Proper Nutrition, Physical Exercise and Appropriate Weight in Individuals With Long Term Mental Illness

May 1, 2008 updated by: Lev-Hasharon Mental Healtlh Center
Based on previous findings that mentally ill inpatients are interested in losing treatment associate weight gain and are capable of adhering to a weight reduction program, this study will investigate the effects of participation in nutrition intervention, physical exercise and will monitor measurement of metabolic profiles (cholesterol, triglycerides and glucose). Hypothesis: participants will reduce weight, maintain weight loss and experience reduction in metabolic values and will experience improved quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study sample: 50 chronic psychiatric inpatients with DSM_IV diagnosis of schizophrenia or schizoaffective disorder, aged 18 or older. Exclusion criteria - pregnancy, severe physical illness, refusal to participate.

Study instruments: Q-LES-Q-18 (quality of life): Positive and Negative Syndrome Scale; Laboratory test- glucose levels, metabolic profiles (cholesterol, triglycerides). Measurements: Weight, BMI, pulse Intervention: Weekly group therapy, lectures on nutrition, physical exercise Duration of study: 3 months

Study Type

Interventional

Enrollment (Anticipated)

50

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
      • Netanya, Israel, 42100
        • Lev Hasharon Mental Health 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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 18 and older
  • Men or women
  • Schizophrenia or schizoaffective disorder
  • BMI greater than 26
  • Agreement to participate and capacity to provide written informed consent

Exclusion Criteria:

  • Pregnancy
  • Severe physical illness
  • Refusal to participate

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
behavioral intervention, group therapy including nutritional guidance and physical exercise
Behavioral: group therapy, physical exercise, nutrition lectures
weekly group therapy, physical exercize, nutrition guidance
No Intervention: B
comparison group, one time explanation of importance of proper nutrition. This group receives no group therapy or organized exercise sessions or nutritional guidance. They are wait listed for this program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight reduction
Time Frame: three months
three months

Secondary Outcome Measures

Outcome Measure
Time Frame
improved metabolic profile
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Lev-Hasharon Mental Healtlh Center

Investigators

  • Principal Investigator: Gloria Ilievici, MD, Lev Hasharon Mental Health Center
  • Study Director: Yuval Melamed, MD, MHA, Lev Hasharon Mental Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

April 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

May 15, 2007

First Submitted That Met QC Criteria

May 15, 2007

First Posted (Estimate)

May 16, 2007

Study Record Updates

Last Update Posted (Estimate)

May 2, 2008

Last Update Submitted That Met QC Criteria

May 1, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LH33/2007.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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