Piloting a Healthy Aging Cohort in Manitoba

Healthy Aging Clinical Trial

— PACMan  

Official title:

Piloting a Healthy Aging Cohort in Manitoba - PACMan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06100224
• Other study ID #: HS25790 (H2022:393)
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: June 2024

Study information

• Verified date: June 2024
• Source: University of Manitoba
• Contact: Kathy Cherepak, BSc
• Phone: 204-632-3541
• Email: kcherepak[@]sogh.mb.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Aging

Locations

Country	Name	City	State
Canada	Seven Oaks Hospital Chronic Disease Innovation Centre	Winnipeg	Manitoba

Sponsors (4)

Lead Sponsor	Collaborator
University of Manitoba	Medical Fitness Association, Seven Oaks Hospital Chronic Disease Innovation Centre, The Wellness Institute Powered by Seven Oaks General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health History	Collected using the PACMan Health History and Facility Usage Questionnaire	At baseline
Primary	Fitness Level	Measured by volitional oxygen intake, otherwise known as VO2 max, using the Ebbeling Treadmill Test (a submaximal walking test)	At baseline
Primary	Diet	Measured using the Mindful Eating Questionnaire and the 3 Factor Eating Questionnaire	At baseline
Primary	Dietary Intake	The RxFood App will be used to measure dietary intake over 3 full days.	At baseline
Primary	Physical Activity	Measured using the International Physical Activity Questionnaire - Long form (IPAQ-L)	At Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Cognition Assessment	The Montreal Cognitive Assessment Score (MoCA) will be used to give insight into how participants mentally process information.	At baseline
Primary	Body Weight	Body weight will be measured.	At baseline
Primary	Body Mass Index (BMI)	Body Mass Index will be measured	At baseline
Primary	Waist circumference	Waist circumference will be measured	At baseline
Primary	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
Primary	Frailty	The Short Physical Performance Battery (balance test, gait speed, and chair stand) and handgrip strength with be collected to measure frailty.	At baseline
Primary	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
Primary	Cholesterol	Total cholesterol, HDL-C, LDL-C, triglycerides, total cholesterol/HDL ratio	At baseline
Primary	HbA1c	Hemoglobin A1C	At baseline
Primary	eGFR	Estimated glomerular filtration rate.	At baseline
Primary	uACR	Urine albumin to creatinine ratio	At baseline
Primary	Urinalysis	Dipstick urinalysis will be measured	At baseline
Primary	10-Year Risk of Cardiovascular Disease	Measured using the Framingham Risk Score	At baseline
Primary	Cardiovascular Assessment	Identification of Metabolic Syndrome and the Framingham Risk Score will be measured.	At baseline
Primary	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
Primary	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
Primary	Wellbeing - Quality of Life	the EQ-5D-5L will be collected to measure quality of life.	At baseline
Primary	Wellbeing - Loneliness	The UCLA Loneliness Scale will be sued to measure loneliness.	At baseline
Primary	Wellbeing - Life Satisfaction	The Satisfaction With Life Scale will be used to measure life satisfaction	At baseline
Primary	Wellbeing - Self-efficacy	The Multidimensional Health Locus of Control (MHLC) Scale Form A will be used to measure self-efficacy	At baseline
Primary	Wellbeing - Depression	The Center for Epidemiologic Studies Short Depression Scale (CES-D-10) will be used to measure depression	At baseline