Clinical trial NCT02334228: Evaluation of the In SHAPE Fitness Intervention for Adults With Serious Mental Illness
Official title: Promoting Health and Functioning in Persons With SMI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Schizoaffective Disorder
Major Depressive Disorder
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2015-01-08
Enrollment: 133
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Exercise Capacity
timeFrame: Baseline, 3-, 6-, 9-, and 12-months
Secondary outcomes:
measure: Body Mass Index
timeFrame: Baseline, 3-, 6-, 9-, and 12-months
measure: Change in Weight
timeFrame: Baseline, 3-, 6-, 9-, and 12-months
measure: Change in Triglycerides and Cholesterol
timeFrame: Baseline, 3-, 6-, 9-, and 12-months
measure: Change in Health Status
timeFrame: Baseline, 3-, 6-, 9-, and 12-months
measure: Change in Community Functioning
timeFrame: Baseline, 9-, and 12-months
measure: Change in Physical Measurements (Fitness)
timeFrame: Baseline, 3-, 6-, 9-, and 12-months
measure: Change in Psychological State
timeFrame: Baseline, 3-, 6-, 9-, and 12-months
measure: Change in Participation in Exercise
timeFrame: Baseline, 3-, 6-, 9-, and 12-months
measure: Change in Diet Behaviors
timeFrame: Baseline, 3-, 6-, 9-, and 12-months
measure: Change in Preventative Health Care
timeFrame: Baseline and 12-months
Other outcomes:
Locations:
city: Concord
country: United States
facility: Riverbend Community Mental Health
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Stephen J Bartels, MD,MS
role: PRINCIPAL_INVESTIGATOR
References: