SchizophreniaNCT01409590
Exercise and Diet Program for Schizophrenia Patients Who Are Taking Atypical Antipsychotic Medications
A study testing Exercise program and Diet in people with Schizophrenia, run by Sheba Medical Center at 1 site in Israel.
Trial summary
In this study the investigators will recruit patients with the diagnosis of schizophrenia that are taking atypical neuroleptics and that are willing to participate in an exercise and diet program. The investigators will measure weight and abdomen circumference. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Exercise program and Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- May 2005to Aug 2009
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Schizophrenia
- Atypical neuroleptics
Who cannot join
- Medical illness preventing exercise
Trial locations and contacts
1 site in 1 country.
About this study
In this study the investigators will recruit patients with the diagnosis of schizophrenia that are taking atypical neuroleptics and that are willing to participate in an exercise and diet program. The investigators will measure weight and abdomen circumference.
- Conditions
- Schizophrenia
- Being tested
- Exercise program, Diet
- Keywords
- Schizophrenia, weight gain, atypical neuroleptics
- Medical subject headings
- Schizophrenia, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programBehavioural
Homogenous exercise program in local fitness centers
DietBehavioural
Weigh loss diet program prescribed by a professional nutritionist
| Study group | Role | What they receive |
|---|---|---|
| Exercise and Diet program | Other | All patients recruited in the study, participated in an homogeneous exercise program and diet. Receives: Behavioral: Exercise program; Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
The weight of the participants of the trial was monitored during the trial, while they were following the exercise program and the diet, starting from the baseline until end of study/early withdrawal.
Measured: One year
Secondary outcomes (1)
Abdomen circumference
The circumference of the abdomen of the participants of the trial was monitored during the trial, while they were following the exercise program and the diet, starting from the baseline until end of study/early withdrawal.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startMay 2005
- Primary completionSep 2006
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Revital Amiaz, MD, Principal investigator, Sackler School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409590
- Sponsor's protocol ID
- SHEBA-05-3627-RA-CTIL
- Status last verified
- Aug 2011
- First submitted
- 3 Aug 2011
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Diet Program for Schizophrenia Patients Who Are Taking Atypical Antipsychotic Medications
- ClinicalTrials.gov ID
- NCT01409590
- Acronym / sponsor ID
- SHEBA-05-3627-RA-CTIL
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, weight gain, atypical neuroleptics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 4 Aug 2011 (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.
In this study the investigators will recruit patients with the diagnosis of schizophrenia that are taking atypical neuroleptics and that are willing to participate in an exercise and diet program. The investigators will measure weight and abdomen circumference.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise and Diet program | Other | Behavioral: Exercise program, Behavioral: DietAll patients recruited in the study, participated in an homogeneous exercise program and diet. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Schizophrenia
- Atypical neuroleptics
Key exclusion criteria (1 listed)
- Medical illness preventing exercise
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 |
|---|---|---|
| Exercise programHomogenous exercise program in local fitness centers | Behavioural | Exercise and Diet program |
| DietWeigh loss diet program prescribed by a professional nutritionist | Behavioural | Exercise and Diet program |
Primary outcome
Weight loss
Time frame: One year
The weight of the participants of the trial was monitored during the trial, while they were following the exercise program and the diet, starting from the baseline until end of study/early withdrawal.
1 secondary outcome
Abdomen circumference
Time frame: One year
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 4 Aug 2011.
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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.
Revital Amiaz, MD principal investigator
Sackler School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program and Diet in people with Schizophrenia, run by Sheba Medical 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 2 inclusion and 1 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 4 Aug 2011. 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 loss (time frame: One year). 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 4 Aug 2011.