Efficacy of the BELA weight management programme to prevent increase of weight in schizophrenic patients treated with olanzapin (BELA = movement - nutrition - learning - accepting)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN23263429

Enrollment

180

Registered

2008-05-30

Start date

2008-04-03

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Schizophrenia Mental and Behavioural Disorders Schizophrenia

Interventions

This trial is taking place at four sites (Düsseldorf, Bochum, Krefeld, Dortmund). Participants will be randomly allocated to the two arms in equal numbers: Intervention group: Standard therapy + BEL

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both males and females 2. Age 18 - 65 years 3. Criteria of the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM IV) for schizophrenia or schizoaffective psychosis 4. Written informed consent 5. Capability of signing informed consent 6. Olanzapin medication

Exclusion criteria

Exclusion criteria: 1. Serious somatic diseases 2. Changes in weight due to somatic diseases 3. Pregnancy or lactation 4. Increase of weight of more than 3 kg over the last 3 months before start of treatment with olanzapin 5. Co-medication with a weight-reducing potential 6. Participation in another interventional trial which could interfere with this trial

Design outcomes

Primary

Measure	Time frame
Weight changes in kg, measured at week 1 and week 10.	—

Secondary

Measure	Time frame
1. Influence of the intervention on further risk factors, assessed by the following: 1.2. Cholesterol at Week 2, 1, 5, 10, 14 and 18 1.3. low density lipoprotein (LDL) at Week 2, 1, 5, 10, 14 and 18 1.4. Triglyzeride at Week 2, 1, 5, 10, 14 and 18 1.5. high density lipoprotein(HDL) at Week 2, 1, 5, 10, 14 and 18 1.6. HbA1c at Week 1, 10 and 18 1.7. Glucose at Week 2, 1, 5, 10, 14 and 18 1.8. Blood-pressure at Week 2, 1, 5, 10, 14 and 18 1.9. Abdominal girth at Week 2, 1, 5, 10, 14 and 18 1.10. Body mass index (BMI) at Week 2, 1, 5, 10, 14 and 18 2. Identification of indicators with regard to weight increase and the response on weight management by acquisition of the following parameters: 2.1. Age, sex, initial weight 2 weeks prior to intervention 2.2. Psycho-pathological rating-scales: a. Positive and Negative Syndrome Scale (PANSS) 2 weeks before intervention and then at weeks 1, 5, 10, 14 and 18 b. Personal social achievement rating scale (persönliche soziale Leistungskala [PSL]) at weeks 1, 10 and 18 c. 36-item Short Form health survey (SF-36) at weeks 1, 10 and 18 d. Body image assessment questionnaire (Fragebogen zur Beurteilung des eigenen Körpers [FBeK]) at weeks 1, 10 and 18 e. Type D Personality Scale (DS14) 2 weeks prior to intervention f. Global Assessment of Functioning (GAF) at weeks 1, 10 and 18 2.3. Medical genetics: Polymorphism for weight increase, assessed at week 1 2.4. Lipometabolism: Participating hormones and interleukine: leptin, ghrelin, adiponektin, cortisone, retinol binding protein 4 (RBP-4), IL-6, TNF-alpha. These will be assessed at weeks 1, 10 and 18 3. Increase of weight (in kg) of the intervention group in comparison to the control group at the end of the follow-up phase (Week 1 [before the intervention phase] vs Week 18 [after the follow-up phase])	—

Measure

Time frame

1. Influence of the intervention on further risk factors, assessed by the following: 1.2. Cholesterol at Week 2, 1, 5, 10, 14 and 18 1.3. low density lipoprotein (LDL) at Week 2, 1, 5, 10, 14 and 18 1.4. Triglyzeride at Week 2, 1, 5, 10, 14 and 18 1.5. high density lipoprotein(HDL) at Week 2, 1, 5, 10, 14 and 18 1.6. HbA1c at Week 1, 10 and 18 1.7. Glucose at Week 2, 1, 5, 10, 14 and 18 1.8. Blood-pressure at Week 2, 1, 5, 10, 14 and 18 1.9. Abdominal girth at Week 2, 1, 5, 10, 14 and 18 1.10. Body mass index (BMI) at Week 2, 1, 5, 10, 14 and 18 2. Identification of indicators with regard to weight increase and the response on weight management by acquisition of the following parameters: 2.1. Age, sex, initial weight 2 weeks prior to intervention 2.2. Psycho-pathological rating-scales: a. Positive and Negative Syndrome Scale (PANSS) 2 weeks before intervention and then at weeks 1, 5, 10, 14 and 18 b. Personal social achievement rating scale (persönliche soziale Leistungskala [PSL]) at weeks 1, 10 and 18 c. 36-item Short Form health survey (SF-36) at weeks 1, 10 and 18 d. Body image assessment questionnaire (Fragebogen zur Beurteilung des eigenen Körpers [FBeK]) at weeks 1, 10 and 18 e. Type D Personality Scale (DS14) 2 weeks prior to intervention f. Global Assessment of Functioning (GAF) at weeks 1, 10 and 18 2.3. Medical genetics: Polymorphism for weight increase, assessed at week 1 2.4. Lipometabolism: Participating hormones and interleukine: leptin, ghrelin, adiponektin, cortisone, retinol binding protein 4 (RBP-4), IL-6, TNF-alpha. These will be assessed at weeks 1, 10 and 18 3. Increase of weight (in kg) of the intervention group in comparison to the control group at the end of the follow-up phase (Week 1 [before the intervention phase] vs Week 18 [after the follow-up phase])

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026