Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2021-11-01
2022-03-31
Brief Summary
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Detailed Description
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Preparation phase objectives:
1.1 Determine which candidate components will be tested in a later optimization phase and at what dose they will be tested 1.2 Examine the feasibility of delivering the different components 1.3 Examine the acceptability of delivering the different components 1.4 Evaluate whether the outcomes can be feasibly measured
Design overview: A 2\^4 (2x2x2x2) factorial experiment will run in the next phase of this project to test all combinations of four candidate components "turned on and off" with 16 different conditions. In the present study, we will ask 16 participants to each participate in and evaluate one of the sixteen conditions. The four candidate components being tested are: Daily resting HRV biofeedback, Momentary HRV biofeedback, Behavioural initiation coaching, and Practice with feedback coaching. Additionally, all participants will be asked to use complete the 8-week health behaviour change and stress management program on the Core health mHealth platform. Participants will be randomized to completing one of the sixteen conditions while completing the eight-week CoreHealth program.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Condition 1
Core Health platform only
Core Health Program
8-week structured stress management and health behaviour change program
Condition 2
Core Health platform plus Practice with feedback coaching
Core Health Program
8-week structured stress management and health behaviour change program
Practice with feedback coaching
15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed
Condition 3
Core Health platform plus behavioural initiation coaching
Core Health Program
8-week structured stress management and health behaviour change program
Behavioural initiation coaching
15-minute health coaching session in first week of program to help participant set goals and create an action plan
Condition 4
Core Health platform plus Practice with feedback coaching and behavioural initiation coaching
Core Health Program
8-week structured stress management and health behaviour change program
Behavioural initiation coaching
15-minute health coaching session in first week of program to help participant set goals and create an action plan
Practice with feedback coaching
15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed
Condition 5
Core Health platform plus Momentary HRV feedback
Core Health Program
8-week structured stress management and health behaviour change program
Momentary HRV feedback
Take regular HRV readings throughout the day when stressed and perform mindfulness activity
Condition 6
Core Health platform plus Momentary HRV feedback and Practice with feedback coaching
Core Health Program
8-week structured stress management and health behaviour change program
Momentary HRV feedback
Take regular HRV readings throughout the day when stressed and perform mindfulness activity
Practice with feedback coaching
15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed
Condition 7
Core Health platform plus Momentary HRV feedback and behavioural initiation coaching
Core Health Program
8-week structured stress management and health behaviour change program
Momentary HRV feedback
Take regular HRV readings throughout the day when stressed and perform mindfulness activity
Behavioural initiation coaching
15-minute health coaching session in first week of program to help participant set goals and create an action plan
Condition 8
Core Health platform plus Momentary HRV feedback, behavioural initiation coaching, and Practice with feedback coaching
Core Health Program
8-week structured stress management and health behaviour change program
Momentary HRV feedback
Take regular HRV readings throughout the day when stressed and perform mindfulness activity
Behavioural initiation coaching
15-minute health coaching session in first week of program to help participant set goals and create an action plan
Practice with feedback coaching
15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed
Condition 9
Core Health platform plus Daily resting HRV
Core Health Program
8-week structured stress management and health behaviour change program
Daily resting HRV
Take regular HRV readings in the morning
Condition 10
Core Health platform plus Daily resting HRV feedback and Practice with feedback coaching
Core Health Program
8-week structured stress management and health behaviour change program
Daily resting HRV
Take regular HRV readings in the morning
Practice with feedback coaching
15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed
Condition 11
Core Health platform plus Daily resting HRV feedback and Behavioural initiation coaching
Core Health Program
8-week structured stress management and health behaviour change program
Daily resting HRV
Take regular HRV readings in the morning
Behavioural initiation coaching
15-minute health coaching session in first week of program to help participant set goals and create an action plan
Condition 12
Core Health platform plus Daily resting HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching
Core Health Program
8-week structured stress management and health behaviour change program
Daily resting HRV
Take regular HRV readings in the morning
Behavioural initiation coaching
15-minute health coaching session in first week of program to help participant set goals and create an action plan
Practice with feedback coaching
15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed
Condition 13
Core Health platform plus Daily resting HRV feedback and Momentary HRV feedback
Core Health Program
8-week structured stress management and health behaviour change program
Daily resting HRV
Take regular HRV readings in the morning
Momentary HRV feedback
Take regular HRV readings throughout the day when stressed and perform mindfulness activity
Condition 14
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Practice with feedback coaching
Core Health Program
8-week structured stress management and health behaviour change program
Daily resting HRV
Take regular HRV readings in the morning
Momentary HRV feedback
Take regular HRV readings throughout the day when stressed and perform mindfulness activity
Practice with feedback coaching
15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed
Condition 15
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Behavioural initiation coaching
Core Health Program
8-week structured stress management and health behaviour change program
Daily resting HRV
Take regular HRV readings in the morning
Momentary HRV feedback
Take regular HRV readings throughout the day when stressed and perform mindfulness activity
Behavioural initiation coaching
15-minute health coaching session in first week of program to help participant set goals and create an action plan
Condition 16
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching
Core Health Program
8-week structured stress management and health behaviour change program
Daily resting HRV
Take regular HRV readings in the morning
Momentary HRV feedback
Take regular HRV readings throughout the day when stressed and perform mindfulness activity
Behavioural initiation coaching
15-minute health coaching session in first week of program to help participant set goals and create an action plan
Practice with feedback coaching
15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed
Interventions
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Core Health Program
8-week structured stress management and health behaviour change program
Daily resting HRV
Take regular HRV readings in the morning
Momentary HRV feedback
Take regular HRV readings throughout the day when stressed and perform mindfulness activity
Behavioural initiation coaching
15-minute health coaching session in first week of program to help participant set goals and create an action plan
Practice with feedback coaching
15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed
Eligibility Criteria
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Inclusion Criteria
* Able to read and comprehend English
* Have smart phone (Android or iPhone 8 or higher)
* Self-report BMI under 40
* report at least Moderate daily stress
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Mitacs
INDUSTRY
Brock University
OTHER
Responsible Party
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Sean Locke
Principal Investigator
Principal Investigators
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Sean Locke, PhD
Role: PRINCIPAL_INVESTIGATOR
Brock University
Locations
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Brock University
St. Catharines, Ontario, Canada
Countries
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Other Identifiers
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20-367
Identifier Type: -
Identifier Source: org_study_id
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