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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334280
• Other study ID #: InSHAPE Implementation Study
• Status: Completed
• Phase: N/A
• First received: January 6, 2015
• Last updated: January 7, 2015
• Start date: September 2009
• Est. completion date: May 2013

Study information

• Verified date: January 2015
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in exercise capacity	Change in exercise capacity measured by the 6-minute walk test.	baseline, 6-, 12-, and 24-months	No
Secondary	Self-reported physical activity	Change in self-reported physical activity measured with International Physical Activity Questionnaire (IPAQ)	baseline, 6-, 12-, and 24-months	No
Secondary	Change in dietary behaviors	Change in dietary behaviors measured with the Block Food Frequency Questionnaire (FFQ)21 and the Questionnaire on Eating and Weight Patterns (QEWP).	baseline, 6-, 12-, and 24-months	No
Secondary	Change in stage of change	Change in stage of change measured with the Weight Loss Behavior-Stage of Change Scale (WLB-SOC) 23 to assess stage of change for engaging in healthy eating and exercise behaviors.	baseline, 6-, 12-, and 24-months	No
Secondary	Change in eating behavior	Change in eating behavior measured with the Dutch Eating Behavior Questionnaire which includes 13 questions assessing emotional eating and 10 questions related to external eating behaviors	baseline, 6-, 12-, and 24-months	No
Secondary	Change in physical measurement	Including height, weight, pulse, CO2 level, lung capacity from spirometer, variables from impedance measure such as percentage of body fat and percentage of lean muscle mass, cholesterol and triglyceride levels from finger stick (cholesterol data for data points that have already passed will be collected from participants' clinic and hospital records), waist circumference: BMI derived from height and weight.	baseline, 6-, 12-, and 24-months	No
Secondary	Change in smoking and substance use	Change in smoking and substance use measured by questions developed for R01DA021245, "Smoking Cessation and Smoking Relapse Prevention in Patients with Schizophrenia," and questions from the "Quit Smoking Decision Aid"( developed by Ferron and Brunette, CPHS # 180) to ascertain smoking frequency, quantity, and cessation attempts	baseline, 6-, 12-, and 24-months	No
Secondary	Change in psychological functioning (depression, negative symptoms, and self-efficacy).	Change in psychological functioning measured by the Center for Epidemiologic Studies Depression Scale,Scale to Assess Negative Symptoms,16 and the Self-Rated Abilities for Health Practices Scale will be used to assess these constructs.	baseline, 6-, 12-, and 24-months	No
Secondary	Change in social functioning	Change in social functioning measured by the Social Network Questionnaire and Lehman Social Contact Scale.	baseline, 6-, 12-, and 24-months	No
Secondary	Change in family contact	Change in family contact measured by the Revised Family Contact Questionnaire.	baseline, 6-, 12-, and 24-months	No
Secondary	Change in social support and eating habits	Change in the impact of social support on eating habits measured by the Social Support and Eating Habits Survey	baseline, 6-, 12-, and 24-months	No
Secondary	Change in social support and exercise	Change in the impact of social support on exercise behaviors measured by the Social Support and Exercise Survey	baseline, 6-, 12-, and 24-months	No
Secondary	Change in comorbid medical illness	Change in comorbid medical illness measured using a medical problems list.	baseline, 6-, 12-, and 24-months	No
Secondary	Change in medications	Change in medications measured by gathering information from participants about type, dose, and frequency of all prescribed medications.	baseline, 6-, 12-, and 24-months	No
Secondary	Change in service use	Measured change in service use based on a measured designed for the In SHAPE studies to collect self-reported use of emergency services and hospitalizations.	baseline, 6-, 12-, and 24-months	No