Proper Nutrition, Physical Exercise and Appropriate Weight in Individuals With Long Term Mental Illness
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Apr 2007
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 15, 2007
CompletedFirst Posted
Study publicly available on registry
May 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedMay 2, 2008
May 1, 2008
6 months
May 15, 2007
May 1, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
weight reduction
three months
Secondary Outcomes (1)
improved metabolic profile
3 months
Study Arms (2)
A
EXPERIMENTALbehavioral intervention, group therapy including nutritional guidance and physical exercise
B
NO INTERVENTIONcomparison 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.
Interventions
weekly group therapy, physical exercize, nutrition guidance
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Severe physical illness
- Refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lev Hasharon Mental Health Center
Netanya, 42100, Israel
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gloria Ilievici, MD
Lev HaSharon Mental Health Center
- STUDY DIRECTOR
Yuval Melamed, MD, MHA
Lev HaSharon Mental Health Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
May 15, 2007
First Posted
May 16, 2007
Study Start
April 1, 2007
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
May 2, 2008
Record last verified: 2008-05