Health Behaviour ChangeNCT04488796
STAND UP to SARS-CoV-2 (COVID-19): Using Behavioural Economics to Reduce Sedentary Behaviour in At-home Office Workers
A study testing Assigned Strategies: Opt-in, Assigned Strategies: Active Choice and Assigned Strategies: Enhanced Active Choice in people with Health Behaviour Change, run by Western University, Canada at 1 site in Canada.
Trial summary
In COVID-19 times, there has been a large increase in number of people working from home; with limited places to go, an abrupt change to people's lives and lack of knowledge about the dangers of sedentary behaviour (SB), it is important to help workers develop and effortlessly incorporate healthy movement routines to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behaviour Change
- What is being tested?
- Assigned Strategies: Opt-in, Assigned Strategies: Active Choice and Assigned Strategies: Enhanced Active Choice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteCanada
- Study dates
- 7 Sep 2020to 16 Dec 2020
- 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 or older
- Self-declare working 5 days per week (Monday to Friday)
- Full-time worker/employee (i.e. employed ≥ 30 hours/week)
- Desk-based office worker currently only working from home
- Have access to a computer with Internet and email
- Able to read and write in English
Who cannot join
- Self-declared medical condition or physical limitation that prevents them from being physically active
- Planning on leaving the current employer or taking a leave of absence for more than 3 consecutive workdays for the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STAND UP to SARS-CoV-2 (COVID-19): Using Behavioural Economics to Reduce Sedentary Behaviour in At-home Office Workers, a Pilot Randomized Controlled Trial
In COVID-19 times, there has been a large increase in number of people working from home; with limited places to go, an abrupt change to people's lives and lack of knowledge about the dangers of sedentary behaviour (SB), it is important to help workers develop and effortlessly incorporate healthy movement routines to optimize daily productivity and health. The combined lack of knowledge on literature on SB profiles of full time, home-based workers, effects of framing of SB reduction strategies, and strategy preference uncertainty makes for a novel study. This will be a 4-week intervention that looks at whether telling a full time, home-based office worker to do pre-selected strategies using different framing structures to break up their sedentary behaviour (SB) (i.e. sitting) will change their SB profiles. Investigators are looking to see whether having the choice (or not) to choose strategies in an unfamiliar health related selection (preference uncertainty) will create greater changes in SBs. As well, the researchers are incorporating behavioural economics' by altering choice structure in relation to behaviour change and program engagement. Workers' work-related SB will be measured by a device at baseline and on the last week of the intervention. Workers will be provided with an SB educational video to increase knowledge and motivation for change. Any SB changes in relation to productivity, mental wellness, behaviour intentions etc. will also be measured.
Read the detailed description
Regardless of group assignment, participants will receive the same three-minute educational video at the beginning (week 1) and halfway through (week 3) the intervention. Each group will also receive two weekly sedentary behaviour reduction strategies that align with the concept of "moving more often".
Participants will be initially randomized into the no choice strategy assignment or choice of strategy assignment groups, then immediately randomized into one of three choice structure conditions. The strategy assignment groups (no choice and choice) will receive two individually randomized (out of the ten "move more" strategies (see Table 2) each week. The two assigned strategies will be randomized to the participant each week; therefore, strategies may or may not change week to week. When presented with the two strategies, the Qualtrics program will state: "These will be your two move more strategies (click next to acknowledge you have seen your strategies)", followed by two multiple choice styled strategies. Regardless of if the person decides to click the boxes beside the strategies or clicks "next", the strategies will be inserted into the one of the three choice structure statements. Those randomized into the "choice of strategy assignment" group will be asked in their baseline questionnaire whether or not they: "prefer to choose and manage their own sitting reduction strategies from a list of expert recommended strategies OR prefer to be assigned with two strategies every week from a list of expert recommended strategies". Those opting to be assigned strategies ("Choice Strategy Assignment" group) will be assigned two random strategies, just like the "No Choice Strategy Assignment" group; however, they remain different from the "No Choice Strategy Assignment" group because they were given and chose the option to be given strategies. Those selecting to choose and manage their own strategies "Choice Strategy Self-Selection" group will be presented the same ten strategies each week, in random order, and will have the option to choose two strategies. The strategies can remain the same or change from week to week.
