Clinical trial NCT06100224: Piloting a Healthy Aging Cohort in Manitoba
Official title: Piloting a Healthy Aging Cohort in Manitoba - PACMan
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Healthy Aging
Keywords: Medical fitness facility
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Seven Oaks Hospital Chronic Disease Innovation Centre
name: The Wellness Institute Powered by Seven Oaks General Hospital
name: Medical Fitness Association
First posted: 2023-10-25
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from individuals that attend The Wellness Institute. This study is a pilot so will only recruit a total of 20 participants.

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 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.

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

Primary outcomes:
measure: Health History
timeFrame: At baseline
measure: Fitness Level
timeFrame: At baseline
measure: Diet
timeFrame: At baseline
measure: Dietary Intake
timeFrame: At baseline
measure: Physical Activity
timeFrame: At Baseline
measure: Physical Activity Assessment
timeFrame: At baseline
measure: Sleep Quality Assessment
timeFrame: At baseline
measure: Sleep Assessment
timeFrame: At baseline
measure: Stress
timeFrame: At baseline
measure: Cognition Assessment
timeFrame: At baseline
measure: Body Weight
timeFrame: At baseline
measure: Body Mass Index (BMI)
timeFrame: At baseline
measure: Waist circumference
timeFrame: At baseline
measure: Blood Pressure
timeFrame: At baseline
measure: Frailty
timeFrame: At baseline
measure: Facility Usage
timeFrame: At baseline
measure: Cholesterol
timeFrame: At baseline
measure: HbA1c
timeFrame: At baseline
measure: eGFR
timeFrame: At baseline
measure: uACR
timeFrame: At baseline
measure: Urinalysis
timeFrame: At baseline
measure: 10-Year Risk of Cardiovascular Disease
timeFrame: At baseline
measure: Cardiovascular Assessment
timeFrame: At baseline
measure: Body Composition
timeFrame: At baseline
measure: Social Determinants of Health
timeFrame: At baseline
measure: Wellbeing - Quality of Life
timeFrame: At baseline
measure: Wellbeing - Loneliness
timeFrame: At baseline
measure: Wellbeing - Life Satisfaction
timeFrame: At baseline
measure: Wellbeing - Self-efficacy
timeFrame: At baseline
measure: Wellbeing - Depression
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Seven Oaks Hospital Chronic Disease Innovation Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Clara Bohm, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: