Sedentary BehaviourNCT03612882
Sedentary Behaviour and Subjective Well-being
An observational study of Sedentary Behaviour, run by Western University, Canada at 1 site in Canada.
Trial summary
This study will investigate the relationship between sedentary behaviour and subjective well-being among a sample of university students. Eligible participants will fill out an online survey with questions assessing their sedentary behaviour, physical activity, subjective well-being, life satisfaction, depression… 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
- What is being tested?
- Online questionnaire
- How many people
- 1,006 participants
- Where
- 1 siteCanada
- Study dates
- 5 Oct 2018to 20 Sep 2019
- Phase
- Observational
- 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
Study population: Full-time University students attending Western University
Who may be able to join
- Currently a full-time student enrolled at Western University
- Are 18 years of age or older
- Are able to read and write in English
- Have access to a computer with internet
Who cannot join
- Part-time enrollment or currently on a leave of absence from full-time studies at Western University
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Relationship Between Sedentary Behaviour and Subjective Well-being in University Students: A Cross-sectional Study
This study will investigate the relationship between sedentary behaviour and subjective well-being among a sample of university students. Eligible participants will fill out an online survey with questions assessing their sedentary behaviour, physical activity, subjective well-being, life satisfaction, depression, anxiety, and demographic variables.
Read the detailed description
An electronic survey will be used to assess outcomes of interest (i.e., demographics, sedentary behaviour and physical activity history, subjective well-being, life satisfaction, depression, and anxiety). The survey will be created and hosted on SoSci Survey. Interested participants will contact the investigators and will be sent a personal link to access the survey. Upon following the link, participants will answer inclusion/exclusion criteria and give electronic consent. Upon confirming consent and eligibility, participants will complete the survey. Upon completion of the survey, participants will be thanked and offered an entry into a draw.
- Conditions
- Sedentary Behaviour
- Being tested
- Online questionnaire
- Keywords
- Sedentary Behaviour, Subjective Well-Being, University Students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online questionnaireOther
Online questionnaire assessing sedentary behaviour, physical activity, subjective well-being, life satisfaction, depression, anxiety, and demographics
| Study group | Role | What they receive |
|---|---|---|
| Western University Students | Online questionnaire Receives: Other: Online questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Well-Being (Affect)
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
Subjective Well-Being (Life Satisfaction)
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
Subjective Well-Being
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: Past seven days
Secondary outcomes (4)
Physical Activity
Average 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: Past seven days
Sedentary Behaviour
Average 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?"
Measured: Past seven days
Depression
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: Past seven days
Anxiety (State)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start5 Oct 2018
- Primary completion30 Apr 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Sedentary BehaviourStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,006 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Social Sciences and Humanities Research Council of Canada
- Responsible party
- Sponsor
- Investigators
- Harry Prapavessis, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612882
- Sponsor's protocol ID
- 111662
- Status last verified
- Sep 2019
- First submitted
- 23 Jul 2018
- Last updated
- 29 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)
Publications
Wijndaele K, DE Bourdeaudhuij I, Godino JG, Lynch BM, Griffin SJ, Westgate K, Brage S. Reliability and validity of a domain-specific last 7-d sedentary time questionnaire. Med Sci Sports Exerc. 2014 Jun;46(6):1248-60. doi: 10.1249/MSS.0000000000000214.
PubMed 24492633Sui W, Prapavessis H. Standing Up for Student Health: An Application of the Health Action Process Approach for Reducing Student Sedentary Behavior-Randomised Control Pilot Trial. Appl Psychol Health Well Being. 2018 Mar;10(1):87-107. doi: 10.1111/aphw.12105. Epub 2017 Dec 5.
PubMed 29205909Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
PubMed 18042300Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
PubMed 16367493Ryan RM, Frederick C. On energy, personality, and health: subjective vitality as a dynamic reflection of well-being. J Pers. 1997 Sep;65(3):529-65. doi: 10.1111/j.1467-6494.1997.tb00326.x.
PubMed 9327588Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.
PubMed 22588767Vilagut G, Forero CG, Barbaglia G, Alonso J. Screening for Depression in the General Population with the Center for Epidemiologic Studies Depression (CES-D): A Systematic Review with Meta-Analysis. PLoS One. 2016 May 16;11(5):e0155431. doi: 10.1371/journal.pone.0155431. eCollection 2016.
