Sedentary BehaviourNCT05115253
Reducing Sedentary Behaviour in Office Workers With a HAPA mHealth Intervention and a Just In-Time Adaptive Intervention
A study testing HAPA behavioural counselling + SMS text message boosters and JITAI in people with Sedentary Behaviour and Health Behaviour Change, run by Western University, Canada at 1 site in Canada.
Trial summary
This study will explore the effectiveness of two different interventions, a Health Action Process Approach (HAPA) mobile health (mHealth) intervention and a Just In-Time Adaptive Intervention (JITAI), on reducing sedentary behaviour in 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 Behaviour, Health Behaviour Change
- What is being tested?
- HAPA behavioural counselling + SMS text message boosters and JITAI
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2021to Jun 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 mobile phone 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.
Canada1 site
The University of Western Ontario
London, Ontario
Harry Prapavessis, PhD
About this study
Official title: Reducing Sedentary Behaviour in Office Workers With a mHealth Health Action Process Approach Intervention and a Just In-Time Adaptive Intervention
This study will explore the effectiveness of two different interventions, a Health Action Process Approach (HAPA) mobile health (mHealth) intervention and a Just In-Time Adaptive Intervention (JITAI), on reducing sedentary behaviour in office workers. One third of participants will receive the mHealth HAPA intervention, consisting of a theory-driven behavioural counselling session with personalized daily SMS text messages, and another third of participants will receive the JITAI intervention, a behaviour tracking mobile phone application that will alert participants once a set sedentary behaviour condition has been met. The last third of participants will act as a control where they will not receive an intervention or any further information from the letter of information. The study will take place over four weeks, with the first acting as a baseline and the intervention period filling the latter three weeks.
Read the 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.
- Conditions
- Sedentary Behaviour, Health Behaviour Change
- Being tested
- HAPA behavioural counselling + SMS text message boosters, JITAI
- Keywords
- Sedentary Behaviour, Health Behaviour Change, HAPA, Health Action Process Approach, JITAI, Just In-Time Adaptive Intervention, Office Workers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAPA behavioural counselling + SMS text message boostersBehavioural
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.
JITAIDevice
Also called mEMA (ilumivu Inc., Boston, MA, www.ilumivu.com)
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.
| Study group | Role | What they receive |
|---|---|---|
| mHealth HAPA Intervention Group | Experimental | 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. Receives: Behavioral: HAPA behavioural counselling + SMS text message boosters |
| JITAI Group | Experimental | 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. Receives: Device: JITAI |
| 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 Frequency of Breaks from Sitting at Work
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
Measured: Baseline, Weeks 2, 3, 4
Changes in Duration of Breaks from Sitting at Work
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
Measured: Baseline, Weeks 2, 3, 4
Changes in Time Spent Sitting at Work
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)
Measured: Baseline, Weeks 2, 3, 4
Changes in Time Spent Standing at Work
mEMA app (ilumivu Inc., Boston, MA, www.ilumivu.com); accelerometer data
Measured: Baseline, Weeks 2, 3, 4
Changes in Time Spent Engaged in Light Physical Activity at Work
mEMA app (ilumivu Inc., Boston, MA, www.ilumivu.com); accelerometer data
Measured: Baseline, Weeks 2, 3, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study startDec 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviourStudies 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 of the two intervention groups, a mHealth HAPA group or a JITAI group, or the control group. The study will run for four weeks with the first week acting as a baseline.
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
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
- NCT05115253
- Sponsor's protocol ID
- 119926
- Status last verified
- Dec 2021
- First submitted
- 29 Oct 2021
- Last updated
- 23 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Sedentary Behaviour in Office Workers With a mHealth Health Action Process Approach Intervention and a Just In-Time Adaptive Intervention
- ClinicalTrials.gov ID
- NCT05115253
- Acronym / sponsor ID
- 119926
- Conditions
- Sedentary Behaviour, Health Behaviour Change
- Keywords
- Sedentary Behaviour, Health Behaviour Change, HAPA, Health Action Process Approach, JITAI, Just In-Time Adaptive Intervention, Office Workers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 10 Nov 2021 (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 two different interventions, a Health Action Process Approach (HAPA) mobile health (mHealth) intervention and a Just In-Time Adaptive Intervention (JITAI), on reducing sedentary behaviour in office workers. One third of participants will receive the mHealth HAPA intervention, consisting of a theory-driven behavioural counselling session with personalized daily SMS text messages, and another third of participants will receive the JITAI intervention, a behaviour tracking mobile phone application that will alert participants once a set sedentary behaviour condition has been met. The last third of participants will act as a control where they will not receive an intervention or any further information from the letter of information. The study will take place over four weeks, with the first acting as a baseline and the intervention period filling the latter three weeks.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Upon obtaining consent, eligible participants will be randomly assigned to either of the two intervention groups, a mHealth HAPA group or a JITAI group, or the control group. The study will run for four weeks with the first week acting as a baseline.
| Arm | Type | Receives |
|---|---|---|
| mHealth HAPA Intervention Group | Experimental | Behavioral: HAPA behavioural counselling + SMS text message boostersThis 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. |
| JITAI Group | Experimental | Device: JITAIThis 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. |
| 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 mobile phone 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 + SMS text message boostersBehavioural 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. | Behavioural | mHealth HAPA Intervention Group |
| JITAIAlso: mEMA (ilumivu Inc., Boston, MA, www.ilumivu.com)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. | Device | JITAI Group |
Primary outcome
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
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
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)
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
Related trials for Sedentary Behaviour
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity
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 + SMS text message boosters and JITAI in people with Sedentary Behaviour 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: status not confirmed, as of the sponsor's last update on 23 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harry Prapavessis, Ph.D (519 661-2111 ext. 80173, hparapave@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Frequency of Breaks from Sitting at Work (time frame: Baseline, Weeks 2, 3, 4). 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 23 Dec 2021.