Health Promotion and Fitness for Younger and Older Adults With SMI

Completed · Not applicable

Conditions studied: Schizophrenia, Bipolar Disorder, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT02090335

Run by

Dartmouth-Hitchcock Medical Center

People needed

210

Starts

2007-05-01

Expected to finish

2013-05-01

Last updated by the study team

2014-03-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Baycove Human Services — Boston, Massachusetts, United States
• Massachusetts Mental Health Center — Boston, Massachusetts, United States
• Vinfen — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.