As mentioned, participants will be randomly assigned to one of three choice structure conditions: opt-in, Active Choice or Enhanced Active Choice. All three messages will contain the following introduction: "As you now know, breaking up your sitting every 45 minutes with 2-3 minutes of light activity can significantly reduce negative health risks associated with prolonged sitting." This message will end with one of the three choice structures.
In the opt-in condition they will be asked to "Place a check in the box [agree] if you will breakup your sitting throughout your work hours by [strategy] this week". The strategy statement is followed up by; OR, click the next button at the bottom." Within the opt-in condition, the default is to not participate (by clicking "next"); participants are not required to explicitly state they do not want to do the strategy.
In the Active choice condition, participants will be required to either, "Place a check in one box: I will break up my sitting throughout my work hours by [strategy] this week or, I will not break up my sitting throughout my work hours by [strategy] this week".
In the Enhanced Active Choice condition, participants will to required to choose between two alternatives: "I will break up my sitting throughout my work hours this week by [strategy] to reduce my risk of diabetes, mental health issues and other detrimental health outcomes and I want to win the eGiftcard or, I will not break up my sitting time during my work hours by [strategy] this week even if it means I increase my risk of developing diabetes, mental health issues and other detrimental health outcomes and I don't care about winning an eGiftcard"
Assigned or self-selected strategies (depending initial group assignment) will be sent in a reminder email on the Wednesday morning of each week and participants will be instructed to self-report their sedentary behaviour patterns on the Friday of each week.
An "interested" participant will email research personal with their initial "interest" in which the research personnel will respond by sending them the baseline questionnaire along with their unique ID code to access it in SoSci. Participants baseline questionnaires will be randomized to be either, a) assignment of choice strategies or b) choice of assignment vs self-management of choice strategies. Those assigned to the "Choice of Assigned Strategies" condition will have an additional question presenting them with the option of having strategies assigned to them or the option to choose and manage their own strategies. The LOI will be the first page of the questionnaire for them to review, and at the bottom will state, "Clicking on the "agree" button below indicates that you have read the above information, you voluntarily agree to participate and you are at least 18 years of age. If you do not wish to participate in the research study, please decline participation by clicking on the "disagree" button and simply exit the browser." Upon completion of the baseline questionnaire, participants will be emailed a PDF version of the LOI/informed consent, and will be asked to sign (digitally) the form and email it back to research personnel. Once consent is received, participants will be randomized into one of 3 choice structure conditions (Opt-in Choice OR Active Choice OR Enhanced Active Choice).
The activPAL will be sent by courier (i.e. FedEx) and participants will receive another email with detailed instructions of how to apply the device [i.e. applied to the mid-thigh using Tegaderm (3M)] along with how to contact investigators upon any issues with application. Participants will be instructed to apply the device on Sunday evening (if possible) and to wear the device all day for a period of 5 working days (Monday to Friday). Once participants complete the device measured baseline assessment, they will place the device back in the package it came in, and using pre-paid postage, the device will be picked up (via courier) and they will then be randomized into one of the three experimental conditions preceding the intervention period. Strategies will be pre-randomized for each condition from the longlist group.
Intervention Week 1. On day one of the intervention (Monday), participants will receive an email containing, 1) a link to watch a 3-minute whiteboard-styled educational video about sedentary behaviour (i.e. health consequences, benefits of breaking up or reducing sedentary behaviour, sedentary behaviour in relation to productivity and mood etc.) and 2) another link that will lead them to a short questionnaire assessing knowledge on sedentary behaviour (fidelity check) as well as their behavioural strategies (different based on the condition assignment; as described earlier). Wednesday morning, they will receive an email reminding them of their strategies. On the last day of the same workweek (Friday), participants will be prompted (via email) with a link (Soci) to self-report their sitting habits (i.e. break frequency and break duration).
Intervention Week 2. On the Monday of week 2, participants will again be assigned or asked to choose their strategies via email (depending on group allocation) for that week and will again receive an email Wednesday morning reminding them of their chosen/assigned strategies. They will again be asked to self-report their sitting habits (via link sent through email) (i.e. break frequency and break duration) on the last day of the week (Friday).
