Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-28 @ 9:17 PM
Study NCT ID:
NCT01029834
Status:
COMPLETED
Last Update Posted:
2023-04-28
First Post:
2009-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating Pre-School Children at Risk for Overweight in the Primary Care Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D003075', 'term': 'Coitus'}], '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'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2009-12-09', 'studyFirstSubmitQcDate': '2009-12-09', 'lastUpdatePostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent BMI overweight for child and parent', 'timeFrame': 'baseline-6,12,18, 24 months'}], 'secondaryOutcomes': [{'measure': 'Reduction in number of sugared drinks, high energy food and sedentary activities. Increase in fruit, vegetable and physical activity', 'timeFrame': 'baseline, 6,12,18,24'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['BMI >85%for age and gender'], 'conditions': ['Overweight']}, 'referencesModule': {'references': [{'pmid': '25049340', 'type': 'DERIVED', 'citation': 'Quattrin T, Roemmich JN, Paluch R, Yu J, Epstein LH, Ecker MA. Treatment outcomes of overweight children and parents in the medical home. Pediatrics. 2014 Aug;134(2):290-7. doi: 10.1542/peds.2013-4084.'}, {'pmid': '22987879', 'type': 'DERIVED', 'citation': 'Quattrin T, Roemmich JN, Paluch R, Yu J, Epstein LH, Ecker MA. Efficacy of family-based weight control program for preschool children in primary care. Pediatrics. 2012 Oct;130(4):660-6. doi: 10.1542/peds.2012-0701. Epub 2012 Sep 17.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to test, in the primary care setting, the efficacy of an innovative intervention program for children aged 2-5 years with a BMI over the 85th percentile and one overweight parent (BMI \\>27 kg/m2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 2-5 year old with a BMI greater than the 85th% for age and sex\n* one overweight parent (BMI\\>27kg/m2)\n* child with normal developmental milestones\n* history of adherence to 90% of scheduled primary care visits\n* parent must be at 5th grade reading and speaking of English language or the spanish language\n* no plans on moving out of the area for the 2 years subsequent to enrollment\n\nExclusion Criteria:\n\n* child with a height 2 SD below the mean for age and sex and/or pathological growth velocity\n* SGA\n* any chronic disorders influencing energy intake and/or growth\n* any orthopedic disorder preventing the child or the parent from ambulation normally and performing the activity prescribed by the program\n* any medication known to have the potential of affecting weight changes\n* parent or child with psychiatric and/or eating disorder\n* participating mother who is pregnant or planning a pregnancy\n* parent being acquainted with the parent of a previously randomized study participant'}, 'identificationModule': {'nctId': 'NCT01029834', 'briefTitle': 'Treating Pre-School Children at Risk for Overweight in the Primary Care Setting', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Treating Overweight Youth: A Family Based Approach in Primary Care', 'orgStudyIdInfo': {'id': '1R01HD053773-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD053773-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention- Lifestyle family based', 'description': 'Behavioral family based', 'interventionNames': ['Behavioral: family based lifestyle and behavioral counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Information control', 'description': 'Child intervention only', 'interventionNames': ['Behavioral: counseling focused on the child']}], 'interventions': [{'name': 'family based lifestyle and behavioral counseling', 'type': 'BEHAVIORAL', 'description': '16 group meetings', 'armGroupLabels': ['Intervention- Lifestyle family based']}, {'name': 'counseling focused on the child', 'type': 'BEHAVIORAL', 'description': '16 meetings', 'armGroupLabels': ['Information control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'WNY urban practices', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'city': 'Williamsville', 'state': 'New York', 'country': 'United States', 'facility': 'WNY suburban practices', 'geoPoint': {'lat': 42.96395, 'lon': -78.73781}}], 'overallOfficials': [{'name': 'Teresa Quattrin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University at Buffalo/Women and Children's Hospital of Buffalo"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Division of Diabetes/Endocrinology', 'investigatorFullName': 'Teresa Quattrin', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}