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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46114

Enrollment

Registered

2016-04-20

Start date

2016-07-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothalamic Obesity

Interventions

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 kilocalori

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Children

Design outcomes

Primary

Measure	Time frame
BMI (before, during and after cessation of the intervention) The criteria for success regarding feasibility of this pilot study are: - At least 70% of all eligible subjects can be recruited - Completion of intervention in at least 80% of subjects included The criteria for success regarding efficiency of this pilot study is: - 80% of subjects show weight reduction or stabilisation during the 1 year intervention period	—

Measure

Time frame

BMI (before, during and after cessation of the intervention) The criteria for success regarding feasibility of this pilot study are: - At least 70% of all eligible subjects can be recruited - Completion of intervention in at least 80% of subjects included The criteria for success regarding efficiency of this pilot study is: - 80% of subjects show weight reduction or stabilisation during the 1 year intervention period

—

Secondary

Measure	Time frame
Secondary outcomes: - The Quality of Life (measured with PedsQL) - The effect of the intervention on the metabolic profile (i.e. blood pressure, cholesterol profile, glycemic control) - Physical activity (measured with GENEactiv wristband and HAES 1.6 questionnaire) - The correlation between daily activity measured by the HAES questionnaire and the GENEActiv wristband	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)