Childhood Obesity Clinical Trial
Official title:
Cognitive Behavioural Treatment for Childhood Obesity- A Clinical Trial.
The study is evaluating the effect of a 14-session cognitive behavioural treatment for childhood obesity. The treatment is family based and 49 families with children with obesity, aged 8-12, will be recruited. Outcome measures are: BMI, waist circumference, self-esteem, social- and psychological functioning, cholesterol, glucose and insulin values, activity level (actigraphs) and a measure of food intake.
Status | Completed |
Enrollment | 44 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 8 Years to 13 Years |
Eligibility |
Inclusion Criteria: - obese status, according to Cole et al.'s (2000) international criteria. Exclusion Criteria: - serious somatic or metal health problems - diabetes - cardiovascular disease |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | University of Bergen | Bergen | Hordaland |
Lead Sponsor | Collaborator |
---|---|
University of Bergen | Helse Vest, The Royal Norwegian Ministry of Health |
Norway,
Achenbach, T. M. Integrative Guide to the 1991 CBCL/4-18, YSR, and TRF Profiles. Burlington, VT: University of Vermont, Department of Psychology 1991.
Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. — View Citation
Cole TJ, Bellizzi MC, Flegal KM, Dietz WH. Establishing a standard definition for child overweight and obesity worldwide: international survey. BMJ. 2000 May 6;320(7244):1240-3. — View Citation
Harter, S. Manual for the self-perception profile for children. Denver, CO: University of Denver, 1985.
Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. — View Citation
Zametkin AJ, Zoon CK, Klein HW, Munson S. Psychiatric aspects of child and adolescent obesity: a review of the past 10 years. J Am Acad Child Adolesc Psychiatry. 2004 Feb;43(2):134-50. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body Mass Index | (pre-treatment), 4-months after starting treatment, 12-months after ending intensive phase of treatment | No | |
Secondary | Self-perception Profile for Children (Harter, 1985) | (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment | No | |
Secondary | Waist circumference | (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment | No | |
Secondary | Child Behavior Checklist (CBCL) | (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment | No | |
Secondary | Children's Depression Inventory (CDI) (Kovacs) | (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment | No | |
Secondary | Physical activity actigraphy and self-report | (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment | No | |
Secondary | Food diary | (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment | No | |
Secondary | Blood measures (cholesterol, triglyceride, insulin, glucose, HbA1c, lipoprotein A) | (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment | No |
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