Page 68 - Go4it

Chapter 5
group. We also hypothesised that the Go4it treatment would have a beneficial effect on HRQoL.
Methods
Subjects and design
The present study is a randomised controlled trial evaluating the effect of the Go4it multidisciplinary group treatment for obese adolescents, on HRQoL at 6 and 18 months follow-up. Adolescents were referred to the outpatient paediatric obesity clinic of the VU University Medical Center Amsterdam by their general practitioner or school physician. During the first visit, one of the 3 paediatric- endocrinologists interviewed all adolescents concerning their medical history, social problems, teasing, weight development, socio-economic status (SES) and ethnicity according to a standard protocol. Subjects were categorised as having a western ethnicity when both parents were Dutch or with at least one parent was born outside the Netherlands, but inside Europe (including former Yugoslavia and Soviet Union), North America, Oceania, Indonesia or Japan. Subjects with at least one parent born in Turkey, Africa, Latin America or Asia were classified as non-western (18). The physical examination included height, weight, waist circumference, blood pressure and pubertal Tanner stage (19). The subjects and their parents received an informational brochure about the study. Within 2 weeks, the research assistant checked their willingness to participate. Subjects were eligible when they met the following inclusion criteria: 1) age 11-18 years; and 2) overweight or obese according to the definition of Cole et al with gender and age specific cut-off values (20). Exclusion criteria were: not Dutch-speaking, obesity as a result of a known syndrome or organic cause (hypothyroidism), mental retardation, physical limitations (e.g. crutches or wheelchair) and diagnosis of type 2 diabetes mellitus. The research assistant used block randomisation to assign subjects randomly to the intervention (60%) or control group (40%), using SPSS for random selection. This distribution was chosen to recruit a sufficient number of adolescents to start the intervention sessions. Randomisation was stratified by sex and age group (11-14 years old and 15-18 years old). Since adolescents knew to which group they were assigned, participants could not be blinded. The medical ethical committee of VU University Medical Center Amsterdam approved the protocol. Adolescents, as well as their parents, gave written informed consent.
Intervention
Go4it is a multidisciplinary group treatment for obese adolescents based on the programs of Braet et al. (16), Epstein et al. (21), and the educational materials of the Dutch Obesity Intervention in Teenagers (DOiT) (22). During 7 sessions with 2-week intervals, the adolescents received education on healthy dietary behaviour, screen behaviour and physical activity. The group size was 8 to 12
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