Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT00277420
Status:
WITHDRAWN
Last Update Posted:
2015-08-25
First Post:
2006-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial of a Culturally-Appropriate Weight Loss Intervention for Overweight Latino Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI has left institution after losing funding for this PI-initiated study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2008-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-21', 'studyFirstSubmitDate': '2006-01-12', 'studyFirstSubmitQcDate': '2006-01-12', 'lastUpdatePostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in body mass index (BMI) z-score'}], 'secondaryOutcomes': [{'measure': 'height, weight, and BMI'}, {'measure': 'percent body fat'}, {'measure': 'physical activity'}, {'measure': 'sedentary activity'}, {'measure': 'dietary habits'}, {'measure': "the child's quality of life"}, {'measure': 'self-esteem'}, {'measure': 'physical fitness'}, {'measure': 'selected health and use of health services measures (missed school days, parental missed work days, and number of healthcare provider visits for illness by child)'}, {'measure': "the parents' BMI"}, {'measure': "the child's satisfaction with opportunities to lose weight and increase physical activity in the past year"}, {'measure': "the parents' satisfaction with opportunities for the child to lose weight and increase physical activity in the past year"}, {'measure': 'costs'}]}, 'conditionsModule': {'conditions': ['Overweight']}, 'descriptionModule': {'briefSummary': 'This project aims to conduct a unique, community-based intervention consisting of a randomized trial of a culturally-appropriate weight loss intervention for overweight Latino children in Milwaukee. The intervention promotes lifestyle changes through a low weight loss regimen, one or more physical activities ranging from soccer to hip-hop dance, and dietary counseling including cooking classes for parents. In addition to weight reduction for overweight Latino children, the project has the potential to reduce missed school days and improve self-esteem and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children must be of Latino descent\n* At risk for becoming overweight or is overweight\n* 6-17 years old.\n\nExclusion Criteria:\n\n* Age \\> 17 years old\n* Not overweight or at risk for becoming overweight\n* Non-Latino ethnicity/race.'}, 'identificationModule': {'nctId': 'NCT00277420', 'briefTitle': 'Trial of a Culturally-Appropriate Weight Loss Intervention for Overweight Latino Children', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'A Randomized Controlled Trial of a Culturally-Appropriate Weight Loss Intervention for Overweight Latino Children', 'orgStudyIdInfo': {'id': '#CHW 05/75, HRRC 214-05'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Comprehensive weight management', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Glenn Flores, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin'}, {'name': 'Jane Brotanek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor of Pediatrics, Department of Pediatrics, Medical College of Wisconsin'}, {'name': 'Julio C Maldonado, BA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Project Coordinator II, Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': 'United Community Center', 'class': 'OTHER'}, {'name': 'Milwaukee SCORES', 'class': 'UNKNOWN'}, {'name': 'Milwaukee Kickers Soccer Club', 'class': 'OTHER'}]}}}