Evaluation of the In SHAPE Fitness Intervention for Adults With Serious Mental Illness
Primary Purpose
Schizophrenia, Bipolar Disorder, Schizoaffective Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In SHAPE Lifestyles
Health Club Membership and Education
Sponsored by
About this trial
This is an interventional prevention trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Age 21 or older
- Serious mental illness defined by an axis I diagnosis of major depression, bipolar disorder, schizoaffective disorder, or schizophrenia
- Persistent impairment in multiple areas of functioning (e.g., work, school, self-care)
- Body mass index (BMI) greater than 25
- Able and willing to provide informed consent
- On stable pharmacological treatment (same psychiatric medications over prior 2 months)
Exclusion Criteria:
- Residing in a nursing home of other institution
- Diagnosis of dementia or significant cognitive impairment (MMSE<24)
- Unable to walk one city block
- Pregnant or planning to become pregnant within the next 18 months
- Unable to speak English
- Terminal illness with life expectancy <1 year
- Current diagnosis of an active substance dependence disorder
Sites / Locations
- Riverbend Community Mental Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
In SHAPE Lifestyles
Health Club Membership and Education
Arm Description
In SHAPE Lifestyle 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.
Fitness club membership with education in using the exercise equipment.
Outcomes
Primary Outcome Measures
Change in Exercise Capacity
Change in fitness as measured by the 6-minute walk test.
Secondary Outcome Measures
Body Mass Index
Change in Weight
Change in weight over time was measured at baseline, 3-, 6-, 9-, and 12-months. Measures were weight (lbs).
Change in Triglycerides and Cholesterol
Change in triglycerides and cholesterol measured with the CardioChek PA Analyzer: Fasting blood glucose and lipids.
Change in Health Status
Change in health status was measured by the SF-12: Medical Outcomes Study Short Form -12
Change in Community Functioning
Change in community functioning was measured by the ILSS: Independent Living Skills Scale
Change in Physical Measurements (Fitness)
Change is physical measurements was determined by measuring waist circumference and resting pulse
Change in Psychological State
Change in psychological state was measured using the CESD: Cntr Epid Studies Dep; SANS: Scale Assess Neg Sx; R-SES: Revised Self-efficacy Scale
Change in Participation in Exercise
Change in participation in exercise was determined by measuring weekly exercise at 3-, 6-, 9-, and 12-months using a physical activity log; weekly health club attendance at 3-, 6-, 9-, and 12-months based on frequency of YMCA visits; total physical activity at baseline, 3-, 6-, 9-, and 12-months based on the YPAS: Yale Physical Activity Scale.
Change in Diet Behaviors
Change in diet behaviors was measured based on the WLB-SOC: Weight Loss Behavior State of Change Scale.
Change in Preventative Health Care
Change in preventative health care was based on the PHC: Preventative Healthcare Checklist
Full Information
NCT ID
NCT02334228
First Posted
January 6, 2015
Last Updated
January 7, 2015
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02334228
Brief Title
Evaluation of the In SHAPE Fitness Intervention for Adults With Serious Mental Illness
Official Title
Promoting Health and Functioning in Persons With SMI
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (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
Few studies targeting obesity in serious mental illness have reported clinically significant risk reduction, and non have been replicated in community settings or demonstrated sustained outcomes after intervention withdrawal. The researchers sought to replicate positive health outcomes demonstrated in a previous randomized effectiveness study of the In SHAPE program across urban community mental health organizations serving an ethnically diverse population.
Detailed Description
In this randomized, controlled study, 133 adults age 21 and older with serious mental illness (SMI) and poor physical fitness (BMI>25, or <10 minutes of exercise 2x over the past month) were randomized to either: a) In SHAPE Lifestyles (ISL) intervention or b) Health Club Membership and Education (HCME): consisting of a YMCA membership, educational materials on exercise and healthy diet, and an on-site introduction to the health club. The following three specific aims were addressed: 1) To compare ISL and HCME with respect to: a) participation in regular exercise and dietary change; (b) participation in preventive health care; and (c) improved fitness and health; (2) to compare ISL and HCME with respect to: (a) indicators of mental health and (b) personal self-efficacy; and (3) to explore differences in ISL and HCME with respect to (a) selected physical, metabolic, dietary, and community functioning secondary outcomes; and (b) the relationship of demographic variables and readiness to change to outcomes. ISL participants received a 6-month intensive program of one-to-one health mentoring, followed by a 3-month period of transitioning to self-directed individual and group programming, with assessments conducted at baseline, 3, 6, 9, and 12 months. If found to be effective, ISL will provide a practical approach to improving health, independent functioning, and longevity in disabled persons with SMI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder, Schizoaffective Disorder, Major Depressive Disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
In SHAPE Lifestyles
Arm Type
Experimental
Arm Description
In SHAPE Lifestyle 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
Health Club Membership and Education
Arm Type
Active Comparator
Arm Description
Fitness club membership with education in using the exercise equipment.
