Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT00424918
Status:
COMPLETED
Last Update Posted:
2017-05-18
First Post:
2007-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"Generation Fit and Exerlearning With In the Groove"
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2007-01-18', 'studyFirstSubmitQcDate': '2007-01-18', 'lastUpdatePostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minutes of activity added in school day.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life change scores'}, {'measure': 'Relation to test scores, absenteeism'}, {'measure': 'Fitness change scores'}, {'measure': 'Change in biological endpoints'}, {'measure': 'Others'}]}, 'conditionsModule': {'keywords': ['Dance', 'Peers', 'middle school-based', 'feasibility'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '17142504', 'type': 'BACKGROUND', 'citation': 'Lanningham-Foster L, Jensen TB, Foster RC, Redmond AB, Walker BA, Heinz D, Levine JA. Energy expenditure of sedentary screen time compared with active screen time for children. Pediatrics. 2006 Dec;118(6):e1831-5. doi: 10.1542/peds.2006-1087.'}], 'seeAlsoLinks': [{'url': 'http://www.maine-nutrition.org/Projects/MNTT.htm', 'label': 'Take Time'}]}, 'descriptionModule': {'briefSummary': 'In middle schools participating in a statewide program called "Take Time", we are randomizing youth to a 10-12 week intervention using the dance mat games on the Playstation2 (like Dance Dance Revolution). This program is testing feasibility of using the dance mats as a way to increase activity during the school day. We are using "Groove Masters" as a peer-mentored mechanism to keep track of the activity of youth in the intervention compared to the control group. Our main objective is increase in activity time.', 'detailedDescription': 'We met with administrators and teachers and obtained consent and assent for this study. After assessing baseline measures (end-of-grade test scores, absenteeism, Pediatric Quality of Life, physical fitness, GEMS Activity Rating Scale, Dennison\'s measure of sedentary screen time, Physical Activity Enjoyment Scale, BMI%ile, (with a small subset assayed for fasting lipids and glucose, with a smaller subset wearing ActiGraphs for objective measures of activity) we randomized to the intervention or control group.\n\nIn our intervention, youth play a dance game at school called "In the Groove", with the goal of 40 additional minutes each week of physical activity during the school hours.\n\nWe will obtain change scores and compare the groups to find an effect size for future studies, this this proves acceptable and feasible in Maine schools.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Take Time middle school in Maine with consent/assent\n\nExclusion Criteria:\n\n* Any condition that prevents a child from doing physical activity on the dance mat like photic seizures, broken leg, blindness.'}, 'identificationModule': {'nctId': 'NCT00424918', 'briefTitle': '"Generation Fit and Exerlearning With In the Groove"', 'organization': {'class': 'OTHER', 'fullName': 'MaineHealth'}, 'officialTitle': 'Generation-Fit, a Pilot Study of Youth in Maine Middle Schools Using an "Exerlearning" Dance Video Game to Promote Physical Activity During School', 'orgStudyIdInfo': {'id': 'MMCRI-3000'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Physical Activity, reduced sedentary behavior', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '04012', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Portland', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}], 'overallOfficials': [{'name': 'Ann E Maloney, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Attending'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MaineHealth', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ann Maloney MD', 'oldOrganization': 'MMCRI'}}}}