- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02844101
Assess Whether Knowledge by the Younger of the Function of the Accelerometer Determines Its Amount of Physical Activity (ACCELORIX2)
December 15, 2025 updated by: University Hospital, Lille
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
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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Lille, France
- Hôpital Jeanne de Flandre - CHRU de Lille
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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
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- abnormal ECG
- known chronic disease
- acute infection dating back at least a week.
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: non-blinded group
The non-blinded subjects will be informed that the accelerometer device (GT3X Actigraph accelerometer) is an accelerometer that assessed physical activity levels and patterns
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Other: blinded group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
during 4 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Frédéric Gottrand, MD, PhD, University Hospital, Lille
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
- 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.
- Vanhelst 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.
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
July 1, 2013
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
July 13, 2016
First Submitted That Met QC Criteria
July 25, 2016
First Posted (Estimated)
July 26, 2016
Study Record Updates
Last Update Posted (Estimated)
December 22, 2025
Last Update Submitted That Met QC Criteria
December 15, 2025
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012_29
- 2012-A01647-36 (Other Identifier: ID-RCB number, ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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