SchizophreniaNCT00158366
Reducing the Weight of Overweight Schizophrenia Patients
A study testing Behavioral training, Social skills training and Behavioral training booster sessions in people with Schizophrenia and Obesity, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will determine the effectiveness of a group-based behavioral program for weight reduction in overweight and obese schizophrenia patients. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Schizophrenia, Obesity
- What is being tested?
- Behavioral training, Social skills training and Behavioral training booster sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to 1 Jul 2018
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of schizophrenia or schizoaffective disorder
- Body mass index (BMI) greater than 27
- Stable on antipsychotic drug regimen for at least 1 month prior to study entry
- Parent or guardian willing to provide informed consent, if applicable
- Positive and negative syndrome scale score less than 90
- Willing to use acceptable methods of contraception during the study
Who cannot join
- Medical contraindication for participating in a weight reduction/exercise program
- Mental retardation
- Current enrollment in another weight management program
- Current use of weight reduction medication
- Unstable cardiovascular or thyroid disease
- Active or end-stage renal disease
Show all 9Show fewer
- Psychiatric hospitalization within 1 month prior to study entry
- Current use of more than one anti-psychotic medication
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Clinical Trial Of Weight Reduction in Schizophrenia
This study will determine the effectiveness of a group-based behavioral program for weight reduction in overweight and obese schizophrenia patients.
Read the detailed description
Researchers have found a link between schizophrenia, high blood pressure, and insulin resistance; this link puts people with schizophrenia at an increased risk for diabetes and obesity. Weight reduction and maintenance is essential for decreasing these risks. Although data indicate that nonpharmacological interventions for weight loss are viable options, studies to determine their effectiveness have not been conducted. This study will determine the effectiveness of behavioral training for reducing weight in schizophrenia patients. This study will also determine the effects of weight reduction on cardiovascular risk factors in this population.
This study comprises two phases. In Phase 1, participants will be randomly assigned to receive either behavioral training or social skills training for 14 weeks. The behavioral training will teach participants ways to control their diet and increase their physical activity. The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support. After 14 weeks, participants in the social skills training group and any participants who have not lost a specified amount of weight will complete the study; participants in the behavioral training group who have a 4% or more weight loss will be enrolled in Phase 2, a 24-month program designed to help participants maintain their weight loss. All participants in Phase 2 will continue to receive weekly behavioral training, but they will be randomly assigned to receive either behavioral training alone or behavioral training combined with biweekly booster treatments where participants discuss their response to different diet and exercise regimens and researchers discuss strategies for increasing one's success with the regimens. Interviews, self-report scales, and blood tests will be used to assess participants at study entry, after Phase 1, and at the end of the study. Assessments will include quality of life, self esteem, exercise frequency, blood pressure, serum lipids, and blood glucose.
- Conditions
- Schizophrenia, Obesity
- Being tested
- Behavioral training, Social skills training, Behavioral training booster sessions
- Keywords
- Weight Loss
- Medical subject headings
- Schizophrenia, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral trainingBehavioural
The behavioral training will teach participants ways to control their diet and increase their physical activity.
Social skills trainingBehavioural
The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support.
Behavioral training booster sessionsBehavioural
During biweekly booster treatment sessions, participants will discuss their response to different diet and exercise regimens, and researchers will discuss strategies for increasing one's success with the regimens.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Phase 1 participants who will receive behavioral training for 14 weeks Receives: Behavioral: Behavioral training |
| 2 | Active comparator | Phase 1 participants who will receive social skills training for 14 weeks Receives: Behavioral: Social skills training |
| 3 | Experimental | Participants in the Phase 1 behavioral training group who have a 4% or more weight loss and will be enrolled in weekly behavioral training alone for 24 months in Phase 2 Receives: Behavioral: Behavioral training |
| 4 | Experimental | Participants in the Phase 1 behavioral training group who have a 4% or more weight loss and will be enrolled in weekly behavioral training plus biweekly booster treatments for 24 months in Phase 2 Receives: Behavioral: Behavioral training booster sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight reduction
Measured: Measured at Week 14 and Month 24
Secondary outcomes (1)
Weight maintenance
Measured: Measured at Week 14 and Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionMay 2010
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Rohan Ganguli, University of Pittsburgh
- Investigators
- Rohan Ganguli, MD, Principal investigator, Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158366
- Sponsor's protocol ID
- R01MH066068
- Other IDs
- R01MH066068, DSIR 83-ATAP
- Status last verified
- Aug 2018
- First submitted
- 7 Sep 2005
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brar JS, Ganguli R, Pandina G, Turkoz I, Berry S, Mahmoud R. Effects of behavioral therapy on weight loss in overweight and obese patients with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2005 Feb;66(2):205-12. doi: 10.4088/jcp.v66n0208.
PubMed 15705006Ganguli R, Brar JS, Ayrton Z. Weight gain over 4 months in schizophrenia patients: a comparison of olanzapine and risperidone. Schizophr Res. 2001 Apr 30;49(3):261-7. doi: 10.1016/s0920-9964(00)00080-3.
PubMed 11356587Ganguli R. Weight gain associated with antipsychotic drugs. J Clin Psychiatry. 1999;60 Suppl 21:20-4.
PubMed 10548138Janney CA, Ganguli R, Richardson CR, Holleman RG, Tang G, Cauley JA, Kriska AM. Sedentary behavior and psychiatric symptoms in overweight and obese adults with schizophrenia and schizoaffective disorders (WAIST Study). Schizophr Res. 2013 Apr;145(1-3):63-8. doi: 10.1016/j.schres.2013.01.010. Epub 2013 Feb 12.
