NCT06100224

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

2.1 years

First QC Date

October 20, 2023

Last Update Submit

November 21, 2025

Conditions

Keywords

Medical fitness facility

Outcome Measures

Primary Outcomes (29)

  • Health History

    Collected using the Chronic Conditions, Health History and Facility Usage Questionnaire and the Family Medical History Questionnaire

    At baseline an Year 1

  • Fitness Level

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

    At baseline an Year 1

  • Diet

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

    At baseline an Year 1

  • Dietary Intake

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

    At baseline an Year 1

  • Physical Activity

    Measured using the International Physical Activity Questionnaire - Short form (IPAQ-S)

    At baseline an Year 1

  • Physical Activity Assessment

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

    At baseline an Year 1

  • Sleep Quality Assessment

    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.

    At baseline and Year 1

  • Sleep Assessment

    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.

    At baseline and Year 1

  • Stress

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

    At baseline and Year 1

  • Cognition Assessment

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

    At baseline and Year 1

  • Body Weight

    Body weight will be measured.

    At baseline and at Year 1

  • Body Mass Index (BMI)

    Body Mass Index will be measured

    At baseline and at Year 1

  • Waist circumference

    Waist circumference will be measured

    At baseline and at Year 1

  • Blood Pressure

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

    At baseline and at Year 1

  • Frailty

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

    At baseline and at Year 1

  • Facility Usage

    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.

    At baseline and at Year 1

  • Cholesterol

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

    At baseline and at Year 1

  • HbA1c

    Hemoglobin A1C

    At baseline and at Year 1

  • eGFR

    Estimated glomerular filtration rate.

    At baseline and at Year 1

  • uACR

    Urine albumin to creatinine ratio

    At baseline and at Year 1

  • 10-Year Risk of Cardiovascular Disease

    Measured using the Framingham Risk Score

    At baseline and at Year 1

  • Cardiovascular Assessment

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

    At baseline and at Year 1

  • Body Composition

    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.

    At baseline and at Year 1

  • Social Determinants of Health

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

    At baseline and at Year 1

  • Wellbeing - Quality of Life

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

    At baseline and at Year 1

  • Wellbeing - Loneliness

    The UCLA Loneliness Scale will be sued to measure loneliness.

    At baseline and at Year 1

  • Wellbeing - Life Satisfaction

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

    At baseline and at Year 1

  • Wellbeing - Self-efficacy

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

    At baseline and at Year 1

  • Wellbeing - Depression

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

    At baseline and at Year 1

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from individuals that attend The Wellness Institute. This study is a pilot with the number of recruited participants set as the initial 20 plus an additional anticipated 80, totaling 100 participants.

You may qualify if:

  • 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.

You may not qualify if:

  • Female participant who is pregnant or lactating
  • Employees of the Wellness Institute
  • Involvement in the planning and/or conduct of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seven Oaks Hospital Chronic Disease Innovation Centre

Winnipeg, Manitoba, R2V 3M3, Canada

RECRUITING

Study Officials

  • Claudio Rigatto, MD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathy Cherepak, BSc

CONTACT

Claudio Rigatto, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Nephrologist

Study Record Dates

First Submitted

October 20, 2023

First Posted

October 25, 2023

Study Start

April 1, 2024

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

November 28, 2025

Record last verified: 2025-11

Locations