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

Primary Purpose

Schizophrenia, Bipolar Disorder, Schizoaffective Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

In SHAPE

Fitness Club Membership

About this trial

This is an interventional prevention 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 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

Sites / Locations

Baycove Human Services
Massachusetts Mental Health Center
Vinfen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

In SHAPE

Fitness Club Membership

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.

Fitness club membership with education in using the exercise equipment.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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.

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.

Change in Blood Pressure

Change in systolic and diastolic blood pressure over time was measured using a blood pressure cuff.

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).

Change in Physical Activity

Change in self-reported physical activity was measured over time using the short-form International Physical Activity Questionnaire (IPAQ).

Full Information

NCT ID

NCT02090335

First Posted

March 13, 2014

Last Updated

March 14, 2014

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT02090335

Brief Title

Health Promotion and Fitness for Younger and Older Adults With SMI

Acronym

InSHAPE

Official Title

Health Promotion and Fitness for Younger and Older Adults With SMI

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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. To compare the treatment groups with respect to improvements in mental health outcomes, including negative symptoms, depression, and self-efficacy. 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.

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.

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

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

210 (Actual)

8. Arms, Groups, and Interventions

Arm Title

In SHAPE

Arm Type

Experimental

Arm Description

Arm Title

Fitness Club Membership

Arm Type

Active Comparator

Arm Description

Fitness club membership with education in using the exercise equipment.

Intervention Type

Behavioral

Intervention Name(s)

In SHAPE

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Fitness Club Membership

Intervention Description

Fitness club membership with education in using the exercise equipment.

Primary Outcome Measure Information:

Title

Change in Weight

Description

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).

Time Frame

Baseline, 3-, 6-, 9-, 12-, and 18-months

Secondary Outcome Measure Information:

Title

Change in Dietary Behaviors

Description

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.

Time Frame