PubMed 23410710
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Of Weight Reduction in Schizophrenia
- ClinicalTrials.gov ID
- NCT00158366
- Acronym / sponsor ID
- R01MH066068
- Conditions
- Schizophrenia, Obesity
- Keywords
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2004
- Primary completion
- May 2010 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 12 Sep 2005 (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.
This study will determine the effectiveness of a group-based behavioral program for weight reduction in overweight and obese schizophrenia patients.
Detailed description
Researchers have found a link between schizophrenia, high blood pressure, and insulin resistance; this link puts people with schizophrenia at an increased risk for diabetes and obesity. Weight reduction and maintenance is essential for decreasing these risks. Although data indicate that nonpharmacological interventions for weight loss are viable options, studies to determine their effectiveness have not been conducted. This study will determine the effectiveness of behavioral training for reducing weight in schizophrenia patients. This study will also determine the effects of weight reduction on cardiovascular risk factors in this population.
This study comprises two phases. In Phase 1, participants will be randomly assigned to receive either behavioral training or social skills training for 14 weeks. The behavioral training will teach participants ways to control their diet and increase their physical activity. The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support. After 14 weeks, participants in the social skills training group and any participants who have not lost a specified amount of weight will complete the study; participants in the behavioral training group who have a 4% or more weight loss will be enrolled in Phase 2, a 24-month program designed to help participants maintain their weight loss. All participants in Phase 2 will continue to receive weekly behavioral training, but they will be randomly assigned to receive either behavioral training alone or behavioral training combined with biweekly booster treatments where participants discuss their response to different diet and exercise regimens and researchers discuss strategies for increasing one's success with the regimens. Interviews, self-report scales, and blood tests will be used to assess participants at study entry, after Phase 1, and at the end of the study. Assessments will include quality of life, self esteem, exercise frequency, blood pressure, serum lipids, and blood glucose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Behavioral trainingPhase 1 participants who will receive behavioral training for 14 weeks |
| 2 | Active comparator | Behavioral: Social skills trainingPhase 1 participants who will receive social skills training for 14 weeks |
| 3 | Experimental | Behavioral: Behavioral trainingParticipants in the Phase 1 behavioral training group who have a 4% or more weight loss and will be enrolled in weekly behavioral training alone for 24 months in Phase 2 |
| 4 | Experimental | Behavioral: Behavioral training booster sessionsParticipants in the Phase 1 behavioral training group who have a 4% or more weight loss and will be enrolled in weekly behavioral training plus biweekly booster treatments for 24 months in Phase 2 |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Diagnosis of schizophrenia or schizoaffective disorder
- Body mass index (BMI) greater than 27
- Stable on antipsychotic drug regimen for at least 1 month prior to study entry
- Parent or guardian willing to provide informed consent, if applicable
- Positive and negative syndrome scale score less than 90
Key exclusion criteria (9 listed)
- Medical contraindication for participating in a weight reduction/exercise program
- Mental retardation
- Current enrollment in another weight management program
- Current use of weight reduction medication
- Unstable cardiovascular or thyroid 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 |
|---|---|---|
| Behavioral trainingThe behavioral training will teach participants ways to control their diet and increase their physical activity. | Behavioural | 1, 3 |
| Social skills trainingThe social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support. | Behavioural | 2 |
| Behavioral training booster sessionsDuring biweekly booster treatment sessions, participants will discuss their response to different diet and exercise regimens, and researchers will discuss strategies for increasing one's success with the regimens. | Behavioural | 4 |
Primary outcome
Weight reduction
Time frame: Measured at Week 14 and Month 24
1 secondary outcome
Weight maintenance
Time frame: Measured at Week 14 and Month 24
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 22 Aug 2018.
- Background: PubMed 15705006Brar JS, Ganguli R, Pandina G, Turkoz I, Berry S, Mahmoud R. Effects of behavioral therapy on weight loss in overweight and obese patients with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2005 Feb;66(2):205-12. doi: 10.4088/jcp.v66n0208.
- Background: PubMed 11356587Ganguli R, Brar JS, Ayrton Z. Weight gain over 4 months in schizophrenia patients: a comparison of olanzapine and risperidone. Schizophr Res. 2001 Apr 30;49(3):261-7. doi: 10.1016/s0920-9964(00)00080-3.
- Background: PubMed 10548138Ganguli R. Weight gain associated with antipsychotic drugs. J Clin Psychiatry. 1999;60 Suppl 21:20-4.
- Derived from this study: PubMed 23410710Janney CA, Ganguli R, Richardson CR, Holleman RG, Tang G, Cauley JA, Kriska AM. Sedentary behavior and psychiatric symptoms in overweight and obese adults with schizophrenia and schizoaffective disorders (WAIST Study). Schizophr Res. 2013 Apr;145(1-3):63-8. doi: 10.1016/j.schres.2013.01.010. Epub 2013 Feb 12.
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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.
Rohan Ganguli, MD principal investigator
Western Psychiatric Institute and Clinic of University of Pennsylvania 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 Behavioral training, Social skills training and Behavioral training booster sessions in people with Schizophrenia and Obesity, run by University of Pittsburgh 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 6 inclusion and 9 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 22 Aug 2018. 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?
Weight reduction (time frame: Measured at Week 14 and Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00158366, which also lists 4 linked publications.
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 22 Aug 2018.