Schizophrenic DisordersNCT00572247
The Psychiatric Rehabilitation Approach to Weight Loss
A study testing Psychiatric Rehabilitation Approach to Weight Loss in people with Schizophrenic Disorders, run by University of Kansas at 1 site in United States.
Trial summary
The primary aim of the project is to examine the efficacy of the Psychiatric Rehabilitation Weight Loss program in reduction of weight and body mass index (BMI. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenic Disorders
- What is being tested?
- Psychiatric Rehabilitation Approach to Weight Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of serious mental illness,
- Age 18 - 65
- BMI > 25
- Medication stable (there have been no changes in antipsychotic medications or mood stabilizers for the last 3 months).
Who cannot join
- Current or history of eating disorder
- Pregnant or breast feeding
- Uncontrolled HTN
- Severe coronary artery disease
- Severe valvular disease
- Uncontrolled diabetes
Show all 10Show fewer
- Sustained arrhythmia
- Insulin using severe physical limitations
- Severe Lung Disorders
- Diagnosis of MR or dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: The Intervention Involves Education on Nutrition and Physical Activity. Outcomes Evaluate Changes in BMI.
The primary aim of the project is to examine the efficacy of the Psychiatric Rehabilitation Weight Loss program in reduction of weight and body mass index (BMI.
Read the detailed description
The study involves 144 individuals who will be randomly assigned to the intervention group or treatment as usual group(control group). All Participants will undergo baseline assessment, assessment at week 12, week 24 and in year from baseline.
- Conditions
- Schizophrenic Disorders
- Being tested
- Psychiatric Rehabilitation Approach to Weight Loss
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric Rehabilitation Approach to Weight LossBehavioural
The use of psychiatric rehabilitation as a way to lose weight
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Behavioral Receives: Behavioral: Psychiatric Rehabilitation Approach to Weight Loss |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The reduction of weight and Body Mass Index (BMI)
Measured: Week 12, Week 24, 1 Year from Baseline Visit
Secondary outcomes (1)
Measure of waist circumference, health promotion practices, dietary intake assessment of physical activity
Measured: Baseline, 12 Weeks, 24 weeks, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startJan 2007
- Primary completionJan 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenic DisordersStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Edna Hamera, PhD, RN, CS, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572247
- Sponsor's protocol ID
- 1R34MH077282-01A1
- Other IDs
- 10575
- Status last verified
- Mar 2012
- First submitted
- 11 Dec 2007
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intervention Involves Education on Nutrition and Physical Activity. Outcomes Evaluate Changes in BMI.
- ClinicalTrials.gov ID
- NCT00572247
- Acronym / sponsor ID
- 1R34MH077282-01A1
- Conditions
- Schizophrenic Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Dec 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.
The primary aim of the project is to examine the efficacy of the Psychiatric Rehabilitation Weight Loss program in reduction of weight and body mass index (BMI.
Detailed description
The study involves 144 individuals who will be randomly assigned to the intervention group or treatment as usual group(control group). All Participants will undergo baseline assessment, assessment at week 12, week 24 and in year from baseline.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Psychiatric Rehabilitation Approach to Weight LossBehavioral |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of serious mental illness,
- Age 18 - 65
- BMI > 25
- Medication stable (there have been no changes in antipsychotic medications or mood stabilizers for the last 3 months).
Key exclusion criteria (10 listed)
- Current or history of eating disorder
- Pregnant or breast feeding
- Uncontrolled HTN
- Severe coronary artery disease
- Severe valvular disease
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 |
|---|---|---|
| Psychiatric Rehabilitation Approach to Weight LossThe use of psychiatric rehabilitation as a way to lose weight | Behavioural | 1 |
Primary outcome
The reduction of weight and Body Mass Index (BMI)
Time frame: Week 12, Week 24, 1 Year from Baseline Visit
1 secondary outcome
Measure of waist circumference, health promotion practices, dietary intake assessment of physical activity
Time frame: Baseline, 12 Weeks, 24 weeks, 1 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 7 Mar 2012.
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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.
Edna Hamera, PhD, RN, CS principal investigator
University of Kansas Medical 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 Psychiatric Rehabilitation Approach to Weight Loss in people with Schizophrenic Disorders, run by University of Kansas at 1 site in United States.
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 4 inclusion and 10 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 7 Mar 2012. 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 United States. 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?
The reduction of weight and Body Mass Index (BMI) (time frame: Week 12, Week 24, 1 Year from Baseline Visit). 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 7 Mar 2012.