Contact information
Type
Scientific
Primary contact
Dr Joachim Cordes
ORCID ID
Contact details
Clinic and Polyclinic for Psychiatry and Psychotherapy
Rheinische Kliniken Düsseldorf
Bergische Landstr. 2
Düsseldorf
40629
Germany
+49 211 9223402
joachim.cordes@lvr.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
GM2_2007
Study information
Scientific title
Acronym
BELA
Study hypothesis
To assess the efficacy of preventative effects of the BELA programme on weight and metabolic parameters in schizophrenic patients treated with olanzapin.
Ethics approval
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)
Study design
Phase IV, multi-centre, open, two-arm randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
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 names
Olanzapin
Primary outcome measures
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 trial start date
03/04/2008
Overall trial end date
15/11/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
180
Participant 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
Recruitment start date
03/04/2008
Recruitment end date
15/11/2010
Locations
Countries of recruitment
Germany
Trial participating centre
Clinic and Polyclinic for Psychiatry and Psychotherapy
Düsseldorf
40629
Germany
Sponsor information
Organisation
Heinrich-Heine University (Germany)
Sponsor details
c/o Dr. med. J. Cordes
Clinic and Polyclinic for Psychiatry and Psychotherapy
Rheinische Kliniken Düsseldorf
Bergische Landstr. 2
Düsseldorf
40629
Germany
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Heinrich-Heine University (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Lilly GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Note: This is an investigator initiated trial.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary