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Completed

NCT Number: NCT00458094

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity intervention with peer support (PA+PS)

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.

Physical activity intervention without peer support (PA)

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.

Primary outcomes

  1. Cardiorespiratory fitness

    Time frame: Measured at Month 4

Secondary outcomes

  1. Weight

    Time frame: Measured at Month 4

  2. Waist circumference

    Time frame: Measured at Month 4

  3. Physical activity

    Time frame: Measured at Month 4

  4. Health status

    Time frame: Measured at Month 4

  5. Center for Epidemiology Depression Scale

    Time frame: Measured at Month 4

  6. Exercise-related self-efficacy

    Time frame: Measured at Month 4

  7. General perceived efficacy

    Time frame: Measured at Month 4

  8. Participation

    Time frame: Measured at Month 4

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Activating Consumers to Exercise in Community Psychiatry Through Peer Support

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 9, 2007
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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