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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474227
• Other study ID #: LH33/2007.CTIL
• Status: Completed
• Phase: N/A
• First received: May 15, 2007
• Last updated: May 1, 2008
• Start date: April 2007
• Est. completion date: October 2007

Study information

• Verified date: May 2008
• Source: Lev-Hasharon Mental Healtlh Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Mental Disorders
• Obesity

Intervention

Behavioral:
• group therapy, physical exercise, nutrition lectures
weekly group therapy, physical exercize, nutrition guidance

Locations

Country	Name	City	State
Israel	Lev Hasharon Mental Health Center	Netanya

Sponsors (1)

Lead Sponsor	Collaborator
Lev-Hasharon Mental Healtlh Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight reduction		three months	Yes
Secondary	improved metabolic profile		3 months	Yes

External Links

•   website of location of study