Condition category
Mental and Behavioural Disorders
Date applied
18/04/2008
Date assigned
30/05/2008
Last edited
30/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.uni-duesseldorf.de

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

Publication citations

Additional files

Editorial Notes