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Completed

NCT Number: NCT02334228

Evaluation of the In SHAPE Fitness Intervention for Adults With Serious Mental Illness

Few studies targeting obesity in serious mental illness have reported clinically significant risk reduction, and non have been replicated in community settings or demonstrated sustained outcomes after intervention withdrawal. The researchers sought to replicate positive health outcomes demonstrated in a previous randomized effectiveness study of the In SHAPE program across urban community mental health organizations serving an ethnically diverse population.

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Key information

Conditions

Schizophrenia Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riverbend Community Mental Health

Concord, New Hampshire, 03301, United States

About this study

In this randomized, controlled study, 133 adults age 21 and older with serious mental illness (SMI) and poor physical fitness (BMI>25, or <10 minutes of exercise 2x over the past month) were randomized to either: a) In SHAPE Lifestyles (ISL) intervention or b) Health Club Membership and Education (HCME): consisting of a YMCA membership, educational materials on exercise and healthy diet, and an on-site introduction to the health club. The following three specific aims were addressed: 1) To compare ISL and HCME with respect to: a) participation in regular exercise and dietary change; (b) participation in preventive health care; and (c) improved fitness and health; (2) to compare ISL and HCME with respect to: (a) indicators of mental health and (b) personal self-efficacy; and (3) to explore differences in ISL and HCME with respect to (a) selected physical, metabolic, dietary, and community functioning secondary outcomes; and (b) the relationship of demographic variables and readiness to change to outcomes. ISL participants received a 6-month intensive program of one-to-one health mentoring, followed by a 3-month period of transitioning to self-directed individual and group programming, with assessments conducted at baseline, 3, 6, 9, and 12 months. If found to be effective, ISL will provide a practical approach to improving health, independent functioning, and longevity in disabled persons 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 a nursing home of 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 Lifestyles

Behavioral

In SHAPE Lifestyles 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.

Health Club Membership and Education

Behavioral

Fitness club membership with education in using the exercise equipment.

Primary outcomes

  1. Change in Exercise Capacity

    Time frame: Baseline, 3-, 6-, 9-, and 12-months

    Change in fitness as measured by the 6-minute walk test.

Secondary outcomes

  1. Body Mass Index

    Time frame: Baseline, 3-, 6-, 9-, and 12-months

  2. Change in Weight

    Time frame: Baseline, 3-, 6-, 9-, and 12-months

    Change in weight over time was measured at baseline, 3-, 6-, 9-, and 12-months. Measures were weight (lbs).

  3. Change in Triglycerides and Cholesterol

    Time frame: Baseline, 3-, 6-, 9-, and 12-months

    Change in triglycerides and cholesterol measured with the CardioChek PA Analyzer: Fasting blood glucose and lipids.

  4. Change in Health Status

    Time frame: Baseline, 3-, 6-, 9-, and 12-months

    Change in health status was measured by the SF-12: Medical Outcomes Study Short Form -12

  5. Change in Community Functioning

    Time frame: Baseline, 9-, and 12-months

    Change in community functioning was measured by the ILSS: Independent Living Skills Scale

  6. Change in Physical Measurements (Fitness)

    Time frame: Baseline, 3-, 6-, 9-, and 12-months

    Change is physical measurements was determined by measuring waist circumference and resting pulse

  7. Change in Psychological State

    Time frame: Baseline, 3-, 6-, 9-, and 12-months

    Change in psychological state was measured using the CESD: Cntr Epid Studies Dep; SANS: Scale Assess Neg Sx; R-SES: Revised Self-efficacy Scale

  8. Change in Participation in Exercise

    Time frame: Baseline, 3-, 6-, 9-, and 12-months

    Change in participation in exercise was determined by measuring weekly exercise at 3-, 6-, 9-, and 12-months using a physical activity log; weekly health club attendance at 3-, 6-, 9-, and 12-months based on frequency of YMCA visits; total physical activity at baseline, 3-, 6-, 9-, and 12-months based on the YPAS: Yale Physical Activity Scale.

  9. Change in Diet Behaviors

    Time frame: Baseline, 3-, 6-, 9-, and 12-months

    Change in diet behaviors was measured based on the WLB-SOC: Weight Loss Behavior State of Change Scale.

  10. Change in Preventative Health Care

    Time frame: Baseline and 12-months

    Change in preventative health care was based on the PHC: Preventative Healthcare Checklist

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

Promoting Health and Functioning in Persons With SMI

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
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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