Intervention Type
Behavioral
Intervention Name(s)
In SHAPE Lifestyles
Intervention Description
In SHAPE Lifestyles 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
Intervention Name(s)
Health Club Membership and Education
Intervention Description
Fitness club membership with education in using the exercise equipment.
Primary Outcome Measure Information:
Title
Change in Exercise Capacity
Description
Change in fitness as measured by the 6-minute walk test.
Time Frame
Baseline, 3-, 6-, 9-, and 12-months
Secondary Outcome Measure Information:
Title
Body Mass Index
Time Frame
Baseline, 3-, 6-, 9-, and 12-months
Title
Change in Weight
Description
Change in weight over time was measured at baseline, 3-, 6-, 9-, and 12-months. Measures were weight (lbs).
Time Frame
Baseline, 3-, 6-, 9-, and 12-months
Title
Change in Triglycerides and Cholesterol
Description
Change in triglycerides and cholesterol measured with the CardioChek PA Analyzer: Fasting blood glucose and lipids.
Time Frame
Baseline, 3-, 6-, 9-, and 12-months
Title
Change in Health Status
Description
Change in health status was measured by the SF-12: Medical Outcomes Study Short Form -12
Time Frame
Baseline, 3-, 6-, 9-, and 12-months
Title
Change in Community Functioning
Description
Change in community functioning was measured by the ILSS: Independent Living Skills Scale
Time Frame
Baseline, 9-, and 12-months
Title
Change in Physical Measurements (Fitness)
Description
Change is physical measurements was determined by measuring waist circumference and resting pulse
Time Frame
Baseline, 3-, 6-, 9-, and 12-months
Title
Change in Psychological State
Description
Change in psychological state was measured using the CESD: Cntr Epid Studies Dep; SANS: Scale Assess Neg Sx; R-SES: Revised Self-efficacy Scale
Time Frame
Baseline, 3-, 6-, 9-, and 12-months
Title
Change in Participation in Exercise
Description
Change in participation in exercise was determined by measuring weekly exercise at 3-, 6-, 9-, and 12-months using a physical activity log; weekly health club attendance at 3-, 6-, 9-, and 12-months based on frequency of YMCA visits; total physical activity at baseline, 3-, 6-, 9-, and 12-months based on the YPAS: Yale Physical Activity Scale.
Time Frame
Baseline, 3-, 6-, 9-, and 12-months
Title
Change in Diet Behaviors
Description
Change in diet behaviors was measured based on the WLB-SOC: Weight Loss Behavior State of Change Scale.
Time Frame
Baseline, 3-, 6-, 9-, and 12-months
Title
Change in Preventative Health Care
Description
Change in preventative health care was based on the PHC: Preventative Healthcare Checklist
Time Frame
Baseline and 12-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 an axis I diagnosis of major depression, bipolar disorder, schizoaffective disorder, or schizophrenia
Persistent impairment in multiple areas of functioning (e.g., work, school, self-care)
Body mass index (BMI) greater than 25
Able and willing to provide informed consent
On stable pharmacological treatment (same psychiatric medications over prior 2 months)
Exclusion Criteria:
Residing in a nursing home of other institution
Diagnosis of dementia or significant cognitive impairment (MMSE<24)
Unable to walk one city block
Pregnant or planning to become pregnant within the next 18 months
Unable to speak English
Terminal illness with life expectancy <1 year
Current diagnosis of an active substance dependence disorder
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
Riverbend Community Mental Health
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
12. IPD Sharing Statement
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Evaluation of the In SHAPE Fitness Intervention for Adults With Serious Mental Illness
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