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

NCT02334280 | Completed DMC

• 1 other identifier: InSHAPE Implementation Study
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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

Conditions

Schizophrenia; Bipolar Disorder; Schizoaffective Disorder

Keywords

Community mental health; Health coach; Weight loss; Fitness; Serious mental illness; Health promotion

Outcome Measures

Primary Outcomes (1)

• Change in exercise capacity

  Change in exercise capacity measured by the 6-minute walk test.

  baseline, 6-, 12-, and 24-months

Secondary Outcomes (14)

• Self-reported physical activity

  baseline, 6-, 12-, and 24-months

• Change in dietary behaviors

  baseline, 6-, 12-, and 24-months

• Change in stage of change

  baseline, 6-, 12-, and 24-months

• Change in eating behavior

  baseline, 6-, 12-, and 24-months

• Change in physical measurement

  baseline, 6-, 12-, and 24-months

Study Arms (2)

In SHAPE

EXPERIMENTAL

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.

Behavioral: In SHAPE

Usual-Care Control

NO INTERVENTION

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

Interventions

In SHAPE 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.

In SHAPE

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (4)

West Central Behavioral Health

Lebanon, New Hampshire, 03766, United States

Location

Mental Health Center of Greater Manchester

Manchester, New Hampshire, 03103, United States

Location

Greater Nashua Mental Health Center at Community Council

Nashua, New Hampshire, 03060, United States

Location

Center for Life Management

Salem, New Hampshire, 03079, United States

Location

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Psychotic Disorders; Weight Loss

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen J Bartels, MD, MS

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 8, 2015
• Study Start: September 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 8, 2015

Record last verified: 2015-01

Locations

US (4)