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

March 14, 2014 updated by: Stephen J. Bartels, Dartmouth-Hitchcock Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Massachusetts Mental Health Center
      • Boston, Massachusetts, United States, 02114
        • Baycove Human Services
      • Cambridge, Massachusetts, United States, 02141-1001
        • Vinfen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, 3-, 6-, 9-, 12-, and 18-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6-, 12-, and 18-months
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.
Baseline, 6-, 12-, and 18-months
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.
Baseline, 6-, 12-, and 18-months
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.
Baseline, 6-, 12-, and 18-months
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).
Baseline, 6-, 12-, and 18-months
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).
Baseline, 3-, 6-, 9-, 12-, and 18-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Stephen J Bartels, MD, MS, Dartmouth-Hitchcock Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

March 13, 2014

First Submitted That Met QC Criteria

March 14, 2014

First Posted (Estimate)

March 18, 2014

Study Record Updates

Last Update Posted (Estimate)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 14, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Boston In SHAPE
  • 1R01MH078052 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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