Intervention Week 3. On the Monday of Week 3, strategies will reset as earlier described for each condition. However, for this week, the participants will be reminded of the video they watched at the beginning of the intervention and be asked to re-watch the same video. In line with the same protocol described in the earlier weeks, a reminder email will be sent on Wednesday morning and self-reported sitting habits will be measured at the end of the week.
Intervention Week 4. Week four of the intervention will be the final week. Again, strategies will reset for all conditions as previously described. Participants again, will wear the activPAL4's (delivered via FedEx) for a total of five days (Monday to Friday). This will serve as the follow-up objectively (device) measured sedentary behaviour measurement. The participants will receive the same reminder email as previous weeks. This last week, however, the Friday questionnaire will include all secondary outcomes that were initially assessed at baseline along with a short exit survey asking about participant satisfaction with the intervention.
Follow Up. Follow-up will occur two weeks post-intervention. Participants will recomplete all secondary outcomes that were initially assessed at baseline (with exception to the activPAL measurements).
- Conditions
- Health Behaviour Change
- Being tested
- Assigned Strategies: Opt-in, Assigned Strategies: Active Choice, Assigned Strategies: Enhanced Active Choice, Choice of Assignment: Opt-in, Choice of Assignment: Active Choice
- Keywords
- randomized controlled trial, office-workers, sedentary behaviour, mHealth, behavioural economics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned Strategies: Opt-inBehavioural
Participants will be assigned two behavioural strategies with the opt-in choice structure
Assigned Strategies: Active ChoiceBehavioural
Participants will be assigned two behavioural strategies with the Active choice structure
Assigned Strategies: Enhanced Active ChoiceBehavioural
Participants will be assigned two behavioural strategies with the Enhanced Active choice structure
Choice of Assignment: Opt-inBehavioural
Participants will have the choice to be assigned strategies or to manage their own strategies. The strategies will be assigned using the Opt-in choice structure
Choice of Assignment: Active ChoiceBehavioural
Participants will have the choice to be assigned strategies or to manage their own strategies. The strategies will be assigned using the Active choice structure
Choice of Assignment: Enhanced Active ChoiceBehavioural
Participants will have the choice to be assigned strategies or to manage their own strategies. The strategies will be assigned using the Enhanced Active choice structure
| Study group | Role | What they receive |
|---|---|---|
| Assigned Strategies: Opt-in | Experimental | Participants in this group will be assigned two behavioural strategies under the theme of "moving more" and will be asked to "Place a check in the box [agree] if you will breakup your sitting throughout your work hours by X this week". The strategy statement is followed up by; OR, click the next button at the bottom." Within the opt-in condition, the default is to not participate (by clicking "next"): participants are not required to explicitly state they do not want to do the strategy Receives: Behavioral: Assigned Strategies: Opt-in |
| Assigned Strategies; Active Choice | Experimental | Participants in this group will be assigned two behavioural strategies under the theme of "moving more". In the Active choice condition, participants will be required to either, "Place a check in one box: I will break up my sitting throughout my work hours by [strategy] this week or, I will not break up my sitting throughout my work hours by [strategy] this week". Receives: Behavioral: Assigned Strategies: Active Choice |
| Assigned Strategies; Enhanced Active Choice | Experimental | Participants in this group will be assigned two behavioural strategies under the theme of "moving more". In the Enhanced Active Choice condition, participants will to required to choose between two alternatives: "I will break up my sitting throughout my work hours this week by [strategy] to reduce my risk of diabetes, mental health issues and other detrimental health outcomes and I want to win the eGiftcard or, I will not break up my sitting time during my work hours by [strategy] this week even if it means I increase my risk of developing diabetes, mental health issues and other detrimental health outcomes and I don't care about winning an eGiftcard" Receives: Behavioral: Assigned Strategies: Enhanced Active Choice |
| Choice of Assignment; Opt-in | Experimental | Those opting to be assigned strategies ("Choice Strategy Assignment" group) will be assigned two random strategies, just like the "No Choice Strategy Assignment" group; however, they remain different from the "No Choice Strategy Assignment" group because they were given and chose the option to be given strategies. Those selecting to choose and manage their own strategies "Choice Strategy Self-Selection" group will be presented the same ten strategies each week, in random order, and will have the option to choose two strategies. The strategies can remain the same or change from week to week. Receives: Behavioral: Choice of Assignment: Opt-in |
