Sedentary LifestyleNCT03694951

The Effect of Experimentally Decreasing Sedentary Behaviour on Subjective Well-being

A study testing HAPA behavioural counseling in people with Sedentary Lifestyle and Quality of Life, run by Western University, Canada at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Sedentary Lifestyle, Quality of Life
What is being tested?: HAPA behavioural counseling
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteCanada
Study dates: 10 Sep 2019to 28 Feb 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 of age or older
Full-time student attending Western University
Able to read and write in English
Objectively report ≥7 hours of average daily sedentary time, via ActivPAL4 inclinometer

Who cannot join

Self-reporting a mental illness
Currently having a physical disability that would prevent walking

Trial locations and contacts

1 site in 1 country.

Canada1 site

Western University
London, Ontario, N6A 3K7

Other trials in Canada

About this study

This study will explore the causality between outcomes of subjective well-being and sedentary behavior, through experimentally decreasing the sedentary behavior levels of university students. Half of the eligible participants will receive a behavioral counseling intervention to increase non-sedentary behavior over one week, while the other half will receive no instructions. After one week, all participants will receive no instructions and continue to wear the inclinometer for another week.

Read the detailed description

The relationship between subjective well-being (SWB) and sedentary behavior (SB) has been briefly explored. However, the causality of the relationship (i.e., do higher levels of SB cause changes in SWB, or vice-versa) has not been fully examined. Experimentally decreasing SB and observing the potential subsequent effect on SWB may help to determine the causation between SB and SWB.

A sedentary sample of full-time university students attending Western University will be recruited. Upon obtaining consent, demographics will be taken. Sedentary behavior will be confirmed objectively through inclinometer wear for 1-week. Upon confirmation of sufficient sedentary time, participants will complete questionnaires assessing past-week: SWB, SB, physical activity, depression, and anxiety questionnaires. Participants will also be randomized to either a behavioral counseling intervention group, or a no-contact control group. Participants will then continue wearing the inclinometer for 1 week. After the intervention week, participants will complete the questionnaires again, after which all participants will be told to continue daily behavior, and wear the inclinometer for another week. Upon completion of this follow-up week, participants will complete questionnaires again.

Conditions: Sedentary Lifestyle, Quality of Life
Being tested: HAPA behavioural counseling
Keywords: Sedentary Behaviour, Subjective Well-Being, University Students
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 counselingBehavioural
Behavioural counseling grounded in the Health Action Process Approach (i.e., action planning and coping planning) to reduce sedentary behaviour.

