Childhood Obesity- Characteristics and Treatment
Cognitive Behavioural Treatment for Childhood Obesity- A Clinical Trial.
4 other identifiers
interventional
44
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2007
Typical duration 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
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 17, 2009
CompletedFirst Posted
Study publicly available on registry
August 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedMay 28, 2014
May 1, 2014
2.8 years
August 17, 2009
May 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body Mass Index
(pre-treatment), 4-months after starting treatment, 12-months after ending intensive phase of treatment
Secondary Outcomes (7)
Self-perception Profile for Children (Harter, 1985)
(pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Waist circumference
(pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Child Behavior Checklist (CBCL)
(pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Children's Depression Inventory (CDI) (Kovacs)
(pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Physical activity actigraphy and self-report
(pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
- +2 more secondary outcomes
Study Arms (2)
Cognitive Behavioral Therapy
OTHERDesign: 49 children (aged 8-12)with obesity was recruited, the children were randomly assigned to a group that started a cognitive behavioural intervention immediately after recruitment, and another group that received the same treatment after a 12-week wait list condition. For further description of the treatment, see summary. Arm 1 (this arm) started receiving a cognitive behavioural intervention immediately after randomization.
12-weeks waitlist condition
OTHERAfter an initial pre-assessment no contact were made before assessment after 12-weeks and start of intervention after this assessment. After the 12-week waitlist condition the families were offered the same familibased cognitive behavioral intervention as in arm one.
Interventions
See summary
See Summary
Eligibility Criteria
You may qualify if:
- obese status, according to Cole et al.'s (2000) international criteria.
You may not qualify if:
- serious somatic or metal health problems
- diabetes
- cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bergenlead
- Helse Vestcollaborator
- The Royal Norwegian Ministry of Healthcollaborator
Study Sites (1)
University of Bergen
Bergen, Hordaland, 5020, Norway
Related Publications (6)
Achenbach, T. M. Integrative Guide to the 1991 CBCL/4-18, YSR, and TRF Profiles. Burlington, VT: University of Vermont, Department of Psychology 1991.
BACKGROUNDBarlow 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. doi: 10.1542/peds.2007-2329C.
PMID: 18055651BACKGROUNDCole 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. doi: 10.1136/bmj.320.7244.1240.
PMID: 10797032BACKGROUNDHarter, S. Manual for the self-perception profile for children. Denver, CO: University of Denver, 1985.
BACKGROUNDKovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available.
PMID: 4089116BACKGROUNDZametkin 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. doi: 10.1097/00004583-200402000-00008.
PMID: 14726719BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yngvild S Danielsen
University of Bergen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Psychologist, PhD-candidate
Study Record Dates
First Submitted
August 17, 2009
First Posted
August 19, 2009
Study Start
February 1, 2007
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
May 28, 2014
Record last verified: 2014-05