PubMed 27182821Radloff LS: The CES-D Scale: a self-report depression scale for research in the general population. Applied Psychological Measurement 1:385-401, 1977.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Relationship Between Sedentary Behaviour and Subjective Well-being in University Students: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03612882
- Acronym / sponsor ID
- 111662
- Conditions
- Sedentary Behaviour
- Keywords
- Sedentary Behaviour, Subjective Well-Being, University Students
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,006 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- Social Sciences and Humanities Research Council of Canada
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 2 Aug 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.
This study will investigate the relationship between sedentary behaviour and subjective well-being among a sample of university students. Eligible participants will fill out an online survey with questions assessing their sedentary behaviour, physical activity, subjective well-being, life satisfaction, depression, anxiety, and demographic variables.
Detailed description
An electronic survey will be used to assess outcomes of interest (i.e., demographics, sedentary behaviour and physical activity history, subjective well-being, life satisfaction, depression, and anxiety). The survey will be created and hosted on SoSci Survey. Interested participants will contact the investigators and will be sent a personal link to access the survey. Upon following the link, participants will answer inclusion/exclusion criteria and give electronic consent. Upon confirming consent and eligibility, participants will complete the survey. Upon completion of the survey, participants will be thanked and offered an entry into a draw.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Western University Students | – | Other: Online questionnaireOnline questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Full-time University students attending Western University
Key inclusion criteria (4 listed)
- Currently a full-time student enrolled at Western University
- Are 18 years of age or older
- Are able to read and write in English
- Have access to a computer with internet
Key exclusion criteria (1 listed)
- Part-time enrollment or currently on a leave of absence from full-time studies at Western University
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 |
|---|---|---|
| Online questionnaireOnline questionnaire assessing sedentary behaviour, physical activity, subjective well-being, life satisfaction, depression, anxiety, and demographics | Other | Western University Students |
Primary outcome
Subjective Well-Being (Affect)
Time frame: Baseline
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.
Subjective Well-Being (Life Satisfaction)
Time frame: Baseline
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.
Subjective Well-Being
Time frame: Past seven days
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.
4 secondary outcomes
Physical Activity
Time frame: Past seven days
Sedentary Behaviour
Time frame: Past seven days
Depression
Time frame: Past seven days
Anxiety (State)
Time frame: Baseline
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 29 May 2020.
- Background: PubMed 24492633Wijndaele K, DE Bourdeaudhuij I, Godino JG, Lynch BM, Griffin SJ, Westgate K, Brage S. Reliability and validity of a domain-specific last 7-d sedentary time questionnaire. Med Sci Sports Exerc. 2014 Jun;46(6):1248-60. doi: 10.1249/MSS.0000000000000214.
- Background: PubMed 29205909Sui W, Prapavessis H. Standing Up for Student Health: An Application of the Health Action Process Approach for Reducing Student Sedentary Behavior-Randomised Control Pilot Trial. Appl Psychol Health Well Being. 2018 Mar;10(1):87-107. doi: 10.1111/aphw.12105. Epub 2017 Dec 5.
- Background: PubMed 18042300Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
- Background: PubMed 3397865Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Background: PubMed 16367493Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
- Background: PubMed 9327588Ryan RM, Frederick C. On energy, personality, and health: subjective vitality as a dynamic reflection of well-being. J Pers. 1997 Sep;65(3):529-65. doi: 10.1111/j.1467-6494.1997.tb00326.x.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 22588767Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.
- Background: PubMed 27182821Vilagut G, Forero CG, Barbaglia G, Alonso J. Screening for Depression in the General Population with the Center for Epidemiologic Studies Depression (CES-D): A Systematic Review with Meta-Analysis. PLoS One. 2016 May 16;11(5):e0155431. doi: 10.1371/journal.pone.0155431. eCollection 2016.
- BackgroundRadloff LS: The CES-D Scale: a self-report depression scale for research in the general population. Applied Psychological Measurement 1:385-401, 1977.
- SoSci Survey website - host of electronic questionnaireLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Upon publication of the research results, IPD will be shared into the Federated Research Data Repository (FRDR)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Prapavessis, 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?
An observational study of Sedentary Behaviour, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 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?
Subjective Well-Being (Affect) (time frame: Baseline). The study lists 3 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 NCT03612882, which also lists 10 linked publications.
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 29 May 2020.