Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00474227
Recruitment Status : Completed
First Posted : May 16, 2007
Last Update Posted : May 2, 2008
Sponsor:
Information provided by:
Lev-Hasharon Mental Healtlh Center

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: group therapy, physical exercise, nutrition lectures Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Proper Nutrition, Physical Exercise and Appropriate Weight in Individuals With Long Term Mental Illness
Study Start Date : April 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A
behavioral intervention, group therapy including nutritional guidance and physical exercise
Behavioral: group therapy, physical exercise, nutrition lectures
weekly group therapy, physical exercize, nutrition guidance

No Intervention: 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.



Primary Outcome Measures :
  1. weight reduction [ Time Frame: three months ]

Secondary Outcome Measures :
  1. improved metabolic profile [ Time Frame: 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474227


Locations
Layout table for location information
Israel
Lev Hasharon Mental Health Center
Netanya, Israel, 42100
Sponsors and Collaborators
Lev-Hasharon Mental Healtlh Center
Investigators
Layout table for investigator information
Principal Investigator: Gloria Ilievici, MD Lev-Hasharon Mental Health Center
Study Director: Yuval Melamed, MD, MHA Lev-Hasharon Mental Health Center
Additional Information:
Layout table for additonal information
Responsible Party: Gloria Ilievici, MD, Lev Hasharon Mental Health Center
ClinicalTrials.gov Identifier: NCT00474227    
Other Study ID Numbers: LH33/2007.CTIL
First Posted: May 16, 2007    Key Record Dates
Last Update Posted: May 2, 2008
Last Verified: May 2008
Keywords provided by Lev-Hasharon Mental Healtlh Center:
obesity
weight gain
schizophrenia
schizoaffective disorder
antipsychotic induced weight gain
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Mental Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight