Health Promotion and Fitness for Younger and Older Adults With SMI (InSHAPE)

Dartmouth Health

Status: Completed

Conditions: Schizophrenia; Bipolar Disorder; Schizoaffective Disorder

Treatments: Behavioral: In SHAPE; Behavioral: Fitness Club Membership

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02090335

Boston In SHAPE

1R01MH078052 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

210 participants in 2 patient groups

In SHAPE

Experimental group

Description:

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.

Treatment:

Behavioral: In SHAPE

Behavioral: Fitness Club Membership

Fitness Club Membership

Active Comparator group

Description:

Fitness club membership with education in using the exercise equipment.

Treatment:

Behavioral: Fitness Club Membership