Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT01419951
Status:
COMPLETED
Last Update Posted:
2014-10-22
First Post:
2011-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Launch II: A Pilot Randomized Control Trial of a Clinic and Clinic Plus Home Intervention for Preschool Obesity
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': 'D000554', 'term': 'Ambulatory Care Facilities'}], 'ancestors': [{'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-20', 'studyFirstSubmitDate': '2011-08-05', 'studyFirstSubmitQcDate': '2011-08-17', 'lastUpdatePostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in BMI z score', 'timeFrame': 'Change from Baseline to 6 months', 'description': 'Body mass index z score'}], 'secondaryOutcomes': [{'measure': 'Change in Parent weight loss', 'timeFrame': 'Change from baseline to 6 months'}, {'measure': 'Change in Child caloric intake', 'timeFrame': 'Change from baseline to 6 months'}, {'measure': 'Change in Home food and activity environment', 'timeFrame': 'Change from baseline to 6 months'}, {'measure': 'Change in Child physical activity', 'timeFrame': 'Change from baseline to 6 months'}, {'measure': 'Change in Parent-child mealtime interactions', 'timeFrame': 'Change from baseline to 6 months'}, {'measure': 'Change in Health related quality of life', 'timeFrame': 'Change from baseline to 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Behavioral treatment', 'Preschool aged children', 'Obesity'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The objective of this project is to pilot test a behavioral intervention that includes a home visit component compared to a clinic only and standard of care for the treatment of obesity in preschool age children. The results of this study will inform the design of a larger randomized control trial.\n\nH1: The clinic + home intervention will result in a significantly greater decrease in BMIz compared to the in clinic only intervention or pediatric standard of care at 6 months post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 2 years 0 months to 5 years 11 months of age\n* at or above the 95th percentile BMI for age and sex\n* have at least one parent with a BMI at or greater than 25\n* medical clearance from pediatrician\n\nExclusion Criteria:\n\n* non-English speaking\n* living greater than 50 miles from medical center\n* a disability or illness that would preclude engagement in moderate activity\n* medical condition/medication associated with weight\n* enrolled in another weight management program'}, 'identificationModule': {'nctId': 'NCT01419951', 'briefTitle': 'Launch II: A Pilot Randomized Control Trial of a Clinic and Clinic Plus Home Intervention for Preschool Obesity', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'LAUNCH II: Learning About Activity and Understanding Nutrition for Better Child Health', 'orgStudyIdInfo': {'id': '2008-0666'}, 'secondaryIdInfos': [{'id': 'K24DK059492', 'link': 'https://reporter.nih.gov/quickSearch/K24DK059492', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Clinic Only Behavioral Intervention', 'description': 'A 6 month intervention consisting of two phases: Phase I Intensive intervention is 6 sessions delivered in a group-based format in clinic (concurrent parent and child groups) every other week. Phase II Maintenance is 3 monthly clinic visits. Treatment targets 3 components: Dietary education, physical activity and parenting training.', 'interventionNames': ['Behavioral: Clinic Only Behavioral Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pediatrician Counseling', 'description': 'A one-time 45 minute visit with a board certified pediatrician that focuses on the AAP guidelines for eating and physical activity for preschool aged children.', 'interventionNames': ['Other: Pediatrician Counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Clinic + Home Behavioral Intervention', 'description': 'A 6 month intervention consisting of two phases: Phase I Intensive intervention is 12 weekly sessions that alternate between a group-based clinic session (concurrent parent and child groups) and individual home visits. Phase II Maintenance is 12 weeks of every other week visits alternating between clinic and home. Treatment targets 3 components: Dietary education, physical activity and parenting training.', 'interventionNames': ['Behavioral: Clinic + Home Behavioral Intervention']}], 'interventions': [{'name': 'Clinic + Home Behavioral Intervention', 'type': 'BEHAVIORAL', 'description': 'A 6 month intervention consisting of two phases: Phase I Intensive intervention is 12 weekly sessions that alternate between a group-based clinic session (concurrent parent and child groups) and individual home visits. Phase II Maintenance is 12 weeks of every other week visits alternating between clinic and home. Treatment targets 3 components: Dietary education, physical activity and parenting training.', 'armGroupLabels': ['Clinic + Home Behavioral Intervention']}, {'name': 'Pediatrician Counseling', 'type': 'OTHER', 'description': 'A one-time 45 minute visit with a board certified pediatrician that focuses on the AAP guidelines for eating and physical activity for preschool aged children.', 'armGroupLabels': ['Pediatrician Counseling']}, {'name': 'Clinic Only Behavioral Intervention', 'type': 'BEHAVIORAL', 'description': 'A 6 month intervention consisting of two phases: Phase I Intensive intervention is 6 sessions delivered in a group-based format in clinic (concurrent parent and child groups) every other week. Phase II Maintenance is 3 monthly clinic visits. Treatment targets 3 components: Dietary education, physical activity and parenting training.', 'armGroupLabels': ['Clinic Only Behavioral Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Lori J Stark, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}