- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00177229
KidQuest Family-Based Weight Control
Family-Based Treatment of Severe Pediatric Obesity
Study Overview
Detailed Description
The prevalence of pediatric obesity has increased significantly, and approximately 11% of American children and adolescents are obese. Of particular concern, the greatest increase in prevalence has occured among the heaviest children. Severe pediatric obesity (defined as > 150% of ideal body weight for height) is associated with higher rates of medical and psychosocial morbidity than milder obesity is. Moreover, severely obese children are likelier than less severely obese children are to become obese adults and suffer the long-term health consequences of obesity. Although the efficacy of family-based behavioral weight control programs in the treatment of moderate pediatric obesity is well established, few studies have focused on the treatment of severe obesity. Thus in this application, we propose a randomized controlled trial to evaluate the efficacy of a family-based behavioral weight control program in the management of severe pediatric obesity.
Two hundred children aged 8-12 will be randomized to a six-month family-based program or usual care, and will complete assessments at pre- and post- treatment and 6-month and 12-month follow-ups. We hypothesized that: 1) Children who participate in the family-based program, when compared to children who receive usual care, will show favorable changes in body mass index, body composition, food intake, activity level, and cardiovascular risk factors. 2) Children who participate in the family-based program, when compared to children who receive usual care, will report higher levels of self-esteem, social competence and health-related quality of life, and report fewer psychiatric symptoms. A secondary aim of the the proposed investigation is to examine the relationships among gender, race, compliance to diet and exercise. level of parent adherence and treatment outcome. The proposed investigation is significant as the first effort to systematically evaluate a treatment program for severely obese children. It will provide data about a serious public health problem and establish a foundation for programmatic research to develop effective treatments for an underserved population.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be >150% of ideal body weight for height and age based on norms of the World Health Organization.
- Have at least one parent or guardian who will participate in the treatment program with child.
Exclusion Criteria:
- Mental retardation, pervasive developmental disorder or psychosis, psychiatric symptomatology sufficiently severe to require immediate treatment.
- Genetic obesity syndrome as determined by the study physician.
- Currently receiving obesity treatment and/or participating in a weight management program.
- Inability to engage in moderate exercise defined as 30 minutes of vigorous activity on most days of the week.
- Acute or severe medical conditions that require aggressive weight management intervention (e.g., diabetes pseudotumor cerebri, or hypoventilation).
- Regular use of a medication that affects body weight such as oral steroids or antipsychotic medications.
- Taking stimulant or antidepressant medication for a period < four months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: B
|
20 weekly group contacts with individual coaching over first 6 months, brief monthly contacts over next 6 months, no contacts over last 6 months.
Medical monitoring throughout study period.
|
No Intervention: A
Enhanced usual care: 2 free, individual consultations with a nutritionist over first 6 months.
Medical monitoring throughout study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BMI and cardiovascular risk factors
Time Frame: 0,6,12,18
|
0,6,12,18
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Eating, activity, and psychosocial functioning
Time Frame: 0,6,12,18
|
0,6,12,18
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marsha D. Marcus, Ph.D., Western Psychiatric Insitute & Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0405048
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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