ObesityNCT00990925
Lifestyle Modification for Weight Loss in Schizophrenia
A study testing Nutritional Lifestyle Modification Group in people with Obesity and Schizophrenia, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to find out how effective lifestyle modification group therapy is on reducing body weight when compared to usual care in individuals with schizophrenia and/or schizoaffective disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Nutritional Lifestyle Modification Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Feb 2012
- 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
- Subjects will be between 18 and 65 years of age.
- Have a BMI of 28 or greater.
- Meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
- Be on a stable dose of antipsychotic medication for at least one month, with positive symptoms stability as judged by the clinical team and investigator.
Who cannot join
- A history of dementia or mental retardation.
- Not capable of giving informed consent for participation in this study.
- Ongoing pregnancy.
- Living in a structured environment where the meals are provided as part of the program, e.g., a group home, nursing home, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
The purpose of this study is to find out how effective lifestyle modification group therapy is on reducing body weight when compared to usual care in individuals with schizophrenia and/or schizoaffective disorder.
- Conditions
- Obesity, Schizophrenia, Schizoaffective Disorder
- Being tested
- Nutritional Lifestyle Modification Group, Usual Care
- Keywords
- Obesity, Schizophrenia, Schizoaffective disorder, weight loss
- Medical subject headings
- Obesity, Schizophrenia, Psychotic Disorders, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional Lifestyle Modification GroupBehavioural
Manualized group treatment to educate about basic nutritional concepts to help improve eating choices with the goal of losing weight.
Usual CareOther
Care as usual
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss Education Group | Experimental | Involvement in weekly manualized, educational group on nutrition and lifestyle modifications to help with weight loss. Receives: Behavioral: Nutritional Lifestyle Modification Group |
| Usual Care | Other | Treatment as usual Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is change in body weight from baseline.
Measured: 16 weeks, 6 month follow-up
Secondary outcomes (2)
Change in lab values from baseline (fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels)
Measured: 16 weeks, 6 month follow-up
Change in questionnaires and assessments (Q-LES-Q, QLS, PANSS, Food craving scales, Food frequency scales, Food preference scales)
Measured: 16 weeks, 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionFeb 2012
- Study completionFeb 2012
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.
- More trials run by Yale UniversityThe 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
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Cenk Tek, Yale University
- Investigators
- Cenk Tek, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990925
- Sponsor's protocol ID
- 0903004806
- Other IDs
- R01MH080048
- Status last verified
- Nov 2015
- First submitted
- 5 Oct 2009
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Modification for Weight Loss in Schizophrenia
- ClinicalTrials.gov ID
- NCT00990925
- Acronym / sponsor ID
- 0903004806
- Conditions
- Obesity, Schizophrenia, Schizoaffective Disorder
- Keywords
- Obesity, Schizophrenia, Schizoaffective disorder, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 Oct 2009 (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 purpose of this study is to find out how effective lifestyle modification group therapy is on reducing body weight when compared to usual care in individuals with schizophrenia and/or schizoaffective disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight Loss Education Group | Experimental | Behavioral: Nutritional Lifestyle Modification GroupInvolvement in weekly manualized, educational group on nutrition and lifestyle modifications to help with weight loss. |
| Usual Care | Other | Other: Usual CareTreatment as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects will be between 18 and 65 years of age.
- Have a BMI of 28 or greater.
- Meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
- Be on a stable dose of antipsychotic medication for at least one month, with positive symptoms stability as judged by the clinical team and investigator.
Key exclusion criteria (4 listed)
- A history of dementia or mental retardation.
- Not capable of giving informed consent for participation in this study.
- Ongoing pregnancy.
- Living in a structured environment where the meals are provided as part of the program, e.g., a group home, nursing home, etc.
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 |
|---|---|---|
| Nutritional Lifestyle Modification GroupManualized group treatment to educate about basic nutritional concepts to help improve eating choices with the goal of losing weight. | Behavioural | Weight Loss Education Group |
| Usual CareCare as usual | Other | Usual Care |
Primary outcome
The primary outcome measure is change in body weight from baseline.
Time frame: 16 weeks, 6 month follow-up
2 secondary outcomes
Change in lab values from baseline (fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels)
Time frame: 16 weeks, 6 month follow-up
Change in questionnaires and assessments (Q-LES-Q, QLS, PANSS, Food craving scales, Food frequency scales, Food preference scales)
Time frame: 16 weeks, 6 month follow-up
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 5 Nov 2015.
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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.
Cenk Tek, M.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Lifestyle Modification Group in people with Obesity and Schizophrenia, run by Yale University 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 4 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 5 Nov 2015. 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 primary outcome measure is change in body weight from baseline. (time frame: 16 weeks, 6 month follow-up). 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 5 Nov 2015.