- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03513341
Levels of Daily Physical Activity and Sedentary Behaviour in Maastricht University's Undergraduate First Year Students
August 13, 2019 updated by: H.Q. Chim, Maastricht University
This study explores the levels of daily physical activity and sedentary behaviour in Maastricht University's undergraduate first year students.
Furthermore, this study explores the correlations between the students' demographical background information with their levels of physical activity and sedentary behaviour.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants are randomly recruited from the student population.
The participants are invited to complete a demographics questionnaire, wear an ActivPAl accelerometer for 7 days, and complete daily diaries (modified International Physical Activity Questionnaire) throughout the 7 days.
Study Type
Observational
Enrollment (Actual)
335
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Limburg
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Maastricht, Limburg, Netherlands, 6200MD
- Maastricht University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Maastricht University 2017-2018 First Year Students
Description
Inclusion Criteria:
- Matriculated Maastricht University 2017-2018 First Year Student
Exclusion Criteria:
- Student of Maastricht University's Maastricht Science Programme (MSP) course. This is because the MSP students are undergoing another intervention (i.e., long term use of standing desks) introduced by the same team of researchers.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Maastricht University First Year Students
Maastricht University 2017-2018 undergraduate first year students are invited to participate in the study.
The participants are invited to complete a demographics questionnaire, wear an ActivPAL accelerometer for 7 days, and to complete daily diaries (modified International Physical Activity Questionnaire) for 7 days.
|
No intervention is given to the participants.
This is an observational study exploring the students' levels of physical activity and sedentary behaviour in their natural setting.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) measured by the ActivPAL accelerometer
Time Frame: 7 days
|
The ActivPAL accelerometer senses limb position and activity.
From this information, it can reliably discriminate periods of upright activity from seated or lying activities.
Furthermore, the cadence (stepping rate) of upright activities can be accurately recorded.
Energy expenditure (estimated by the ActivPAL accelerometer using Metabolic Equivalent of Task (MET)) and cadence (step frequency, i.e., steps per minute) will be used to distinguish between sleeping, being sedentary, standing and stepping.
The time spent sleeping, being sedentary, standing and stepping will be measured and compared against global recommendations of physical activity (e.g., WHO recommendations).
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlations (r) between age (measured with a Demographics Questionnaire) and time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping; measured by the ActivPAL accelerometer)
Time Frame: 7 days
|
The correlations between age (days/months/years) and the time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) will be measured to explore the determinants of the various activities (sleeping, being sedentary, standing and stepping).
|
7 days
|
Correlations (r) between gender (measured with a Demographics Questionnaire) and time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping; measured by the ActivPAL accelerometer)
Time Frame: 7 days
|
The correlations between gender ("gender variant/non-conforming" or "male" or "female" or "transgender male" or "transgender female" or "prefer not to answer" or "not listed (please specify)") and the time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) will be measured to explore the determinants of the various activities (sleeping, being sedentary, standing and stepping).
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7 days
|
Correlations (r) between height (measured with a Demographics Questionnaire) and time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping; measured by the ActivPAL accelerometer)
Time Frame: 7 days
|
The correlations between height (metres) and the time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) will be measured to explore the determinants of the various activities (sleeping, being sedentary, standing and stepping).
|
7 days
|
Correlations (r) between weight (measured with a Demographics Questionnaire) and time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping; measured by the ActivPAL accelerometer)
Time Frame: 7 days
|
The correlations between weight (kilograms) and the time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) will be measured to explore the determinants of the various activities (sleeping, being sedentary, standing and stepping).
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7 days
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Correlations (r) between race/ethnicity (measured with a Demographics Questionnaire) and time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping; measured by the ActivPAL accelerometer)
Time Frame: 7 days
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The correlations between race/ethnicity ("White/Caucasian" or "African" or "Middle Eastern" or "South Asian" or "Latino/Hispanic" or "East Asian" or "Caribbean" or "Prefer not to answer" or "Other (please specify)") and the time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) will be measured to explore the determinants of the various activities (sleeping, being sedentary, standing and stepping).
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7 days
|
Correlations (r) between nationality (measured with a Demographics Questionnaire) and time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping; measured by the ActivPAL accelerometer)
Time Frame: 7 days
|
The correlations between nationality (reported by name of nationality) and the time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) will be measured to explore the determinants of the various activities (sleeping, being sedentary, standing and stepping).
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7 days
|
Correlations (r) between living area (measured with a Demographics Questionnaire) and time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping; measured by the ActivPAL accelerometer)
Time Frame: 7 days
|
The correlations between living area (coded as "rural" or "urban" by analysing postal code) and the time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) will be measured to explore the determinants of the various activities (sleeping, being sedentary, standing and stepping).
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7 days
|
Correlations (r) between education status (measured with a Demographics Questionnaire) and time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping; measured by the ActivPAL accelerometer)
Time Frame: 7 days
|
The correlations between education status (years of study, years in tertiary education and hours of classes per day) and the time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) will be measured to explore the determinants of the various activities (sleeping, being sedentary, standing and stepping).
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7 days
|
Correlations (r) between commuting status (measured with a Demographics Questionnaire) and time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping; measured by the ActivPAL accelerometer)
Time Frame: 7 days
|
The correlations between commuting status (i.e., mode of transportation, availability of transportation type, and travel duration in minutes) and the time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) will be measured to explore the determinants of the various activities (sleeping, being sedentary, standing and stepping).
