Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-28 @ 9:45 AM
Study NCT ID:
NCT00717132
Status:
COMPLETED
Last Update Posted:
2022-05-16
First Post:
2008-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-effectiveness of Family Based Pediatric Obesity Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-11', 'studyFirstSubmitDate': '2008-07-10', 'studyFirstSubmitQcDate': '2008-07-10', 'lastUpdatePostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Standardized BMI', 'timeFrame': 'baseline, 6 months, 12 months', 'description': "The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared. Children's BMI also accounts for age and sex."}], 'secondaryOutcomes': [{'measure': 'change in quality adjusted life years (QALY)', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'The quality-adjusted life-year (QALY) is a measure of the value of health outcomes. Health is calculated by length of life and quality of life. QALY takes the value of years living and the quality into a single index number. The QALY calculation is the change in utility value resulting from the treatment multiplied by the duration of the treatment effect to provide the number of QALYs. QALYs can then be incorporated with medical costs to arrive at a final common denominator of cost/QALY.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['weight', 'cost effectiveness', 'obesity', 'family based behavioral treatment'], 'conditions': ['Weight Change', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'To determine the cost effectiveness of treating the child alone and parent alone to traditional family-based method of obesity treatment. It is hypothesized that a family-based approach will be more cost effective, and will support the savings and effectiveness of treating multiple family members together.', 'detailedDescription': 'Research has shown that family-based treatment programs produce significant short and long-term decreases in weight relative to height. Reductions in relative weight are observed for both parents and their children, with a significant relationship between parent and child relative weight changes.\n\nUsual care for families with obesity is for the parent and child to be treated separately by their individual physicians, often with different types of treatment plans. This may be less efficacious for the parent and child than a family-based intervention in which the parent and child are treated together. The separate treatments may also be more expensive than concurrent treatment following the same treatment plan.\n\nThere are many reasons to hypothesize that a family-based treatment will be more efficacious and more cost effective than other formats for treating families with multiple generations of obesity. If family members are treated together, they have the same treatment goals. They can learn to support each other, model positive behaviors, work together to change behaviors and modify the shared family environment. The simultaneous treatment of parents and children in a group format, which is how family-based treatments are administered, reduces the time therapists provide treatment in comparison to the usual format in which each parent and child would be seen individually.\n\nAn important challenge for obesity treatment is to develop efficacious and cost-effective interventions to treat pediatric obesity. The goal of this study is to evaluate the efficacy and cost effectiveness over 12 month follow-up for 50 families with overweight parents and children randomized to family-based behavioral treatment in comparison to the treatment of the parents and children separately, by different therapists, which represent usual care for families with obese parents and children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight child and parent in each family\n\nExclusion Criteria:\n\n* The parent and child must have no dietary or activity limitations that would preclude making the requested behavior changes; no current psychiatric problems and no history of eating disorders, including anorexia nervosa, bulimia nervosa or binge eating disorder. Families with a first degree relative with any of the mentioned eating disorders will also be excluded. The participating child must be able to read at a 3rd grade level and demonstrate the ability to maintain diet and activity records in a simulated recording interview. Both parent and child must be able to read the English language well enough to understand the consent and assent forms.'}, 'identificationModule': {'nctId': 'NCT00717132', 'briefTitle': 'Cost-effectiveness of Family Based Pediatric Obesity Treatment', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Cost-effectiveness of Family Based Pediatric Obesity Treatment', 'orgStudyIdInfo': {'id': 'Cost-effectiveness'}, 'secondaryIdInfos': [{'id': 'A-45270', 'type': 'OTHER_GRANT', 'domain': 'HealthNow'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individual Behavioral Modification', 'description': 'Individual behavioral weight control treatment; parent and child are treated separately for 15 total sessions.', 'interventionNames': ['Behavioral: Individual Behavior Modification']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Family-based Behavioral Modification', 'description': 'Family-based behavioral weight control treatment; parent and child are treated together for 15 total sessions.', 'interventionNames': ['Behavioral: Family-based behavior modification']}], 'interventions': [{'name': 'Individual Behavior Modification', 'type': 'BEHAVIORAL', 'description': 'Individual behavioral treatment for obesity. Children and parents meeting individually for 15 total behavioral modification intervention sessions.', 'armGroupLabels': ['Individual Behavioral Modification']}, {'name': 'Family-based behavior modification', 'type': 'BEHAVIORAL', 'description': 'Family-base behavior treatment for obesity. Children and parents meeting together for 15 total behavioral modification intervention sessions.', 'armGroupLabels': ['Family-based Behavioral Modification']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14214', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY @ Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Leonard H Epstein, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SUNY @ Buffalo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be submitted'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Healthnow', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Leonard H. Epstein, Ph.D.', 'investigatorFullName': 'Leonard Epstein', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}