Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-24 @ 3:00 PM
Study NCT ID:
NCT04297059
Status:
COMPLETED
Last Update Posted:
2020-03-05
First Post:
2020-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Ajyal Salima Longitudinal Study to Prevent Childhood Obesity
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1239}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2020-03-04', 'studyFirstSubmitQcDate': '2020-03-04', 'lastUpdatePostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in knowledge score', 'timeFrame': '3 school years', 'description': 'Change in the knowledge scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and all post- assessment phases'}, {'measure': 'Change in dietary habits', 'timeFrame': '3 school years', 'description': "Change in the percentage of children consuming sugary drinks, unhealthy and healthy snacks, fruits and vegetables/change in the percentage of children's physical activity frequency (self-reported in the questionnaires during pre- and all post- assessment phases)"}, {'measure': 'Change in self-efficacy score', 'timeFrame': '3 school years', 'description': 'Change in the self-efficacy scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and all post- assessment phases'}, {'measure': 'Change in Body Mass Index', 'timeFrame': '3 school years', 'description': 'Change in mean BMIz scores (based on anthropometric measurements during pre- and post- assessment phases'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BMI', 'Health policies', 'School health promotion', 'Intervention'], 'conditions': ['Childhood Obesity']}, 'descriptionModule': {'briefSummary': 'The study was carried out to determine the long-term effectiveness of a school-based intervention programme when implemented over 2 years and its sustained effect one year later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSchoolchildren Aged 8-12 years\n\nExclusion Criteria:\n\n* no exclusion criteria'}, 'identificationModule': {'nctId': 'NCT04297059', 'briefTitle': 'The Ajyal Salima Longitudinal Study to Prevent Childhood Obesity', 'organization': {'class': 'OTHER', 'fullName': 'American University of Beirut Medical Center'}, 'officialTitle': '2-year Intervention and 1-year Follow-up of a School-based Programme to Promote Healthy Behaviours and Prevent Childhood Obesity in Lebanese Children: the Healthier Kids - Ajyal Salima Study', 'orgStudyIdInfo': {'id': 'NUT.NH.16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Implementation of Ajyal Salima intervention to promote healthy eating and encourage physical activity in Lebanese school-children.', 'interventionNames': ['Other: Ajyal Salima']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Group of students not receiving any intervention'}], 'interventions': [{'name': 'Ajyal Salima', 'type': 'OTHER', 'description': 'It comprises in class-activities, meetings with parents and improvement of school foodservice', 'armGroupLabels': ['Intervention group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American University of Beirut Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}