Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-05 @ 11:31 AM
Study NCT ID:
NCT05403060
Status:
COMPLETED
Last Update Posted:
2023-02-09
First Post:
2022-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Educational Nutritional Intervention for Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'An intervention group and a control group (no intervention, with usual education)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2022-02-24', 'studyFirstSubmitQcDate': '2022-06-01', 'lastUpdatePostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in vegetables and fruits', 'timeFrame': '2 months', 'description': 'Pre-post intervention change in vegetable and fruit consumption (servings/day (direct values, no scores assigned), post intervention consumption minus pre intervention consumption, as measured by a semiquantitative food frequency questionnaire, positive values of change are desirable , that is, increased consumption of vegetables and fruits)'}, {'measure': 'Change in ultra-processed foods', 'timeFrame': '2 months', 'description': 'Pre-post intervention change in consumption of ultra-processed foods (servings/day (direct values, no scores assigned)), post intervention consumption minus pre intervention consumption, as measured by a semiquantitative food frequency questionnaire, negative values of change are desirable, that is, reduction in the consumption of ultra-processed foods)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vegetables', 'Fruit', 'Ultra-processed Food'], 'conditions': ['Early Intervention, Educational', 'Health Promotion', 'Feeding Behavior', 'Adolescent Health']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'McAlister AL, Perry CL, Parcel G. How individuals, environments and health behavior interact: social cognitive theory. In: Glanz K, Rimer BK, Viswanath K, eds. Health Behavior and Health Education: Theory, Research and Practice. 4°. Jossey-Bass A Wiley Imprint; 2008:169-188.'}], 'seeAlsoLinks': [{'url': 'http://ensanut.insp.mx/encuestas/ensanut2018/doctos/informes/ensanut_2018_presentacion_resultados.pdf', 'label': 'Encuesta Nacional de Salud y Nutrición 2018'}]}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial by conglomerates whose objective is to evaluate the effectiveness of an educational nutritional intervention, based on the Social Cognitive Theory, for the increase in the consumption of vegetables and fruits and the decrease in the consumption of ultra-processed foods in adolescent high school students, in the University of Guadalajara, in Guadalajara, Jalisco.', 'detailedDescription': 'Background: Adolescent nutrition is of vital importance for their growth and development, at this stage eating habits for adult life are consolidated. However, currently the eating habits of adolescents are mainly characterized by a high consumption of ultra-processed foods and a low consumption of vegetables and fruits. Effective nutritional interventions focused on this age group can contribute to the prevention of adolescent diseases at the current stage and in later stages.\n\nObjective: To evaluate the efficacy of an educational nutritional intervention, based on the Social Cognitive Theory, to increase the consumption of vegetables and fruits and decrease the consumption of ultra-processed foods, in adolescent high school students at the University of Guadalajara (UDG), in Guadalajara, Jalisco, in the year 2022.\n\nMaterial and methods: Randomized controlled trial by conglomerates, students from the school groups chosen at random, from two high schools (one as a control group and another intervention) also chosen at random will be included. Adolescents who agree to participate will complete pre- and post-intervention assessments on fruit and vegetable consumption and ultra-processed foods. A multilevel analysis will be used to compare post-intervention variables between groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Students enrolled in the included high schools (1st to 6th semester, morning and evening shift)\n* That they agree to participate and complete the assent and informed consent form\n\nExclusion Criteria:\n\n* Students who do not wish to participate'}, 'identificationModule': {'nctId': 'NCT05403060', 'briefTitle': 'Educational Nutritional Intervention for Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Centro Universitario de Ciencias de la Salud, Mexico'}, 'officialTitle': 'Educational Nutritional Intervention to Increase the Consumption of Vegetables and Fruits and Decrease the Consumption of Ultra-processed Foods in Adolescents: Randomized Controlled Trial by Conglomerates', 'orgStudyIdInfo': {'id': '21-88'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Educational nutritional intervention, based on the Social Cognitive Theory', 'interventionNames': ['Behavioral: ALIADA: Alimentación, Adolescencia y Ambiente']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Regular school education, without educational nutritional intervention'}], 'interventions': [{'name': 'ALIADA: Alimentación, Adolescencia y Ambiente', 'type': 'BEHAVIORAL', 'description': 'The objective of the educational nutritional intervention is to promote in adolescents an increase in their consumption of vegetables and fruits and a decrease in their consumption of ultra-processed foods, through the application of the TSC constructs, with the use of education by pairs as the main strategy (peer leaders). It lasts two months, includes three exclusive sessions for peer leaders and five sessions for all participants, where the leaders, together with the researchers, will lead the activities of the sessions, as well as a general event for all high school students. Intervention activities include: electronic presentations, videos, food preparation and label reading workshops, individual and team reflection activities, goal setting and monitoring, board games, contests, among others. In addition, each participant is given a workbook, which contains key messages and activities for each educational session.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Upper Secondary Education System of the University of Guadalajara', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'overallOfficials': [{'name': 'Gabriela Macedo Ojeda, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Universitario de Ciencias de la Salud, Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD in Public Health Sciences', 'investigatorFullName': 'Gabriela Macedo Ojeda', 'investigatorAffiliation': 'Centro Universitario de Ciencias de la Salud, Mexico'}}}}