Clinical trial NCT02334280: Evaluation of A Statewide Program to Prevent Early Mortality and to Promote Fitness in Persons With SMI
Official title: Evaluation of A Statewide Program to Prevent Early Mortality and to Promote Fitness in Persons With SMI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Schizoaffective Disorder
Keywords: Community mental health
Health coach
Weight loss
Fitness
Serious mental illness
Health promotion
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2015-01-08
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in exercise capacity
timeFrame: baseline, 6-, 12-, and 24-months
Secondary outcomes:
measure: Self-reported physical activity
timeFrame: baseline, 6-, 12-, and 24-months
measure: Change in dietary behaviors
timeFrame: baseline, 6-, 12-, and 24-months
measure: Change in stage of change
timeFrame: baseline, 6-, 12-, and 24-months
measure: Change in eating behavior
timeFrame: baseline, 6-, 12-, and 24-months
measure: Change in physical measurement
timeFrame: baseline, 6-, 12-, and 24-months
measure: Change in smoking and substance use
timeFrame: baseline, 6-, 12-, and 24-months
measure: Change in psychological functioning (depression, negative symptoms, and self-efficacy).
timeFrame: baseline, 6-, 12-, and 24-months
measure: Change in social functioning
timeFrame: baseline, 6-, 12-, and 24-months
measure: Change in family contact
timeFrame: baseline, 6-, 12-, and 24-months
measure: Change in social support and eating habits
timeFrame: baseline, 6-, 12-, and 24-months
measure: Change in social support and exercise
timeFrame: baseline, 6-, 12-, and 24-months
measure: Change in comorbid medical illness
timeFrame: baseline, 6-, 12-, and 24-months
measure: Change in medications
timeFrame: baseline, 6-, 12-, and 24-months
measure: Change in service use
timeFrame: baseline, 6-, 12-, and 24-months
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: West Central Behavioral Health
state: New Hampshire
city: Manchester
country: United States
facility: Mental Health Center of Greater Manchester
state: New Hampshire
city: Nashua
country: United States
facility: Greater Nashua Mental Health Center at Community Council
state: New Hampshire
city: Salem
country: United States
facility: Center for Life Management
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Stephen J Bartels, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: