PACMan: Piloting a Healthy Aging Cohort in Manitoba

Sponsor
University of Manitoba (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06100224
Collaborator
Seven Oaks Hospital Chronic Disease Innovation Centre (Other), The Wellness Institute Powered by Seven Oaks General Hospital (Other), Medical Fitness Association (Other)
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Study Details

Study Description

Brief Summary

The purpose of this study is to set up and pilot baseline data collection for a prospective cohort designed to explore the relationships between medical fitness facility usage, lifestyle behaviours and health outcomes as individuals age. Additionally, this pilot study will set up the overall objectives for the larger, prospective cohort study using a public engagement participatory approach with public/patient partners involved in determining which healthy aging outcomes to include.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This project will cover the set-up, development, and user-testing of the baseline visit data collection in the first 20 participants. Data will be collected on physical activity, diet, sleep, stress, cognition, frailty, health history (including diabetes, alcohol and smoking), facility and program usage at the Wellness Institute (WI), height, weight, volitional oxygen intake (VO2 max), blood pressure, heart rate, clinical chemistry, urinalysis, body composition, social determinants of health, and wellbeing.

    Additionally, a public engagement participatory approach will be used to determine which healthy aging outcomes are important to study, including discussion on research priorities, research question, research design, data collection approaches, outcome measures, analysis of results, relevance of findings, and dissemination of findings. Therefore, this pilot project will include the formation of a project advisory group that will include public/patient partners. The advisory group members will discuss ideas around healthy aging and lifestyle and what outcomes are most important to them; and will provide information on the reasons for joining as well as the use of the medical fitness facility, any barriers they face and program needs. The project advisory group will be an integral part of this pilot project. The information obtained from the advisory group meetings and the pilot project will be used to develop the outcomes for the larger cohort study.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Piloting a Healthy Aging Cohort in Manitoba - PACMan
    Anticipated Study Start Date :
    Nov 1, 2023
    Anticipated Primary Completion Date :
    Mar 1, 2024
    Anticipated Study Completion Date :
    Mar 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Health History [At baseline]

      Collected using the PACMan Health History and Facility Usage Questionnaire

    2. Fitness Level [At baseline]

      Measured by volitional oxygen intake, otherwise known as VO2 max, using the Ebbeling Treadmill Test (a submaximal walking test)

    3. Diet [At baseline]

      Measured using the Mindful Eating Questionnaire and the 3 Factor Eating Questionnaire

    4. Dietary Intake [At baseline]

      The RxFood App will be used to measure dietary intake over 3 full days.

    5. Physical Activity [At Baseline]

      Measured using the International Physical Activity Questionnaire - Long form (IPAQ-L)

    6. Physical Activity Assessment [At baseline]

      An Actigraph activity monitor will be used to measure physical activity for 7 days, wtih participants asked to wear the monitor at all times.

    7. Sleep Quality Assessment [At baseline]

      Measured using the Pittsburgh Sleep Quality Index Questionnaire (PSQI), an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction.

    8. Sleep Assessment [At baseline]

      An ActiGraph activity monitor will be used to measure sleep quality patterns for 7 days, wtih participants asked to wear the monitor at all times, including when they sleep.

    9. Stress [At baseline]

      The Perceived Stress Questionnaire (PSQ) will be completed to assess stressful life events and circumstances that tend to trigger or exacerbate disease symptoms.

    10. Cognition Assessment [At baseline]

      The Montreal Cognitive Assessment Score (MoCA) will be used to give insight into how participants mentally process information.

    11. Body Weight [At baseline]

      Body weight will be measured.

    12. Body Mass Index (BMI) [At baseline]

      Body Mass Index will be measured

    13. Waist circumference [At baseline]

      Waist circumference will be measured

    14. Blood Pressure [At baseline]

      Blood pressure while awake, while asleep, and total will be measured using an ambulatory blood pressure monitor, worn for 3 consecutive days.

    15. Frailty [At baseline]

      The Short Physical Performance Battery (balance test, gait speed, and chair stand) and handgrip strength with be collected to measure frailty.

    16. Facility Usage [At baseline]

      Participants will complete a questionnaire on attendance in hours per week, and # of times per week, and specific program/facility usage at the Wellness Institute. The Wellness Institute swipe data will be used to record the number of times swiped per week and per month since joining.

    17. Cholesterol [At baseline]

      Total cholesterol, HDL-C, LDL-C, triglycerides, total cholesterol/HDL ratio

    18. HbA1c [At baseline]

      Hemoglobin A1C

    19. eGFR [At baseline]

      Estimated glomerular filtration rate.

    20. uACR [At baseline]

      Urine albumin to creatinine ratio

    21. Urinalysis [At baseline]

      Dipstick urinalysis will be measured

    22. 10-Year Risk of Cardiovascular Disease [At baseline]

      Measured using the Framingham Risk Score

    23. Cardiovascular Assessment [At baseline]

      Identification of Metabolic Syndrome and the Framingham Risk Score will be measured.

    24. Body Composition [At baseline]

      DEXA scan measurements including total mass, fat mass, lean mass, % fat, visceral adipose tissue, total body bone mineral density), and relative skeletal muscle index (RSMI) will be collected.

    25. Social Determinants of Health [At baseline]

      Access to general medical and dental care, postal code, household income, education level and marital status will be collected.

    26. Wellbeing - Quality of Life [At baseline]

      the EQ-5D-5L will be collected to measure quality of life.

    27. Wellbeing - Loneliness [At baseline]

      The UCLA Loneliness Scale will be sued to measure loneliness.

    28. Wellbeing - Life Satisfaction [At baseline]

      The Satisfaction With Life Scale will be used to measure life satisfaction

    29. Wellbeing - Self-efficacy [At baseline]

      The Multidimensional Health Locus of Control (MHLC) Scale Form A will be used to measure self-efficacy

    30. Wellbeing - Depression [At baseline]

      The Center for Epidemiologic Studies Short Depression Scale (CES-D-10) will be used to measure depression

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Male or female, aged 30 years or above.

    • Able to communicate in English and provide written informed consent

    • Current member of the Wellness Institute

    • Access to a device such as an android or iOS smartphone or tablet for use with the dietary tracking application.

    Exclusion Criteria:

    • Female participant who is pregnant or lactating

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seven Oaks Hospital Chronic Disease Innovation Centre Winnipeg Manitoba Canada R2V 3M3

    Sponsors and Collaborators

    • University of Manitoba
    • Seven Oaks Hospital Chronic Disease Innovation Centre
    • The Wellness Institute Powered by Seven Oaks General Hospital
    • Medical Fitness Association

    Investigators

    • Principal Investigator: Clara Bohm, MD, MPH, University of Manitoba

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clara Bohm, Associate Professor, Nephrologist, University of Manitoba
    ClinicalTrials.gov Identifier:
    NCT06100224
    Other Study ID Numbers:
    • HS25790 (H2022:393)
    First Posted:
    Oct 25, 2023
    Last Update Posted:
    Oct 25, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Clara Bohm, Associate Professor, Nephrologist, University of Manitoba

    Study Results

    No Results Posted as of Oct 25, 2023