Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-06-26 @ 4:51 AM
Study NCT ID:
NCT02157402
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2014-05-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EYTO (European Youth Tackling Obesity): A Randomized Controlled Trial in Catalonia (Spain)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2014-05-28', 'studyFirstSubmitQcDate': '2014-06-03', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Fruit intake', 'timeFrame': 'Change from Baseline in fruit Intake at 2 academic years', 'description': 'Health Behaviour in School-aged Children (HBSC) survey'}, {'measure': 'Change of Vegetable intake', 'timeFrame': 'Change from Baseline in vegetable Intake at 2 academic years', 'description': 'Health Behaviour in School-aged Children (HBSC) survey'}, {'measure': 'Change of Physical activity practice', 'timeFrame': 'Change from Baseline in physical activity practice at 2 academic years', 'description': 'Health Behaviour in School-aged Children (HBSC) survey'}], 'secondaryOutcomes': [{'measure': 'Change of Sedentary behaviour', 'timeFrame': 'Change from Baseline in sedentary behaviour at 2 academic years', 'description': 'Health Behaviour in School-aged Children (HBSC) survey'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Adolescent'], 'conditions': ['Obesity', 'Life Style']}, 'referencesModule': {'references': [{'pmid': '35255220', 'type': 'DERIVED', 'citation': 'Aceves-Martins M, Llaurado E, Tarro L, Papell-Garcia I, Prades-Tena J, Kettner-Hoeberg H, Puiggros F, Arola L, Davies A, Giralt M, Sola R. "Som la Pera," a School-Based, Peer-Led Social Marketing Intervention to Engage Spanish Adolescents in a Healthy Lifestyle: A Parallel-Cluster Randomized Controlled Study. Child Obes. 2022 Dec;18(8):556-571. doi: 10.1089/chi.2021.0207. Epub 2022 Mar 7.'}, {'pmid': '26137843', 'type': 'DERIVED', 'citation': 'Llaurado E, Aceves-Martins M, Tarro L, Papell-Garcia I, Puiggros F, Arola L, Prades-Tena J, Montagut M, Moragas-Fernandez CM, Sola R, Giralt M. A youth-led social marketing intervention to encourage healthy lifestyles, the EYTO (European Youth Tackling Obesity) project: a cluster randomised controlled0 trial in Catalonia, Spain. BMC Public Health. 2015 Jul 3;15:607. doi: 10.1186/s12889-015-1920-1.'}]}, 'descriptionModule': {'briefSummary': 'Our hypothesis is that healthy lifestyles improvement by an intervention designed according 8 social marketing Benchmark criteria, can reduce overweight or obesity implemented by adolescents on their colleges.\n\nThe general aim of EYTO program is to improve health and well-being among adolescents who live in low socioeconomically communities, through an intervention study designed by selected adolescents with the inclusion of social marketing Benchmark criteria.', 'detailedDescription': '5 adolescent coordinators (of intervention high-schools) will be trained by experts in social marketing and health promotion. This 5 selected adolescent as coordinators who will be in charge of the design of an 8 social marketing criteria intervention to implement their peers´ lifestyles.\n\nThe program has over two academic years. The participants will be followed for the duration of 2 academic years, an expected of up to 16 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent signed by parents and/or guardians.\n* Adolescents between 13 and 17 years old.\n\nExclusion Criteria:\n\n\\- The lack of one or more inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT02157402', 'acronym': 'EYTO-SPAIN', 'briefTitle': 'EYTO (European Youth Tackling Obesity): A Randomized Controlled Trial in Catalonia (Spain)', 'organization': {'class': 'OTHER', 'fullName': 'University Rovira i Virgili'}, 'officialTitle': 'A Youth Led Social Marketing Campaign to Encourage Healthy Lifestyles. EYTO (European Youth Tackling Obesity): A Randomized Controlled Trial in Catalonia (Spain)', 'orgStudyIdInfo': {'id': 'EYTO-SPAIN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'The intervention group will received activities and social events designed according 8 social marketing Benchmark criteria to promote healthy lifestyles.', 'interventionNames': ['Behavioral: Social marketing activities and pop-up events to promote healthy lifestyles']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The control group will not received any intervention activities and social events to promote healthy lifestyles.'}], 'interventions': [{'name': 'Social marketing activities and pop-up events to promote healthy lifestyles', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43204', 'city': 'Reus', 'state': 'Tarragona', 'country': 'Spain', 'facility': 'Universitat Rovira i Virgili', 'geoPoint': {'lat': 41.15612, 'lon': 1.10687}}], 'overallOfficials': [{'name': 'Rosa Solà Alberich, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Tecnológico de Nutrición y Salud'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Rovira i Virgili', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Commission', 'class': 'OTHER'}, {'name': 'Centro Tecnológico de Nutrición y Salud', 'class': 'OTHER'}, {'name': 'Hospital Universitari Sant Joan de Reus', 'class': 'OTHER'}, {'name': 'Companhia de Ideas', 'class': 'UNKNOWN'}, {'name': 'Komunikujeme', 'class': 'OTHER'}, {'name': "National Children's Bureau", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Rosa Sola', 'investigatorAffiliation': 'University Rovira i Virgili'}}}}