| Choice of Assignment; Active Choice | Experimental | Those opting to be assigned strategies ("Choice Strategy Assignment" group) will be assigned two random strategies, just like the "No Choice Strategy Assignment" group; however, they remain different from the "No Choice Strategy Assignment" group because they were given and chose the option to be given strategies. Those selecting to choose and manage their own strategies "Choice Strategy Self-Selection" group will be presented the same ten strategies each week, in random order, and will have the option to choose two strategies. The strategies can remain the same or change from week to week. Receives: Behavioral: Choice of Assignment: Active Choice |
| Choice of Assignment; Enhanced Active Choice | Experimental | Those opting to be assigned strategies ("Choice Strategy Assignment" group) will be assigned two random strategies, just like the "No Choice Strategy Assignment" group; however, they remain different from the "No Choice Strategy Assignment" group because they were given and chose the option to be given strategies. Those selecting to choose and manage their own strategies "Choice Strategy Self-Selection" group will be presented the same ten strategies each week, in random order, and will have the option to choose two strategies. The strategies can remain the same or change from week to week. Receives: Behavioral: Choice of Assignment: Enhanced Active Choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sedentary behaviour break frequency
measured via ActivPAL
Measured: change from baseline to 4 weeks
Change in sedentary behaviour break duration
measured via ActivPAL
Measured: change from baseline to 4 weeks
Secondary outcomes (11)
Change in work-related quality of life
Short form 36 health survey (SF-36) measured on a 5-point Likert scale from 1 "all of the time" to 5 "None of the time".
Measured: change from baseline to 6 weeks
Change in Health outcomes
Questions regarding work productivity, concentration and focus will be measured with questions adapted from The Health and Work Questionnaire (HWQ). The HWQ is a multidimensional tool used to measure various aspects of productivity. The HWQ consists of 24 questions, several items being multi-part questions with internal consistency scores ranging from alpha = 0.72 to 0.96. The questions are designed to assess work quality, quantity, and efficiency, as well as impatience, concentration/focus, work satisfaction and non-work satisfaction. For the current study, 15 items were chosen from this questionnaire that were relevant to "home-based" office workers. Items will be assessed with a ten-point response scale, tailored to each question (e.g., "my worst ever" to "my best ever").
Measured: change from baseline to 6 weeks
Change in sitting time
measured with the ActivPAL4
Measured: change in baseline to 4 weeks
Change in standing time
measured with the ActivPAL4
Measured: change in baseline to 4 weeks
Change in moving time
measured with the ActivPAL4
Measured: change in baseline to 4 weeks
Change in prolonged sitting bouts
measured with the ActivPAL4
Measured: change in baseline to 4 weeks
Change in percentage of time spent sitting
The validated three-item modified Occupational Sitting and Physical activity questionnaire (OSPAQ). The OSPAQ is a brief instrument reported to have excellent test-retest reliability (intraclass correlation coefficients = 0.73-0.90), moderate criterion validity for time spent sitting and standing (r = 0.65 and 0.49, respectively), and lower validity for time spent walking (r = 0.29). At each assessment period (baseline, week 1, week 2, week 3, week 4 and follow-up), participants will be asked to record both the number of days they were at work and total number of hours they worked in the last 7 days. Participants will then be asked to record a percentage of time spent sitting, standing, and moving (i.e. walking) (cumulative total of 100%) during work hours on a typical workday in the last 7 days.
Measured: change from baseline to 6 weeks
Change in percentage of time spent standing
The validated three-item modified Occupational Sitting and Physical activity questionnaire (OSPAQ). The OSPAQ is a brief instrument reported to have excellent test-retest reliability (intraclass correlation coefficients = 0.73-0.90), moderate criterion validity for time spent sitting and standing (r = 0.65 and 0.49, respectively), and lower validity for time spent walking (r = 0.29). At each assessment period (baseline, week 1, week 2, week 3, week 4 and follow-up), participants will be asked to record both the number of days they were at work and total number of hours they worked in the last 7 days. Participants will then be asked to record a percentage of time spent sitting, standing, and moving (i.e. walking) (cumulative total of 100%) during work hours on a typical workday in the last 7 days.
