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The Effect of a Weight Management Program During Treatment With Olanzapine

H

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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