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

Study Overview
=================
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

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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: group therapy, physical exercise, nutrition lectures


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>behavioral intervention, group therapy including nutritional guidance and physical exercise | Behavioral: group therapy, physical exercise, nutrition lectures<br>* weekly group therapy, physical exercize, nutrition guidance<br>|
| No Intervention: B<br>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 | Measure Description | Time Frame |
| --- | --- | --- |
| weight reduction |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improved metabolic profile |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, weight gain, schizophrenia, schizoaffective disorder, antipsychotic induced weight gain