Measured: change from baseline to 6 weeks
Change in percentage of time spent moving
The validated three-item modified Occupational Sitting and Physical activity questionnaire (OSPAQ). The OSPAQ is a brief instrument reported to have excellent test-retest reliability (intraclass correlation coefficients = 0.73-0.90), moderate criterion validity for time spent sitting and standing (r = 0.65 and 0.49, respectively), and lower validity for time spent walking (r = 0.29). At each assessment period (baseline, week 1, week 2, week 3, week 4 and follow-up), participants will be asked to record both the number of days they were at work and total number of hours they worked in the last 7 days. Participants will then be asked to record a percentage of time spent sitting, standing, and moving (i.e. walking) (cumulative total of 100%) during work hours on a typical workday in the last 7 days.
Measured: change from baseline to 6 weeks
Change in sedentary break frequency
measured using a modified version of the SIT-Q 7d;modified the base questionnaire to include domain-specific (work-related) break frequency and duration scores, which were the only items assessed for purposes of this study
Measured: change from baseline to 6 weeks
Change in sedentary break duration
measured using a modified version of the SIT-Q 7d;modified the base questionnaire to include domain-specific (work-related) break frequency and duration scores, which were the only items assessed for purposes of this study
Measured: change from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start7 Sep 2020
- Primary completion16 Dec 2020
- Study completion16 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Behaviour ChangeStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This will be a 2 (automated vs. choice of automation) by 3 (Opt-in, active choice or enhanced active choice) factorial design pilot randomized control trial
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Principal investigator, Marc Mitchell, Western University, Canada
- Investigators
- Marc Mitchell, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488796
- Sponsor's protocol ID
- 116127
- Status last verified
- Apr 2021
- First submitted
- 22 Jul 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STAND UP to SARS-CoV-2 (COVID-19): Using Behavioural Economics to Reduce Sedentary Behaviour in At-home Office Workers, a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04488796
- Acronym / sponsor ID
- 116127
- Conditions
- Health Behaviour Change
- Keywords
- randomized controlled trial, office-workers, sedentary behaviour, mHealth, behavioural economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 16 Dec 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 28 Jul 2020 (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.
In COVID-19 times, there has been a large increase in number of people working from home; with limited places to go, an abrupt change to people's lives and lack of knowledge about the dangers of sedentary behaviour (SB), it is important to help workers develop and effortlessly incorporate healthy movement routines to optimize daily productivity and health. The combined lack of knowledge on literature on SB profiles of full time, home-based workers, effects of framing of SB reduction strategies, and strategy preference uncertainty makes for a novel study. This will be a 4-week intervention that looks at whether telling a full time, home-based office worker to do pre-selected strategies using different framing structures to break up their sedentary behaviour (SB) (i.e. sitting) will change their SB profiles. Investigators are looking to see whether having the choice (or not) to choose strategies in an unfamiliar health related selection (preference uncertainty) will create greater changes in SBs. As well, the researchers are incorporating behavioural economics' by altering choice structure in relation to behaviour change and program engagement. Workers' work-related SB will be measured by a device at baseline and on the last week of the intervention. Workers will be provided with an SB educational video to increase knowledge and motivation for change. Any SB changes in relation to productivity, mental wellness, behaviour intentions etc. will also be measured.
Detailed description
Regardless of group assignment, participants will receive the same three-minute educational video at the beginning (week 1) and halfway through (week 3) the intervention. Each group will also receive two weekly sedentary behaviour reduction strategies that align with the concept of "moving more often".
