Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-31 @ 9:48 AM
Study NCT ID:
NCT06488235
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Qualitative Evaluation of Pediatric Obesity Therapeutic Education Programs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D057085', 'term': 'Tooth Wear'}], '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'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2024-06-18', 'studyFirstSubmitQcDate': '2024-06-27', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Categorization of the reasons given by children and parents', 'timeFrame': 'during the data analysis, either 6 months following the focus group period', 'description': 'Description and categorization of the reasons given by children and parents'}], 'secondaryOutcomes': [{'measure': 'Mirroring of the respective experiences of attrition by children', 'timeFrame': 'during the data analysis, either 6 months following the focus group period', 'description': 'Description and mirroring of the respective experiences of attrition by children'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric obesity', 'attrition', 'Educational care program'], 'conditions': ['Pediatric Obesity']}, 'descriptionModule': {'briefSummary': 'Obesity concerns almost the entire planet and is considered in France as a major public health issue: 17% of children are overweight and 4% obese.\n\nBecause of this situation, the public authorities have set up programs in order to overcome obesity. Accompanying the child and its family in a process of change through Educational care program seems to be the most suitable. Unfortunately, the abandonment rate of these programs is often high.', 'detailedDescription': 'The main aim of this study is to explore, describe and understand the phenomenon of attrition in different pediatric obesity Educational care program since 2017 by collecting their experience by describing and characterizing the reasons for attrition reported by the patients included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescents who have stopped their Educational Care Programme (early in 1 of the 4 centers over the last 3 years.\n\nThey may still be receiving individual follow-up at their center, or may have had a break in care.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children who have started an educational care program between 2017 and 2022 at one of the four participating centers.\n* Children whose parents or legal guardians have signed the program participation letter.\n* Children who have participated in at least one group session and have stopped the educational care program early.\n* Children whose parents have agreed to take part in the focus group for themselves and their child.\n* Children over 12 years of age at the time of the focus group.\n\nExclusion Criteria:\n\n* Child who has completed the Educational Care program\n* Parent/child pairs where at least 1 of the 2 refused to take part in the study'}, 'identificationModule': {'nctId': 'NCT06488235', 'acronym': 'QUALIPOP', 'briefTitle': 'Qualitative Evaluation of Pediatric Obesity Therapeutic Education Programs', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': "Evaluation Qualitative de Programmes d'Education Thérapeutique d'obésité pédiatrique", 'orgStudyIdInfo': {'id': '23_0304'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'obese adolescents over 12 years of age and their parents', 'description': 'Children who have started an educational care program between 2017 and 2022 at one of the four participating centers and have stopped the educational care program early.\n\nChild over 12 years of age at the time of the focus group.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Emmanuelle Labarre', 'role': 'CONTACT', 'email': 'emmanuelle.labarre@chu-angers.fr', 'phone': '02 41 35 40 53', 'phoneExt': '+33'}, {'name': 'Elise Houssin', 'role': 'CONTACT', 'email': 'DRCI-Promotion-Interne@chu-angers.fr', 'phone': '02 41 35 36 37', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Emmanuelle Labarre', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Angers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}