- 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 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Clara Bohm, MD, MPH
- Phone Number: 204-631-3834
- Email: cbohm@sogh.mb.ca
Study Contact Backup
- Name: Kathy Cherepak, BSc
- Phone Number: 204-632-3541
- Email: kcherepak@sogh.mb.ca
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R2V 3M3
- Seven Oaks Hospital Chronic Disease Innovation Centre
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Contact:
- Clara Bohm, MD, MPH
- Phone Number: 204-631-3834
- Email: cbohm@sogh.mb.ca
-
Principal Investigator:
- Clara Bohm, MD, MPH
-
Contact:
- Kathy Cherepak, B.Sc.
- Phone Number: 204-632-3541
- Email: kcherepak@sogh.mb.ca
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Principal Investigator:
- Claudio Rigatto, MD, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
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
|
Collected using the PACMan Health History and Facility Usage Questionnaire
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At baseline
|
Fitness Level
Time Frame: At baseline
|
Measured by volitional oxygen intake, otherwise known as VO2 max, using the Ebbeling Treadmill Test (a submaximal walking test)
|
At baseline
|
Diet
Time Frame: At baseline
|
Measured using the Mindful Eating Questionnaire and the 3 Factor Eating Questionnaire
|
At baseline
|
Dietary Intake
Time Frame: At baseline
|
The RxFood App will be used to measure dietary intake over 3 full days.
|
At baseline
|
Physical Activity
Time Frame: At Baseline
|
Measured using the International Physical Activity Questionnaire - Long form (IPAQ-L)
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At Baseline
|
Physical Activity Assessment
Time Frame: At baseline
|
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
|
Sleep Quality Assessment
Time Frame: At baseline
|
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
|
Sleep Assessment
Time Frame: At baseline
|
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
|
Stress
Time Frame: At baseline
|
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
|
Cognition Assessment
Time Frame: At baseline
|
The Montreal Cognitive Assessment Score (MoCA) will be used to give insight into how participants mentally process information.
|
At baseline
|
Body Weight
Time Frame: At baseline
|
Body weight will be measured.
|
At baseline
|
Body Mass Index (BMI)
Time Frame: At baseline
|
Body Mass Index will be measured
|
At baseline
|
Waist circumference
Time Frame: At baseline
|
Waist circumference will be measured
|
At baseline
|
Blood Pressure
Time Frame: At baseline
|
Blood pressure while awake, while asleep, and total will be measured using an ambulatory blood pressure monitor, worn for 3 consecutive days.
|
At baseline
|
Frailty
Time Frame: At baseline
|
The Short Physical Performance Battery (balance test, gait speed, and chair stand) and handgrip strength with be collected to measure frailty.
|
At baseline
|
Facility Usage
Time Frame: At baseline
|
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
|
Cholesterol
Time Frame: At baseline
|
Total cholesterol, HDL-C, LDL-C, triglycerides, total cholesterol/HDL ratio
|
At baseline
|
HbA1c
Time Frame: At baseline
|
Hemoglobin A1C
|
At baseline
|
eGFR
Time Frame: At baseline
|
Estimated glomerular filtration rate.
|
At baseline
|
uACR
Time Frame: At baseline
|
Urine albumin to creatinine ratio
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At baseline
|
Urinalysis
Time Frame: At baseline
|
Dipstick urinalysis will be measured
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At baseline
|
10-Year Risk of Cardiovascular Disease
Time Frame: At baseline
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Measured using the Framingham Risk Score
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At baseline
|
Cardiovascular Assessment
Time Frame: At baseline
|
Identification of Metabolic Syndrome and the Framingham Risk Score will be measured.
|
At baseline
|
Body Composition
Time Frame: At baseline
|
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
|
Social Determinants of Health
Time Frame: At baseline
|
Access to general medical and dental care, postal code, household income, education level and marital status will be collected.
|
At baseline
|
Wellbeing - Quality of Life
Time Frame: At baseline
|
the EQ-5D-5L will be collected to measure quality of life.
|
At baseline
|
Wellbeing - Loneliness
Time Frame: At baseline
|
The UCLA Loneliness Scale will be sued to measure loneliness.
|
At baseline
|
Wellbeing - Life Satisfaction
Time Frame: At baseline
|
The Satisfaction With Life Scale will be used to measure life satisfaction
|
At baseline
|
Wellbeing - Self-efficacy
Time Frame: At baseline
|
The Multidimensional Health Locus of Control (MHLC) Scale Form A will be used to measure self-efficacy
|
At baseline
|
Wellbeing - Depression
Time Frame: At baseline
|
The Center for Epidemiologic Studies Short Depression Scale (CES-D-10) will be used to measure depression
|
At baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Clara Bohm, MD, MPH, University of Manitoba
Study record dates
Study Major Dates
Study Start (Estimated)
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
- 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
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.
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