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

Dartmouth Health

Status: Completed

Conditions: Major Depressive Disorder; Schizophrenia; Bipolar Disorder; Schizoaffective Disorder

Treatments: Behavioral: Health Club Membership and Education; Behavioral: In SHAPE Lifestyles

Study type: Interventional

Funder types: Other

Identifiers

NCT02334228

Concord InSHAPE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 133 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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133 participants in 2 patient groups

In SHAPE Lifestyles

Experimental group

Description:

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.

Treatment:

Behavioral: In SHAPE Lifestyles

Health Club Membership and Education

Active Comparator group

Description:

Fitness club membership with education in using the exercise equipment.

Treatment:

Behavioral: Health Club Membership and Education