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Effectiveness of a Lifestyle Intervention for Increasing Physical Activity in Adults With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Physically Ready for Invigorating Movement Every Day (PRIME)
Program for Activity, Leisure Skills, and Socialization (PALSS)
Sponsored by
Veterans Medical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Lifestyle Intervention, Schizoaffective Disorder

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Speaks English Diagnosis of schizophrenia or schizoaffective disorder Currently living in a residential facility Currently receiving outpatient care Medical clearance Willing to sign a release of medical information Exclusion Criteria: Inability to complete assessments Medical conditions that may make increasing physical activity unsafe Pregnant Currently participating in regular moderate to vigorous physical activity (defined as more than 150 minutes per week)

Sites / Locations

  • University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive the Physically Ready for Invigorating Movement Every Day program

Participants will receive the Program for Activity, Leisure Skills, and Socialization

Outcomes

Primary Outcome Measures

Frequency and intensity of PA

Secondary Outcome Measures

Quality of life
Body mass index (BMI)
Blood pressure

Full Information

First Posted
June 16, 2006
Last Updated
August 6, 2013
Sponsor
Veterans Medical Research Foundation
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00338832
Brief Title
Effectiveness of a Lifestyle Intervention for Increasing Physical Activity in Adults With Schizophrenia
Official Title
Adapting a Physical Activity Intervention for Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Veterans Medical Research Foundation
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the effectiveness of a lifestyle intervention in increasing physical activity and reducing disease symptoms in sedentary adults with schizophrenia.
Detailed Description
Schizophrenia is a severely disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. Physical activity (PA) has been shown not only to increase quality of life, but also to reduce risk factors for several chronic diseases and conditions. The majority of adults, however, do not engage in the recommended amount of PA. Research has shown that people with schizophrenia are even less likely to be regularly physically active. Symptoms of schizophrenia, pharmacological treatments for the disease, and the lifestyle associated with the disease tend to contribute to physical inactivity and the resulting complications. Effective interventions to increase PA have been developed for the general adult population, but very little is known about how to adapt them for use in adults with schizophrenia. The PRIME (Physically Ready for Invigorating Movement Every Day) program is a lifestyle intervention focused on increasing physical activity. This study will evaluate the effectiveness of a modified PRIME program in reducing the risk for morbidity in sedentary adults with schizophrenia. Participants in this 24-week, single-blind study will be randomly assigned to either the PRIME intervention group or the comparison group, which will involve the Program for Activity, Leisure Skills, and Socialization (PALSS). All participants will attend 90-minute sessions weekly for the first 16 weeks, then biweekly for the remaining 8 weeks. PRIME sessions will focus on learning about PA, setting PA-related goals, and assessing short- and long-term goals. Goals may include early-stage process-oriented goals, such as reading about PA benefits or finding a walking partner. Goals tailored to later stages of change include explicit PA goals, such as increasing frequency, duration, and intensity of PA. Training will also be accomplished online and via printed material. PALSS sessions will focus on motivating participants to engage in leisure and social activity. Sessions will include interactive, structured activity that will be led by a therapist, as well as unstructured leisure activities, such as board games, cards, general socialization, and viewing a travel video. Social and communication skills will not be explicitly taught or practiced. All participants will attend study visits at Months 2, 6, and 8 to assess outcomes. A follow-up visit will be held 2 months post-intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Lifestyle Intervention, Schizoaffective Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive the Physically Ready for Invigorating Movement Every Day program
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive the Program for Activity, Leisure Skills, and Socialization
Intervention Type
Behavioral
Intervention Name(s)
Physically Ready for Invigorating Movement Every Day (PRIME)
Intervention Description
The PRIME program is a lifestyle intervention focused on increasing physical activity. The intervention is cognitive/behaviorally based, 24-weeks in length, and a lifestyle PA intervention known to be effective in the general population of adults. The program has been modified based on theory and empirical findings about this special subgroup. All participants will attend 90-minute sessions weekly for the first 16 weeks, then biweekly for the remaining 8 weeks. PRIME sessions will focus on learning about PA, setting PA-related goals, and assessing short- and long-term goals. Goals may include early-stage process-oriented goals, such as reading about PA benefits or finding a walking partner.
Intervention Type
Behavioral
Intervention Name(s)
Program for Activity, Leisure Skills, and Socialization (PALSS)
Intervention Description
PALSS sessions will focus on motivating participants to engage in leisure and social activity. Sessions will include interactive, structured activity that will be led by a therapist, as well as unstructured leisure activities, such as board games, cards, general socialization, and viewing a travel video. Social and communication skills will not be explicitly taught or practiced. All participants will attend 90-minute sessions weekly for the first 16 weeks, then biweekly for the remaining 8 weeks.
Primary Outcome Measure Information:
Title
Frequency and intensity of PA
Time Frame
Measured at baseline and Months 2, 6, and 8
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
Measured at baseline and Months 2, 6, and 8
Title
Body mass index (BMI)
Time Frame
Measured at Months 2, 6, and 8
Title
Blood pressure
Time Frame
Measured at baseline and Months 2, 6, and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Speaks English Diagnosis of schizophrenia or schizoaffective disorder Currently living in a residential facility Currently receiving outpatient care Medical clearance Willing to sign a release of medical information Exclusion Criteria: Inability to complete assessments Medical conditions that may make increasing physical activity unsafe Pregnant Currently participating in regular moderate to vigorous physical activity (defined as more than 150 minutes per week)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie Lindamer, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of a Lifestyle Intervention for Increasing Physical Activity in Adults With Schizophrenia

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