The effect evaluation of a multidiscipinary treatment in children with obesity.

The prevalence of childhood overweight and obesity has increased rapidly during
the last two decades in the Netherlands. Genetic as well as environmental
factors have contributed to this trend. Genetic variations in the insulin
receptor substrate-1 gene (IRS-1) and in the glucocorticoid receptor (GR) are
associated with the degree of obesity and insulin resistance. Also several
gastrointestinal hormones, responsible for appetite and food intake, are
impaired in overweight and obese subjects. Parental overweight or obesity and
low social economic status or education are risk factors for childhood
overweight or obesity. Childhood overweight or obesity affects self-esteem and
has negative consequences on cognitive and social development. Overweight
increases the risk for developing cardiovascular complications, diabetes
mellitus type 2, metabolic syndrome, joint problems, and psychosocial problems.
Because of the increasing prevalence of childhood overweight and obesity and
the impact on individuals and society, prevention of overweight and obesity is
of high importance.

The main parameter of the study is evaluation and effectiveness of the
treatment program on Body Mass Index (BMI) (as defined by Cole et al) compared
to a standard intervention (increased physical activity and nutrient advice).
Also the effectiveness of the treatment compared to the standard intervention,
on sum of skinfolds, insulin sensitivity, metabolic syndrome, gastrointestinal
hormones, cardiovascular fitness, and quality of life will be studied.

An open randomised controlled intervention study.
Newly presented children/adolescents with obesity will be physically examined.
All children eligible for the study and their parents will be informed by the
paediatrician and will be asked to read the information letter before giving
their informed consent. After dividing the participants in a children's group
(8-12 years) and an adolescent group (13-17 years) stratification (on sex and
ethnicity) and randomisation will take place. An experienced person blinded for
the study design will measure weight and height (main study parameter).

The intervention group is offered 7 group meetings of 2 1/2 hour and the
parents are offered 4 separate parent meetings en 1 meeting together with the
children/adolescents. Main topics are education on nutrition, physical activity
and improvement of self-esteem.
Children/adolescents in the control group are given a standard treatment
(increased physical activity and nutrition advice). They are offered to
participate in the treatment program after the 12 months study period.

For evaluation of short-term, midterm and long-term effects of the treatment,
measurements will be taken at the beginning of the treatment, after 3 months of
treatment and after 12 and 24 (intervention group only) months of follow-up.
During these three (four) visits the following procedures will be performed:
pysical examination, metabolic screening, cardiovascular fitness evaluation,
mixed meal test and quality of life questionnaires.