Clinical Trials Directory

Trials / Completed

CompletedNCT02334228

Evaluation of the In SHAPE Fitness Intervention for Adults With Serious Mental Illness

Promoting Health and Functioning in Persons With SMI

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

Summary

Few studies targeting obesity in serious mental illness have reported clinically significant risk reduction, and non have been replicated in community settings or demonstrated sustained outcomes after intervention withdrawal. The researchers sought to replicate positive health outcomes demonstrated in a previous randomized effectiveness study of the In SHAPE program across urban community mental health organizations serving an ethnically diverse population.

Detailed description

In this randomized, controlled study, 133 adults age 21 and older with serious mental illness (SMI) and poor physical fitness (BMI\>25, or \<10 minutes of exercise 2x over the past month) were randomized to either: a) In SHAPE Lifestyles (ISL) intervention or b) Health Club Membership and Education (HCME): consisting of a YMCA membership, educational materials on exercise and healthy diet, and an on-site introduction to the health club. The following three specific aims were addressed: 1) To compare ISL and HCME with respect to: a) participation in regular exercise and dietary change; (b) participation in preventive health care; and (c) improved fitness and health; (2) to compare ISL and HCME with respect to: (a) indicators of mental health and (b) personal self-efficacy; and (3) to explore differences in ISL and HCME with respect to (a) selected physical, metabolic, dietary, and community functioning secondary outcomes; and (b) the relationship of demographic variables and readiness to change to outcomes. ISL participants received a 6-month intensive program of one-to-one health mentoring, followed by a 3-month period of transitioning to self-directed individual and group programming, with assessments conducted at baseline, 3, 6, 9, and 12 months. If found to be effective, ISL will provide a practical approach to improving health, independent functioning, and longevity in disabled persons with SMI.

Conditions

Interventions

TypeNameDescription
BEHAVIORALIn SHAPE LifestylesIn SHAPE Lifestyles 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.
BEHAVIORALHealth Club Membership and EducationFitness club membership with education in using the exercise equipment.

Timeline

Start date
2006-09-01
Primary completion
2009-08-01
Completion
2009-08-01
First posted
2015-01-08
Last updated
2015-01-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02334228. Inclusion in this directory is not an endorsement.