- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02080585
Effectiveness of a Web-based, Computer-tailored, Pedometer-based Physical Activity Intervention for Adults: a Cluster-randomized Controlled Trial
March 5, 2014 updated by: University Ghent
The present study used a cluster-randomized controlled trial to evaluate the effects of a computer-tailored, pedometer-based Physical Activity (PA) intervention delivered through the Internet.
An invitation e-mail with study information was sent to managers of 18 white-collar workplaces.
Eight workplaces consented to participate.
All employees of a single workplace were allocated at random to either the intervention or a waiting list control group, in order to avoid contamination between employees receiving the intervention and those who were not receiving the intervention.
Subsequently, employees of the participating workplaces were recruited by e-mail.
Only Dutch speaking employees between 18 and 65 years old, who had access to the Internet at work or at home, were eligible.
Interested employees could sign up by returning a confirmation e-mail to the researchers.
On receiving this information, a meeting was organized in each of the eight worksites to deliver all documents for baseline measurement (T0) to the participants, including an informed consent form, a blinded pedometer, an activity log and a self-administered questionnaire.
During this meeting, information was provided on how to use the pedometer, how to log PA activities and how to answer the questionnaire.
Moreover, the participants were asked to adhere to their usual PA pattern throughout the baseline measurement.
After one week, all measurement tools were collected, and average daily step counts were calculated.
At this point, participants in the intervention condition received (1) a booklet with information on how to increase steps, (2) a non-blinded pedometer, which they could use for three months, and (3) a username, a password and the amount of average daily steps, calculated by the researchers, so that participants could use this number when requesting the online computer-tailored step advice.
Participants in the control condition did not receive any of the above mentioned intervention components.
One and three months later, all participants again received a blinded pedometer, which was worn for one week.
When wearing the blinded-pedometer one month (T1) and three months (T2) post baseline, intervention participants were allowed to also were the non-blinded pedometer.
Furthermore, the same self-reported questionnaire was used to measure PA level at T1 and T2 in order to test the effectiveness of the intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
274
Phase
- Not Applicable
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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Ghent, Belgium, 9000
- Ghent University - Department of Movement and Sports Sciences
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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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Dutch speaking
- Age range: 18 - 65 years old
- Access to the Internet at work or at home
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
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group without advice
Control group receives no intervention or physical activity advice.
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|
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Experimental: Computer-tailored physical activity advice
Subjects receive computer-tailored physical activity advice.
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Subjects receive advice regarding physical activities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amount of physical activity at baseline.
Time Frame: at baseline
|
Using International Physical Activity Questionnaire (IPAQ) and Omron HJ-203-ED pedometer.
|
at baseline
|
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Amount of Physical activity 1 month after baseline.
Time Frame: 1 month after baseline
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Using International Physical Activity Questionnaire (IPAQ) and Omron HJ-203-ED pedometer.
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1 month after baseline
|
|
Amount of physical activity 3 months after baseline.
Time Frame: 3 months after baseline
|
Using International Physical Activity Questionnaire (IPAQ) and Omron HJ-203-ED pedometer.
|
3 months after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sedentary behaviour at baseline.
Time Frame: at baseline
|
International Physical Activity Questionnaire (IPAQ)
|
at baseline
|
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Sedentary behaviour 1 month after baseline.
Time Frame: 1 month after baseline
|
International Physical Activity Questionnaire (IPAQ)
|
1 month after baseline
|
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Sedentary behaviour 3 months after baseline.
Time Frame: 3 months after baseline
|
International Physical Activity Questionnaire (IPAQ)
|
3 months after baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ilse De Bourdeaudhuij, PhD, University Ghent
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.
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
May 1, 2012
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
March 4, 2014
First Submitted That Met QC Criteria
March 5, 2014
First Posted (Estimate)
March 6, 2014
Study Record Updates
Last Update Posted (Estimate)
March 6, 2014
Last Update Submitted That Met QC Criteria
March 5, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2005/027
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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