Study groups in NCT03694951
Study group	Role	What they receive
Intervention Group	Experimental	The intervention group will receive a pedometer and HAPA behavioural counseling with the aim of reducing their daily sedentary behaviour to <7 hours per day, over a one week period. Counseling strategies will be grounded in the HAPA model - specifically, creating an action plan and coping strategies for reducing their daily sedentary behaviour. Strategies may include: setting an alarm while studying to break up sedentary behaviour, to stand rather than sit on transit, and/or to achieve an active step profile (i.e., ≥10,000 steps a day) through pedometer self-monitoring. Receives: Behavioral: HAPA behavioural counseling
Control Group	No intervention	The control group will not receive any behavioural intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from pre-randomization Subjective Well-Being (Affect) at 1-week post-intervention and 1-week follow-up
Subjective Well-Being (specifically, affect) will be assessed through the Positive Affect \& Negative Affect Scale (PANAS).
The PANAS consists of a number of words that describe different feelings and emotions. Participants indicate the extent to which they feel a particular feeling and emotion over the past week, using a 5-point scale that ranges from 1 "very slightly or not at all" to 5 "extremely".
An overall score for both positive and negative affect is calculated by summing up the points for those particular feelings/emotions (e.g., interested for positive affect, distressed for negative affect). Scores for positive affect can range from 10-50, with higher scores representing higher levels of positive affect. Scores for negative affect can range from 10-50, with lower scores representing lower levels of negative affect.
Measured: Baseline, 1-week post-intervention, and 1-week follow-up
Change from pre-randomization Subjective Well-Being (Life Satisfaction) at 1-week post-intervention and 1-week follow-up
Subjective Well-Being (specifically, life satisfaction) will be assessed through the Satisfaction with Life Scale (SWLS); a 5-item scale designed to measure global cognitive judgments of one's life satisfaction.
Participants indicate how much they agree or disagree with each of the 5-items over the past week, using a 7-point scale that ranges from 7 "strongly agree" to 1 "strongly disagree". An overall score (from 5 to 35) is calculated through summing the responses to the 5-items.
Recommended cutoffs for interpretation are: 5-9, extremely dissatisfied; 10-14, dissatisfied; 15-19, slightly dissatisfied; 20, neutral; 21-25, slightly satisfied; 26-30, satisfied; 31-35, very satisfied.
Measured: Baseline, 1-week post-intervention, and 1-week follow-up
Change from pre-randomization Subjective Well-Being (Eudaimonic Well-Being) at 1-week post-intervention and 1-week follow-up
Subjective Well-Being (Eudaimonic Well-Being) will be assessed through the Subjective Vitality Scale (SVS); a 6- or 7-item scale that assesses the state of feeling alive and alert - to having energy available to the self. For the purposes of this study, the 6-item individual difference level version of the SVS will be utilized.
Participants indicate the degree in which a statement/item is true in general in their life, ranging from 1 "not at all" to 7 "very true". An overall score is obtained by averaging the scores for each of the 6-items, with higher scores indicating a greater feeling of vitality.
Measured: Baseline, 1-week post-intervention, and 1-week follow-up
Change from pre-randomization Subjective Well-Being at 1-week post-intervention and 1-week follow-up
Subjective Well-Being will be assessed through the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).
The WEMWBS consists of 14-items that assesses subjective well-being through both hedonic and eudaimonic dimensions of well-being. Participants select the option that best describes their experience with each of the 14-items over the last week (note: the original questionnaire assesses the last two weeks), using a 5-point scale that ranges from 1 "none of the time" to 5 "all of the time".
A total score is calculated by summing the 14 individual statement scores. The minimum score is 14 and the maximum is 70, with higher scores indicating greater levels of subjective well-being.
Measured: Baseline, 1-week post-intervention, and 1-week follow-up

Secondary outcomes (5)

Change from pre-randomization self-reported Physical Activity at 1-week post-intervention and 1-week follow-up
Average self-reported total weekday and weekend time spent in moderate and vigorous physical activities in the last 7 days will be assessed through the International Physical Activity Questionnaire Seven - Short Form Past 7 Days (IPAQ-S7S).
Participants report how many days per week (0-7) and how many hours/minutes per day they spent engaged in vigorous and moderate intensity physical activity, as well as walking.
Measured: Baseline, 1-week post-intervention, and 1-week follow-up
Change from pre-randomization self-reported Sedentary Behaviour at 1-week post-intervention and 1-week follow-up
Average self-reported weekday and weekend domain-specific time spent sedentary over the past 7 days will be assessed through the modified SIT-Q 7d questionnaire. Participants indicate on a scale of responses the range of times that best correspond to the average amount of time they spent sedentary on weekdays/weekends in domains of: Sleeping and Napping, Meals, Transportation, Occupation(s), Screen Time, and Other Activities, during the past 7 days. Response ranges typically span 30 minutes to 1 hour (e.g., Less than 30 minutes, 1-2 hours).
Average total sitting time per weekday will be assessed through a single question on the International Physical Activity Questionnaire Seven - Short Form Past 7 Days (IPAQ-S7S): "During the last 7 days, how much time did you spend sitting on a weekday?" Average total sitting time per day; assessed through the International Physical Activity Questionnaire Seven - Short Form Past 7 Days (IPAQ-S7S)
Measured: Baseline, 1-week post-intervention, and 1-week follow-up
Change from pre-randomization Depression at 1-week post-intervention and 1-week follow-up
Depressive symptomatology will be assessed through the Centre for Epidemiological Studies Depression Scale (CES-D).
The CES-D scale is a short self-report scale designed to measure depressive symptomatology in the general population. Participants indicate how often in the past week they have felt or behaved for each of the 20 feelings/behaviors in the scale. Options range from: rarely or none of the time (less than 1 day), some or little of the time (1-2 days), occasionally or a moderate amount of time (3-5 days), and most or all of the time (5-7 days). These options correspond to a score of either: 0, 1, 2, or 3, depending on the framing of the question.
A total score is achieved through summing the scores for all 20 questions; scores range from 0-60, with lower scores indicating a lower symptomatomology for depression. A clinical cut-off point of 20 has been recommended.
Measured: Baseline, 1-week post-intervention, and 1-week follow-up
Change from pre-randomization Anxiety (State) at 1-week post-intervention and 1-week follow-up
State anxiety will be assessed through the State-Trait Anxiety Inventory (STAI) Form Y-1. Participants read each of the 20 statements and then write the number in the blank at the end of the statement that indicates how they feel right now (i.e., at this moment).
Responses range from: 1 - not at all, to 4 - very much so; these response correspond to a score of 1-4 for anxiety-related items, and 4-1 for anxiety-absent items. A total score is obtained by summing the scores for each question. Total scores range from 20-80, with higher scores indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale.
Measured: Baseline, 1-week post-intervention, and 1-week follow-up
Change from pre-randomization objectively-measured Sedentary Behaviour at 1-week post-intervention and 1-week follow-up
Average objectively-reported weekday and weekend time spent sedentary over the past 7 days will be assessed through the ActivPAL4 inclinometer. Participants will wear the device on their thigh for a period of 7 days. The inclinometer is able to track and distinguish between sitting, standing, and other non-sedentary behaviours. The ActivPAL software can be used to extract data from the device to form daily levels of sedentary behaviour over the last 7 days. Activity can then be averaged to form a weekly average of time spent sedentary.
Measured: Baseline, 1-week post-intervention, and 1-week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 201928 Feb 2020

