The Effect of a Weight Management Program During Treatment With Olanzapine

Study Overview
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Brief Summary
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The study is a prospective, randomized, open-label study.

Detailed Description
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The principal objective of this trial is to investigate the effect of a comprehensive behavioural treatment program on weight gain in schizophrenic patients under olanzapine treatment, and on subjective well-being.

Official Title
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The Effect of a Weight Management Program to Prevent Weight Gain and Metabolic Abnormalities During Treatment With the Atypical Neuroleptic Olanzapine: A Randomised Study

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: weight management program
* Behavioral: weight management program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia Ages between 18 and 65 Informed consent Weight gain of at least 1.5 kg in the first 4 weeks A sufficient understanding to participate adequately in the weight management program Patients must agree to cooperate with all tests and examinations required by the protocol. Each patient must understand the nature of the study and must sign an informed consent document. Exclusion Criteria: Serious, unstable somatic illnesses Illnesses associated with weight gain including renal and endocrine diseases Weight change greater than 3 kg in the preceding three months Weight gain less than 1.5 kg in the first 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard<br>standard information | Behavioral: weight management program<br>* 12 sessions, psychoeducation<br>Behavioral: weight management program<br>* 2 weekly, 12 sessions, psychoeducational weight management<br>|
| Active Comparator: Intervention<br>weight management program, 12 sessions, 2 weekly, psychoeducational program, interactive topics like healthy food, diet behavior, physical activity, stress reduction. | Behavioral: weight management program<br>* 12 sessions, psychoeducation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in mean weight gain |  | November 2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in waist circumference, blood pressure, blood lipids, fasting glucose |  | November 2007 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, weight management programme