Health Promotion and Fitness for Younger and Older Adults With SMI

Schizophrenia Clinical Trial

— InSHAPE  

Official title:

Health Promotion and Fitness for Younger and Older Adults With SMI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02090335
• Other study ID #: Boston In SHAPE
• Secondary ID: 1R01MH078052
• Status: Completed
• Phase: N/A
• First received: March 13, 2014
• Last updated: March 14, 2014
• Start date: May 2007
• Est. completion date: May 2013

Study information

• Verified date: March 2014
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• 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 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

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.
• Fitness Club Membership
Fitness club membership with education in using the exercise equipment.

Locations

Country	Name	City	State
United States	Baycove Human Services	Boston	Massachusetts
United States	Massachusetts Mental Health Center	Boston	Massachusetts
United States	Vinfen	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight	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).	Baseline, 3-, 6-, 9-, 12-, and 18-months	No
Secondary	Change in Dietary Behaviors	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.	Baseline, 6-, 12-, and 18-months	No
Secondary	Change in Dietary Intake	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.	Baseline, 6-, 12-, and 18-months	No
Secondary	Change in Serum lipids	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.	Baseline, 6-, 12-, and 18-months	No
Secondary	Change in Blood Pressure	Change in systolic and diastolic blood pressure over time was measured using a blood pressure cuff.	Baseline, 6-, 12-, and 18-months	No
Secondary	Change in Cardiorespiratory Fitness	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).	Baseline, 6-, 12-, and 18-months	No
Secondary	Change in Physical Activity	Change in self-reported physical activity was measured over time using the short-form International Physical Activity Questionnaire (IPAQ).	Baseline, 3-, 6-, 9-, 12-, and 18-months	No