NCT00458094

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 6, 2017

Status Verified

December 1, 2017

Enrollment Period

2.8 years

First QC Date

April 5, 2007

Last Update Submit

December 4, 2017

Conditions

Keywords

ExerciseMental IllnessCommunity PsychiatryPeer SupportMental Disorders

Outcome Measures

Primary Outcomes (1)

  • Cardiorespiratory fitness

    Measured at Month 4

Secondary Outcomes (8)

  • Weight

    Measured at Month 4

  • Waist circumference

    Measured at Month 4

  • Physical activity

    Measured at Month 4

  • Health status

    Measured at Month 4

  • Center for Epidemiology Depression Scale

    Measured at Month 4

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Participants will receive the peer-supported physical activity intervention

Behavioral: Physical activity intervention with peer support (PA+PS)

2

ACTIVE COMPARATOR

Participants will receive physical activity without peer support

Behavioral: Physical activity intervention without peer support (PA)

Interventions

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.

1

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

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

SchizophreniaDepressionBipolar DisorderAnxiety DisordersCognitive DysfunctionPersonality DisordersMotor ActivityMental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersBehavioral SymptomsBehaviorBipolar and Related DisordersMood DisordersCognition DisordersNeurocognitive Disorders

Study Officials

  • Gail L. Daumit, MD, MHS

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2007

First Posted

April 9, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 6, 2017

Record last verified: 2017-12

Locations