InactivityNCT02080585
Effectiveness of a Web-based, Computer-tailored, Pedometer-based Physical Activity Intervention for Adults: a Cluster-randomized Controlled Trial
A study testing Physical Activity advice. in people with Inactivity, run by University Ghent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inactivity
- What is being tested?
- Physical Activity advice.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteBelgium
- Study dates
- May 2012to Jun 2013
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dutch speaking
- Age range: 18 - 65 years old
- Access to the Internet at work or at home
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Ghent University - Department of Movement and Sports Sciences
Ghent, 9000
About this study
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.
- Conditions
- Inactivity
- Being tested
- Physical Activity advice.
- Keywords
- Inactivity
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity advice.Behavioural
Subjects receive advice regarding physical activities.
| Study group | Role | What they receive |
|---|---|---|
| Control group without advice | No intervention | Control group receives no intervention or physical activity advice. |
| Computer-tailored physical activity advice | Experimental | Subjects receive computer-tailored physical activity advice. Receives: Behavioral: Physical Activity advice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of physical activity at baseline.
Using International Physical Activity Questionnaire (IPAQ) and Omron HJ-203-ED pedometer.
Measured: at baseline
Amount of Physical activity 1 month after baseline.
Using International Physical Activity Questionnaire (IPAQ) and Omron HJ-203-ED pedometer.
Measured: 1 month after baseline
Amount of physical activity 3 months after baseline.
Using International Physical Activity Questionnaire (IPAQ) and Omron HJ-203-ED pedometer.
Measured: 3 months after baseline
Secondary outcomes (3)
Sedentary behaviour at baseline.
International Physical Activity Questionnaire (IPAQ)
Measured: at baseline
Sedentary behaviour 1 month after baseline.
International Physical Activity Questionnaire (IPAQ)
Measured: 1 month after baseline
Sedentary behaviour 3 months after baseline.
International Physical Activity Questionnaire (IPAQ)
Measured: 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startMay 2012
- Primary completionFeb 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InactivityStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Sponsor
- Investigators
- Ilse De Bourdeaudhuij, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080585
- Sponsor's protocol ID
- 2005/027
- Status last verified
- Mar 2014
- First submitted
- 4 Mar 2014
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Compernolle S, Vandelanotte C, Cardon G, De Bourdeaudhuij I, De Cocker K. Effectiveness of a web-based, computer-tailored, pedometer-based physical activity intervention for adults: a cluster randomized controlled trial. J Med Internet Res. 2015 Feb 9;17(2):e38. doi: 10.2196/jmir.3402.
PubMed 25665498
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Web-based, Computer-tailored, Pedometer-based Physical Activity Intervention for Adults: a Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02080585
- Acronym / sponsor ID
- 2005/027
- Conditions
- Inactivity
- Keywords
- Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- May 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Mar 2014 (estimated)
- 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group without advice | No intervention | –Control group receives no intervention or physical activity advice. |
| Computer-tailored physical activity advice | Experimental | Behavioral: Physical Activity advice.Subjects receive computer-tailored physical activity advice. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dutch speaking
- Age range: 18 - 65 years old
- Access to the Internet at work or at home
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Physical Activity advice.Subjects receive advice regarding physical activities. | Behavioural | Computer-tailored physical activity advice |
Primary outcome
Amount of physical activity at baseline.
Time frame: at baseline
Using International Physical Activity Questionnaire (IPAQ) and Omron HJ-203-ED pedometer.
Amount of Physical activity 1 month after baseline.
Time frame: 1 month after baseline
Using International Physical Activity Questionnaire (IPAQ) and Omron HJ-203-ED pedometer.
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 secondary outcomes
Sedentary behaviour at baseline.
Time frame: at baseline
Sedentary behaviour 1 month after baseline.
Time frame: 1 month after baseline
Sedentary behaviour 3 months after baseline.
Time frame: 3 months after 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 6 Mar 2014.
- Derived from this study: PubMed 25665498Compernolle S, Vandelanotte C, Cardon G, De Bourdeaudhuij I, De Cocker K. Effectiveness of a web-based, computer-tailored, pedometer-based physical activity intervention for adults: a cluster randomized controlled trial. J Med Internet Res. 2015 Feb 9;17(2):e38. doi: 10.2196/jmir.3402.
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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.
Ilse De Bourdeaudhuij, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity advice. in people with Inactivity, run by University Ghent at 1 site in Belgium.
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 3 inclusion and 0 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 6 Mar 2014. 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 Belgium. 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?
Amount of physical activity at baseline. (time frame: at 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 NCT02080585, which also lists 1 linked publication.
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 6 Mar 2014.