- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05115253
Reducing Sedentary Behaviour in Office Workers With a HAPA mHealth Intervention and a Just In-Time Adaptive Intervention
Reducing Sedentary Behaviour in Office Workers With a mHealth Health Action Process Approach Intervention and a Just In-Time Adaptive Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This three-arm repeated measure randomized control trial will randomize participants into two intervention groups and one control group to attempt to reduce sedentary behaviour in office workers. The study will last for four weeks, the first week of the study will be used for baseline measurement and the remaining three weeks used for the intervention.
Participants will be full time office workers primarily recruited from large businesses and corporations. The primary purpose of the study will be to decrease sedentary behaviour in office workers from pre- to post-intervention by breaking up extended periods of sedentary time. The secondary objectives of the study are to compare the effectiveness of each group against one another to assess for any significant differences in sedentary behaviour profiles, total time spent sitting, break frequency, break duration, and time not spent sedentary as well as to examine whether physical activity changed over the course of the intervention.
One intervention group will attempt to reduce sedentary behaviour by receiving push notifications from an EMA tracking mobile phone application after a pre-set sedentary behaviour condition has been met. The application will monitor and collect data from the on-board accelerometer of the participant's phone and when a threshold of 30 consecutive sedentary minutes has been reached, the application will administer a notification asking the participant to break the extended sedentary behaviour they are currently engaged in.
The other intervention group will receive a theory-based behaviour change counselling session paired with daily personalized SMS text message boosters to achieve the study's aims. The counselling sessions and SMS text messages will be framed through the Health Action Process Approach, a behaviour change model that centres around action planning and coping planning. The control group will receive no intervention or further information from 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 an EMA tracking mobile phone application that will be downloaded by each participant as well as a weekly online sedentary behaviour questionnaire. Outcome measures will be compared within and between groups to detect differences.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Harry Prapavessis, Ph.D
- Phone Number: 80173 519 661-2111
- Email: hparapave@uwo.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada
- The University of Western Ontario
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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 mobile phone 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 |
---|---|
Experimental: mHealth HAPA Intervention Group
This intervention group will receive a single one-on-one online behavioural counselling session and daily personalized SMS text message boosters 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 an action plan and the development of coping strategies to increase sedentary behaviour breaks.
The SMS text message boosters will be personalized based on participant's preferences of timing, type, frequency, and length.
The boosters will framed through HAPA principles with content focusing on risk awareness, outcome expectancy, action and coping planning, barriers and resources, and self-efficacy.
The intervention will last for three weeks.
|
Behavioural counseling grounded in the Health Action Process Approach (HAPA; i.e., action planning and coping planning) paired with daily personalized HAPA guided SMS text message boosters to reduce consecutive workplace sedentary behaviour.
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Experimental: JITAI Group
This intervention group will receive push notifications from a EMA behaviour monitoring mobile application that will be downloaded to each participants' mobile phones.
The application will measure and monitor a participant's sedentary behaviour and once a pre-set condition of 30 consecutive sedentary minutes has been reached, the application will administer a push notification notifying the participant to break their sedentary behaviour.
The push notifications will ask the participants to stand up, stretch, or lightly walk around to break their current behaviour.
The intervention will last for three weeks.
|
EMA monitoring mobile phone application that uses a phone's on-board accelerometer to monitor a participant's sedentary behaviour and deliver a push notification once a set condition has been met.
This intervention will be utilized to reduce consecutive workplace sedentary behaviour.
Other Names:
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No Intervention: Control Group
The control group will receive no intervention or further instruction past the letter of information.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Frequency of Breaks from Sitting at Work
Time Frame: Baseline, Weeks 2, 3, 4
|
mEMA app (ilumivu Inc., Boston, MA, www.ilumivu.com);
accelerometer data Modified version of the SIT-Q 7d (Wijndaele et al., 2014; Sui & Prapavessis, 2016); 1-item; 12-point scale
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Baseline, Weeks 2, 3, 4
|
Changes in Duration of Breaks from Sitting at Work
Time Frame: Baseline, Weeks 2, 3, 4
|
mEMA app (ilumivu Inc., Boston, MA, www.ilumivu.com);
accelerometer data Modified version of the SIT-Q 7d (Wijndaele et al., 2014; Sui & Prapavessis, 2016); 1-item; 10-point scale
|
Baseline, Weeks 2, 3, 4
|
Changes in Time Spent Sitting at Work
Time Frame: Baseline, Weeks 2, 3, 4
|
mEMA app (ilumivu Inc., Boston, MA, www.ilumivu.com);
accelerometer data Modified version of the SIT-Q 7d (Wijndaele et al., 2014; Sui & Prapavessis, 2016)
|
Baseline, Weeks 2, 3, 4
|
Changes in Time Spent Standing at Work
Time Frame: Baseline, Weeks 2, 3, 4
|
mEMA app (ilumivu Inc., Boston, MA, www.ilumivu.com);
accelerometer data
|
Baseline, Weeks 2, 3, 4
|
Changes in Time Spent Engaged in Light Physical Activity at Work
Time Frame: Baseline, Weeks 2, 3, 4
|
mEMA app (ilumivu Inc., Boston, MA, www.ilumivu.com);
accelerometer data
|
Baseline, Weeks 2, 3, 4
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age
Time Frame: Baseline
|
Assessed with a single item question: "What is your age?"
|
Baseline
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Sex
Time Frame: Baseline
|
Assessed with a single item question: "What is your sex?"
|
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?"
|
Baseline
|
Ethnicity
Time Frame: Baseline
|
Assessed with a single item question: "What ethnicity do you most identify with?"
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Baseline
|
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
|
Baseline
|
Type of Occupation
Time Frame: Baseline
|
Assessed with a four item question: "What general sector does your occupation fall under?";
private, public, charity, other
|
Baseline
|
Hours of Work per Week
Time Frame: Baseline
|
Assessed with a single item question: "What are your typical hours of work on an average week?"
|
Baseline
|
Education Level
Time Frame: Baseline
|
Assessed with a single item question: "What is your current formal education level?"
|
Baseline
|
Height
Time Frame: Baseline
|
Assessed with a single item question: "What is your height in either inches or centimetres?"
|
Baseline
|
Weight
Time Frame: Baseline
|
Assessed with a single item question: "What is your weight in either pounds or kilograms?"
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- 119926
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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