- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05216159
Mobile Health-Health Action Process Approach Based Intervention on Sedentary Behaviour and Stress in Office Workers
Effects of a Mobile Health-Health Action Process Approach Based Intervention on Sedentary Behaviour and Stress Among Desk-Basked Office Working Adults
Study Overview
Status
Intervention / Treatment
Detailed Description
This two-arm, repeated measure randomized control trial will randomize participants into two groups, an intervention group and a no-contact control group in an attempt to reduce sedentary behaviour in desk-based office workers. The study will last for eight weeks, comprising of a four week intervention period and a follow-up at week eight.
Participants will be full time desk-based office workers primarily recruited from large businesses and corporations. The primary objective of the study is to reduce sedentary behaviour, while the secondary objective is to determine if a theory-based behaviour change intervention tailored to workplace sedentary would affect general stress levels of desk-based office workers over the course of the intervention.
The intervention group will receive an initial theory-based behaviour change counselling session through video chat and then continued through a mobile application where weekly worksheets will be delivered to a participant's mobile phone and encourage the participant to create their own personal and specific action plans and coping strategies. The control group will receive no intervention or further instruction past the letter of information.
Sedentary behaviour will be collected in the form of duration of time spent sitting, frequency of sedentary behaviour breaks, and duration of sedentary behaviour breaks. These variables will be measured through a sedentary behaviour and perceived stress questionnaires that will be delivered through a downloadable mobile phone application.
Outcome measures will be compared within and between groups to detect differences. Participants will be recruited through emails to relevant liaisons and senior executives as well as through emails directly to office working employees in the London area.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Harry Prapavessis, Ph.D
- Phone Number: 80173 5196612111
- Email: hparapave@uwo.ca
Study Locations
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Ontario
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London, Ontario, Canada
- The University of Western Ontario
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years of age or older
- full-time employee in a desk-based office job (work from home accepted)
- have access to a smartphone with internet connection
- can read and write in English
Exclusion Criteria:
- any medical or physical limitation that would prevent standing, stretching, and/or light physical activity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
The control group will receive no intervention or further instruction past the letter of information.
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Experimental: mHealth HAPA Intervention Group
This intervention group will receive a single one-on-one behavioural counselling session and weekly action and coping planning worksheets delivered through a downloaded smartphone application with the aim of increasing the breaking of consecutive work related sedentary behaviour.
Counselling strategies will be grounded in the HAPA model, specifically focusing on the creation of action plans and the development of coping strategies to increase sedentary behaviour breaks.
The weekly HAPA based worksheets will be sent out to participants at the beginning of their work week so that they can formulate their own personal action plans and coping strategies for the week to come.
They will be prompted to refer back to the information conveyed in one-on-one counselling session where they should try to create action plans that are specific and meaningful to them.
The intervention will last for a total of four weeks with the outcomes being measured through questionnaires.
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Behavioural counselling grounded in the Health Action Process Approach (HAPA; ie., action planning and coping planning) paired with weekly HAPA based worksheets delivered through a mobile application, SEMA3, to reduce consecutive workplace sedentary behaviour.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Time Spent Sitting at Work
Time Frame: Baseline, Weeks 1, 2, 3, 4, 8
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modified Occupational Physical Activity Questionnaire (Reis et al., 2005; Chau et al., 2012); 5-items
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Baseline, Weeks 1, 2, 3, 4, 8
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Changes in Time Spent Standing at Work
Time Frame: Baseline, Weeks 1, 2, 3, 4, 8
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modified Occupational Physical Activity Questionnaire (Reis et al., 2005; Chau et al., 2012); 5-items
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Baseline, Weeks 1, 2, 3, 4, 8
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Changes in Time Spent Engaged in Light-Intensity Physical Activity at Work
Time Frame: Baseline, Weeks 1, 2, 3, 4, 8
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modified Occupational Physical Activity Questionnaire (Reis et al., 2005; Chau et al., 2012); 5-items
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Baseline, Weeks 1, 2, 3, 4, 8
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Changes in Frequency of Breaks from Sitting at Work
Time Frame: Baseline, Weeks 1, 2, 3, 4, 8
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Modified version of the Last 7-day Sedentary Behaviour Questionnaire (SIT-Q 7d) (Wijndaele et al., 2014; Sui & Prapavessis, 2016); 1-item; 12-point scale (Less than every 30 min, Every 30-45 min, Every 45 min-1 hour, Every 1-1.5 hours, Every 1.5-2 hours, Every 2-3 hours, Every 3-4 hours, Every 4-5 hours, Over every 5 hours, No interruption); Lower values represent a better outcome
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Baseline, Weeks 1, 2, 3, 4, 8
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Changes in Duration of Breaks from Sitting at Work
Time Frame: Baseline, Weeks 1, 2, 3, 4, 8
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Modified version of the Last 7-day Sedentary Behaviour Questionnaire (SIT-Q 7d) (Wijndaele et al., 2014; Sui & Prapavessis, 2016); 1-item; 10-point scale (Less than 30 sec, 30 sec-1 min, 1-2 min, 2-3 min, 3-4 min, 4-5 min, 5-10 min, 10-15 min, 15-30 min, Over 30 min); Higher values represent a better outcome
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Baseline, Weeks 1, 2, 3, 4, 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Perceived Stress
Time Frame: Baseline, Week 4
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Perceived Stress Scale (PSS) (Cohen, Kamarck & Mermelstein, 1983); 10-item; 5-point scale (Never, Almost NEver, Sometimes, Fairly Often, Very Often); Lower values represent a better outcome
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Baseline, Week 4
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age
Time Frame: Baseline
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Assessed with a single item question: "What is your age?"
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Baseline
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Sex
Time Frame: Baseline
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Assessed with a single item question: "What is your sex?"
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Baseline
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Gender
Time Frame: Baseline
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Assessed with a single item question: "What gender do you most identify with?"
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Baseline
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Ethnicity
Time Frame: Baseline
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Assessed with a single item question: "What ethnicity do you most identify with?"
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Baseline
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Work Environment
Time Frame: Baseline
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Assessed with a three item question: "What is your current work environment?"; in office, at home, hybrid
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Baseline
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Type of Occupation
Time Frame: Baseline
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Assessed with a four item question: "What general sector does your occupation fall under?";
private, public, charity, other
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Baseline
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Hours of Work per Week
Time Frame: Baseline
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Assessed with a single item question: "What are your typical hours of work on an average week?"
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Baseline
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Education Level
Time Frame: Baseline
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Assessed with a single item question: "What is your current formal education level?"
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Harry Prapavessis, Ph.D, Western University
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 (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
- 120488
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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