HRV and Coaching Preparation Phase Study
Pilot Testing a Health Coaching and Heart Rate Variability Biofeedback Program to Improve Stress and Well-being
1 other identifier
interventional
16
1 country
1
Brief Summary
This pilot study will evaluate possible intervention components to be included in a future stress management and health behaviour change trial and to pilot test their feasibility and acceptability in a small sample.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2021
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 15, 2021
CompletedFirst Posted
Study publicly available on registry
December 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedApril 12, 2022
April 1, 2022
3 months
November 15, 2021
April 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Feasibility and acceptability of intervention components
Acceptability and Feasibility of Intervention Measure (Scale range 1\[completely disagree\] to 5 \[completely agree\] with higher scores being better; Weiner et al., 2017)
Assessment taken immediately after the intervention
Participant perceptions of intervention components
Semi-structured interview questions to evaluate experiences, likes, dislikes, potential changes, and perceived feasibility
Assessment taken immediately after the intervention
Health coach perceptions of intervention delivery
Semi-structured interview questions to evaluate experiences, likes, dislikes, potential changes, and perceived feasibility
Assessment taken immediately after the intervention
Secondary Outcomes (3)
Heart rate variability
Assessment taken immediately before and after the intervention
Completion of survey measures
Assessment taken immediately before and after the intervention
User engagement
continuously collected during 8-week intervention
Study Arms (16)
Condition 1
EXPERIMENTALCore Health platform only
Condition 2
EXPERIMENTALCore Health platform plus Practice with feedback coaching
Condition 3
EXPERIMENTALCore Health platform plus behavioural initiation coaching
Condition 4
EXPERIMENTALCore Health platform plus Practice with feedback coaching and behavioural initiation coaching
Condition 5
EXPERIMENTALCore Health platform plus Momentary HRV feedback
Condition 6
EXPERIMENTALCore Health platform plus Momentary HRV feedback and Practice with feedback coaching
Condition 7
EXPERIMENTALCore Health platform plus Momentary HRV feedback and behavioural initiation coaching
Condition 8
EXPERIMENTALCore Health platform plus Momentary HRV feedback, behavioural initiation coaching, and Practice with feedback coaching
Condition 9
EXPERIMENTALCore Health platform plus Daily resting HRV
Condition 10
EXPERIMENTALCore Health platform plus Daily resting HRV feedback and Practice with feedback coaching
Condition 11
EXPERIMENTALCore Health platform plus Daily resting HRV feedback and Behavioural initiation coaching
Condition 12
EXPERIMENTALCore Health platform plus Daily resting HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching
Condition 13
EXPERIMENTALCore Health platform plus Daily resting HRV feedback and Momentary HRV feedback
Condition 14
EXPERIMENTALCore Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Practice with feedback coaching
Condition 15
EXPERIMENTALCore Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Behavioural initiation coaching
Condition 16
EXPERIMENTALCore Health platform plus Daily resting HRV feedback, Momentary HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching
Interventions
8-week structured stress management and health behaviour change program
Take regular HRV readings in the morning
Take regular HRV readings throughout the day when stressed and perform mindfulness activity
15-minute health coaching session in first week of program to help participant set goals and create an action plan
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
You may qualify if:
- years and older
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brock Universitylead
- Mitacscollaborator
Study Sites (1)
Brock University
St. Catharines, Ontario, L2S 3A1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean Locke, PhD
Brock University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 15, 2021
First Posted
December 9, 2021
Study Start
November 1, 2021
Primary Completion
January 30, 2022
Study Completion
March 31, 2022
Last Updated
April 12, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share