Clinical trial NCT00215189: Evaluation of a Health Promotion Intervention for Persons With Mental Illness
Official title: Evaluation of a Health Promotion Intervention for Persons With Mental Illness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Illness
Keywords: health
mental illness
fitness
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Endowment for Health
name: Robert Wood Johnson Foundation
First posted: 2005-09-22
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Mental Health Center

Brief summary: 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.

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 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).

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Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Keene
country: United States
facility: Monadnock Family Services
state: New Hampshire
Study officials:
affiliation: Professor in Psychiatry, Dartmouth Medical School
name: Stephen J Bartels, MD
role: PRINCIPAL_INVESTIGATOR
References: