Exercise and Diet Program for Schizophrenia Patients Who Are Taking Atypical Antipsychotic Medications

August 3, 2011 updated by: Sheba Medical Center
In this study the investigators will recruit patients with the diagnosis of schizophrenia that are taking atypical neuroleptics and that are willing to participate in an exercise and diet program. The investigators will measure weight and abdomen circumference.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Ramat Gan
      • Tel Hashomer, Ramat Gan, Israel, 52621
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Schizophrenia
  • Atypical neuroleptics

Exclusion Criteria:

  • Medical illness preventing exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Exercise and Diet program
All patients recruited in the study, participated in an homogeneous exercise program and diet.
Behavioral: Exercise program
Homogenous exercise program in local fitness centers
Behavioral: Diet
Weigh loss diet program prescribed by a professional nutritionist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: One year
The weight of the participants of the trial was monitored during the trial, while they were following the exercise program and the diet, starting from the baseline until end of study/early withdrawal.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdomen circumference
Time Frame: One year
The circumference of the abdomen of the participants of the trial was monitored during the trial, while they were following the exercise program and the diet, starting from the baseline until end of study/early withdrawal.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Revital Amiaz, MD, Sackler School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

August 3, 2011

First Submitted That Met QC Criteria

August 3, 2011

First Posted (Estimate)

August 4, 2011

Study Record Updates

Last Update Posted (Estimate)

August 4, 2011

Last Update Submitted That Met QC Criteria

August 3, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-05-3627-RA-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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