Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT01388205
Status:
COMPLETED
Last Update Posted:
2015-10-12
First Post:
2011-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial of a Novel Family-Based Intervention to Increase Outdoor Time and Fitness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye 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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 285}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-08', 'studyFirstSubmitDate': '2011-06-30', 'studyFirstSubmitQcDate': '2011-07-01', 'lastUpdatePostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical fitness/Exercise capacity', 'timeFrame': 'Outcome measure will be assessed at baseline and 12 month follow-up visit', 'description': 'Physical fitness/Exercise capacity assessed through 6-minutes walking test'}], 'secondaryOutcomes': [{'measure': 'Outdoor time', 'timeFrame': 'Outcome measure will be assessed at baseline and 12 month follow-up visit', 'description': 'Time spent outdoors assessed using the WHO Risk factor Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myopia', 'Outdoor activity', 'Physical activity', 'Randomized Controlled Trial', 'Pedometer', 'Behavior modification', 'Obesity'], 'conditions': ['Myopia', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '23415616', 'type': 'DERIVED', 'citation': 'Finkelstein EA, Tan YT, Malhotra R, Lee CF, Goh SS, Saw SM. A cluster randomized controlled trial of an incentive-based outdoor physical activity program. J Pediatr. 2013 Jul;163(1):167-72.e1. doi: 10.1016/j.jpeds.2013.01.009. Epub 2013 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to implement a new family-based health behavior community program to increase time spent outdoors and physical activity among Singapore children aged 6 to 12 years in a 1-year randomized clinical trial. 300 children from 250 families will be randomly assigned to either a family-based intervention or no intervention. The family-based intervention comprises structured weekend outdoor activities organized by National Parks and incentives for children to wear a pedometer and increase their daily steps. Families who meet their monthly step and outdoor activity goals will receive a range of prizes and incentives. Both groups will receive brochures on the National Myopia Prevention Program and physical activity. The success of the intervention will be evaluated through light meters, 7-day outdoor diaries, questionnaires documenting outdoor time and myopia; as well as pedometer steps, walking tests, and body mass index. A community-based intervention will be developed to improve the health of Singapore children by increasing outdoor time and physical activity to prevent myopia and obesity.', 'detailedDescription': 'To develop, implement, and evaluate a novel incentive-based family intervention to increase time spent outdoors and physical activity among children aged 6 to 12 years in a 1-year randomized controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children between 6 and 12 years of age with no known health problems preventing them from staying outdoors or walking for physical activity will be included as long as they are Singapore citizens or permanent residents.\n* Both myopic and non-myopic children will be included\n\nExclusion Criteria:\n\n* Children with medical conditions such as Type 1 diabetes, severe asthma, cancer or mental illness will be excluded.'}, 'identificationModule': {'nctId': 'NCT01388205', 'acronym': 'FIT', 'briefTitle': 'Trial of a Novel Family-Based Intervention to Increase Outdoor Time and Fitness', 'organization': {'class': 'OTHER', 'fullName': 'National University of Singapore'}, 'officialTitle': 'An Exploratory Randomized Controlled Trial of a Novel Family-Based Intervention to Increase Outdoor Time for the Prevention of Myopia and Increase Physical Activity Among Singapore Youth', 'orgStudyIdInfo': {'id': 'FIT-NUS-10-520'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Family-based Intervention Arm', 'interventionNames': ['Behavioral: Family-based Outdoor program']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Family-based Outdoor program', 'type': 'BEHAVIORAL', 'otherNames': ['Outdoor intervention'], 'description': '2 to 3 hour outdoor activities organized in conjunction with National Parks, Singapore', 'armGroupLabels': ['Family-based Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119077', 'city': 'Kent Ridge', 'country': 'Singapore', 'facility': 'National University of Singapore', 'geoPoint': {'lat': 1.29306, 'lon': 103.78444}}], 'overallOfficials': [{'name': 'Saw Seang Mei, MBBS,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University of singapore, Department of Epidemiology & Public Health'}, {'name': 'Eric Andrew Finkelstein, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke-NUS Graduate Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Epidemiology', 'investigatorFullName': 'Saw Seang Mei', 'investigatorAffiliation': 'National University of Singapore'}}}}