Physical ActivityACCELORIX2NCT02844101
Assess Whether Knowledge by the Younger of the Function of the Accelerometer Determines Its Amount of Physical Activity
A study testing GT3X Actigraph accelerometer. in people with Physical Activity, run by University Hospital, Lille at 1 site in France.
Trial summary
Eighty healthy youngsters, aged 10-18 years, will be equally randomized between the blinded and the non-blinded group. The blinded subjects will be informed that we were testing the reliability of a new device for body posture assessment and these youngsters will did not receive any information with regards to… Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- GT3X Actigraph accelerometer.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Jun 2015
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 10-18 years old adolescent
- normal clinical examination,
- normal nutritional status at baseline defined by a weight / height ratio between - 2 and + 2 DS DS
Who cannot join
- abnormal ECG
- known chronic disease
- acute infection dating back at least a week.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assess Whether Knowledge by the Children and Adolescents of the Function of the Accelerometer Determines Its Amount of Physical Activity
Eighty healthy youngsters, aged 10-18 years, will be equally randomized between the blinded and the non-blinded group. The blinded subjects will be informed that we were testing the reliability of a new device for body posture assessment and these youngsters will did not receive any information with regards to physical activity. Conversely, the non-blinded subjects were informed that the device was an accelerometer that assessed physical activity levels and patterns. Participants will be instructed to wear the accelerometer for 4 consecutive days and to keep a non-wear log diary over the 4 day-monitoring. The overall duration and the duration relative to the quality of the physical activity patterns (sedentary, light, moderate, vigorous and moderate to vigorous) were computed for each group during the 4-day monitoring, then compared between the two groups using the Student's t test.
- Conditions
- Physical Activity
- Being tested
- GT3X Actigraph accelerometer.
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT3X Actigraph accelerometer.Device
| Study group | Role | What they receive |
|---|---|---|
| non-blinded group | Other | The non-blinded subjects will be informed that the accelerometer device (GT3X Actigraph accelerometer) is an accelerometer that assessed physical activity levels and patterns Receives: Device: GT3X Actigraph accelerometer. |
| blinded group | Other | The blinded subjects will be informed that they will test the reliability of a new device for body posture assessment and these youngsters will not receive any information with regards to physical activity. Receives: Device: GT3X Actigraph accelerometer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity by GT3X Actigraph accelerometer.
The physical activity measured in counts/day using an GT3X Actigraph accelerometer.
Participants were instructed to wear the accelerometer for 4 consecutive days and to keep a non-wear log diary over the 4 day-monitoring.
Measured: during 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJul 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Gottrand, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844101
- Sponsor's protocol ID
- 2012_29
- Other IDs
- 2012-A01647-36
- Acronym
- ACCELORIX2
- Status last verified
- Oct 2016
- First submitted
- 13 Jul 2016
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vanhelst J, Beghin L, Drumez E, Coopman S, Gottrand F. Awareness of wearing an accelerometer does not affect physical activity in youth. BMC Med Res Methodol. 2017 Jul 11;17(1):99. doi: 10.1186/s12874-017-0378-5.
PubMed 28693500Vanhelst J, Vidal F, Drumez E, Beghin L, Baudelet JB, Coopman S, Gottrand F. Comparison and validation of accelerometer wear time and non-wear time algorithms for assessing physical activity levels in children and adolescents. BMC Med Res Methodol. 2019 Apr 2;19(1):72. doi: 10.1186/s12874-019-0712-1.
PubMed 30940079
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess Whether Knowledge by the Children and Adolescents of the Function of the Accelerometer Determines Its Amount of Physical Activity
- ClinicalTrials.gov ID
- NCT02844101
- Acronym / sponsor ID
- ACCELORIX2 / 2012_29
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Jul 2016 (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.
Eighty healthy youngsters, aged 10-18 years, will be equally randomized between the blinded and the non-blinded group. The blinded subjects will be informed that we were testing the reliability of a new device for body posture assessment and these youngsters will did not receive any information with regards to physical activity. Conversely, the non-blinded subjects were informed that the device was an accelerometer that assessed physical activity levels and patterns. Participants will be instructed to wear the accelerometer for 4 consecutive days and to keep a non-wear log diary over the 4 day-monitoring. The overall duration and the duration relative to the quality of the physical activity patterns (sedentary, light, moderate, vigorous and moderate to vigorous) were computed for each group during the 4-day monitoring, then compared between the two groups using the Student's t test.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-blinded group | Other | Device: GT3X Actigraph accelerometer.The non-blinded subjects will be informed that the accelerometer device (GT3X Actigraph accelerometer) is an accelerometer that assessed physical activity levels and patterns |
| blinded group | Other | Device: GT3X Actigraph accelerometer.The blinded subjects will be informed that they will test the reliability of a new device for body posture assessment and these youngsters will not receive any information with regards to physical activity. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 10-18 years old adolescent
- normal clinical examination,
- normal nutritional status at baseline defined by a weight / height ratio between - 2 and + 2 DS DS
Key exclusion criteria (3 listed)
- abnormal ECG
- known chronic disease
- acute infection dating back at least a week.
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 |
|---|---|---|
| GT3X Actigraph accelerometer. | Device | blinded group, non-blinded group |
Primary outcome
physical activity by GT3X Actigraph accelerometer.
Time frame: during 4 days
The physical activity measured in counts/day using an GT3X Actigraph accelerometer. Participants were instructed to wear the accelerometer for 4 consecutive days and to keep a non-wear log diary over the 4 day-monitoring.
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 22 Dec 2025.
- Results publication: PubMed 28693500Vanhelst J, Beghin L, Drumez E, Coopman S, Gottrand F. Awareness of wearing an accelerometer does not affect physical activity in youth. BMC Med Res Methodol. 2017 Jul 11;17(1):99. doi: 10.1186/s12874-017-0378-5.
- Derived from this study: PubMed 30940079Vanhelst J, Vidal F, Drumez E, Beghin L, Baudelet JB, Coopman S, Gottrand F. Comparison and validation of accelerometer wear time and non-wear time algorithms for assessing physical activity levels in children and adolescents. BMC Med Res Methodol. 2019 Apr 2;19(1):72. doi: 10.1186/s12874-019-0712-1.
- Individual participant dataSharing planned: No
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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.
Frédéric Gottrand, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GT3X Actigraph accelerometer. in people with Physical Activity, run by University Hospital, Lille at 1 site in France.
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 3 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 22 Dec 2025. 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 France. 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?
physical activity by GT3X Actigraph accelerometer. (time frame: during 4 days). 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 NCT02844101, which also lists 2 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 22 Dec 2025.