Childhood Obesity- Characteristics and Treatment

Childhood Obesity Clinical Trial

Official title:

Cognitive Behavioural Treatment for Childhood Obesity- A Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00961740
• Other study ID #: 911180- Helse Vest
• Secondary ID: 15792- NSD241.06
• Status: Completed
• Phase: N/A
• First received: August 17, 2009
• Last updated: May 25, 2014
• Start date: February 2007
• Est. completion date: December 2009

Study information

• Verified date: May 2014
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Description:

Aim of the study: Evaluating a manualized treatment program for childhood obesity.

Participants: 49 families with children with obesity, aged 8-12. The participants will be recruited through referrals from medical doctors or nurses in primary health care or through ads in newspapers. Inclusion criteria: age between 8 and 12 and satisfying the criteria for obesity according to Coles indexes for BMI for the given gender and age group (Cole et al, 2000). Exclusion criteria are cardiovascular disease, diabetes and severe psychopathology. Before inclusion the child will go through a medical examination by a pediatrician as well as an interview by a psychologist.

Procedure/treatment program: The manualized treatment is based on principles from cognitive behavioural therapy and is family based. The treatment consists of 14 sessions (60 minutes), where a clinical psychologist meet the family together. The first 12 sessions are given at a weekly basis, the last two sessions are administered half a year and one year after the more intensive part of the treatment. The treatment program includes elements such as: 1) general overview of the treatment plan, 2) basic information about nutrition, physical activity and metabolism, 3) keeping a food and activity diary, 4) a behavioral modification plan aimed at changing habits such as watching TV, video and PC causing sedentary behavior, 5) a behavioral modification plan aimed at changing eating patterns and level of physical activity 6) a module consisting of identifying and avoiding risk factors associated with unhealthy and/or excessive eating and sedentary behavior, 7) a module focusing upon parent counseling 8)modules focusing on problem solving skills, reactions in stressful situations and automatic thoughts 9) modules discussing bullying and self-esteem 10)home work assignments between sessions(Barlow & Dietz, 1998; Zametkin et al, 2004). In all, 20 subjects will be randomized to immediate treatment (12 weeks) while the other half of the subjects will randomized to a waiting-list control group. The waiting-list control group will receive treatment.

Instruments measuring the results of the treatment:

Behavioural change: Daily logs on activity and nutrition will be kept by the subjects for one week prior to and one week following the intensive phase of the treatment (12-sessions), as well as after one year. In the same periods actigraphs will be used in order to obtain objective data on physical activity levels.

Self-report measures: The Self-Perception Profile for Children (SPPC) (Harter, 1985)is a well recognized self-report measure that assesses general and dimensional (cognitive, social, and physical) self-esteem in children and adolescents. The Children's Depression Inventory (CDI) a commonly used screening device for pediatric depression containing a 27-item, symptom-oriented scale (Kovacs, 1985). Child Behavior Check-list (CBCL,a well recognized parent-report measure, measuring children's social competence and behavioral problems(Achenbach,1991).

Physiological measures: Fasting plasma insulin, glucose and triglyceride, cholesterol (total, HDL, LDL), HbA1c and lipoprotein A.

Physical measures: Weight, BMI, waist circumference, blood pressure. All measures will be administered pre-treatment (and pre-wait-list for the control group), after 12-sessions of treatment and after one year.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Cognitive Behavioural Therapy
See summary

Other:
• Waitlist condition
See Summary

Locations

Country	Name	City	State
Norway	University of Bergen	Bergen	Hordaland

Sponsors (3)

Lead Sponsor	Collaborator
University of Bergen	Helse Vest, The Royal Norwegian Ministry of Health

Country where clinical trial is conducted

Norway, 

References & 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.

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

Outcome

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