- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02337075
PAthway To Health (PATH): Fostering Culturally Appropriate Physical Activities in Indigenous Communities (PATH)
PAthway To Health (PATH): Fostering Culturally Appropriate Physical Activities Using Digital Technology in Indigenous Communities
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Promoting an active lifestyle is a priority identified by the communities served by KDC Health. Statistics Canada estimates obesity in one in four adults based on 2007-2009 data, with higher prevalence among Indigenous people compared to non-Aboriginal population (between 26% and 36% among adults living off-reserve and on-reserve, respectively). Furthermore, Indigenous people also report higher prevalence of obesity associated complications, including diabetes, cardiovascular disease, and arthritis. The association between physical inactivity and obesity suggests that increasing physical activity is important.
KDC Health offers a variety of free programs to community members, however, the use of these services has been low. KDC Health has previously partnered with the CIHR-funded IMPAKT project, and has expressed a strong interest in developing an intervention to improve health and wellness in the communities.
Objectives:
- To determine whether the PATH program can improve physical activity participation in the communities served by KDC Health.
- To assess the effect of this program on reducing sedentary time, and increasing the use of health promotion and wellness services offered by KDC Health
- To assess the correlation of physical activity levels and the secondary outcome measures among individuals who are living in the same household.
Methods: The investigators will conduct a community-based proof-of-concept randomized controlled trial (RCT) with 60 eligible participants. Only 1 member per household will be enrolled. If more than 1 member is interested, they will select 1 person by consensus or by a random draw.
After obtaining the baseline measures, participants will be randomly assigned to the 'Now Group' (target=30) or 'Later Group' (target=30).
The Now Group will participate in a brief education session held at the KDC Health Centre, use a wearable physical activity tracker (Fitbit Flex), and physical activity mentoring by a KDC Health Staff (the Activity Mentors). The Activity Mentors have received training for the project from the Principal Investigator. In Month 1-2, participants will meet with their Activity Mentor once every 2 weeks to review their physical activity status, activity goals, and the health programs available at the Centre. In Month 3-4, they will continue to use Fitbit Flex but will no longer have regular meetings with the Activity Mentor.
The Later Group will receive intervention two months later (i.e., Month 3-4).
The primary outcome measure will be the time spent in moderate/vigorous physical activity. In addition, time spent in sedentary behaviours will be recorded. Participants will wear a SenseWear Mini accelerometer for 7 days at baseline, 2 months, and 4 months. Secondary outcome measures include sedentary time measured with SenseWear Mini, health status that will be measured using the SF-36 (a generic measure of health-related quality of life), and body weight. Participants' use of KDC Health programs and their motivation to be physically active will also be recorded.
At the end of the program, participants will be interviewed for 30 minutes in person about their opinion on the intervention. Interviews will focus on 1) barriers/facilitators to being physically active, 2) their experience with the intervention, and 3) the nature of activities they engage in.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Richmond, British Columbia, Canada, V6X 2C7
- Arthritis Research Canada
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Participants are eligible if they:
- Are a person from KDC Health Member Nations
- Are 19 years or older
- Have no health condition that prevents them from being physically active
- Are able to participate in a 4-month project -
Exclusion Criteria: Participants are not eligible to participate if they:
- Do not meet the criteria above
- Use medication that may impair activity tolerance (e.g., beta blockers),
- Are unable to provide informed consent -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Now Group - PATH Program
The Now Group will receive the PATH program.
They will participate in a brief education session, use a wearable physical activity tracker, and physical activity mentoring by an Activity Mentors.
In Month 1 and 2, participants will meet with their Activity Mentor once every 2 weeks to review their physical activity status, activity goals, and the health programs available at the Centre.
In Month 3 and 4, they will continue to use physical activity tracker but will no longer have regular meetings with the Activity Mentor.
|
A brief education session, use of a wearable physical activity tracker, and physical activity mentoring by an Activity Mentor every 2 weeks.
|
Active Comparator: Later Group
The Later Group will receive the PATH program in Month 1-2.
Intervention will be provided two months later (i.e., Month 3 and 4).
|
A brief education session, use of a wearable physical activity tracker, and physical activity mentoring by an Activity Mentor every 2 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time spent in Moderate to Vigorous Physical Activity (MVPA), measured by SenseWear Mini accelerometer
Time Frame: Change from baseline in Time spent in MVPA at 2 months and 4 months
|
Participants will wear a SenseWear Mini accelerometer for 7 days at baseline, and Months 2 and 4.
|
Change from baseline in Time spent in MVPA at 2 months and 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time spent in sedentary behaviours, measured by SenseWear Mini accelerometer
Time Frame: Change from baseline in time spent in sedentary behaviours at 2 months and 4 months
|
Participants will wear a SenseWear Mini accelerometer for 7 days at baseline, and Months 2 and 4.
|
Change from baseline in time spent in sedentary behaviours at 2 months and 4 months
|
Change in Health Status, measured by SF-36 Questionnaire
Time Frame: Change from baseline health status at 2 months and 4 months
|
SF-36 Questionnaire
|
Change from baseline health status at 2 months and 4 months
|
Change in Body weight, measured by measured with a calibrated scale
Time Frame: Change from baseline body weight at 2 months and 4 months
|
Measured with a calibrated scale
|
Change from baseline body weight at 2 months and 4 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Linda Li, PT, PhD, Arthritis Research Canada
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
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
- H12-02526
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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