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

NCT ID: NCT00474227

Last Updated: 2008-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-10-31

Brief Summary

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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

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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

Conditions

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Obesity

Keywords

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obesity weight gain schizophrenia schizoaffective disorder antipsychotic induced weight gain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A

behavioral intervention, group therapy including nutritional guidance and physical exercise

Group Type EXPERIMENTAL

group therapy, physical exercise, nutrition lectures

Intervention Type BEHAVIORAL

weekly group therapy, physical exercize, nutrition guidance

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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group therapy, physical exercise, nutrition lectures

weekly group therapy, physical exercize, nutrition guidance

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lev-Hasharon Mental Healtlh Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Lev Hasharon Mental Health Center

Principal Investigators

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Gloria Ilievici, MD

Role: PRINCIPAL_INVESTIGATOR

Lev HaSharon Mental Health Center

Yuval Melamed, MD, MHA

Role: STUDY_DIRECTOR

Lev HaSharon Mental Health Center

Locations

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Lev Hasharon Mental Health Center

Netanya, , Israel

Site Status

Countries

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Israel

Related Links

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http://www.lev-hasharon.co.il

website of location of study

Other Identifiers

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LH33/2007.CTIL

Identifier Type: -

Identifier Source: org_study_id