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Reducing the Weight of Overweight Schizophrenia Patients

Primary Purpose

Schizophrenia, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral training
Social skills training
Behavioral training booster sessions
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Weight Loss

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 Psychiatric hospitalization within 1 month prior to study entry Current use of more than one anti-psychotic medication Pregnancy or breastfeeding

Sites / Locations

  • Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Phase 1 participants who will receive behavioral training for 14 weeks

Phase 1 participants who will receive social skills training for 14 weeks

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

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

Outcomes

Primary Outcome Measures

Weight reduction

Secondary Outcome Measures

Weight maintenance

Full Information

First Posted
September 7, 2005
Last Updated
August 20, 2018
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00158366
Brief Title
Reducing the Weight of Overweight Schizophrenia Patients
Official Title
A Clinical Trial Of Weight Reduction in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Obesity
Keywords
Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Phase 1 participants who will receive behavioral training for 14 weeks
Arm Title
2
Arm Type
Active Comparator
Arm Description
Phase 1 participants who will receive social skills training for 14 weeks
Arm Title
3
Arm Type
Experimental
Arm Description
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
Arm Title
4
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Behavioral training
Intervention Description
The behavioral training will teach participants ways to control their diet and increase their physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Social skills training
Intervention Description
The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral training booster sessions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight reduction
Time Frame
Measured at Week 14 and Month 24
Secondary Outcome Measure Information:
Title
Weight maintenance
Time Frame
Measured at Week 14 and Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Psychiatric hospitalization within 1 month prior to study entry Current use of more than one anti-psychotic medication Pregnancy or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rohan Ganguli, MD
Organizational Affiliation
Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15705006
Citation
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.
Results Reference
background
PubMed Identifier
11356587
Citation
Ganguli 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.
Results Reference
background
PubMed Identifier
10548138
Citation
Ganguli R. Weight gain associated with antipsychotic drugs. J Clin Psychiatry. 1999;60 Suppl 21:20-4.
Results Reference
background
PubMed Identifier
23410710
Citation
Janney 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. Erratum In: Schizophr Res. 2013 Aug;148(1-3):188.
Results Reference
derived

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Reducing the Weight of Overweight Schizophrenia Patients

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