Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-29 @ 10:41 AM
Study NCT ID:
NCT00359957
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2006-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Increasing Physical Activity to Reduce Children's Visceral Fat
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-01', 'studyFirstSubmitDate': '2006-08-01', 'studyFirstSubmitQcDate': '2006-08-01', 'lastUpdatePostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visceral adiposity', 'timeFrame': 'Change over 3-4 month period'}], 'secondaryOutcomes': [{'measure': 'Subcutaneous abdominal adiposity', 'timeFrame': 'Change over 3-4 month period'}, {'measure': 'Total body fat', 'timeFrame': 'Change over 3-4 month period'}, {'measure': 'Body mass index', 'timeFrame': 'Change over 3-4 month period'}, {'measure': 'Physical activity', 'timeFrame': 'Change over 3-4 month period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pediatric obesity', 'Physical activity', 'Visceral fat', 'Weight'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '20528109', 'type': 'DERIVED', 'citation': "Saelens BE, Grow HM, Stark LJ, Seeley RJ, Roehrig H. Efficacy of increasing physical activity to reduce children's visceral fat: a pilot randomized controlled trial. Int J Pediatr Obes. 2011 Apr;6(2):102-12. doi: 10.3109/17477166.2010.482157. Epub 2010 Jun 7."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to examine whether adding greater physical activity to standard family-based behavioral pediatric obesity treatment decreases the amount of visceral fat among treated overweight children.', 'detailedDescription': "Adult studies suggest that greater visceral fat confers more health risk than peripheral fat accumulation and that physical activity interventions (as part of general weight control interventions) are efficacious in reducing adults' visceral fat. There are few studies examining the impact of physical activity and/or general weight loss on children's visceral fat accumulation. The present study compares standard family-based behavioral weight control treatment for pediatric obesity (STANDARD) with standard treatment plus added emphasis on participants attaining high levels of physical activity (ADDED). Both conditions receive the same behavioral dietary intervention and therapeutic contact and attention. The ADDED condition receives the recommendation and goal to be active at least 90 minutes per day, with behavioral strategies targeting increasing and sustaining these high levels of physical activity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 7-12 years old\n* \\>85th percentile BMI\n* have at least one parent with a BMI\\>25\n* able to engage in at least moderate intensity physical activity\n* child and parent willing and able to participate in behavioral treatment\n* English-speaking\n\nExclusion Criteria:\n\n* child or parent already enrolled in another weight control program\n* child or parent with a medical condition known to affect weight or growth\n* child or parent with significant mental illness that would interfere with engaging in treatment\n* child or parent with a current or past diagnosed eating disorder\n* child or parent currently taking any medication that affects weight or growth\n* child who is more than 120% above their median BMI for age and gender'}, 'identificationModule': {'nctId': 'NCT00359957', 'acronym': 'ADVANCE', 'briefTitle': "Efficacy of Increasing Physical Activity to Reduce Children's Visceral Fat", 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Activity, Diet, and Visceral Adiposity: New Care Emerging (ADVANCE) Project', 'orgStudyIdInfo': {'id': 'DK60476 (completed)'}, 'secondaryIdInfos': [{'id': 'NIH/NIDDK K23 DK60476'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'ADDED condition - behavioral intervention for modifying diet and physical activity, with greater emphasis on physical activity than the STANDARD condition', 'interventionNames': ['Behavioral: Pediatric Obesity Intervention + High Activity (ADDED)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'STANDARD condition - behavioral intervention for modifying diet, with little emphasis on physical activity', 'interventionNames': ['Behavioral: Pediatric Obesity Intervention (STANDARD)']}], 'interventions': [{'name': 'Pediatric Obesity Intervention (STANDARD)', 'type': 'BEHAVIORAL', 'description': '14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes)', 'armGroupLabels': ['2']}, {'name': 'Pediatric Obesity Intervention + High Activity (ADDED)', 'type': 'BEHAVIORAL', 'description': '14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes)', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98115', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Children's Hospital and Regional Medical Center", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Brian E Saelens, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital and Regiona Medical Center, Seattle"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'collaborators': [{'name': "Seattle Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Brian Saelens, PhD', 'oldOrganization': "Children's Hospital and Regional Medical Center, Seattle"}}}}