First posted3 Oct 2018
Study start10 Sep 2019
Primary completion28 Feb 2020
Study completion28 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sedentary LifestyleStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Upon obtaining consent, eligible participants will complete a week-long baseline period and then will be randomly assigned to either a 1-week intervention or control group, followed by a 1-week follow-up period.
Masking: Single blind
Who is masked: Participant
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03694951
Sponsor's protocol ID: 112399
Status last verified: Sep 2019
First submitted: 14 Aug 2018
Last updated: 28 May 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Upon publication of the research results, IPD will be shared into the Federated Research Data Repository (FRDR)

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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

All Sedentary Lifestyle trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Experimentally Decreasing Sedentary Behaviour on Subjective Well-being
ClinicalTrials.gov ID: NCT03694951
Acronym / sponsor ID: 112399
Conditions: Sedentary Lifestyle, Quality of Life
Keywords: Sedentary Behaviour, Subjective Well-Being, University Students
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Western University, CanadaUniversity, hospital or other
Collaborators: Social Sciences and Humanities Research Council of Canada
Study start: 10 Sep 2019 (actual)
Primary completion: 28 Feb 2020 (actual)
Study completion: 28 Feb 2020 (actual)
First posted: 3 Oct 2018 (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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Upon obtaining consent, eligible participants will complete a week-long baseline period and then will be randomly assigned to either a 1-week intervention or control group, followed by a 1-week follow-up period.

Arm	Type	Receives
Intervention Group	Experimental	Behavioral: HAPA behavioural counselingThe intervention group will receive a pedometer and HAPA behavioural counseling with the aim of reducing their daily sedentary behaviour to <7 hours per day, over a one week period. Counseling strategies will be grounded in the HAPA model - specifically, creating an action plan and coping strategies for reducing their daily sedentary behaviour. Strategies may include: setting an alarm while studying to break up sedentary behaviour, to stand rather than sit on transit, and/or to achieve an active step profile (i.e., ≥10,000 steps a day) through pedometer self-monitoring.
Control Group	No intervention	–The control group will not receive any behavioural intervention.

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 student attending Western University
Able to read and write in English
Objectively report ≥7 hours of average daily sedentary time, via ActivPAL4 inclinometer

Key exclusion criteria (2 listed)

Self-reporting a mental illness
Currently having a physical disability that would prevent walking

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 counselingBehavioural counseling grounded in the Health Action Process Approach (i.e., action planning and coping planning) to reduce sedentary behaviour.	Behavioural	Intervention Group

