Clinical trial NCT00961740: Childhood Obesity- Characteristics and Treatment
Official title: Cognitive Behavioural Treatment for Childhood Obesity- A Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Childhood Obesity
CBT
Family
Lifestyle change
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Helse Vest
name: The Royal Norwegian Ministry of Health
First posted: 2009-08-19
Enrollment: 44
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* obese status, according to Cole et al.'s (2000) international criteria.

Exclusion Criteria:

* serious somatic or metal health problems
* diabetes
* cardiovascular disease

Primary outcomes:
measure: Body Mass Index
timeFrame: (pre-treatment), 4-months after starting treatment, 12-months after ending intensive phase of treatment
Secondary outcomes:
measure: Self-perception Profile for Children (Harter, 1985)
timeFrame: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
measure: Waist circumference
timeFrame: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
measure: Child Behavior Checklist (CBCL)
timeFrame: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
measure: Children's Depression Inventory (CDI) (Kovacs)
timeFrame: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
measure: Physical activity actigraphy and self-report
timeFrame: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
measure: Food diary
timeFrame: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
measure: Blood measures (cholesterol, triglyceride, insulin, glucose, HbA1c, lipoprotein A)
timeFrame: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
state: Hordaland
Study officials:
affiliation: University of Bergen
name: Yngvild S Danielsen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Achenbach, T. M. Integrative Guide to the 1991 CBCL/4-18, YSR, and TRF Profiles. Burlington, VT: University of Vermont, Department of Psychology 1991.
citation: 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. doi: 10.1542/peds.2007-2329C.
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. doi: 10.1136/bmj.320.7244.1240.
citation: Harter, S. Manual for the self-perception profile for children. Denver, CO: University of Denver, 1985.
citation: Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available.
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. doi: 10.1097/00004583-200402000-00008.