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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gail Daumit, MD, MHS, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00458094
First received: April 5, 2007
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Depression
Bipolar Disorder
Anxiety Disorders
Cognitive Disorders
Personality Disorders
Behavioral: Physical activity intervention with peer support (PA+PS)
Behavioral: Physical activity intervention without peer support (PA)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Activating Consumers to Exercise in Community Psychiatry Through Peer Support

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Cardiorespiratory fitness [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
  • Health status [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
  • Center for Epidemiology Depression Scale [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
  • Exercise-related self-efficacy [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
  • General perceived efficacy [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
  • Participation [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: March 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive the peer-supported physical activity intervention
Behavioral: Physical activity intervention with peer support (PA+PS)
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.
Active Comparator: 2
Participants will receive physical activity without peer support
Behavioral: Physical activity intervention without peer support (PA)
Participants in the PA group will attend the three weekly exercise sessions for 4 months but will not attend meetings with the peer educator.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458094

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Gail L. Daumit, MD, MHS Johns Hopkins University
  More Information

No publications provided

Responsible Party: Gail Daumit, MD, MHS, MD, MHS, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00458094     History of Changes
Other Study ID Numbers: R34 MH078613, R34MH078613, DAHBR 96-BHB
Study First Received: April 5, 2007
Last Updated: April 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
Exercise
Mental Illness
Community Psychiatry
Peer Support
Mental Disorders

Additional relevant MeSH terms:
Anxiety Disorders
Bipolar Disorder
Cognition Disorders
Depression
Disease
Personality Disorders
Schizophrenia
Affective Disorders, Psychotic
Behavioral Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Mood Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 23, 2014