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Clinical Trials/NCT06100224
NCT06100224
Recruiting
Not Applicable

Piloting a Healthy Aging Cohort in Manitoba - PACMan

University of Manitoba1 site in 1 country100 target enrollmentApril 1, 2024
ConditionsHealthy Aging

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Aging
Sponsor
University of Manitoba
Enrollment
100
Locations
1
Primary Endpoint
Health History
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Detailed Description

This project will cover the set-up, development, and user-testing of the baseline visit data collection in the first 100 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.

Registry
clinicaltrials.gov
Start Date
April 1, 2024
End Date
May 1, 2026
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Claudio Rigatto

Professor of Medicine, Nephrologist

University of Manitoba

Eligibility Criteria

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
  • Employees of the Wellness Institute
  • Involvement in the planning and/or conduct of the study

Outcomes

Primary Outcomes

Health History

Time Frame: At baseline an Year 1

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

Waist circumference

Time Frame: At baseline and at Year 1

Waist circumference will be measured

Fitness Level

Time Frame: At baseline an Year 1

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

Diet

Time Frame: At baseline an Year 1

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

Dietary Intake

Time Frame: At baseline an Year 1

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

Physical Activity

Time Frame: At baseline an Year 1

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

Physical Activity Assessment

Time Frame: At baseline an Year 1

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

Sleep Quality Assessment

Time Frame: At baseline and Year 1

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.

Sleep Assessment

Time Frame: At baseline and Year 1

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.

Stress

Time Frame: At baseline and Year 1

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

Cognition Assessment

Time Frame: At baseline and Year 1

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

Body Weight

Time Frame: At baseline and at Year 1

Body weight will be measured.

Body Mass Index (BMI)

Time Frame: At baseline and at Year 1

Body Mass Index will be measured

Blood Pressure

Time Frame: At baseline and at Year 1

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

Frailty

Time Frame: At baseline and at Year 1

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

Facility Usage

Time Frame: At baseline and at Year 1

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.

Cholesterol

Time Frame: At baseline and at Year 1

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

HbA1c

Time Frame: At baseline and at Year 1

Hemoglobin A1C

eGFR

Time Frame: At baseline and at Year 1

Estimated glomerular filtration rate.

uACR

Time Frame: At baseline and at Year 1

Urine albumin to creatinine ratio

10-Year Risk of Cardiovascular Disease

Time Frame: At baseline and at Year 1

Measured using the Framingham Risk Score

Cardiovascular Assessment

Time Frame: At baseline and at Year 1

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

Body Composition

Time Frame: At baseline and at Year 1

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.

Social Determinants of Health

Time Frame: At baseline and at Year 1

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

Wellbeing - Quality of Life

Time Frame: At baseline and at Year 1

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

Wellbeing - Loneliness

Time Frame: At baseline and at Year 1

The UCLA Loneliness Scale will be sued to measure loneliness.

Wellbeing - Life Satisfaction

Time Frame: At baseline and at Year 1

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

Wellbeing - Self-efficacy

Time Frame: At baseline and at Year 1

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

Wellbeing - Depression

Time Frame: At baseline and at Year 1

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

Study Sites (1)

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