Peer Support for Increasing Physical Activity in People With Serious Mental Illnesses - Full Text View

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
Mental Disorders	Behavioral: Physical activity intervention with peer support (PA+PS) Behavioral: Physical activity intervention without peer support (PA)	Phase II

MedlinePlus related topics:

Exercise and Physical Fitness Mental Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Official Title:	Activating Consumers to Exercise in Community Psychiatry Through Peer Support

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment:	100
Study Start Date:	March 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator 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

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

Contacts


Contact: Gail L. Daumit, MD, MHS	410-614-6460	gdaumit@jhmi.edu

Contact: Jennifer H. Hayes, MEd, MPH	410-502-7839	jhayes17@jhmi.edu

Locations


United States, Maryland
	Johns Hopkins University	Recruiting
	Baltimore, Maryland, United States, 21205

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Gail L. Daumit, MD, MHS	Johns Hopkins University

More Information

Responsible Party:	Johns Hopkins University School of Medicine ( Gail L. Daumit, MD, MHS )
Study ID Numbers:	R34 MH78613, DAHBR 96-BHB
First Received:	April 5, 2007
Last Updated:	February 12, 2008
ClinicalTrials.gov Identifier:	NCT00458094
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Exercise

Mental Illness

Community Psychiatry

Peer Support

Study placed in the following topic categories:

Mental Disorders

ClinicalTrials.gov processed this record on November 19, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00458094