Evaluation of a Health Promotion Intervention for Persons With Mental Illness

September 22, 2009 updated by: Dartmouth-Hitchcock Medical Center

This pilot study evaluates an individualized health promotion program for people with mental illness receiving services at a mental health center in Keene, NH. The study will test the following hypotheses:

Hypothesis 1: Compared to baseline (pre-study) levels, participants in the In SHAPE program will demonstrate increased physical activity as indicated by self-report and observed measures.

Hypothesis 2: Compared to baseline (pre-study) levels, participants in the In SHAPE program will demonstrate improved fitness and health status as indicated by greater capacity on the 6-minute walk test, one mile walk test, weight and body composition, and flexibility indexes.

The following secondary (exploratory) hypotheses will be considered:

Compared to baseline (pre-study) levels, participants in the In SHAPE program will demonstrate improved subjective health status, quality of life, mood, and self-efficacy. In addition, participants will demonstrate improved cardiovascular fitness as indicated by lower pulse rate and blood pressure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The In SHAPE program aims to improve the physical fitness and health of persons with mental illness. Participants in the program are assigned a health mentor who assesses individual lifestyle habits and health status, identifies goals for lifestyle change, and serves as a motivator and physical trainer. The individualized components of the In SHAPE program are supplemented with group-level positive reinforcement and motivational incentives. This evaluation project systematically evaluates the In SHAPE health promotion intervention.

Study Type

Observational

Enrollment (Actual)

145

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Keene, New Hampshire, United States, 03431
        • Monadnock Family Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community Mental Health Center

Description

Inclusion Criteria:

Age 18 or older, and enrolled in the In SHAPE program. Mental illness Receiving mental health services for 3 months or longer Voluntary informed consent or guardian consent Signed letter of permission to participate by a physician for individuals with a history of a medical illness or indications of health problems during the evaluation -

Exclusion Criteria:

Inability to give informed, voluntary consent. Primary diagnosis of dementia or a diagnosis of a psychiatric disorder secondary to a medical condition.

Co-morbid dementia as indicated by an MMSE score <20. Exclusion for eligibility as determined by the participant's physician due to medical contraindications (e.g., recent myocardial infarction, stroke (thrombotic or embolic), uncontrolled insulin-dependent diabetes).

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Robert Wood Johnson Foundation
Endowment for Health

Investigators

  • Principal Investigator: Stephen J Bartels, MD, Professor in Psychiatry, Dartmouth Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 15, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 23, 2009

Last Update Submitted That Met QC Criteria

September 22, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IS200406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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