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 |
| Secondary identifying numbers | GM2_2007 |
- 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
Scientific
Clinic and Polyclinic for Psychiatry and Psychotherapy
Rheinische Kliniken Düsseldorf
Bergische Landstr. 2
Düsseldorf
40629
Germany
| Phone | +49 211 9223402 |
|---|---|
| joachim.cordes@lvr.de |
Study information
| Study design | Phase IV, multi-centre, open, two-arm randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Olanzapin |
| Primary outcome measure | Weight changes in kg, measured at week 1 and week 10. |
| Secondary outcome measures | 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]) |
| Overall study start date | 03/04/2008 |
| Completion date | 15/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
40629
Germany
Sponsor information
Heinrich-Heine University (Germany)
University/education
University/education
c/o Dr. med. J. Cordes
Clinic and Polyclinic for Psychiatry and Psychotherapy
Rheinische Kliniken Düsseldorf
Bergische Landstr. 2
Düsseldorf
40629
Germany
| Website | http://www.uni-duesseldorf.de |
|---|---|
"ROR" |
https://ror.org/024z2rq82 |
Funders
Funder type
University/education
Heinrich-Heine University (Germany)
No information available
Lilly GmbH (Germany)
No information available
Note: This is an investigator initiated trial.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
