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