The Effect of a Weight Management Program During Treatment With Olanzapine

Heinrich-Heine University, Duesseldorf

Status: Completed

Conditions: Schizophrenia

Treatments: Behavioral: weight management program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00169702

F1D-SB-018

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Standard

Other group

Description:

standard information

Treatment:

Behavioral: weight management program

Behavioral: weight management program

Intervention

Active Comparator group

Description:

weight management program, 12 sessions, 2 weekly, psychoeducational program, interactive topics like healthy food, diet behavior, physical activity, stress reduction.

Treatment:

Behavioral: weight management program

Behavioral: weight management program