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Completed

NCT Number: NCT02090335

Health Promotion and Fitness for Younger and Older Adults With SMI

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.

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Key information

Conditions

Schizophrenia Bipolar Disorder Bipolar and Related Disorders Body Weight Body Weight Changes Mental Disorders Mood Disorders Pathological Conditions, Signs and Symptoms Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms Weight Loss

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baycove Human Services, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In SHAPE

Behavioral

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

Behavioral

Fitness club membership with education in using the exercise equipment.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: InSHAPE

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Mar 18, 2014
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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