Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-02-24 @ 10:06 AM
Study NCT ID:
NCT04307966
Status:
COMPLETED
Last Update Posted:
2020-03-13
First Post:
2020-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Pre-adolescent Inter-generational Intervention to Address HIV and Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 852}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-11', 'studyFirstSubmitDate': '2020-03-11', 'studyFirstSubmitQcDate': '2020-03-11', 'lastUpdatePostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HIV/AIDS-related knowledge, attitude, behaviour, practices and skills', 'timeFrame': '3 months', 'description': 'The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.'}, {'measure': 'obesity-related awareness, attitude and skills', 'timeFrame': '3 months', 'description': 'The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.'}, {'measure': 'nutrition-related awareness, attitude, behaviour and skills', 'timeFrame': '3 months', 'description': 'The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.'}, {'measure': 'physical activity-related awareness, attitude, behaviour and skills', 'timeFrame': '3 months', 'description': 'The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.'}, {'measure': 'child-parent communication', 'timeFrame': '3 months', 'description': 'The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.'}], 'secondaryOutcomes': [{'measure': 'pre-adolescent parent inter-generational knowledge transfer', 'timeFrame': '3 months', 'description': 'The second outcome determined whether the intervention, delivered to students, could influence knowledge transfer and translation in parents.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inter-generational outcomes', 'Pre-adolescents'], 'conditions': ['Hiv', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '34895196', 'type': 'DERIVED', 'citation': 'Arthur K, Christofides N, Nelson G. Effectiveness of a pre-adolescent inter-generational intervention to address HIV and obesity in South Africa, using a pretest-posttest design. BMC Public Health. 2021 Dec 11;21(1):2251. doi: 10.1186/s12889-021-12228-z.'}]}, 'descriptionModule': {'briefSummary': 'The study evaluates an intervention, The CIrCLE of Life Initiative, which was developed to address HIV and obesity prevention. We evaluated whether the combined HIV and obesity intervention increased knowledge, enhanced skills, and/or promoted healthy behaviour among pre-adolescent students (9-12 years old) and their parents.', 'detailedDescription': 'The CIrCLE of Life Initiative had both a school and home component, each comprising a learning curriculum, environmental support, and activity-based constituents that aimed to increase student knowledge and skills, and to engage parents. Trained educators delivered lessons about HIV and obesity to all Grade 6 students at 5 government-run schools. The classroom curriculum for students required delivery of a five-hour face-to-face intervention delivered weekly through 10 30-minute lessons. Students were asked to communicate their learnings to their parents at home. Parents were requested to read through the lesson in a workbook and to sign acknowledgement that they had read the content. The workbook contained shared student-parent homework activities that took approximately 30 minutes per week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '9 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All Grade 6 learners and their parents from 5 government-run primary schools', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04307966', 'briefTitle': 'Effectiveness of a Pre-adolescent Inter-generational Intervention to Address HIV and Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University of Witwatersrand, South Africa'}, 'officialTitle': 'Addressing the Double Burden of Diseases Through a Pre-adolescent Transdisciplinary Intervention for Inter-generational Outcomes', 'orgStudyIdInfo': {'id': 'UWitwatersrand'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention', 'description': '537 pre-adolescent grade 6 learners and their parent (n=537) were invited to participate. Trained educators delivered lessons about HIV and obesity to all Grade 6 students at 5 government-run schools. The classroom curriculum for students required delivery of a five-hour face-to-face intervention delivered weekly through 10 30-minute lessons. Students were asked to communicate their learnings to their parents at home. Parents were requested to read through the lesson in a workbook and to sign acknowledgement that they had read the content. The workbook contained shared student-parent homework activities that took approximately 30 minutes per week. Data was only collected from Learners (n=425) and parents (n= 427)who had consented to the study. A pretest was conducted. The intervention was then implemented. A posttest was conducted afterwards. Both parents and learners answered self-reported questionnaires.', 'interventionNames': ['Behavioral: The CIrCLE of Life Initiative']}], 'interventions': [{'name': 'The CIrCLE of Life Initiative', 'type': 'BEHAVIORAL', 'description': 'HIV and obesity prevention programme delivered directly to Grade 6 preadolescents and indirectly to their parents.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1779', 'city': 'Westonaria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Kamogelo Primary school', 'geoPoint': {'lat': -26.31905, 'lon': 27.6486}}, {'zip': '1779', 'city': 'Westonaria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Westonaria primary school', 'geoPoint': {'lat': -26.31905, 'lon': 27.6486}}, {'zip': '1780', 'city': 'Westonaria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Westonaria primary mine school', 'geoPoint': {'lat': -26.31905, 'lon': 27.6486}}, {'zip': '1787', 'city': 'Westonaria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Zuurbekom Primary School', 'geoPoint': {'lat': -26.31905, 'lon': 27.6486}}, {'zip': '5670', 'city': 'Westonaria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Izanokhanyo Primary school', 'geoPoint': {'lat': -26.31905, 'lon': 27.6486}}], 'overallOfficials': [{'name': 'Gill Nelson, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of the Witwatersrand, South Africa'}, {'name': 'Nicola Christofides, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of the Witwatersrand, South Africa'}]}, 'ipdSharingStatementModule': {'url': 'https://zenodo.org/record/3679352#.XmlHeC2B3LY', 'infoTypes': ['CSR'], 'timeFrame': 'Data has already been made available.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data for all primary and secondary outcome measures will be made available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Witwatersrand, South Africa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fogarty Clinical Research Inc.', 'class': 'OTHER'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mrs', 'investigatorFullName': 'Keshni Arthur', 'investigatorAffiliation': 'University of Witwatersrand, South Africa'}}}}