Health Promotion and Fitness for Younger and Older Adults With SMI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2013-05-31

Brief Summary

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The goal of this project, which has not changed, is to improve the health and fitness of persons with serious mental illness (SMI) using an innovative model: In SHAPE Lifestyles. Participants are randomly assigned to the In SHAPE program or Health Club Membership and Education only.

The three specific aims of this study are to:

1. To compare the treatment groups with respect to improvement in physical fitness outcomes, including: (a) health behaviors (engagement in exercise and diet changes); and (b) indicators of physical fitness.
2. To compare the treatment groups with respect to improvements in mental health outcomes, including negative symptoms, depression, and self-efficacy.
3. To explore differences in the treatment groups with respect to psychosocial functioning, health status, and acute service use, and the effects of selected demographic, clinical, and health behavior variables on primary outcomes.

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Detailed Description

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Individuals with SMI die 10-25 years earlier than the general population and have disproportionately greater rates of medical comorbidity and disability associated with high rates of obesity, sedentary lifestyle, metabolic syndrome, and poor dietary habits. Despite greater costs and adverse outcomes associated with the combination of mental illness and poor physical health, little attention has been paid to the development of health promotion interventions designed to address the needs of the high-risk group of people with SMI. This study is testing an innovative approach to reducing these problems and developing a program that will potentially have a downstream effect on early mortality for the vulnerable population of people with SMI.

Conditions

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Schizophrenia Bipolar Disorder Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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In SHAPE

In SHAPE is a health promotion intervention consisting of a fitness club membership and a health promotion coach with basic certification as a fitness trainer, instruction on principles of healthy eating and nutrition, and training in tailoring individual wellness plans to the needs of persons with serious mental illness.

Group Type EXPERIMENTAL

In SHAPE

Intervention Type BEHAVIORAL

In SHAPE is a health promotion intervention consisting of a fitness club membership and a health promotion coach with basic certification as a fitness trainer, instruction on principles of healthy eating and nutrition, and training in tailoring individual wellness plans to the needs of persons with serious mental illness.

Fitness Club Membership

Intervention Type BEHAVIORAL

Fitness club membership with education in using the exercise equipment.

Fitness Club Membership

Fitness club membership with education in using the exercise equipment.

Group Type ACTIVE_COMPARATOR

Fitness Club Membership

Intervention Type BEHAVIORAL

Fitness club membership with education in using the exercise equipment.

Interventions

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In SHAPE

In SHAPE is a health promotion intervention consisting of a fitness club membership and a health promotion coach with basic certification as a fitness trainer, instruction on principles of healthy eating and nutrition, and training in tailoring individual wellness plans to the needs of persons with serious mental illness.

Intervention Type BEHAVIORAL

Fitness Club Membership

Fitness club membership with education in using the exercise equipment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* age 21 or older
* serious mental illness defined by an axis I diagnosis of major depression, bipolar disorder, schizoaffective disorder, or schizophrenia
* persistent impairment in multiple areas of functioning (e.g., work, school, self-care)
* body mass index (BMI) greater than 25
* able and willing to provide informed consent
* on stable pharmacological treatment (same psychiatric medications over prior 2 months)

Exclusion Criteria

* residing in nursing home or other institution
* diagnosis of dementia or significant cognitive impairment (MMSE\<24)
* unable to walk one city block
* pregnant or planning to become pregnant within the next 18 months
* unable to speak English
* terminal illness with life expectancy\<1 year
* current diagnosis of an active substance dependence disorder

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No