- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00215189
Evaluation of a Health Promotion Intervention for Persons With Mental Illness
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New Hampshire
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Keene, New Hampshire, United States, 03431
- Monadnock Family Services
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Principal Investigator: Stephen J Bartels, MD, Professor in Psychiatry, Dartmouth Medical School
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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