Childhood Obesity- Characteristics and Treatment
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

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.
    

Intervention name(s): Cognitive Behavioural Therapy; Waitlist condition
Intervention type(s): Behavioral; Other
Intervention description(s): See summary; See Summary
Other intervention name(s): 12-week waitlist condition, before CBT as in arm 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Childhood Obesity; CBT; Family; Lifestyle change