Evaluation of A Statewide Program to Prevent Early Mortality and to Promote Fitness in Persons With SMI

NCT ID: NCT02334280

Last Updated: 2015-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-05-31

Brief Summary

The goal of this project, which has not changed, is to evaluate the statewide implementation of a two-component intervention (health promotion plus academic detailing) with respect to consumer outcomes and changes in provider prescribing. The intervention, called In SHAPE, is delivered to people with serious mental illness (SMI) by two community mental health clinics (CMHCs). These CMHCs are compared to two CMHCs delivering usual-care to individuals with SMI. The specific aims of this study are:

1. Evaluate person-level and provider-level outcomes including: (a) consumer health behaviors, health indicators, mental health indicators, and acute health service utilization, (b) provider prescribing practices and program fidelity, and (c) program costs.

2. Evaluate system-level outcomes including: (a) consumer health behaviors and health indicators, (b) provider prescribing and program fidelity, and (c) acute services use.

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 natural experiment presents an unprecedented opportunity to evaluate the public health impact of a statewide health-promotion program for persons with SMI, a potential model for reducing early mortality among persons with SMI served by state mental-health systems nationwide.

Conditions

Schizophrenia; Bipolar Disorder; Schizoaffective Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Usual-Care Control

Usual-care consumers agreed to delay participation in In SHAPE for 12 months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Eligibility Criteria

Inclusion Criteria

• Age 21 or older
• Serious mental illness defined by (a) an axis I diagnosis of major depression, bipolar disorder, schizoaffective disorder, or schizophrenia, (b) moderate impairment across multiple areas of psychological functioning, or (c) Global Assessment of Functioning (GAF) score less than 61
• Able to provide voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian or conservator
• Poor fitness as indicated by BMI > 25 or failure to adhere to the US Department of Health and Human Services Physical Activity Guidelines for Americans, i.e., at least 2.5 hr/week of moderate or 75 min/week of vigorous activity in more than one session
• Medical clearance for participation in an exercise and dietary modification program by a physician, physician assistant, or nurse practitioner
• An expressed willingness to participate in a diet and exercise program
• Currently taking an atypical antipsychotic medication
• Able to walk a city block
• Responsible for choice of foods and how they are prepared

Exclusion Criteria

• Currently residing in a nursing home or group home
• Terminal physical illness expected to result in the death of the study subject within one year
• Primary diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by a Mini-Mental State Examination (MMSE) score < 24
• Inability to speak and understand English
• Pregnancy

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen J Bartels, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

West Central Behavioral Health

Lebanon, New Hampshire, United States

Mental Health Center of Greater Manchester

Manchester, New Hampshire, United States

Greater Nashua Mental Health Center at Community Council

Nashua, New Hampshire, United States

Center for Life Management

Salem, New Hampshire, United States

Countries

United States

Other Identifiers

InSHAPE Implementation Study

Identifier Type: -

Identifier Source: org_study_id