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7 days
|
Correlations (r) between employment status (measured with a Demographics Questionnaire) and time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping; measured by the ActivPAL accelerometer)
Time Frame: 7 days
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The correlations between employment status (absence or presence of a part-time job secondary to being a student) and the time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) will be measured to explore the determinants of the various activities (sleeping, being sedentary, standing and stepping).
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7 days
|
Correlations (r) between living status (measured with a Demographics Questionnaire) and time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping; measured by the ActivPAL accelerometer)
Time Frame: 7 days
|
The correlations between living status ("Alone", "With parent(s)/guardian(s)", "With siblings", "With friend(s)/flatmate(s)", "With partner(s)", "With child(ren)", and/or "Other (please specify)") and the time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) will be measured to explore the determinants of the various activities (sleeping, being sedentary, standing and stepping).
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7 days
|
Correlations (r) between social class (measured with a Demographics Questionnaire) and time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping; measured by the ActivPAL accelerometer)
Time Frame: 7 days
|
The correlations between social class (measured by the highest achieved level of education by parents(s)/guardian(s)) and the time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) will be measured to explore the determinants of the various activities (sleeping, being sedentary, standing and stepping).
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7 days
|
Correlations (r) between gym or sports club membership (measured with a Demographics Questionnaire) and time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping; measured by the ActivPAL accelerometer)
Time Frame: 7 days
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The correlations between gym membership (absence, presence or presence but inactive of a gym or sports club membership) and the time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) will be measured to explore the determinants of the various activities (sleeping, being sedentary, standing and stepping).
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7 days
|
Correlations (r) between sleep duration (measured with a Demographics Questionnaire) and time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping; measured by the ActivPAL accelerometer)
Time Frame: 7 days
|
The correlations between sleep duration (hours) and the time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) will be measured to explore the determinants of the various activities (sleeping, being sedentary, standing and stepping).
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7 days
|
Correlations (r) between smoking status (measured with a Demographics Questionnaire) and time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping; measured by the ActivPAL accelerometer)
Time Frame: 7 days
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The correlations between smoking status ("Yes", "No, I stopped less than 6 months ago", "No, I stopped more than 6 months ago", or "No, I have never smoked") and the time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) will be measured to explore the determinants of the various activities (sleeping, being sedentary, standing and stepping).
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7 days
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Correlations (r) between smoking type (measured with a Demographics Questionnaire) and time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping; measured by the ActivPAL accelerometer)
Time Frame: 7 days
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The correlations between smoking type ("Pipe", "Cigarettes/Shag", "Cigar", "E-cigarettes/Vaporizers or any other electronic devices", "Not applicable" or "Other (please specify)") and the time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) will be measured to explore the determinants of the various activities (sleeping, being sedentary, standing and stepping).
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7 days
|
Correlations (r) between smoking frequency (measured with a Demographics Questionnaire) and time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping; measured by the ActivPAL accelerometer)
Time Frame: 7 days
|
The correlations between smoking frequency (counts per day) and the time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) will be measured to explore the determinants of the various activities (sleeping, being sedentary, standing and stepping).
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7 days
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Correlations (r) between alcohol consumption (measured with a Demographics Questionnaire) and time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping; measured by the ActivPAL accelerometer)
Time Frame: 7 days
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The correlations between alcohol consumption ("Every day", "3-5 times a week", "Once a week", "Only on weekends", "Only on special occasions" or "Never") and the time (minutes) spent in various activities (sleeping, being sedentary, standing and stepping) will be measured to explore the determinants of the various activities (sleeping, being sedentary, standing and stepping).
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7 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hui Qing Chim, Maastricht University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Duvivier BM, Schaper NC, Bremers MA, van Crombrugge G, Menheere PP, Kars M, Savelberg HH. Minimal intensity physical activity (standing and walking) of longer duration improves insulin action and plasma lipids more than shorter periods of moderate to vigorous exercise (cycling) in sedentary subjects when energy expenditure is comparable. PLoS One. 2013;8(2):e55542. doi: 10.1371/journal.pone.0055542. Epub 2013 Feb 13. Erratum In: PLoS One. 2014;9(8):e105135.
- Penedo FJ, Dahn JR. Exercise and well-being: a review of mental and physical health benefits associated with physical activity. Curr Opin Psychiatry. 2005 Mar;18(2):189-93. doi: 10.1097/00001504-200503000-00013.
- Hagstromer M, Oja P, Sjostrom M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006 Sep;9(6):755-62. doi: 10.1079/phn2005898.
- Wilmot EG, Edwardson CL, Achana FA, Davies MJ, Gorely T, Gray LJ, Khunti K, Yates T, Biddle SJ. Sedentary time in adults and the association with diabetes, cardiovascular disease and death: systematic review and meta-analysis. Diabetologia. 2012 Nov;55(11):2895-905. doi: 10.1007/s00125-012-2677-z. Epub 2012 Aug 14. Erratum In: Diabetologia. 2013 Apr;56(4):942-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Actual)
July 31, 2018
Study Completion (Actual)
July 31, 2018
Study Registration Dates
First Submitted
March 17, 2018
First Submitted That Met QC Criteria
April 30, 2018
First Posted (Actual)
May 1, 2018
Study Record Updates
Last Update Posted (Actual)
August 14, 2019
Last Update Submitted That Met QC Criteria
August 13, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 808
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Time Frame
A maximum of 1 year after publication of study in a journal.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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