Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-01-02 @ 5:45 AM
Study NCT ID:
NCT03040258
Status:
COMPLETED
Last Update Posted:
2017-02-02
First Post:
2017-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity- Pilot Study
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': 374}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2010-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2017-01-25', 'studyFirstSubmitQcDate': '2017-01-31', 'lastUpdatePostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in knowledge score', 'timeFrame': 'One school year', 'description': 'Change in the knowledge scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and -post assessment phases'}, {'measure': 'Change in dietary habits', 'timeFrame': 'One school year', '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 -post assessment phases)"}, {'measure': 'Change in self-efficacy score', 'timeFrame': 'One school year', 'description': 'Change in the self-efficacy scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and -post assessment phases'}], 'secondaryOutcomes': [{'measure': 'Change in body weight status', 'timeFrame': 'One school year', 'description': 'Change in Body Mass Index - BMI (in kg/m\\^2) at pre- and post-assesment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['School-based intervention'], 'conditions': ['Childhood Obesity']}, 'descriptionModule': {'briefSummary': 'Evaluate the feasibility and effectiveness of a multi-component school-based intervention to promote healthy eating and physical activity with school children ages 9 to 11 years in Lebanon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schoolchildren\n* Aged 9 to 11 years\n\nExclusion Criteria:\n\n\\- no exclusion criteria'}, 'identificationModule': {'nctId': 'NCT03040258', 'briefTitle': 'Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity- Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'American University of Beirut Medical Center'}, 'officialTitle': 'Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity-Pilot Study', 'orgStudyIdInfo': {'id': 'NUT.NH.12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group- Health-E-PALS-Pilot', 'description': 'Group of students receiving the school-based intervention: Health-E-PALS (pilot), it consists of in class activities and lessons.', 'interventionNames': ['Other: Health-E-PALS-Pilot']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Group of students not receiving any intervention'}], 'interventions': [{'name': 'Health-E-PALS-Pilot', 'type': 'OTHER', 'description': 'Intervention to promote Healthy Eating and Physical Activity in Lebanese School-Children It comprises in class-activities, meetings with parents, improvement of school food service', 'armGroupLabels': ['Intervention group- Health-E-PALS-Pilot']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nahla Houalla, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American University of Beirut Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American University of Beirut Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}