Proper Nutrition, Physical Exercise and Appropriate Weight in Individuals With Long Term Mental Illness - Full Text View

Sponsored by:	Lev-Hasharon Mental Healtlh Center
Information provided by:	Lev-Hasharon Mental Healtlh Center
ClinicalTrials.gov Identifier:	NCT00474227

Purpose

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.

Condition	Intervention
Obesity	Behavioral: group therapy, physical exercise, nutrition lectures

MedlinePlus related topics: Exercise and Physical Fitness Mental Health Obesity Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment
Official Title:	Proper Nutrition, Physical Exercise and Appropriate Weight in Individuals With Long Term Mental Illness

Further study details as provided by Lev-Hasharon Mental Healtlh Center:

Primary Outcome Measures:

weight reduction [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

improved metabolic profile [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	April 2007
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental behavioral intervention, group therapy including nutritional guidance and physical exercise	Behavioral: group therapy, physical exercise, nutrition lectures weekly group therapy, physical exercize, nutrition guidance
B: No Intervention 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.

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474227

Locations

Israel
Lev Hasharon Mental Health Center
Netanya, Israel, 42100

Sponsors and Collaborators

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

More Information

website of location of study This link exits the ClinicalTrials.gov site

Responsible Party:	Lev Hasharon Mental Health Center ( Gloria Ilievici, MD )
Study ID Numbers:	LH33/2007.CTIL
Study First Received:	May 15, 2007
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00474227
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Lev-Hasharon Mental Healtlh Center:

obesity
weight gain
schizophrenia
schizoaffective disorder
antipsychotic induced weight gain

Study placed in the following topic categories:

Schizophrenia
Body Weight
Signs and Symptoms
Obesity
Mental Disorders

Nutrition Disorders
Overweight
Overnutrition
Weight Gain

ClinicalTrials.gov processed this record on January 16, 2009