The Effect of a Weight Management Program During Treatment With Olanzapine

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Behavioral: weight management program

• Registration Number: NCT00169702
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

Brief Summary

The study is a prospective, randomized, open-label study.

Detailed Description

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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Status Verified: 2007-04
• Study Completion: 2007-07
• Last Update Submitted: 2008-01-28
• Last Update Posted: 2008-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	weight management program	standard information
Intervention	weight management program	weight management program, 12 sessions, 2 weekly, psychoeducational program, interactive topics like healthy food, diet behavior, physical activity, stress reduction.

Primary Outcome Measures

Name	Time	Method
difference in mean weight gain	November 2007

Secondary Outcome Measures

Name	Time	Method
changes in waist circumference, blood pressure, blood lipids, fasting glucose	November 2007

Trial Locations

Locations (1)

Heinrich-Heine-University, Rhineland State Clinics Düsseldorf; 🇩🇪 Düsseldorf, Rhineland State, Germany