Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT01156805
Status:
COMPLETED
Last Update Posted:
2020-08-17
First Post:
2010-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Assessment of an School-based Intervention in Eating Habits and Physical Activity in Schoolchildren: the AVall Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ellargues@fhag.es', 'phone': '938425000', 'title': 'Dr. Esteve Llargues', 'phoneExt': '2675', 'organization': 'Hospital General de Granollers'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Educational Intervention, Control', 'description': "No untoward or unfavorable medical occurrence in a participants. There's no medication", 'otherNumAtRisk': 237, 'deathsNumAtRisk': 237, 'otherNumAffected': 0, 'seriousNumAtRisk': 237, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non Intervention', 'description': 'No intervention has been made.', 'otherNumAtRisk': 272, 'deathsNumAtRisk': 272, 'otherNumAffected': 0, 'seriousNumAtRisk': 272, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Anthropometric Variables', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Educational Intervention, Control', 'description': 'Experimental, intervention group has received educational training to improve food habits and physical activity\n\nEducational program: The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of 1st phase of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test'}, {'id': 'OG001', 'title': 'Non Intervention', 'description': 'No intervention has been made.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '17.0', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-effects linear regression, adjusted for clustering within schools and children to assess the effect of intervention on changes in BMI over time'}], 'paramType': 'MEAN', 'timeFrame': 'every two years', 'description': 'BMI progression in the intervention and the control group. Secondary outcomes measured in this study were changes in eating habits and in physical activity.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Qualitative variables are described in absolute and relative frequencies (percentages). Continuous variables are described as mean and SD.'}, {'type': 'SECONDARY', 'title': 'Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Educational Intervention, Control', 'description': 'Experimental, intervention group has received educational training to improve food habits and physical activity\n\nEducational program: The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of 1st phase of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test'}, {'id': 'OG001', 'title': 'Non Intervention', 'description': 'No intervention has been made.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.21', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'every two years', 'unitOfMeasure': 'm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Qualitative variables are described in absolute and relative frequencies (percentages). Continuous variables are described as mean and SD'}, {'type': 'SECONDARY', 'title': "Father's Height", 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Educational Intervention, Control', 'description': 'Experimental, intervention group has received educational training to improve food habits and physical activity\n\nEducational program: The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of 1st phase of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test'}, {'id': 'OG001', 'title': 'Non Intervention', 'description': 'No intervention has been made.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.74', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '1.75', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'every two years', 'unitOfMeasure': 'm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Qualitative variables are described in absolute and relative frequencies (percentages). Continuous variables are described as mean and SD.'}, {'type': 'SECONDARY', 'title': "Mother's Height", 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Educational Intervention, Control', 'description': 'Experimental, intervention group has received educational training to improve food habits and physical activity\n\nEducational program: The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of 1st phase of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test'}, {'id': 'OG001', 'title': 'Non Intervention', 'description': 'No intervention has been made.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.61', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'every two years', 'unitOfMeasure': 'm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Qualitative variables are described in absolute and relative frequencies (percentages). Continuous variables are described as mean and SD.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Educational Intervention, Control', 'description': 'Experimental, intervention group has received educational training to improve food habits and physical activity\n\nEducational program: The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of 1st phase of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test'}, {'id': 'FG001', 'title': 'Non Intervention', 'description': 'No intervention has been made.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '237'}, {'groupId': 'FG001', 'numSubjects': '272'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '216'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '56'}]}]}], 'recruitmentDetails': "In 2006, the 16 schools in Granollers were randomly distributed to the intervention or control group stratified according to public or semi-private status, number of first-year's classrooms and socioeconomic status of the local neighborhood."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'BG000'}, {'value': '272', 'groupId': 'BG001'}, {'value': '509', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Educational Intervention, Control', 'description': 'Experimental, intervention group has received educational training to improve food habits and physical activity\n\nEducational program: The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of 1st phase of the study (2006 and 2008) the weight and height of each child was measured in situ'}, {'id': 'BG001', 'title': 'Non Intervention', 'description': 'No intervention has been made.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '6.03', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '6.03', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '6.03', 'spread': '0.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 509}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-06', 'studyFirstSubmitDate': '2010-07-02', 'resultsFirstSubmitDate': '2017-08-11', 'studyFirstSubmitQcDate': '2010-07-02', 'lastUpdatePostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-25', 'studyFirstPostDateStruct': {'date': '2010-07-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anthropometric Variables', 'timeFrame': 'every two years', 'description': 'BMI progression in the intervention and the control group. Secondary outcomes measured in this study were changes in eating habits and in physical activity.'}], 'secondaryOutcomes': [{'measure': 'Height', 'timeFrame': 'every two years'}, {'measure': "Father's Height", 'timeFrame': 'every two years'}, {'measure': "Mother's Height", 'timeFrame': 'every two years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Children', 'School-based program', 'Obesity'], 'conditions': ['Obesity', 'Food Habits', 'Physical Activity']}, 'referencesModule': {'references': [{'pmid': '30737048', 'type': 'DERIVED', 'citation': 'Recasens MA, Xicola-Coromina E, Manresa JM, Ullmo PA, Jensen BB, Franco R, Suarez A, Nadal A, Vila M, Recasens I, Perez MJ, Castell C, Llargues E. Impact of school-based nutrition and physical activity intervention on body mass index eight years after cessation of randomized controlled trial (AVall study). Clin Nutr. 2019 Dec;38(6):2592-2598. doi: 10.1016/j.clnu.2018.12.029. Epub 2019 Jan 24.'}, {'pmid': '28177448', 'type': 'DERIVED', 'citation': 'Llargues E, Recasens MA, Manresa JM, Jensen BB, Franco R, Nadal A, Vila M, Recasens I, Perez MJ, Castell C. Four-year outcomes of an educational intervention in healthy habits in schoolchildren: the Avall 3 Trial. Eur J Public Health. 2017 Feb 1;27(1):42-47. doi: 10.1093/eurpub/ckw199. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the efficacy of an intervention on food habits and physical activity in school-age children.', 'detailedDescription': 'A two-year cluster-randomised prospective study with two parallel arms was used to evaluate an intervention programme in children in their first year of primary schooling (5-6 years of age) in schools in the city of Granollers. The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children born in 2000 who attended schools in Granollers City\n\nExclusion Criteria:\n\n* Schoolchildren who need special diet for metabolic or digestive disorder, physical activity incapacity, no family acceptance or attendance to school was discontinued'}, 'identificationModule': {'nctId': 'NCT01156805', 'acronym': 'AVALL', 'briefTitle': 'Assessment of an School-based Intervention in Eating Habits and Physical Activity in Schoolchildren: the AVall Study', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Granollers'}, 'officialTitle': 'Assessment of an School-based Intervention in Eating Habits and Physical Activity in Schoolchildren: the AVall Study.', 'orgStudyIdInfo': {'id': 'AVALL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educational intervention, Control', 'description': 'Experimental, intervention group has received specific educational training to improve food habits and physical activity during the period of the study.', 'interventionNames': ['Other: Educational program']}, {'type': 'NO_INTERVENTION', 'label': 'Educational program', 'description': 'No intervention has been made.'}], 'interventions': [{'name': 'Educational program', 'type': 'OTHER', 'description': 'The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of 1st phase of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test', 'armGroupLabels': ['Educational intervention, Control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Assumpta Recasens, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital de Granollers'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Granollers', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}