Evaluation of a Health Promotion Intervention for Persons With Mental Illness

Mental Illness Clinical Trial

Official title:

Evaluation of a Health Promotion Intervention for Persons With Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215189
• Other study ID #: IS200406
• Status: Completed
• Phase: N/A
• First received: September 15, 2005
• Last updated: September 22, 2009
• Start date: August 2004
• Est. completion date: December 2007

Study information

• Verified date: September 2009
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Mental Disorders
• Mental Illness

Intervention

Behavioral:
• In SHAPE (Pilot Health Promotion Intervention)

Locations

Country	Name	City	State
United States	Monadnock Family Services	Keene	New Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Endowment for Health, Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States,