Het HELIOS onderzoek naar behandeling van kinderen en adolescenten met ernstige obesitas.

Recruiting

Conditions: Obesity, adiposityObesiteit, zwaarlijvigheid

Registration Number: NL-OMON20813

Lead Sponsor: Type organisation: Universiteiten Name organisation: Vrije Universiteit Address De Boelelaan 1085 Postal code and place: 1081 HV Amsterdam Country: The NederlandsTelephone nr: 020-5986995 Fax 020-5986940 Email: jaap.seidell@falw.vu.nl

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

Children and adolescents (8-19 years) with a SDS-BMI ≥ 3.0 (99.9th age- and sex-specific percentile of BMI in the fourth Dutch nationwide growth study of 1997), or a SDS-BMI ≥ 2.3 (99th age- and sex-specific percentile of BMI in the fourth Dutch nationwide growth study of 1997) in combination with obesity-related comorbidity. All participants were referred by their local pediatrician after insufficient response to ambulatory treatment to reduce weight.

Exclusion Criteria

1. Syndromal/chromosomal determined obesity;
2. Obesity cause by endocrine disorders (e.g. hypothyroidism, Cushing syndrome, primary hyperinsulinemia, pseudohypoparathyroidism, acquired (structural) hypothalamic damage) or use of medication (e.g. antiepileptic drugs, antidepressants);
3. Psychiatric disorders (e.g. severe depression, schizophrenia) that may obstruct adequate treatment;
4. Presence of eating disorders (e.g. binge eating disorder, bulimia nervosa) to such a degree that specific therapeutic attention is needed before starting the intervention;
5. Children/adolescents or parents that can or will not give `informed consent`, parents that can or will not participate in the treatment;
6. Children/adolescents with an IQ below 75 or attending a school for intellectually challenged children.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SDS-BMI (costs of treatment per change in relative BMI).

Secondary Outcome Measures

Name	Time	Method
1. Psychological and psychosocial data on issues such as motivation, competence, self-esteem, anxiety, mental stress;<br /><br>2. Cardiovascular risk factors (blood pressure, serum lipids, liver function tests, glucose and insulin);<br /><br>3. Waist circumference;<br /><br>4. Dietary behavior by Food Frequency Questionnaire;<br /><br>5. Questionnaires on eating behavior, physical activity (sedentary behavior);<br /><br>6. Quality of life (generic, weigh-specific and health-related quality of life).