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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
group therapy, physical exercise, nutrition lectures
Sponsored by
Lev-Hasharon Mental Healtlh Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring obesity, weight gain, schizophrenia, schizoaffective disorder, antipsychotic induced weight gain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lev Hasharon Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A

B

Arm Description

behavioral intervention, group therapy including nutritional guidance and physical exercise

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.

Outcomes

Primary Outcome Measures

weight reduction

Secondary Outcome Measures

improved metabolic profile

Full Information

First Posted
May 15, 2007
Last Updated
May 1, 2008
Sponsor
Lev-Hasharon Mental Healtlh Center
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1. Study Identification

Unique Protocol Identification Number
NCT00474227
Brief Title
Proper Nutrition, Physical Exercise and Appropriate Weight in Individuals With Long Term Mental Illness
Official Title
Proper Nutrition, Physical Exercise and Appropriate Weight in Individuals With Long Term Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lev-Hasharon Mental Healtlh Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, weight gain, schizophrenia, schizoaffective disorder, antipsychotic induced weight gain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
behavioral intervention, group therapy including nutritional guidance and physical exercise
Arm Title
B
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
group therapy, physical exercise, nutrition lectures
Intervention Description
weekly group therapy, physical exercize, nutrition guidance
Primary Outcome Measure Information:
Title
weight reduction
Time Frame
three months
Secondary Outcome Measure Information:
Title
improved metabolic profile
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gloria Ilievici, MD
Organizational Affiliation
Lev HaSharon Mental Health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuval Melamed, MD, MHA
Organizational Affiliation
Lev HaSharon Mental Health Center
Official's Role
Study Director
Facility Information:
Facility Name
Lev Hasharon Mental Health Center
City
Netanya
ZIP/Postal Code
42100
Country
Israel

12. IPD Sharing Statement

Links:
URL
http://www.lev-hasharon.co.il
Description
website of location of study

Learn more about this trial

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

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