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Early Adiposity Rebound Amongst 4-y.o. Children and Overweight Risk Amongst 11-y.o Children : Third Phase of a Cohort Study in Franche-Comté (CoOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03342092
Recruitment Status : Unknown
Verified November 2017 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Active, not recruiting
First Posted : November 14, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Study Description
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Brief Summary:
This study aims to assess different methods for early adiposity rebound determination at the age of 4/5 years old according to current medical screening criteria in schools, and to assess their prognostic value for obesity amongst 11 years old pre-adolescents according to the known risk factors.

Condition or disease Intervention/treatment
Childhood Obesity Other: Questionnaire

Study Design
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Study Type : Observational
Actual Enrollment : 868 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rebond d'adiposité précoce Chez l'Enfant de 4 Ans et Risque de Surpoids Chez l'Enfant de 11 Ans : troisième Temps d'Une Cohorte Franc-comtoise.
Actual Study Start Date : September 24, 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017
Groups and Cohorts
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Group/Cohort Intervention/treatment
Questionnaire
Questionnaires distributed to the families 15 days before child's medical consultation
 Other: Questionnaire
Questionnaires distributed to the families 15 days before child's medical consultation + anthropometric measures and data collected from the personal interview with school nurse


Outcome Measures
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Primary Outcome Measures :
  1. Body mass index of 11 years old pre-adolescents [ Time Frame: month 22 ]
    Composite outcome based on height and weight


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children initially enrolled in two successive surveys of build evolution and overweight determinants among a children cohort (both surveys representing the first time of the cohort), conducted in 2008.
Criteria

Inclusion Criteria:

  • Boys and girls born between 1st July 2003 and 30th June 2004
  • Attending school in Haute-Saône
  • Enrolled in the 2008 cohort survey

Exclusion Criteria:

  • Children whose parents refused to take part in this cohort study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342092


Locations
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France
CHU de Besançon
Besançon, France, 25000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Stéphanie Pasteur, MD CHU de Besançon
More Information
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03342092    
Other Study ID Numbers: API/2013/43
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
 Nutrition Disorders
Overweight
Body Weight