Clinical Trials Directory

Trials / Completed

CompletedNCT02090335

Health Promotion and Fitness for Younger and Older Adults With SMI

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
210 (actual)
Sponsor
Dartmouth-Hitchcock Medical Center · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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

Interventions

TypeNameDescription
BEHAVIORALIn SHAPEIn 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.
BEHAVIORALFitness Club MembershipFitness club membership with education in using the exercise equipment.

Timeline

Start date
2007-05-01
Primary completion
2013-05-01
Completion
2013-05-01
First posted
2014-03-18
Last updated
2014-03-18

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02090335. Inclusion in this directory is not an endorsement.