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Peer Support for Increasing Physical Activity in People With Serious Mental Illnesses

Primary Purpose

Schizophrenia, Depression, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical activity intervention with peer support (PA+PS)
Physical activity intervention without peer support (PA)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Exercise, Mental Illness, Community Psychiatry, Peer Support, Mental Disorders

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient at the Johns Hopkins Community Psychiatry program
  • Plans to remain in Baltimore for 8 months after study entry
  • If currently breastfeeding, has received approval from a physician to participate in the study

Exclusion Criteria:

  • Any condition that would make weight loss medically inadvisable
  • Diagnosis of or treatment for cancer (except non-melanoma skin cancer) within 2 years prior to study entry
  • Liver failure
  • History of anorexia nervosa
  • Pregnant or planning to become pregnant during the study
  • Inability to walk or participate in an exercise class
  • Consumes more than 14 alcoholic drinks per week
  • Symptoms of angina or a cardiovascular event within 6 months prior to study entry

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive the peer-supported physical activity intervention

Participants will receive physical activity without peer support

Outcomes

Primary Outcome Measures

Cardiorespiratory fitness

Secondary Outcome Measures

Weight
Waist circumference
Physical activity
Health status
Center for Epidemiology Depression Scale
Exercise-related self-efficacy
General perceived efficacy
Participation

Full Information

First Posted
April 5, 2007
Last Updated
December 4, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00458094
Brief Title
Peer Support for Increasing Physical Activity in People With Serious Mental Illnesses
Official Title
Activating Consumers to Exercise in Community Psychiatry Through Peer Support
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
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 peer support system in increasing physical activity and effecting health behavior change in people with serious mental illnesses.
Detailed Description
People with serious mental illnesses (SMIs) are, by definition, significantly functionally impaired by the illness for an indefinite period of time. Schizophrenia, major depression, and bipolar disorder are considered SMIs. Severe anxiety disorders, cognitive disorders, and some personality disorders are sometimes categorized as SMIs, as well. The rate of obesity among people with SMIs is higher than that of people without mental illnesses. This disparity may be due to the negative symptoms that people with SMIs experience, such as vulnerability to stress, extreme dependency, and lack of motivation. This study will design and test a culturally appropriate physical activity intervention based on a peer support model for people with SMIs in an urban community psychiatry program. The intervention will be evaluated to determine its effectiveness in increasing physical activity and effecting health behavior change in people with SMIs. Participants in this 4-month, open-label study will be randomly assigned to participate in either a physical activity intervention with peer support (PA+PS) or a physical activity intervention without peer support (PA). Participants in the PA+PS group will have three exercise sessions each week, which will include group exercise classes and open gym hours for supervised individual exercise. They will also meet with a peer educator once a week for 15 minutes. Peer educators will provide emotional, informational, instrumental, and appraisal support that is aimed to motivate participants to partake in the exercise sessions. Participants in the PA group will attend the three weekly exercise sessions but will not attend meetings with the peer educator. All outcomes will be assessed at a follow-up visit at the end of the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Depression, Bipolar Disorder, Anxiety Disorders, Cognitive Disorders, Personality Disorders
Keywords
Exercise, Mental Illness, Community Psychiatry, Peer Support, Mental Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive the peer-supported physical activity intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive physical activity without peer support
Intervention Type
Behavioral
Intervention Name(s)
Physical activity intervention with peer support (PA+PS)
Intervention Description
Participants in the PA+PS group will have three exercise sessions each week for 4 months, which will include group exercise classes and open gym hours for supervised individual exercise. They will also meet with a peer educator once a week for 15 minutes. Peer educators will provide emotional, informational, instrumental, and appraisal support that is aimed to motivate participants to partake in the exercise sessions.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity intervention without peer support (PA)
Intervention Description
Participants in the PA group will attend the three weekly exercise sessions for 4 months but will not attend meetings with the peer educator.
Primary Outcome Measure Information:
Title
Cardiorespiratory fitness
Time Frame
Measured at Month 4
Secondary Outcome Measure Information:
Title
Weight
Time Frame
Measured at Month 4
Title
Waist circumference
Time Frame
Measured at Month 4
Title
Physical activity
Time Frame
Measured at Month 4
Title
Health status
Time Frame
Measured at Month 4
Title
Center for Epidemiology Depression Scale
Time Frame
Measured at Month 4
Title
Exercise-related self-efficacy
Time Frame
Measured at Month 4
Title
General perceived efficacy
Time Frame
Measured at Month 4
Title
Participation
Time Frame
Measured at Month 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient at the Johns Hopkins Community Psychiatry program Plans to remain in Baltimore for 8 months after study entry If currently breastfeeding, has received approval from a physician to participate in the study Exclusion Criteria: Any condition that would make weight loss medically inadvisable Diagnosis of or treatment for cancer (except non-melanoma skin cancer) within 2 years prior to study entry Liver failure History of anorexia nervosa Pregnant or planning to become pregnant during the study Inability to walk or participate in an exercise class Consumes more than 14 alcoholic drinks per week Symptoms of angina or a cardiovascular event within 6 months prior to study entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail L. Daumit, MD, MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

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Peer Support for Increasing Physical Activity in People With Serious Mental Illnesses

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