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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00458094
First received: April 5, 2007
Last updated: April 10, 2009
Last verified: April 2009

April 5, 2007
April 10, 2009
March 2007
December 2009   (final data collection date for primary outcome measure)
Cardiorespiratory fitness [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
Cardiorespiratory fitness
Complete list of historical versions of study NCT00458094 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Weight
  • Waist circumference
  • Physical activity
  • Health status
  • Center for Epidemiology Depression Scale
  • Exercise-related self-efficacy
  • General perceived efficacy
  • Participation
Not Provided
Not Provided
 
Peer Support for Increasing Physical Activity in People With Serious Mental Illnesses
Activating Consumers to Exercise in Community Psychiatry Through Peer Support

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Depression
  • Bipolar Disorder
  • Anxiety Disorders
  • Cognitive Disorders
  • Personality Disorders
  • 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.
  • 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.
  • Experimental: 1
    Participants will receive the peer-supported physical activity intervention
    Intervention: Behavioral: Physical activity intervention with peer support (PA+PS)
  • Active Comparator: 2
    Participants will receive physical activity without peer support
    Intervention: Behavioral: Physical activity intervention without peer support (PA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact: Gail L. Daumit, MD, MHS 410-614-6460 gdaumit@jhmi.edu
Contact: Elisabeth Leatherman, MS, LGPC 410 818 8049 esultzb1@jhmi.edu
United States
 
NCT00458094
R34 MH078613, DAHBR 96-BHB
Yes
Gail L. Daumit, MD, MHS, Johns Hopkins University School of Medicine
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Gail L. Daumit, MD, MHS Johns Hopkins University
National Institute of Mental Health (NIMH)
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP