Health Effect of Lifestyle Interventions in Obese children and adolescents Study

Severe obesity is increasingly common in The Netherlands and poses a dilemma in
clinical medicine. Intensive treatment is required but evidence-based
cost-effective options are not yet available. The best practice that has been
proposed by the soon to be released Dutch "Guideline for Diagnosis and
Treatment of Obesity in Children and Adults" is an intensive combined lifestyle
therapy but it is acknowledged that programs that are effective on the
long-term are not yet available. Previously, an extensive six-month inpatient
treatment program has shown to be much more effective in one year than
ambulatory usual care but there are some critical issues remaining. Long-term
treatment outcomes are not available and long-term inpatient programs are
undesirable for both the patients and their families. Moreover, this option is
extremely expensive. The Ministry of Health, Welfare and Sports has now agreed
to fund intensive treatment of severe obesity on an experimental research basis
with the requirement that less intensive and more cost-effective treatments are
being developed and evaluated. This is the basis of the current proposal. In
addition, there is little insight in the psychological features that may be
crucial in determining the long-term outcome. Finally, such intensive treatment
programs need to be integrated in a chronic disease management program. It is
currently poorly defined what the pretreatment requirements are before a
patient is referred to an intensive inpatient program. Similarly, there is not
a long-term care protocol following the intensive treatment program.

The objectives of this proposal are
1. to compare the effects and costs of two intensive one-year interventions in
severely obese children and adolescents of which the first six months are
different with respect to the length of hospitalization; there will aso be a
comparison with a one year usual care treatment (waitinglist control)
2. to study psychosocial determinants in the children and their parents
relevant to the outcome of the interventions (change in BMI, improvement in
quality of life (generic and weight-specific health-related quality of life));
3. to integrate intensive lifestyle treatment in a national standard for
chronic disease management in collaboration with the relevant professional
organizations (pediatricians, general practitioners, dietitians,
physiotherapists, psychologists etc); health care insurance companies and
patient organizations.

A randomized clinical trial with three study arms. There will be a triage
system at which patients are evaluated for inclusion in the trial. There will
be two intervention-groups: one with a six months intensive multidisciplinary
inpatient treatment program and one arm with an intensive multidisciplinary
program with twee months continuous hospitalization (on weekdays) followed by
biweekly hospital admissions of two days during the following vier months. Both
treatment programs are followed by six months follow-up of monthly clinical
booster sessions of two days each. The second year there will be usual care in
the local setting of the child. A third arm will be an evaluation of ambulatory
usual care treatment after which they will be randomized into each of the two
treatment groups (waitinglist control).

The treatment program lasts een years for both groups. Patients will be
randomized into three groups. Group A will be hospitalized for six months
during weekdays. Group B will be hospitalized during weekdays for two months,
followed by biweekly hospital admissions for two days during four months. Group
C will recieve usual care for a year after which they will be randomized into
one of the two inpatient intervention groups. Both intervention programs are
intensive lifestyle intervention programs with emphasis on nutrition, exercise,
behavior (especially self-regulation). During the second six months there will
be six 'clinical booster sessions' each of two days duration aimed at
reinforcement of the interventions. The second year there will be usual care
in the local setting of the child. In both intervention programs there is an
active participation of the parents.

Because of the healt risks and the importance of effective therapy with
children and adolescents with extreme overweight this study is conducted in
children in the age of 8-19 years. De questionnaires and interviews, the
physical examination, the venapunctions and other treatments during the
hospital stay are part of the normal therapy. The extra burden for the patients
consists only of extra psychological and psychosocial questionnaires. The study
will not cause any additional risk for the participants.