Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children
1 other identifier
interventional
200
1 country
1
Brief Summary
To compare anthropometric and metabolic effects of a comprehensive weight management program on obese adolescents and children in comparison to regular clinical weight management visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 6, 2006
CompletedFirst Posted
Study publicly available on registry
December 8, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedJune 24, 2008
June 1, 2008
4.4 years
December 6, 2006
June 20, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
weight
6 months and 1 year
body mass index
6 months and 1 year
% body fat
6 months and 1 year
lipids
6 months and 1 year
blood pressure
6 months and 1 year
glucose
6 months and 1 year
insulin
6 months and 1 year
HOMA index
6 months and 1 year
Secondary Outcomes (1)
planned to compare dieting with non-dieting approach in weight management group
6 months and 1 year
Interventions
Eligibility Criteria
You may qualify if:
- Ages 8-16 years old
- BMI \>95th percentile for age/gender based on CDC
- Both primary caregiver/parent and child must agree to participate in the nutrition classes
You may not qualify if:
- endocrinopathies, including hypothyroidism and diabetes
- Psychiatric disorders that will interfere with ability to complete follow-up and adherence to protocol
- Any behavioral or psychosocial issue that will interfere with subject's completion of program, including eating disorder.
- Any use of medication (steroids, for ex.) that contributes to excess adiposity.
- Any use of pharmacological intervention for weight management, including prescription medications, over-the-counter medications, or herbal supplements.
- Any concurrent membership in a weight management program.
- Inability or unwillingness of parent to accompany the child to nutrition classes.
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Related Publications (1)
Savoye M, Shaw M, Dziura J, Tamborlane WV, Rose P, Guandalini C, Goldberg-Gell R, Burgert TS, Cali AM, Weiss R, Caprio S. Effects of a weight management program on body composition and metabolic parameters in overweight children: a randomized controlled trial. JAMA. 2007 Jun 27;297(24):2697-704. doi: 10.1001/jama.297.24.2697.
PMID: 17595270DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sonia Caprio, MD
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 6, 2006
First Posted
December 8, 2006
Study Start
May 1, 2002
Primary Completion
October 1, 2006
Study Completion
February 1, 2007
Last Updated
June 24, 2008
Record last verified: 2008-06