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

NCT ID: NCT00458094

Last Updated: 2017-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia Depression Bipolar Disorder Anxiety Disorders Cognitive Disorders Personality Disorders

Keywords

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Exercise Mental Illness Community Psychiatry Peer Support Mental Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Participants will receive the peer-supported physical activity intervention

Group Type EXPERIMENTAL

Physical activity intervention with peer support (PA+PS)

Intervention Type BEHAVIORAL

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

Participants will receive physical activity without peer support

Group Type ACTIVE_COMPARATOR

Physical activity intervention without peer support (PA)

Intervention Type BEHAVIORAL

Participants in the PA group will attend the three weekly exercise sessions for 4 months but will not attend meetings with the peer educator.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gail L. Daumit, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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R34MH078613

Identifier Type: NIH

Identifier Source: secondary_id

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DAHBR 96-BHB

Identifier Type: -

Identifier Source: secondary_id

R34MH078613

Identifier Type: NIH

Identifier Source: org_study_id

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