Sedentary BehaviorNCT05216159
Mobile Health-Health Action Process Approach Based Intervention on Sedentary Behaviour and Stress in Office Workers
A study testing HAPA behavioural counselling + weekly HAPA worksheets in people with Sedentary Behavior and Health Behaviour Change, run by Western University, Canada at 1 site in Canada.
Trial summary
This study will explore the effectiveness of a Health Action Process Approach (HAPA) mobile health (mHealth) intervention on reducing sedentary behaviour and perceived stress in desk-based office workers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Health Behaviour Change, Perceived Stress
- What is being tested?
- HAPA behavioural counselling + weekly HAPA worksheets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- 8 Mar 2022to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- any medical or physical limitation that would prevent standing, stretching, and/or light physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Mobile Health-Health Action Process Approach Based Intervention on Sedentary Behaviour and Stress Among Desk-Basked Office Working Adults
This study will explore the effectiveness of a Health Action Process Approach (HAPA) mobile health (mHealth) intervention on reducing sedentary behaviour and perceived stress in desk-based office workers. Half of participants will receive a mHealth HAPA intervention consisting of a theory-driven behavioural counselling session and weekly HAPA based worksheets delivered through a mobile application. The other half of participants will act as a control group and will receive no intervention or information past the letter of information. The study will take place over eight weeks, with the first four weeks acting as the intervention period and a follow-up at the end of week eight.
Read the 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.
- Being tested
- HAPA behavioural counselling + weekly HAPA worksheets
- Keywords
- Sedentary Behaviour, Health Behaviour Change, Perceived Stress, Health Action Process Approach, Office Workers, mHealth, Mobile Health
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAPA behavioural counselling + weekly HAPA worksheetsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| mHealth HAPA Intervention Group | Experimental | 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. Receives: Behavioral: HAPA behavioural counselling + weekly HAPA worksheets |
| Control Group | No intervention | The control group will receive no intervention or further instruction past the letter of information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Time Spent Sitting at Work
modified Occupational Physical Activity Questionnaire (Reis et al., 2005; Chau et al., 2012); 5-items
Measured: Baseline, Weeks 1, 2, 3, 4, 8
Changes in Time Spent Standing at Work
modified Occupational Physical Activity Questionnaire (Reis et al., 2005; Chau et al., 2012); 5-items
Measured: Baseline, Weeks 1, 2, 3, 4, 8
Changes in Time Spent Engaged in Light-Intensity Physical Activity at Work
modified Occupational Physical Activity Questionnaire (Reis et al., 2005; Chau et al., 2012); 5-items
Measured: Baseline, Weeks 1, 2, 3, 4, 8
Changes in Frequency of Breaks from Sitting at Work
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
Measured: Baseline, Weeks 1, 2, 3, 4, 8
Changes in Duration of Breaks from Sitting at Work
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
Measured: Baseline, Weeks 1, 2, 3, 4, 8
Secondary outcomes (1)
Changes in Perceived Stress
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
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start8 Mar 2022
- Primary completion30 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Upon obtaining consent, eligible participants will be randomly assigned to either the intervention group or the control group. The study will run for eight weeks, with a four week intervention period and a follow-up at the end of week eight.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Harry Prapavessis, Western University, Canada
- Investigators
- Harry Prapavessis, Ph.D, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216159
- Sponsor's protocol ID
- 120488
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2022
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Mobile Health-Health Action Process Approach Based Intervention on Sedentary Behaviour and Stress Among Desk-Basked Office Working Adults
- ClinicalTrials.gov ID
- NCT05216159
- Acronym / sponsor ID
- 120488
- Keywords
- Sedentary Behaviour, Health Behaviour Change, Perceived Stress, Health Action Process Approach, Office Workers, mHealth, Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will explore the effectiveness of a Health Action Process Approach (HAPA) mobile health (mHealth) intervention on reducing sedentary behaviour and perceived stress in desk-based office workers. Half of participants will receive a mHealth HAPA intervention consisting of a theory-driven behavioural counselling session and weekly HAPA based worksheets delivered through a mobile application. The other half of participants will act as a control group and will receive no intervention or information past the letter of information. The study will take place over eight weeks, with the first four weeks acting as the intervention period and a follow-up at the end of week eight.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Upon obtaining consent, eligible participants will be randomly assigned to either the intervention group or the control group. The study will run for eight weeks, with a four week intervention period and a follow-up at the end of week eight.
| Arm | Type | Receives |
|---|---|---|
| mHealth HAPA Intervention Group | Experimental | Behavioral: HAPA behavioural counselling + weekly HAPA worksheetsThis 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. |
| Control Group | No intervention | –The control group will receive no intervention or further instruction past the letter of information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- any medical or physical limitation that would prevent standing, stretching, and/or light physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAPA behavioural counselling + weekly HAPA worksheetsBehavioural 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. | Behavioural | mHealth HAPA Intervention Group |
Primary outcome
Changes in Time Spent Sitting at Work
Time frame: Baseline, Weeks 1, 2, 3, 4, 8
modified Occupational Physical Activity Questionnaire (Reis et al., 2005; Chau et al., 2012); 5-items
Changes in Time Spent Standing at Work
Time frame: Baseline, Weeks 1, 2, 3, 4, 8
modified Occupational Physical Activity Questionnaire (Reis et al., 2005; Chau et al., 2012); 5-items
Changes in Time Spent Engaged in Light-Intensity Physical Activity at Work
Time frame: Baseline, Weeks 1, 2, 3, 4, 8
modified Occupational Physical Activity Questionnaire (Reis et al., 2005; Chau et al., 2012); 5-items
Changes in Frequency of Breaks from Sitting at Work
Time frame: Baseline, Weeks 1, 2, 3, 4, 8
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
Changes in Duration of Breaks from Sitting at Work
Time frame: Baseline, Weeks 1, 2, 3, 4, 8
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
1 secondary outcome
Changes in Perceived Stress
Time frame: Baseline, Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Prapavessis, Ph.D principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HAPA behavioural counselling + weekly HAPA worksheets in people with Sedentary Behavior and Health Behaviour Change, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Time Spent Sitting at Work (time frame: Baseline, Weeks 1, 2, 3, 4, 8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.