A new dietary intervention for children with hypothalamic obesity after treatment for a craniopharyngioma: a pilot-study
Completed
- Conditions
- Hypothalamic Obesity1002111210003018
- Registration Number
- NL-OMON46114
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
- Children or adolescents with hypothalamic obesity, BMI > 1,9 SD, currently visiting a pediatric endocrinologist after treatment for sellar or suprasellar lesions are eligible for this study.
- patients must be in complete remission or have residual disease > 1 year
Exclusion Criteria
- Children < age of 5 years
- Current progression of disease.
- Diabetes Mellitus type 1
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>BMI (before, during and after cessation of the intervention)<br /><br><br /><br>The criteria for success regarding feasibility of this pilot study are:<br /><br>- At least 70% of all eligible subjects can be recruited<br /><br>- Completion of intervention in at least 80% of subjects included<br /><br><br /><br>The criteria for success regarding efficiency of this pilot study is:<br /><br>- 80% of subjects show weight reduction or stabilisation during the 1 year<br /><br>intervention period</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes:<br /><br>- The Quality of Life (measured with PedsQL)<br /><br>- The effect of the intervention on the metabolic profile (i.e. blood pressure,<br /><br>cholesterol profile, glycemic control)<br /><br>- Physical activity (measured with GENEactiv wristband and HAES 1.6<br /><br>questionnaire)<br /><br>- The correlation between daily activity measured by the HAES questionnaire and<br /><br>the GENEActiv wristband</p><br>