Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT00365651
Status:
COMPLETED
Last Update Posted:
2007-05-21
First Post:
2006-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutrition and Soccer for Pediatric Overweight and Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-05-18', 'studyFirstSubmitDate': '2006-08-15', 'studyFirstSubmitQcDate': '2006-08-15', 'lastUpdatePostDateStruct': {'date': '2007-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI', 'timeFrame': '5 months'}], 'secondaryOutcomes': [{'measure': 'My Tips for Families Quiz', 'timeFrame': '5 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['obesity', 'overweight'], 'conditions': ['Obesity', 'Overweight']}, 'descriptionModule': {'briefSummary': 'This study will examine whether two months of youth soccer, combined with a single brief behavioral/nutritional intervention, can reduce BMI in 5th grade overweight or obese females.', 'detailedDescription': 'Female overweight and obese public school students will be recruited during the summer of 2006 based on FitnessGram testing done by graduate students at MSU during their prior (4th grade) school year. After receiving informed consent from parent/child, the subjects will be checked for height/weight and other screening criteria, then exposed to 2005 My Pyramid for Kids, "Tips for Families" information, and watch a short 8 minute DVD that discusses the importance of exercise and fitness by way of interviewing two club level female soccer players of equivalent age. Subjects will then be randomly assigned to fall youth soccer in Starkville, or spring youth soccer, after first phase data collection occurs in November, 2006.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obese or overweight 4th grade public school student in Starkville\n\nExclusion Criteria:\n\n* unable to run or physical disease or disability'}, 'identificationModule': {'nctId': 'NCT00365651', 'briefTitle': 'Nutrition and Soccer for Pediatric Overweight and Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Leach Chiropractic Clinic'}, 'officialTitle': 'Multi Intervention Approach to Pediatric Overweight and Obesity: A Randomized Control Group Trial', 'orgStudyIdInfo': {'id': 'LEA2006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Youth Soccer', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '39759', 'city': 'Starkville', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Leach Chiropractic Clinic, Inc.', 'geoPoint': {'lat': 33.45049, 'lon': -88.81961}}], 'overallOfficials': [{'name': 'Robert A Leach, DC, MS(c)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leach Chiropractic Clinic, Inc'}, {'name': 'Joyce M Yates, Ed.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Mississippi University for Women'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leach Chiropractic Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mississippi University for Women', 'class': 'OTHER'}, {'name': "MUW Southern Women's Institute", 'class': 'UNKNOWN'}]}}}