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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20813
Enrollment
80
Registered
2009-02-20
Start date
2009-03-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Obesity, adiposity Obesiteit, zwaarlijvigheid

Interventions

Control group (current protocol): there will be an exercise program for three days per week (30-60 minutes each, mean duration of exercise sessions 43 minutes) and nutrition education/behavior modific
less intensive and less costly): The treatment here is identical to the control group except for the first six months. Instead of six months hospitalization this group will be hospitalized for two mon

Sponsors

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

Eligibility

Inclusion criteria

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

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.

Design outcomes

Secondary

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

Primary

MeasureTime frame
SDS-BMI (costs of treatment per change in relative BMI).

Contacts

Public ContactJ.C. Seidell

VU University Medical Center, Afdeling Voeding en Gezondheid/ Instituut Gezondheidswetenschappen, Faculteit Aard en Levenswetenschappen, De Boelelaan 1085

jaap.seidell@falw.vu.nl+31 (0)20 5986985

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)