a electrical bioimpedance device
Time frame: At baseline
Liver fat content
Measured with liver elastography
Time frame: At baseline
Arterial stiffness
Measured by pulse wave velocity
Time frame: At baseline
Plan to share: Undecided — According to OCAP(TM) principles, each community owns their data, controls its dissemination, and decides when and what research is in the best interests of their specific community.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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