Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-04 @ 10:30 AM
Study NCT ID:
NCT02034994
Status:
COMPLETED
Last Update Posted:
2019-09-19
First Post:
2014-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], '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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2014-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-16', 'studyFirstSubmitDate': '2014-01-10', 'studyFirstSubmitQcDate': '2014-01-10', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sedentary activities', 'timeFrame': 'One year'}, {'measure': 'Sugar sweetened beverages intake', 'timeFrame': 'one year'}, {'measure': 'cookies intake', 'timeFrame': 'one year'}, {'measure': 'fruits intake', 'timeFrame': 'one year'}, {'measure': 'physical activity', 'timeFrame': 'one year'}], 'primaryOutcomes': [{'measure': 'Body Mass Index', 'timeFrame': 'One Year'}], 'secondaryOutcomes': [{'measure': 'Mean lean and fatty body mass proportions: measured by portable electrical bioimpedance bean', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['school-based intervention', 'after school physical activity', 'sugar sweetened beverages', 'sedentary behavior', 'schoolchildren'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The main objective is to evaluate the effects of a multicomponent, school-based intervention combining change in nutritional behaviors with after school physical activity activities in reducing the excessive weight gain in schoolchildren.', 'detailedDescription': 'Specific objectives are:\n\n\\- evaluate the effect of the program on: change in nutritional behaviors, such as reducing sugar sweetened beverages and cookies intake reduction of time spent in sedentary activities gains in school performance and cognition outcomes the amount of daily physical activity on the percentage of body fat, changes in biochemical markers and blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBoth prevention programs:\n\n* 6th and 7th grades students\n* consent form signed by parents / tutors\n\nSecondary prevention program:\n\n\\- overweight and obese children\n\nExclusion Criteria:\n\n* pregnant girls'}, 'identificationModule': {'nctId': 'NCT02034994', 'briefTitle': 'Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School', 'organization': {'class': 'OTHER', 'fullName': 'Rio de Janeiro State University'}, 'officialTitle': 'Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School', 'orgStudyIdInfo': {'id': 'IMS-PAPPAS2-project'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Reduction of sugar sweetened beverages. cookies, sedentary activities and increasing physical activity', 'interventionNames': ['Behavioral: Eating behavior and physical activity change']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No intervention'}], 'interventions': [{'name': 'Eating behavior and physical activity change', 'type': 'BEHAVIORAL', 'description': 'A combination of two prevention school based programs will be addressed to schoolchildren over one year. Primary prevention will be developed monthly in order to reduce cookies and sugar sweetened beverages consumption, reduction of sedentary activities, increase meal consumption frequency and quality etc, in all children from 6th and 7th grades. Overweight and obese children will be invited to participate on a secondary prevention program in which daily physical activity classes will be performed by physical education teachers in school facilities.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Niterói', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Public Schools', 'geoPoint': {'lat': -22.88333, 'lon': -43.10361}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rio de Janeiro State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade Federal do Rio de Janeiro', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD. Full Professor of Epidemiology', 'investigatorFullName': 'Rosely Sichieri', 'investigatorAffiliation': 'Rio de Janeiro State University'}}}}