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Completed

NCT Number: NCT02334280

Evaluation of A Statewide Program to Prevent Early Mortality and to Promote Fitness in Persons With SMI

The goal of this project, which has not changed, is to evaluate the statewide implementation of a two-component intervention (health promotion plus academic detailing) with respect to consumer outcomes and changes in provider prescribing. The intervention, called In SHAPE, is delivered to people with serious mental illness (SMI) by two community mental health clinics (CMHCs). These CMHCs are compared to two CMHCs delivering usual-care to individuals with SMI. The specific aims of this study are:

1. Evaluate person-level and provider-level outcomes including: (a) consumer health behaviors, health indicators, mental health indicators, and acute health service utilization, (b) provider prescribing practices and program fidelity, and (c) program costs. 2. Evaluate system-level outcomes including: (a) consumer health behaviors and health indicators, (b) provider prescribing and program fidelity, and (c) acute services use.

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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

West Central Behavioral Health, Lebanon, New Hampshire, 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 natural experiment presents an unprecedented opportunity to evaluate the public health impact of a statewide health-promotion program for persons with SMI, a potential model for reducing early mortality among persons with SMI served by state mental-health systems nationwide.

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 (a) an axis I diagnosis of major depression, bipolar disorder, schizoaffective disorder, or schizophrenia, (b) moderate impairment across multiple areas of psychological functioning, or (c) Global Assessment of Functioning (GAF) score less than 61
  • Able to provide voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian or conservator
  • Poor fitness as indicated by BMI > 25 or failure to adhere to the US Department of Health and Human Services Physical Activity Guidelines for Americans, i.e., at least 2.5 hr/week of moderate or 75 min/week of vigorous activity in more than one session
  • Medical clearance for participation in an exercise and dietary modification program by a physician, physician assistant, or nurse practitioner
  • An expressed willingness to participate in a diet and exercise program
  • Currently taking an atypical antipsychotic medication
  • Able to walk a city block
  • Responsible for choice of foods and how they are prepared

Exclusion criteria

  • Currently residing in a nursing home or group home
  • Terminal physical illness expected to result in the death of the study subject within one year
  • Primary diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by a Mini-Mental State Examination (MMSE) score < 24
  • Inability to speak and understand English
  • Pregnancy

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.

Primary outcomes

  1. Change in exercise capacity

    Time frame: baseline, 6-, 12-, and 24-months

    Change in exercise capacity measured by the 6-minute walk test.

Secondary outcomes

  1. Self-reported physical activity

    Time frame: baseline, 6-, 12-, and 24-months

    Change in self-reported physical activity measured with International Physical Activity Questionnaire (IPAQ)

  2. Change in dietary behaviors

    Time frame: baseline, 6-, 12-, and 24-months

    Change in dietary behaviors measured with the Block Food Frequency Questionnaire (FFQ)21 and the Questionnaire on Eating and Weight Patterns (QEWP).

  3. Change in stage of change

    Time frame: baseline, 6-, 12-, and 24-months

    Change in stage of change measured with the Weight Loss Behavior-Stage of Change Scale (WLB-SOC) 23 to assess stage of change for engaging in healthy eating and exercise behaviors.

  4. Change in eating behavior

    Time frame: baseline, 6-, 12-, and 24-months

    Change in eating behavior measured with the Dutch Eating Behavior Questionnaire which includes 13 questions assessing emotional eating and 10 questions related to external eating behaviors

  5. Change in physical measurement

    Time frame: baseline, 6-, 12-, and 24-months

    Including height, weight, pulse, CO2 level, lung capacity from spirometer, variables from impedance measure such as percentage of body fat and percentage of lean muscle mass, cholesterol and triglyceride levels from finger stick (cholesterol data for data points that have already passed will be collected from participants' clinic and hospital records), waist circumference: BMI derived from height and weight.

  6. Change in smoking and substance use

    Time frame: baseline, 6-, 12-, and 24-months

    Change in smoking and substance use measured by questions developed for R01DA021245, "Smoking Cessation and Smoking Relapse Prevention in Patients with Schizophrenia," and questions from the "Quit Smoking Decision Aid"( developed by Ferron and Brunette, CPHS # 180) to ascertain smoking frequency, quantity, and cessation attempts

  7. Change in psychological functioning (depression, negative symptoms, and self-efficacy).

    Time frame: baseline, 6-, 12-, and 24-months

    Change in psychological functioning measured by the Center for Epidemiologic Studies Depression Scale,Scale to Assess Negative Symptoms,16 and the Self-Rated Abilities for Health Practices Scale will be used to assess these constructs.

  8. Change in social functioning

    Time frame: baseline, 6-, 12-, and 24-months

    Change in social functioning measured by the Social Network Questionnaire and Lehman Social Contact Scale.

  9. Change in family contact

    Time frame: baseline, 6-, 12-, and 24-months

    Change in family contact measured by the Revised Family Contact Questionnaire.

  10. Change in social support and eating habits

    Time frame: baseline, 6-, 12-, and 24-months

    Change in the impact of social support on eating habits measured by the Social Support and Eating Habits Survey

  11. Change in social support and exercise

    Time frame: baseline, 6-, 12-, and 24-months

    Change in the impact of social support on exercise behaviors measured by the Social Support and Exercise Survey

  12. Change in comorbid medical illness

    Time frame: baseline, 6-, 12-, and 24-months

    Change in comorbid medical illness measured using a medical problems list.

  13. Change in medications

    Time frame: baseline, 6-, 12-, and 24-months

    Change in medications measured by gathering information from participants about type, dose, and frequency of all prescribed medications.

  14. Change in service use

    Time frame: baseline, 6-, 12-, and 24-months

    Measured change in service use based on a measured designed for the In SHAPE studies to collect self-reported use of emergency services and hospitalizations.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 8, 2015
Registry last updated
Jan 8, 2015

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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