Primary outcome

Change from pre-randomization Subjective Well-Being (Affect) at 1-week post-intervention and 1-week follow-up
Time frame: Baseline, 1-week post-intervention, and 1-week follow-up
Subjective Well-Being (specifically, affect) will be assessed through the Positive Affect \& Negative Affect Scale (PANAS). The PANAS consists of a number of words that describe different feelings and emotions. Participants indicate the extent to which they feel a particular feeling and emotion over the past week, using a 5-point scale that ranges from 1 "very slightly or not at all" to 5 "extremely". An overall score for both positive and negative affect is calculated by summing up the points for those particular feelings/emotions (e.g., interested for positive affect, distressed for negative affect). Scores for positive affect can range from 10-50, with higher scores representing higher levels of positive affect. Scores for negative affect can range from 10-50, with lower scores representing lower levels of negative affect.
Change from pre-randomization Subjective Well-Being (Life Satisfaction) at 1-week post-intervention and 1-week follow-up
Time frame: Baseline, 1-week post-intervention, and 1-week follow-up
Subjective Well-Being (specifically, life satisfaction) will be assessed through the Satisfaction with Life Scale (SWLS); a 5-item scale designed to measure global cognitive judgments of one's life satisfaction. Participants indicate how much they agree or disagree with each of the 5-items over the past week, using a 7-point scale that ranges from 7 "strongly agree" to 1 "strongly disagree". An overall score (from 5 to 35) is calculated through summing the responses to the 5-items. Recommended cutoffs for interpretation are: 5-9, extremely dissatisfied; 10-14, dissatisfied; 15-19, slightly dissatisfied; 20, neutral; 21-25, slightly satisfied; 26-30, satisfied; 31-35, very satisfied.
Change from pre-randomization Subjective Well-Being (Eudaimonic Well-Being) at 1-week post-intervention and 1-week follow-up
Time frame: Baseline, 1-week post-intervention, and 1-week follow-up
Subjective Well-Being (Eudaimonic Well-Being) will be assessed through the Subjective Vitality Scale (SVS); a 6- or 7-item scale that assesses the state of feeling alive and alert - to having energy available to the self. For the purposes of this study, the 6-item individual difference level version of the SVS will be utilized. Participants indicate the degree in which a statement/item is true in general in their life, ranging from 1 "not at all" to 7 "very true". An overall score is obtained by averaging the scores for each of the 6-items, with higher scores indicating a greater feeling of vitality.
Change from pre-randomization Subjective Well-Being at 1-week post-intervention and 1-week follow-up
Time frame: Baseline, 1-week post-intervention, and 1-week follow-up
Subjective Well-Being will be assessed through the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). The WEMWBS consists of 14-items that assesses subjective well-being through both hedonic and eudaimonic dimensions of well-being. Participants select the option that best describes their experience with each of the 14-items over the last week (note: the original questionnaire assesses the last two weeks), using a 5-point scale that ranges from 1 "none of the time" to 5 "all of the time". A total score is calculated by summing the 14 individual statement scores. The minimum score is 14 and the maximum is 70, with higher scores indicating greater levels of subjective well-being.

5 secondary outcomes

Change from pre-randomization self-reported Physical Activity at 1-week post-intervention and 1-week follow-up
Time frame: Baseline, 1-week post-intervention, and 1-week follow-up
Change from pre-randomization self-reported Sedentary Behaviour at 1-week post-intervention and 1-week follow-up
Time frame: Baseline, 1-week post-intervention, and 1-week follow-up
Change from pre-randomization Depression at 1-week post-intervention and 1-week follow-up
Time frame: Baseline, 1-week post-intervention, and 1-week follow-up
Change from pre-randomization Anxiety (State) at 1-week post-intervention and 1-week follow-up
Time frame: Baseline, 1-week post-intervention, and 1-week follow-up
Change from pre-randomization objectively-measured Sedentary Behaviour at 1-week post-intervention and 1-week follow-up
Time frame: Baseline, 1-week post-intervention, and 1-week follow-up

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 28 May 2020.
Individual participant dataSharing planned: Yes. Upon publication of the research results, IPD will be shared into the Federated Research Data Repository (FRDR)

Related trials for Sedentary Lifestyle

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, 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 HAPA behavioural counseling in people with Sedentary Lifestyle and Quality of Life, 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 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 28 May 2020. 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 from pre-randomization Subjective Well-Being (Affect) at 1-week post-intervention and 1-week follow-up (time frame: Baseline, 1-week post-intervention, and 1-week follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03694951.

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 28 May 2020.