A new dietary intervention for children with hypothalamic obesity after treatment for a craniopharyngioma: a pilot-study

Hypothalamic obesity (HO) due to hypothalamic damage is a major concern in
children and adults treated for craniopharyngioma. It greatly disrupts quality
of life, increases the risk for cardiovascular complications and up to now
therapeutic interventions have been disappointing. These children have a lack
of hunger satisfaction and also a the lower metabolic state. The Happy Weight
Diet has been designed for children with HO in patients with Prader Willi
syndrome, which is comparable to children with HO due to a craniopharyngioma,
and has demonstrated a significant weight reduction in this patientgroup.

This pilot-study is designed to assess the feasibility and efficacy of a new
dietary intervention (Happy Weight Dotsplan) and therefore to learn if it might
be effective on a broad scale with the inclusion of a larger cohort nationwide.
We will therefore investigate the effect of *The Happy Weight Diet* on BMI,
metabolic profile and quality of life in a small group of children with
hypothalamic obesity after treatment for a craniopharyngioma or suprasellar
tumor.

In total, a small cohort of children will be included in this prospective
intervention pilot-study. A dietary intervention (The Happy Weight Dotsplan)
will be offered to these patients, including a coaching trajectory. Differences
in BMI before, during and after cessation of intervention will be compared.
Three monds after the end of the active intervention period, BMI will be
defined again.

Subjects will be assigned for intervention with *The Happy Weight Diet* with
personal support by the dietician and the coach of *s Heeren Loo. The dietary
advice will be calculated by the kilocalorie use of 65-70 % of normal, as
calculated by the following method (7-8 kcal/cm body height).
In these children, *The Happy Weight Diet* will be followed according to the
happy weight method (www.happyweight.nl) and a coaching program is also
included.
Daily activity will be stimulated but no active intervention will be done.
Daily activity will be measured at start and after twelve months of the
intervention by an accelerometer and a questionnaire.

Visits:
1.Pediatric endocrinologist:
All children will have their regular check-ups at the endocrinologist (every
three months)
2.Dietician:
The patients will been seen by the dietician at intake, after 3 months and
after 1 year. In between the visits, the dietician will have monthly contact
with the patient for 30 minutes by telephone, email or skype.
3. Coach:
The coach will have an intake, an evaluation at 3 months, at 6 months and after
one year.
4. Pediatric physiotherapist:
The physiotherapist will have an intake and an evaluation after one year.

All included patients will be intensively active with their diet and
psychological coaching during one year. The burden or risk for the subjects is
considered as acceptable as there is currently no treatment available for
hypothalamic obesity after treatment for craniopharyngioma.
The possible benefit for the subjects may be great with possible weight
reduction or stabilization, resulting in improvement of glycemic control,
improvement of cardiovascular risk profile and improvement of quality of life.
There are no possible risks for the patients.

Group relatedness:
The incidence of severe obesity after treatment for craniopharyngioma ranges
from 22 to 62%. Patients with craniopharyngioma have a 3-fold greater
cardiovascular mortality rate associated with morbid obesity as compared to the
normal population . Due to the fact that hypothalamic obesity is a such a
clinical relevant problem for craniopharyngioma patients already during
childhood and young adulthood, research into new treatment strategies must be
done in all relevant patient groups, thereby involving minors. The Happy Weight
Dotsplan is developed for children with Prader Wille syndrome, which have a
comparable lack of hunger satisfaction and obesity. This Dotsplan might also be
effective in children with hypothalamic obesity after treatment for a
suprasellar tumor.