An interventional study of In SHAPE Lifestyles and Health Club Membership and Education in Schizophrenia, Bipolar Disorder and Schizoaffective Disorder, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2015-01-08.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Prevention
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.
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 133 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.
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Exclusion Criteria:
In SHAPE Lifestyle 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 Lifestyles
Fitness club membership with education in using the exercise equipment.
Behavioral: Health Club Membership and Education
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.
Fitness club membership with education in using the exercise equipment.
Change in Exercise Capacity
Change in fitness as measured by the 6-minute walk test.
Time frame: Baseline, 3-, 6-, 9-, and 12-months
Body Mass Index
Time frame: Baseline, 3-, 6-, 9-, and 12-months
Change in Weight
Change in weight over time was measured at baseline, 3-, 6-, 9-, and 12-months. Measures were weight (lbs).
Time frame: Baseline, 3-, 6-, 9-, and 12-months
Change in Triglycerides and Cholesterol
Change in triglycerides and cholesterol measured with the CardioChek PA Analyzer: Fasting blood glucose and lipids.
Time frame: Baseline, 3-, 6-, 9-, and 12-months
Change in Health Status
Change in health status was measured by the SF-12: Medical Outcomes Study Short Form -12
Time frame: Baseline, 3-, 6-, 9-, and 12-months
Change in Community Functioning
Change in community functioning was measured by the ILSS: Independent Living Skills Scale
Time frame: Baseline, 9-, and 12-months
Change in Physical Measurements (Fitness)
Change is physical measurements was determined by measuring waist circumference and resting pulse
Time frame: Baseline, 3-, 6-, 9-, and 12-months
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
Time frame: Baseline, 3-, 6-, 9-, and 12-months
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.
Time frame: Baseline, 3-, 6-, 9-, and 12-months
Change in Diet Behaviors
Change in diet behaviors was measured based on the WLB-SOC: Weight Loss Behavior State of Change Scale.
Time frame: Baseline, 3-, 6-, 9-, and 12-months
Change in Preventative Health Care
Change in preventative health care was based on the PHC: Preventative Healthcare Checklist
Time frame: Baseline and 12-months
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Dartmouth-Hitchcock Medical Center