Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-01 @ 8:00 AM
Study NCT ID:
NCT03342092
Status:
UNKNOWN
Last Update Posted:
2017-11-14
First Post:
2017-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 868}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-09', 'studyFirstSubmitDate': '2017-11-07', 'studyFirstSubmitQcDate': '2017-11-09', 'lastUpdatePostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body mass index of 11 years old pre-adolescents', 'timeFrame': 'month 22', 'description': 'Composite outcome based on height and weight'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Childhood Obesity']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Boys and girls born between 1st July 2003 and 30th June 2004\n* Attending school in Haute-Saône\n* Enrolled in the 2008 cohort survey\n\nExclusion Criteria:\n\n* Children whose parents refused to take part in this cohort study.'}, 'identificationModule': {'nctId': 'NCT03342092', 'acronym': 'CoOP', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': "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.", 'orgStudyIdInfo': {'id': 'API/2013/43'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Questionnaire', 'description': "Questionnaires distributed to the families 15 days before child's medical consultation", 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': "Questionnaires distributed to the families 15 days before child's medical consultation + anthropometric measures and data collected from the personal interview with school nurse", 'armGroupLabels': ['Questionnaire']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'overallOfficials': [{'name': 'Stéphanie Pasteur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Besançon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}