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Health Promotion and Fitness for Younger and Older Adults With SMI (InSHAPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02090335
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : March 18, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Stephen J. Bartels, Dartmouth-Hitchcock Medical Center

Study Description
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Brief Summary:

The goal of this project, which has not changed, is to improve the health and fitness of persons with serious mental illness (SMI) using an innovative model: In SHAPE Lifestyles. Participants are randomly assigned to the In SHAPE program or Health Club Membership and Education only.

The three specific aims of this study are to:

  1. To compare the treatment groups with respect to improvement in physical fitness outcomes, including: (a) health behaviors (engagement in exercise and diet changes); and (b) indicators of physical fitness.
  2. To compare the treatment groups with respect to improvements in mental health outcomes, including negative symptoms, depression, and self-efficacy.
  3. To explore differences in the treatment groups with respect to psychosocial functioning, health status, and acute service use, and the effects of selected demographic, clinical, and health behavior variables on primary outcomes.

Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar Disorder Schizoaffective Disorder Behavioral: In SHAPE Behavioral: Fitness Club Membership Not Applicable

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 study is testing an innovative approach to reducing these problems and developing a program that will potentially have a downstream effect on early mortality for the vulnerable population of people with SMI.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Health Promotion and Fitness for Younger and Older Adults With SMI
Study Start Date : May 2007
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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.

Behavioral: Fitness Club Membership
Fitness club membership with education in using the exercise equipment.
Active Comparator: Fitness Club Membership
Fitness club membership with education in using the exercise equipment.
 Behavioral: Fitness Club Membership
Fitness club membership with education in using the exercise equipment.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Weight [ Time Frame: Baseline, 3-, 6-, 9-, 12-, and 18-months ]
    Change in weight over time was measured at baseline, 3-, 6-, 9-, 12-, and 18-months. Measures were weight (kg) and body mass index (kg/m2).


Secondary Outcome Measures :
  1. Change in Dietary Behaviors [ Time Frame: Baseline, 6-, 12-, and 18-months ]
    Change in dietary behaviors was assessed over time using a scale adapted from the Stages of Change Modified Motivational Interviewing instrument focused on dietary behaviors and physical activity.

  2. Change in Dietary Intake [ Time Frame: Baseline, 6-, 12-, and 18-months ]
    Change in dietary intake over time was assessed using the Brief Block Food Frequency Questionnaire and nutrient analysis was conducted with NutritionQuest using a nutrient database developed from the USDA Nutrient Database for Standard Reference.

  3. Change in Serum lipids [ Time Frame: Baseline, 6-, 12-, and 18-months ]
    Change in serum lipids over time was measured using the CardioChek PA Analyzer, a hand-held dual testing system that produces values for total cholesterol, LDL, HDL, and triglycerides using a multi-panel test strip and a single drop of blood acquired with a finger prick.

  4. Change in Blood Pressure [ Time Frame: Baseline, 6-, 12-, and 18-months ]
    Change in systolic and diastolic blood pressure over time was measured using a blood pressure cuff.

  5. Change in Cardiorespiratory Fitness [ Time Frame: Baseline, 6-, 12-, and 18-months ]
    Change in cardiorespiratory fitness over time was measured using the 6 Minute Walk Test (distance in m that a participant can walk in 6 minutes).

  6. Change in Physical Activity [ Time Frame: Baseline, 3-, 6-, 9-, 12-, and 18-months ]
    Change in self-reported physical activity was measured over time using the short-form International Physical Activity Questionnaire (IPAQ).


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 nursing home or 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090335


Locations
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United States, Massachusetts
Baycove Human Services
Boston, Massachusetts, United States, 02114
Massachusetts Mental Health Center
Boston, Massachusetts, United States, 02115
Vinfen
Cambridge, Massachusetts, United States, 02141-1001
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Stephen J Bartels, MD, MS Dartmouth-Hitchcock Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stephen J. Bartels, Professor of Psychiatry, of Community and Family Medicine, and of TDI, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02090335    
Other Study ID Numbers: Boston In SHAPE
1R01MH078052 ( U.S. NIH Grant/Contract )
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014
Keywords provided by Stephen J. Bartels, Dartmouth-Hitchcock Medical Center:
community mental health
health coach
weight loss
 fitness
serious mental illness
health promotion
Additional relevant MeSH terms:
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Schizophrenia
Bipolar Disorder
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
 Mental Disorders
Bipolar and Related Disorders
Mood Disorders