Piloting a Healthy Aging Cohort in Manitoba - PACMan
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Health History
研究概览
简要总结
The purpose of this study is to set up and pilot baseline and year 1 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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Female participant who is pregnant or lactating
- •Employees of the Wellness Institute
- •Involvement in the planning and/or conduct of the study
结局指标
主要结局
Health History
时间窗: At baseline an Year 1
Collected using the Chronic Conditions, Health History and Facility Usage Questionnaire and the Family Medical History Questionnaire
Waist circumference
时间窗: At baseline and at Year 1
Waist circumference will be measured
Fitness Level
时间窗: 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
时间窗: At baseline an Year 1
Measured using the Mindful Eating Questionnaire and the 3 Factor Eating Questionnaire
Dietary Intake
时间窗: At baseline an Year 1
The RxFood App will be used to measure dietary intake over 3 full days.
Physical Activity
时间窗: At baseline an Year 1
Measured using the International Physical Activity Questionnaire - Short form (IPAQ-S)
Physical Activity Assessment
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: At baseline and at Year 1
Body weight will be measured.
Body Mass Index (BMI)
时间窗: At baseline and at Year 1
Body Mass Index will be measured
Blood Pressure
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: At baseline and at Year 1
Total cholesterol, HDL-C, LDL-C, triglycerides, total cholesterol/HDL ratio
HbA1c
时间窗: At baseline and at Year 1
Hemoglobin A1C
eGFR
时间窗: At baseline and at Year 1
Estimated glomerular filtration rate.
uACR
时间窗: At baseline and at Year 1
Urine albumin to creatinine ratio
10-Year Risk of Cardiovascular Disease
时间窗: At baseline and at Year 1
Measured using the Framingham Risk Score
Cardiovascular Assessment
时间窗: At baseline and at Year 1
Identification of Metabolic Syndrome and the Framingham Risk Score will be measured.
Body Composition
时间窗: 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
时间窗: 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
时间窗: At baseline and at Year 1
the EQ-5D-5L will be collected to measure quality of life.
Wellbeing - Loneliness
时间窗: At baseline and at Year 1
The UCLA Loneliness Scale will be sued to measure loneliness.
Wellbeing - Life Satisfaction
时间窗: At baseline and at Year 1
The Satisfaction With Life Scale will be used to measure life satisfaction
Wellbeing - Self-efficacy
时间窗: 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
时间窗: At baseline and at Year 1
The Center for Epidemiologic Studies Short Depression Scale (CES-D-10) will be used to measure depression
次要结局
未报告次要终点
研究者
Claudio Rigatto
Professor of Medicine, Nephrologist
University of Manitoba