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Evaluation of a Health Promotion Intervention for Persons With Mental Illness

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00215189
First Posted: September 22, 2005
Last Update Posted: September 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Endowment for Health
Robert Wood Johnson Foundation
Information provided by:
Dartmouth-Hitchcock Medical Center
  Purpose

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.


Condition Intervention
Mental Illness Behavioral: In SHAPE (Pilot Health Promotion Intervention)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of a Health Promotion Intervention for Persons With Mental Illness

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Enrollment: 145
Study Start Date: August 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community Mental Health Center
Criteria

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).

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215189


Locations
United States, New Hampshire
Monadnock Family Services
Keene, New Hampshire, United States, 03431
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Endowment for Health
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Stephen J Bartels, MD Professor in Psychiatry, Dartmouth Medical School
  More Information

Responsible Party: Stephen J. Bartels, MD MS, Dartmouth Medical School
ClinicalTrials.gov Identifier: NCT00215189     History of Changes
Other Study ID Numbers: IS200406
First Submitted: September 15, 2005
First Posted: September 22, 2005
Last Update Posted: September 23, 2009
Last Verified: September 2009

Keywords provided by Dartmouth-Hitchcock Medical Center:
health
mental illness
fitness

Additional relevant MeSH terms:
Mental Disorders