Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-05 @ 7:17 PM
Study NCT ID:
NCT00537160
Status:
WITHDRAWN
Last Update Posted:
2012-10-29
First Post:
2007-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diet and Exercise in Overweight Children Postburn
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D002056', 'term': 'Burns'}], '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': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D015596', 'term': 'Nutrition Assessment'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-25', 'studyFirstSubmitDate': '2007-09-27', 'studyFirstSubmitQcDate': '2007-09-27', 'lastUpdatePostDateStruct': {'date': '2012-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI', 'timeFrame': '12 and 24 months following intervention'}], 'secondaryOutcomes': [{'measure': 'fitness level', 'timeFrame': '12 and 24 months following intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pediatrics'], 'conditions': ['Obesity', 'Burns']}, 'descriptionModule': {'briefSummary': 'Examine clinical results of an interdisciplinary weight management program that includes medical evaluation, nutrition counseling, exercise, and behavioral interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 10-18 years old\n* BMI \\> or = 95th percentile\n* \\> 1 year postburn and out of pressure garments\n* Live within 100 minle radius of SHC\n* Informed consent and HIPPA form signed\n* Parent/guardia willing to make time commitment\n\nExclusion Criteria:\n\n* Undergone major surgery in the 4 months prior to start of program or have any major surgery planned in 2 year time frame\n* Physical/health condition that precludes regular exercise\n* Significant mental health diagnosis\n* Advised by MD not to exercise\n* Thyroid disease, routine steroid use,pregnancy\n* Unable to understand the instructions/content of program'}, 'identificationModule': {'nctId': 'NCT00537160', 'briefTitle': 'Diet and Exercise in Overweight Children Postburn', 'organization': {'class': 'OTHER', 'fullName': 'Shriners Hospitals for Children'}, 'officialTitle': 'The Impact of a Diet and Exercise Program in Overweight Pediatric Patients During Burn Rehabilitation', 'orgStudyIdInfo': {'id': '06-04-26-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Behavior modification, Nutrition Education, Exercise', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michele M Gottschlich, PhD, RD, CNSD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shriners Hospital for Children'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shriners Hospitals for Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Dietitian', 'investigatorFullName': 'Michele Gottschlich', 'investigatorAffiliation': 'Shriners Hospitals for Children'}}}}