Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-30 @ 10:38 AM
Study NCT ID:
NCT00006169
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2000-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral Treatment of Weight Gain in CF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'PREVENTION'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '1999-11'}, 'lastUpdateSubmitDate': '2010-03-01', 'studyFirstSubmitDate': '2000-08-08', 'studyFirstSubmitQcDate': '2000-08-08', 'lastUpdatePostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-08-09', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Nutrition', 'Behavior Therapy', 'Cystic Fibrosis'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '19805710', 'type': 'DERIVED', 'citation': 'Stark LJ, Quittner AL, Powers SW, Opipari-Arrigan L, Bean JA, Duggan C, Stallings VA. Randomized clinical trial of behavioral intervention and nutrition education to improve caloric intake and weight in children with cystic fibrosis. Arch Pediatr Adolesc Med. 2009 Oct;163(10):915-21. doi: 10.1001/archpediatrics.2009.165.'}]}, 'descriptionModule': {'briefSummary': 'The current study examines the efficacy of two treatments to help children with cystic fibrosis (CF) meet their dietary calorie requirements of 120% to 150% of the recommended daily allowance of energy and the effect of these treatments on weight gain and maintenance. One treatment provides children with CF and their parents nutrition education about the best foods for meeting their dietary needs. The second treatment gives children with CF and their families similar nutritional information plus behavioral parenting methods for motivating children to eat the recommended foods. Children with CF and their families are seen weekly for 7 treatment sessions across 9 weeks for the active phase of treatment. Families are then followed for 2 years after treatment in order to better understand how long the treatments are effective and to determine the health benefits of better nutrition status and weight gain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weight percentile for age or height below 40th for age and sex\n* Pancreatic insufficiency\n\nExclusion Criteria:\n\n* Developmental delays\n* Pseudomonas cepacia\n* Supplemental enteral or parenteral nutrition'}, 'identificationModule': {'nctId': 'NCT00006169', 'briefTitle': 'Behavioral Treatment of Weight Gain in CF', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Behavioral Treatment of Weight Gain in CF', 'orgStudyIdInfo': {'id': 'Stark (completed)'}, 'secondaryIdInfos': [{'id': '50092'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Behavioral Treatment', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32601', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Children's Hospital Medical Center, Cincinnati", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Lori Stark', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital & Medical Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}}}}