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

ISRCTN	ISRCTN23263429
DOI	https://doi.org/10.1186/ISRCTN23263429
Protocol serial number	GM2_2007
Sponsor	Heinrich-Heine University (Germany)
Funders	Heinrich-Heine University (Germany), Lilly GmbH (Germany), Note: This is an investigator initiated trial.

Submission date: 18/04/2008
Registration date: 30/05/2008
Last edited: 30/05/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Joachim Cordes
Scientific

Clinic and Polyclinic for Psychiatry and Psychotherapy
Rheinische Kliniken Düsseldorf
Bergische Landstr. 2
Düsseldorf
40629
Germany

Phone	+49 211 9223402
Email	joachim.cordes@lvr.de

Study information

Primary study design	Interventional
Study design	Phase IV, multi-centre, open, two-arm randomised controlled trial.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	BELA
Study objectives	To assess the efficacy of preventative effects of the BELA programme on weight and metabolic parameters in schizophrenic patients treated with olanzapin.
Ethics approval(s)	1. Ethics Committee of Medical Faculty of Heinrich-Heine University. Date of approval: 07/02/2008 (ref: MC-LKP-249) 2. Federal Institute for Drugs and Medical Devices (BfArM). Date of approval: 06/12/2007 (ref: 4033665)
Health condition(s) or problem(s) studied	Schizophrenia
Intervention	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 + BELA weight management programme Control group: Standard therapy only The psychoeducation programme BELA has been developed at the beginning of 2005 for psychiatric patients. The contents of the psychoeducation are based on the knowledge that better nutrition and regular exercise may stabilise the individual course of disease, the detection of bad habits and the implementation, practice and stabilisation of individual, appropriate habits. As far as methods are concerned, these are simple pedagogic and informational modules (adapted to the type of patients) and which result in experiment-orientated, practical exercises. The BELA concept is geared to small groups (6 - 10 patients) in order to, for example, allow the planning, shopping, cooking of a meal. Over a period of 10 weeks there are group meetings, each 60 minutes, with knowledge transfer of nutrition and exercising. Content of patient-education: 1. Aim of the course 2. Energy and calories 3. Types of provisions 4. Major nutrients 5. Pathology 6. Planning the day 7. Fats 8. Recipes 9. Cooking with vegetables, etc. (practical) 10. Relevance of exercises
Intervention type	Drug
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Olanzapin
Primary outcome measure(s)	Weight changes in kg, measured at week 1 and week 10.
Key secondary outcome measure(s)	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])
Completion date	15/11/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	180
Key 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
Key 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
Date of first enrolment	03/04/2008
Date of final enrolment	15/11/2010

Locations

Countries of recruitment

Germany

Study participating centre

Clinic and Polyclinic for Psychiatry and Psychotherapy

Düsseldorf
40629
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes