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Trial record 1 of 2 for:    Physical activity accelerometer Lille | Completed, Terminated Studies | France
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Assess Whether Knowledge by the Younger of the Function of the Accelerometer Determines Its Amount of Physical Activity (ACCELORIX2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT02844101
First received: July 13, 2016
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Physical Activity Device: GT3X Actigraph accelerometer.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Official Title: Assess Whether Knowledge by the Children and Adolescents of the Function of the Accelerometer Determines Its Amount of Physical Activity

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • 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.



Enrollment: 80
Study Start Date: July 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: GT3X Actigraph accelerometer.
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.
Device: GT3X Actigraph accelerometer.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02844101

Locations
France
Hôpital Jeanne de Flandre - CHRU de Lille
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Frédéric Gottrand, MD, PhD University Hospital, Lille
  More Information

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02844101     History of Changes
Other Study ID Numbers: 2012_29
2012-A01647-36 ( Other Identifier: ID-RCB number, ANSM )
Study First Received: July 13, 2016
Last Updated: October 26, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

ClinicalTrials.gov processed this record on July 26, 2017