Participants will be initially randomized into the no choice strategy assignment or choice of strategy assignment groups, then immediately randomized into one of three choice structure conditions. The strategy assignment groups (no choice and choice) will receive two individually randomized (out of the ten "move more" strategies (see Table 2) each week. The two assigned strategies will be randomized to the participant each week; therefore, strategies may or may not change week to week. When presented with the two strategies, the Qualtrics program will state: "These will be your two move more strategies (click next to acknowledge you have seen your strategies)", followed by two multiple choice styled strategies. Regardless of if the person decides to click the boxes beside the strategies or clicks "next", the strategies will be inserted into the one of the three choice structure statements. Those randomized into the "choice of strategy assignment" group will be asked in their baseline questionnaire whether or not they: "prefer to choose and manage their own sitting reduction strategies from a list of expert recommended strategies OR prefer to be assigned with two strategies every week from a list of expert recommended strategies". Those opting to be assigned strategies ("Choice Strategy Assignment" group) will be assigned two random strategies, just like the "No Choice Strategy Assignment" group; however, they remain different from the "No Choice Strategy Assignment" group because they were given and chose the option to be given strategies. Those selecting to choose and manage their own strategies "Choice Strategy Self-Selection" group will be presented the same ten strategies each week, in random order, and will have the option to choose two strategies. The strategies can remain the same or change from week to week.
As mentioned, participants will be randomly assigned to one of three choice structure conditions: opt-in, Active Choice or Enhanced Active Choice. All three messages will contain the following introduction: "As you now know, breaking up your sitting every 45 minutes with 2-3 minutes of light activity can significantly reduce negative health risks associated with prolonged sitting." This message will end with one of the three choice structures.
In the opt-in condition they will be asked to "Place a check in the box [agree] if you will breakup your sitting throughout your work hours by [strategy] this week". The strategy statement is followed up by; OR, click the next button at the bottom." Within the opt-in condition, the default is to not participate (by clicking "next"); participants are not required to explicitly state they do not want to do the strategy.
In the Active choice condition, participants will be required to either, "Place a check in one box: I will break up my sitting throughout my work hours by [strategy] this week or, I will not break up my sitting throughout my work hours by [strategy] this week".
In the Enhanced Active Choice condition, participants will to required to choose between two alternatives: "I will break up my sitting throughout my work hours this week by [strategy] to reduce my risk of diabetes, mental health issues and other detrimental health outcomes and I want to win the eGiftcard or, I will not break up my sitting time during my work hours by [strategy] this week even if it means I increase my risk of developing diabetes, mental health issues and other detrimental health outcomes and I don't care about winning an eGiftcard"
Assigned or self-selected strategies (depending initial group assignment) will be sent in a reminder email on the Wednesday morning of each week and participants will be instructed to self-report their sedentary behaviour patterns on the Friday of each week.
An "interested" participant will email research personal with their initial "interest" in which the research personnel will respond by sending them the baseline questionnaire along with their unique ID code to access it in SoSci. Participants baseline questionnaires will be randomized to be either, a) assignment of choice strategies or b) choice of assignment vs self-management of choice strategies. Those assigned to the "Choice of Assigned Strategies" condition will have an additional question presenting them with the option of having strategies assigned to them or the option to choose and manage their own strategies. The LOI will be the first page of the questionnaire for them to review, and at the bottom will state, "Clicking on the "agree" button below indicates that you have read the above information, you voluntarily agree to participate and you are at least 18 years of age. If you do not wish to participate in the research study, please decline participation by clicking on the "disagree" button and simply exit the browser." Upon completion of the baseline questionnaire, participants will be emailed a PDF version of the LOI/informed consent, and will be asked to sign (digitally) the form and email it back to research personnel. Once consent is received, participants will be randomized into one of 3 choice structure conditions (Opt-in Choice OR Active Choice OR Enhanced Active Choice).
The activPAL will be sent by courier (i.e. FedEx) and participants will receive another email with detailed instructions of how to apply the device [i.e. applied to the mid-thigh using Tegaderm (3M)] along with how to contact investigators upon any issues with application. Participants will be instructed to apply the device on Sunday evening (if possible) and to wear the device all day for a period of 5 working days (Monday to Friday). Once participants complete the device measured baseline assessment, they will place the device back in the package it came in, and using pre-paid postage, the device will be picked up (via courier) and they will then be randomized into one of the three experimental conditions preceding the intervention period. Strategies will be pre-randomized for each condition from the longlist group.
