- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06100224
Piloting a Healthy Aging Cohort in Manitoba (PACMan)
Piloting a Healthy Aging Cohort in Manitoba - PACMan
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R2V 3M3
- Seven Oaks Hospital Chronic Disease Innovation Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals, aged 30 years or older at the time of signing the informed consent
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health History
Time Frame: At baseline and Year 1
|
Collected using the Chronic Conditions, Health History and Facility Usage Questionnaire and the Family Medical History Questionnaire
|
At baseline and Year 1
|
|
Fitness Level
Time Frame: At baseline and Year 1
|
Measured by volitional oxygen intake, otherwise known as VO2 max, using the Ebbeling Treadmill Test (a submaximal walking test)
|
At baseline and Year 1
|
|
Diet
Time Frame: At Baseline and Year 1
|
Measured using the Mindful Eating Questionnaire and the 3 Factor Eating Questionnaire
|
At Baseline and Year 1
|
|
Dietary Intake
Time Frame: At Baseline and Year 1
|
The RxFood App will be used to measure dietary intake over 3 full days.
|
At Baseline and Year 1
|
|
Physical Activity
Time Frame: At Baseline and Year 1
|
Measured using the International Physical Activity Questionnaire - Short form (IPAQ-S)
|
At Baseline and Year 1
|
|
Physical Activity Assessment
Time Frame: At Baseline and 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.
|
At Baseline and Year 1
|
|
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.
|
At Baseline and Year 1
|
|
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.
|
At Baseline and Year 1
|
|
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.
|
At Baseline and Year 1
|
|
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.
|
At Baseline and Year 1
|
|
Body Weight
Time Frame: At Baseline and Year 1
|
Body weight will be measured.
|
At Baseline and Year 1
|
|
Body Mass Index (BMI)
Time Frame: At Baseline and Year 1
|
Body Mass Index will be measured
|
At Baseline and Year 1
|
|
Waist circumference
Time Frame: At Baseline and Year 1
|
Waist circumference will be measured
|
At Baseline and Year 1
|
|
Blood Pressure
Time Frame: At Baseline and Year 1
|
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 Year 1
|
|
Frailty
Time Frame: At Baseline and Year 1
|
The Short Physical Performance Battery (balance test, gait speed, and chair stand) and handgrip strength with be collected to measure frailty.
|
At Baseline and Year 1
|
|
Facility Usage
Time Frame: At Baseline and 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.
|
At Baseline and Year 1
|
|
Cholesterol
Time Frame: At Baseline and Year 1
|
Total cholesterol, HDL-C, LDL-C, triglycerides, total cholesterol/HDL ratio
|
At Baseline and Year 1
|
|
HbA1c
Time Frame: At Baseline and Year 1
|
Hemoglobin A1C
|
At Baseline and Year 1
|
|
eGFR
Time Frame: At Baseline and Year 1
|
Estimated glomerular filtration rate.
|
At Baseline and Year 1
|
|
uACR
Time Frame: At Baseline and Year 1
|
Urine albumin to creatinine ratio
|
At Baseline and Year 1
|
|
10-Year Risk of Cardiovascular Disease
Time Frame: At Baseline and Year 1
|
Measured using the Framingham Risk Score
|
At Baseline and Year 1
|
|
Cardiovascular Assessment
Time Frame: At Baseline and Year 1
|
Identification of Metabolic Syndrome and the Framingham Risk Score will be measured.
|
At Baseline and Year 1
|
|
Body Composition
Time Frame: At Baseline and 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.
|
At Baseline and Year 1
|
|
Social Determinants of Health
Time Frame: At Baseline and Year 1
|
Access to general medical and dental care, postal code, household income, education level and marital status will be collected.
|
At Baseline and Year 1
|
|
Wellbeing - Quality of Life
Time Frame: At Baseline and Year 1
|
the EQ-5D-5L will be collected to measure quality of life.
|
At Baseline and Year 1
|
|
Wellbeing - Loneliness
Time Frame: At Baseline and Year 1
|
The UCLA Loneliness Scale will be sued to measure loneliness.
|
At Baseline and Year 1
|
|
Wellbeing - Life Satisfaction
Time Frame: At Baseline and Year 1
|
The Satisfaction With Life Scale will be used to measure life satisfaction
|
At Baseline and Year 1
|
|
Wellbeing - Self-efficacy
Time Frame: At Baseline and Year 1
|
The Multidimensional Health Locus of Control (MHLC) Scale Form A will be used to measure self-efficacy
|
At Baseline and Year 1
|
|
Wellbeing - Depression
Time Frame: At Baseline and Year 1
|
The Center for Epidemiologic Studies Short Depression Scale (CES-D-10) will be used to measure depression
|
At Baseline and Year 1
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Claudio Rigatto, MD, University of Manitoba
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 3566 / HS25790 (H2022:393)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.