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

Schizophrenia Clinical Trial

Official title:

Promoting Health and Functioning in Persons With SMI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334228
• Other study ID #: Concord InSHAPE
• Status: Completed
• Phase: N/A
• First received: January 6, 2015
• Last updated: January 7, 2015
• Start date: September 2006
• Est. completion date: August 2009

Study information

• Verified date: January 2015
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• In SHAPE Lifestyles
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
Fitness club membership with education in using the exercise equipment.

Locations

Country	Name	City	State
United States	Riverbend Community Mental Health	Concord	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Exercise Capacity	Change in fitness as measured by the 6-minute walk test.	Baseline, 3-, 6-, 9-, and 12-months	No
Secondary	Body Mass Index		Baseline, 3-, 6-, 9-, and 12-months	No
Secondary	Change in Weight	Change in weight over time was measured at baseline, 3-, 6-, 9-, and 12-months. Measures were weight (lbs).	Baseline, 3-, 6-, 9-, and 12-months	No
Secondary	Change in Triglycerides and Cholesterol	Change in triglycerides and cholesterol measured with the CardioChek PA Analyzer: Fasting blood glucose and lipids.	Baseline, 3-, 6-, 9-, and 12-months	No
Secondary	Change in Health Status	Change in health status was measured by the SF-12: Medical Outcomes Study Short Form -12	Baseline, 3-, 6-, 9-, and 12-months	No
Secondary	Change in Community Functioning	Change in community functioning was measured by the ILSS: Independent Living Skills Scale	Baseline, 9-, and 12-months	No
Secondary	Change in Physical Measurements (Fitness)	Change is physical measurements was determined by measuring waist circumference and resting pulse	Baseline, 3-, 6-, 9-, and 12-months	No
Secondary	Change in Psychological State	Change in psychological state was measured using the CESD: Cntr Epid Studies Dep; SANS: Scale Assess Neg Sx; R-SES: Revised Self-efficacy Scale	Baseline, 3-, 6-, 9-, and 12-months	No
Secondary	Change in Participation in Exercise	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.	Baseline, 3-, 6-, 9-, and 12-months	No
Secondary	Change in Diet Behaviors	Change in diet behaviors was measured based on the WLB-SOC: Weight Loss Behavior State of Change Scale.	Baseline, 3-, 6-, 9-, and 12-months	No
Secondary	Change in Preventative Health Care	Change in preventative health care was based on the PHC: Preventative Healthcare Checklist	Baseline and 12-months	No