NCT07869069

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
42mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Feb 2026Mar 2030

Study Start

First participant enrolled

February 11, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2026

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2030

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

3.1 years

First QC Date

February 24, 2026

Last Update Submit

October 6, 2026

Conditions

Keywords

Cardiovascular DiseaseCardiovascular-Kidnay-Metabolic HealthCommunity-Driven AND Culturally Safe Care and ResearchDiabetesHealth Equity and InclusivityIndigenous HealthMobile Healthcare UnitPreventive CareSocial Determinants of HealthWomen's Health

Outcome Measures

Primary Outcomes (11)

  • Height in meters

    Measured using a stadiometer

    Once, at baseline.

  • Weight in kilograms

    Measured using an electronic body scale

    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

    At baseline and at 1 year

  • Waist circumference in centimeters

    Waist circumference will be measured using an ergonomic circumference measuring tape

    At baseline and at 1 year

  • Blood pressure

    In mm Hg, using a digital blood pressure device

    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.

    At baseline and at one-year follow-up

  • Physical activity measure

    Using the International Physical Activity Questionnaire (IPAQ)

    At baseline and at one-year follow-up

  • Glycated hemoglobin (HbA1c)

    Blood test, expressed as %

    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.

    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

    At baseline and at one-year follow-up

  • Framingham risk score

    Estimated 10-year cardiovascular risk, expressed as a percentage (%)

    At baseline and at one-year follow-up

Secondary Outcomes (1)

  • Participant feedback on intervention

    At baseline and at one-year follow-up

Other Outcomes (3)

  • Body fat distribution

    At baseline

  • Liver fat content

    At baseline

  • Arterial stiffness

    At baseline

Study Arms (1)

Preventive care

OTHER
Other: Cardiovascular risk screeningOther: Follow-up of cardiovascular risk factors

Interventions

Extensive cardiovascular risk screening offered locally in underserved/ underrepresented communities (see Study Description for more details)

Preventive care

Measure changes in cardiovascular risk factors among participants who took place in the screening phase.

Preventive care

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 27 kg/m\^2

You may not qualify if:

  • Being pregnant;
  • Known heart condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IUCPQ-ULaval

Québec, Quebec, Canada

RECRUITING

Related Publications (11)

  • 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: 37650501BACKGROUND
  • 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: 39216457BACKGROUND
  • 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: 39358160BACKGROUND
  • 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: 31023435BACKGROUND
  • 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: 33882682BACKGROUND
  • 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: 32063119BACKGROUND
  • 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: 26321431BACKGROUND
  • 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: 32437302BACKGROUND
  • 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: 35718241BACKGROUND
  • 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: 38474854BACKGROUND
  • 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: 31868600BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical physician and associate professor

Study Record Dates

First Submitted

February 24, 2026

First Posted

October 9, 2026

Study Start

February 11, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2030

Last Updated

October 9, 2026

Record last verified: 2026-10

Locations