ObesityNCT00474227
Proper Nutrition, Physical Exercise and Appropriate Weight in Individuals With Long Term Mental Illness
A study testing group therapy, physical exercise, nutrition lectures in people with Obesity, run by Lev-Hasharon Mental Healtlh Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- group therapy, physical exercise, nutrition lectures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2007to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Severe physical illness
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Obesity
- Being tested
- group therapy, physical exercise, nutrition lectures
- Keywords
- obesity, weight gain, schizophrenia, schizoaffective disorder, antipsychotic induced weight gain
- Medical subject headings
- Obesity, Weight Gain, Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group therapy, physical exercise, nutrition lecturesBehavioural
weekly group therapy, physical exercize, nutrition guidance
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | behavioral intervention, group therapy including nutritional guidance and physical exercise Receives: Behavioral: group therapy, physical exercise, nutrition lectures |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight reduction
Measured: three months
Secondary outcomes (1)
improved metabolic profile
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startApr 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lev-Hasharon Mental Healtlh Center
- Sponsor type
- Other government
- Investigators
- Gloria Ilievici, MD, Principal investigator, Lev HaSharon Mental Health CenterYuval Melamed, MD, MHA, Study director, Lev HaSharon Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474227
- Sponsor's protocol ID
- LH33/2007.CTIL
- Status last verified
- May 2008
- First submitted
- 15 May 2007
- Last updated
- 2 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proper Nutrition, Physical Exercise and Appropriate Weight in Individuals With Long Term Mental Illness
- ClinicalTrials.gov ID
- NCT00474227
- Acronym / sponsor ID
- LH33/2007.CTIL
- Conditions
- Obesity
- Keywords
- obesity, weight gain, schizophrenia, schizoaffective disorder, antipsychotic induced weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lev-Hasharon Mental Healtlh CenterOther government
- Study start
- Apr 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 16 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: group therapy, physical exercise, nutrition lecturesbehavioral intervention, group therapy including nutritional guidance and physical exercise |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Severe physical illness
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group therapy, physical exercise, nutrition lecturesweekly group therapy, physical exercize, nutrition guidance | Behavioural | A |
Primary outcome
weight reduction
Time frame: three months
1 secondary outcome
improved metabolic profile
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2008.
- website of location of studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gloria Ilievici, MD principal investigator
Lev HaSharon Mental Health Center
Yuval Melamed, MD, MHA study director
Lev HaSharon Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group therapy, physical exercise, nutrition lectures in people with Obesity, run by Lev-Hasharon Mental Healtlh Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight reduction (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2008.