Intervention Week 1. On day one of the intervention (Monday), participants will receive an email containing, 1) a link to watch a 3-minute whiteboard-styled educational video about sedentary behaviour (i.e. health consequences, benefits of breaking up or reducing sedentary behaviour, sedentary behaviour in relation to productivity and mood etc.) and 2) another link that will lead them to a short questionnaire assessing knowledge on sedentary behaviour (fidelity check) as well as their behavioural strategies (different based on the condition assignment; as described earlier). Wednesday morning, they will receive an email reminding them of their strategies. On the last day of the same workweek (Friday), participants will be prompted (via email) with a link (Soci) to self-report their sitting habits (i.e. break frequency and break duration).
Intervention Week 2. On the Monday of week 2, participants will again be assigned or asked to choose their strategies via email (depending on group allocation) for that week and will again receive an email Wednesday morning reminding them of their chosen/assigned strategies. They will again be asked to self-report their sitting habits (via link sent through email) (i.e. break frequency and break duration) on the last day of the week (Friday).
Intervention Week 3. On the Monday of Week 3, strategies will reset as earlier described for each condition. However, for this week, the participants will be reminded of the video they watched at the beginning of the intervention and be asked to re-watch the same video. In line with the same protocol described in the earlier weeks, a reminder email will be sent on Wednesday morning and self-reported sitting habits will be measured at the end of the week.
Intervention Week 4. Week four of the intervention will be the final week. Again, strategies will reset for all conditions as previously described. Participants again, will wear the activPAL4's (delivered via FedEx) for a total of five days (Monday to Friday). This will serve as the follow-up objectively (device) measured sedentary behaviour measurement. The participants will receive the same reminder email as previous weeks. This last week, however, the Friday questionnaire will include all secondary outcomes that were initially assessed at baseline along with a short exit survey asking about participant satisfaction with the intervention.
Follow Up. Follow-up will occur two weeks post-intervention. Participants will recomplete all secondary outcomes that were initially assessed at baseline (with exception to the activPAL measurements).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This will be a 2 (automated vs. choice of automation) by 3 (Opt-in, active choice or enhanced active choice) factorial design pilot randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Assigned Strategies: Opt-in | Experimental | Behavioral: Assigned Strategies: Opt-inParticipants in this group will be assigned two behavioural strategies under the theme of "moving more" and will be asked to "Place a check in the box [agree] if you will breakup your sitting throughout your work hours by X this week". The strategy statement is followed up by; OR, click the next button at the bottom." Within the opt-in condition, the default is to not participate (by clicking "next"): participants are not required to explicitly state they do not want to do the strategy |
| Assigned Strategies; Active Choice | Experimental | Behavioral: Assigned Strategies: Active ChoiceParticipants in this group will be assigned two behavioural strategies under the theme of "moving more". In the Active choice condition, participants will be required to either, "Place a check in one box: I will break up my sitting throughout my work hours by [strategy] this week or, I will not break up my sitting throughout my work hours by [strategy] this week". |
| Assigned Strategies; Enhanced Active Choice | Experimental | Behavioral: Assigned Strategies: Enhanced Active ChoiceParticipants in this group will be assigned two behavioural strategies under the theme of "moving more". In the Enhanced Active Choice condition, participants will to required to choose between two alternatives: "I will break up my sitting throughout my work hours this week by [strategy] to reduce my risk of diabetes, mental health issues and other detrimental health outcomes and I want to win the eGiftcard or, I will not break up my sitting time during my work hours by [strategy] this week even if it means I increase my risk of developing diabetes, mental health issues and other detrimental health outcomes and I don't care about winning an eGiftcard" |
| Choice of Assignment; Opt-in | Experimental | Behavioral: Choice of Assignment: Opt-inThose opting to be assigned strategies ("Choice Strategy Assignment" group) will be assigned two random strategies, just like the "No Choice Strategy Assignment" group; however, they remain different from the "No Choice Strategy Assignment" group because they were given and chose the option to be given strategies. Those selecting to choose and manage their own strategies "Choice Strategy Self-Selection" group will be presented the same ten strategies each week, in random order, and will have the option to choose two strategies. The strategies can remain the same or change from week to week. |
| Choice of Assignment; Active Choice | Experimental | Behavioral: Choice of Assignment: Active ChoiceThose opting to be assigned strategies ("Choice Strategy Assignment" group) will be assigned two random strategies, just like the "No Choice Strategy Assignment" group; however, they remain different from the "No Choice Strategy Assignment" group because they were given and chose the option to be given strategies. Those selecting to choose and manage their own strategies "Choice Strategy Self-Selection" group will be presented the same ten strategies each week, in random order, and will have the option to choose two strategies. The strategies can remain the same or change from week to week. |
| Choice of Assignment; Enhanced Active Choice | Experimental | Behavioral: Choice of Assignment: Enhanced Active ChoiceThose opting to be assigned strategies ("Choice Strategy Assignment" group) will be assigned two random strategies, just like the "No Choice Strategy Assignment" group; however, they remain different from the "No Choice Strategy Assignment" group because they were given and chose the option to be given strategies. Those selecting to choose and manage their own strategies "Choice Strategy Self-Selection" group will be presented the same ten strategies each week, in random order, and will have the option to choose two strategies. The strategies can remain the same or change from week to week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- Self-declare working 5 days per week (Monday to Friday)
- Full-time worker/employee (i.e. employed ≥ 30 hours/week)
- Desk-based office worker currently only working from home
- Have access to a computer with Internet and email
Key exclusion criteria (2 listed)
- Self-declared medical condition or physical limitation that prevents them from being physically active
- Planning on leaving the current employer or taking a leave of absence for more than 3 consecutive workdays for the duration of the study
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 |
|---|---|---|
| Assigned Strategies: Opt-inParticipants will be assigned two behavioural strategies with the opt-in choice structure | Behavioural | Assigned Strategies: Opt-in |
| Assigned Strategies: Active ChoiceParticipants will be assigned two behavioural strategies with the Active choice structure | Behavioural | Assigned Strategies; Active Choice |
| Assigned Strategies: Enhanced Active ChoiceParticipants will be assigned two behavioural strategies with the Enhanced Active choice structure | Behavioural | Assigned Strategies; Enhanced Active Choice |
| Choice of Assignment: Opt-inParticipants will have the choice to be assigned strategies or to manage their own strategies. The strategies will be assigned using the Opt-in choice structure | Behavioural | Choice of Assignment; Opt-in |
| Choice of Assignment: Active ChoiceParticipants will have the choice to be assigned strategies or to manage their own strategies. The strategies will be assigned using the Active choice structure | Behavioural | Choice of Assignment; Active Choice |
| Choice of Assignment: Enhanced Active ChoiceParticipants will have the choice to be assigned strategies or to manage their own strategies. The strategies will be assigned using the Enhanced Active choice structure | Behavioural | Choice of Assignment; Enhanced Active Choice |
Primary outcome
Change in sedentary behaviour break frequency
Time frame: change from baseline to 4 weeks
measured via ActivPAL
Change in sedentary behaviour break duration
Time frame: change from baseline to 4 weeks
measured via ActivPAL
11 secondary outcomes
Change in work-related quality of life
Time frame: change from baseline to 6 weeks
Change in Health outcomes
Time frame: change from baseline to 6 weeks
Change in sitting time
Time frame: change in baseline to 4 weeks
Change in standing time
Time frame: change in baseline to 4 weeks
Change in moving time
Time frame: change in baseline to 4 weeks
Change in prolonged sitting bouts
Time frame: change in baseline to 4 weeks
Change in percentage of time spent sitting
Time frame: change from baseline to 6 weeks
Change in percentage of time spent standing
Time frame: change from baseline to 6 weeks
Change in percentage of time spent moving
Time frame: change from baseline to 6 weeks
Change in sedentary break frequency
Time frame: change from baseline to 6 weeks
Change in sedentary break duration
Time frame: change from baseline to 6 weeks
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 8 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Marc Mitchell, PhD 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 Assigned Strategies: Opt-in, Assigned Strategies: Active Choice and Assigned Strategies: Enhanced Active Choice in people with 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 6 inclusion and 2 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 8 Apr 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?
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?
Change in sedentary behaviour break frequency (time frame: change from baseline to 4 weeks). The study lists 2 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 8 Apr 2021.