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

Primary Purpose

Schizophrenia, Bipolar Disorder, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In SHAPE
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Schizophrenia focused on measuring Community mental health, Health coach, Weight loss, Fitness, Serious mental illness, Health promotion

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • West Central Behavioral Health
  • Mental Health Center of Greater Manchester
  • Greater Nashua Mental Health Center at Community Council
  • Center for Life Management

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

In SHAPE

Usual-Care Control

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Self-reported physical activity
Change in self-reported physical activity measured with International Physical Activity Questionnaire (IPAQ)
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).
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.
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
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.
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
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.
Change in social functioning
Change in social functioning measured by the Social Network Questionnaire and Lehman Social Contact Scale.
Change in family contact
Change in family contact measured by the Revised Family Contact Questionnaire.
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
Change in social support and exercise
Change in the impact of social support on exercise behaviors measured by the Social Support and Exercise Survey
Change in comorbid medical illness
Change in comorbid medical illness measured using a medical problems list.
Change in medications
Change in medications measured by gathering information from participants about type, dose, and frequency of all prescribed medications.
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.

Full Information

First Posted
January 6, 2015
Last Updated
January 7, 2015
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02334280
Brief Title
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

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder, Schizoaffective Disorder
Keywords
Community mental health, Health coach, Weight loss, Fitness, Serious mental illness, Health promotion

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In SHAPE
Arm Type
Experimental
Arm 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.
Arm Title
Usual-Care Control
Arm Type
No Intervention
Arm Description
Usual-care consumers agreed to delay participation in In SHAPE for 12 months.
Intervention Type
Behavioral
Intervention Name(s)
In SHAPE
Intervention 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.
Primary Outcome Measure Information:
Title
Change in exercise capacity
Description
Change in exercise capacity measured by the 6-minute walk test.
Time Frame
baseline, 6-, 12-, and 24-months
Secondary Outcome Measure Information:
Title
Self-reported physical activity
Description
Change in self-reported physical activity measured with International Physical Activity Questionnaire (IPAQ)
Time Frame
baseline, 6-, 12-, and 24-months
Title
Change in dietary behaviors
Description
Change in dietary behaviors measured with the Block Food Frequency Questionnaire (FFQ)21 and the Questionnaire on Eating and Weight Patterns (QEWP).
Time Frame
baseline, 6-, 12-, and 24-months
Title
Change in stage of change
Description
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.
Time Frame
baseline, 6-, 12-, and 24-months
Title
Change in eating behavior
Description
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
Time Frame
baseline, 6-, 12-, and 24-months
Title
Change in physical measurement
Description
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.
Time Frame
baseline, 6-, 12-, and 24-months
Title
Change in smoking and substance use
Description
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
Time Frame
baseline, 6-, 12-, and 24-months
Title
Change in psychological functioning (depression, negative symptoms, and self-efficacy).
Description
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.
Time Frame
baseline, 6-, 12-, and 24-months
Title
Change in social functioning
Description
Change in social functioning measured by the Social Network Questionnaire and Lehman Social Contact Scale.
Time Frame
baseline, 6-, 12-, and 24-months
Title
Change in family contact
Description
Change in family contact measured by the Revised Family Contact Questionnaire.
Time Frame
baseline, 6-, 12-, and 24-months
Title
Change in social support and eating habits
Description
Change in the impact of social support on eating habits measured by the Social Support and Eating Habits Survey
Time Frame
baseline, 6-, 12-, and 24-months
Title
Change in social support and exercise
Description
Change in the impact of social support on exercise behaviors measured by the Social Support and Exercise Survey
Time Frame
baseline, 6-, 12-, and 24-months
Title
Change in comorbid medical illness
Description
Change in comorbid medical illness measured using a medical problems list.
Time Frame
baseline, 6-, 12-, and 24-months
Title
Change in medications
Description
Change in medications measured by gathering information from participants about type, dose, and frequency of all prescribed medications.
Time Frame
baseline, 6-, 12-, and 24-months
Title
Change in service use
Description
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.
Time Frame
baseline, 6-, 12-, and 24-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Bartels, MD, MS
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Central Behavioral Health
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Facility Name
Mental Health Center of Greater Manchester
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03103
Country
United States
Facility Name
Greater Nashua Mental Health Center at Community Council
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Center for Life Management
City
Salem
State/Province
New Hampshire
ZIP/Postal Code
03079
Country
United States

12. IPD Sharing Statement

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

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