| Registry | NCT07869069 |
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| Status | Recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none, prevention |
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| Enrollment | 500 (Estimated) |
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| Sponsor | Laval University (Other); collaborators: Canadian Institutes of Health Research (CIHR) |
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| Conditions | Cardiovascular (CV) Risk, Metabolic Health, Primary Prevention |
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| Interventions | Cardiovascular risk screening, Follow-up of cardiovascular risk factors (Other) |
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| Dates | start 2026-02-11, primary completion 2029-03-31 (estimated), completion 2030-03-31 (estimated), first posted 2026-10-09, last updated 2026-10-09 |
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| Locations | 1 site in Canada |
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Related Papers Related Patents Related Grants Related Experts
All trials for Cardiovascular (CV) Risk All trials for Metabolic Health All trials of Cardiovascular risk screening All trials of Follow-up of cardiovascular risk factors
-Summary
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.
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+Detailed description
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:
* Clinical examination including anthropometric measurements;
* Auscultation by a cardiologist with a digital stethoscope;
* Translated and validated questionnaires on demographics and medical history;
* Pregnancy and reproductive health questionnaires;
* Blood pressure, assessed by oscillometry;
* Peripheral artery disease assessment;
* Cardiometabolic blood markers (NT-proBNP, HbA1C, hs-CRP, CBC, lipids, etc.)
* Arrythmia and atrial fibrillation, assessed by electrocardiogram;
* Anthropometric indices and body fat distribution by elastography;
* Maximal stress test on a treadmill;
* Questionnaire on participant satisfaction and areas of improvement in health equity.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Preventive care | Other | Other: Cardiovascular risk screening; Other: Follow-up of cardiovascular risk factors | |
- Cardiovascular risk screening (Other): Extensive cardiovascular risk screening offered locally in underserved/ underrepresented communities (see Study Description for more details)
- Follow-up of cardiovascular risk factors (Other): Measure changes in cardiovascular risk factors among participants who took place in the screening phase.
+Outcome measures
Primary outcomes
- Height in meters [Once, at baseline.]: Measured using a stadiometer
- Weight in kilograms [At baseline and at 1 year]: Measured using an electronic body scale
- Body mass index in kg/(m^2) [At baseline and at 1 year]: BMI will be calculated by dividing the weight in kilograms by the square of the height in meters
- Waist circumference in centimeters [At baseline and at 1 year]: Waist circumference will be measured using an ergonomic circumference measuring tape
- Blood pressure [At baseline and at one-year follow-up]: In mm Hg, using a digital blood pressure device
- Lipid profile [At baseline and at one-year follow-up]: Assessment of hypercholesterolemia (LDL-C, HDL-C, triglycerides, non-HDL-C in mmol/L) and apoB levels in g/L.
- Physical activity measure [At baseline and at one-year follow-up]: Using the International Physical Activity Questionnaire (IPAQ)
- Glycated hemoglobin (HbA1c) [At baseline and at one-year follow-up]: Blood test, expressed as %
- Dietary habits [At baseline and at one-year follow-up]: Frequency of intake per month of fruits, vegetables, whole grains, lean proteins, saturated fats and added sugars, using the Canadian Food Intake Screener.
- Smoking habits [At baseline and at one-year follow-up]: Self-reported smoking habits as current smoker, former smoker or never smoked, as well as frequency of smoking
- Framingham risk score [At baseline and at one-year follow-up]: Estimated 10-year cardiovascular risk, expressed as a percentage (%)
Secondary outcomes
- Participant feedback on intervention [At baseline and at one-year follow-up]: Questionnaire on participant satisfaction and areas of improvement in health equity.
Other outcomes
- Body fat distribution [At baseline]: Percentage and kilograms, using a electrical bioimpedance device
- Liver fat content [At baseline]: Measured with liver elastography
- Arterial stiffness [At baseline]: Measured by pulse wave velocity
+Eligibility
Sex: All, ages: 35 Years to 65 Years, accepts healthy volunteers
Inclusion Criteria:
* BMI > 27 kg/m\^2
Exclusion Criteria:
* Being pregnant;
* Known heart condition
+Locations (1)
| Facility | City | Country | Status |
|---|
| IUCPQ-ULaval | Québec, Quebec | Canada | Recruiting |
+Publications
- Lajeunesse-Trempe F, Boit MK, Kaduka LU, De Lucia-Rolfe E, Baass A, Paquette M, Piche ME, Tchernof A, Christensen DL. Validation of the Fatty Liver Index for identifying non-alcoholic fatty liver disease in a Kenyan population. Trop Med Int Health. 2023 Oct;28(10):830-838. doi: 10.1111/tmi.13927. Epub 2023 Aug 31. PMID 37650501
- Leveille N, Provost H, Keutcha Kamani C, Chen M, Deghan Manshadi S, Ades M, Shanahan K, Nauche B, Drudi LM. Exploring Prognostic Implications of Race and Ethnicity in Patients With Peripheral Arterial Disease. J Surg Res. 2024 Oct;302:739-754. doi: 10.1016/j.jss.2024.07.120. Epub 2024 Aug 30. PMID 39216457
- Lajeunesse-Trempe F, Piche ME, Kaduka L, Lopez Y Taylor JR, Sagastume RC. Moving from helicopter research to proximity research and capacity building. Trends Endocrinol Metab. 2025 Mar;36(3):193-195. doi: 10.1016/j.tem.2024.08.011. Epub 2024 Oct 1. PMID 39358160
- Lane-Cordova AD, Khan SS, Grobman WA, Greenland P, Shah SJ. Long-Term Cardiovascular Risks Associated With Adverse Pregnancy Outcomes: JACC Review Topic of the Week. J Am Coll Cardiol. 2019 Apr 30;73(16):2106-2116. doi: 10.1016/j.jacc.2018.12.092. PMID 31023435
- Powell-Wiley TM, Poirier P, Burke LE, Despres JP, Gordon-Larsen P, Lavie CJ, Lear SA, Ndumele CE, Neeland IJ, Sanders P, St-Onge MP; American Heart Association Council on Lifestyle and Cardiometabolic Health; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Epidemiology and Prevention; and Stroke Council. Obesity and Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2021 May 25;143(21):e984-e1010. doi: 10.1161/CIR.0000000000000973. Epub 2021 Apr 22. PMID 33882682
- Norris CM, Yip CYY, Nerenberg KA, Clavel MA, Pacheco C, Foulds HJA, Hardy M, Gonsalves CA, Jaffer S, Parry M, Colella TJF, Dhukai A, Grewal J, Price JAD, Levinsson ALE, Hart D, Harvey PJ, Van Spall HGC, Sarfi H, Sedlak TL, Ahmed SB, Baer C, Coutinho T, Edwards JD, Green CR, Kirkham AA, Srivaratharajah K, Dumanski S, Keeping-Burke L, Lappa N, Reid RD, Robert H, Smith G, Martin-Rhee M, Mulvagh SL. State of the Science in Women's Cardiovascular Disease: A Canadian Perspective on the Influence of Sex and Gender. J Am Heart Assoc. 2020 Feb 18;9(4):e015634. doi: 10.1161/JAHA.119.015634. Epub 2020 Feb 17. No abstract available. PMID 32063119
- Reading J. Confronting the Growing Crisis of Cardiovascular Disease and Heart Health Among Aboriginal Peoples in Canada. Can J Cardiol. 2015 Sep;31(9):1077-80. doi: 10.1016/j.cjca.2015.06.012. Epub 2015 Jun 21. PMID 26321431
- Piche ME, Tchernof A, Despres JP. Obesity Phenotypes, Diabetes, and Cardiovascular Diseases. Circ Res. 2020 May 22;126(11):1477-1500. doi: 10.1161/CIRCRESAHA.120.316101. Epub 2020 May 21. PMID 32437302
- Aziz H, Marchand M, Pop C, King A, Anand SS, Arbour L, Atzema C, Spaziano M, Merveille N, Filimon S, Poirier P, Huynh T. A Call to Action: Optimizing Indigenous Cardiovascular Health in Canada. Can J Cardiol. 2022 Oct;38(10):1584-1587. doi: 10.1016/j.cjca.2022.06.011. Epub 2022 Jun 16. No abstract available. PMID 35718241
- Lajeunesse-Trempe F, Piche ME, Poirier P, Tchernof A, Ayotte P. Adiposity Phenotypes and Associated Cardiometabolic Risk Profile in the Inuit Population of Nunavik. Nutrients. 2024 Mar 2;16(5):725. doi: 10.3390/nu16050725. PMID 38474854
- Anand SS, Abonyi S, Arbour L, Balasubramanian K, Brook J, Castleden H, Chrisjohn V, Cornelius I, Davis AD, Desai D, de Souza RJ, Friedrich MG, Harris S, Irvine J, L'Hommecourt J, Littlechild R, Mayotte L, McIntosh S, Morrison J, Oster RT, Picard M; Pictou Landing First Nation; Poirier P, Schulze KM, Toth EL; Canadian Alliance for Healthy Hearts and Minds First Nations Research Group. Explaining the variability in cardiovascular risk factors among First Nations communities in Canada: a population-based study. Lancet Planet Health. 2019 Dec;3(12):e511-e520. doi: 10.1016/S2542-5196(19)30237-2. PMID 31868600