Clinical trial NCT02090335: Health Promotion and Fitness for Younger and Older Adults With SMI
Official title: Health Promotion and Fitness for Younger and Older Adults With SMI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Schizoaffective Disorder
Keywords: community mental health
health coach
weight loss
fitness
serious mental illness
health promotion
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-03-18
Enrollment: 210
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: The goal of this project, which has not changed, is to improve the health and fitness of persons with serious mental illness (SMI) using an innovative model: In SHAPE Lifestyles. Participants are randomly assigned to the In SHAPE program or Health Club Membership and Education only.

The three specific aims of this study are to:

1. To compare the treatment groups with respect to improvement in physical fitness outcomes, including: (a) health behaviors (engagement in exercise and diet changes); and (b) indicators of physical fitness.
2. To compare the treatment groups with respect to improvements in mental health outcomes, including negative symptoms, depression, and self-efficacy.
3. To explore differences in the treatment groups with respect to psychosocial functioning, health status, and acute service use, and the effects of selected demographic, clinical, and health behavior variables on primary outcomes.

Detailed description: Individuals with SMI die 10-25 years earlier than the general population and have disproportionately greater rates of medical comorbidity and disability associated with high rates of obesity, sedentary lifestyle, metabolic syndrome, and poor dietary habits. Despite greater costs and adverse outcomes associated with the combination of mental illness and poor physical health, little attention has been paid to the development of health promotion interventions designed to address the needs of the high-risk group of people with SMI. This study is testing an innovative approach to reducing these problems and developing a program that will potentially have a downstream effect on early mortality for the vulnerable population of people 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 nursing home or 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 Weight
timeFrame: Baseline, 3-, 6-, 9-, 12-, and 18-months
Secondary outcomes:
measure: Change in Dietary Behaviors
timeFrame: Baseline, 6-, 12-, and 18-months
measure: Change in Dietary Intake
timeFrame: Baseline, 6-, 12-, and 18-months
measure: Change in Serum lipids
timeFrame: Baseline, 6-, 12-, and 18-months
measure: Change in Blood Pressure
timeFrame: Baseline, 6-, 12-, and 18-months
measure: Change in Cardiorespiratory Fitness
timeFrame: Baseline, 6-, 12-, and 18-months
measure: Change in Physical Activity
timeFrame: Baseline, 3-, 6-, 9-, 12-, and 18-months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Baycove Human Services
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts Mental Health Center
state: Massachusetts
city: Cambridge
country: United States
facility: Vinfen
state: Massachusetts
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Stephen J Bartels, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Naslund JA, Aschbrenner KA, Pratt SI, Lohman MC, Scherer EA, McHugo GJ, Marsch LA, Unutzer J, Bartels SJ. Association Between Cardiovascular Risk and Depressive Symptoms Among People With Serious Mental Illness. J Nerv Ment Dis. 2017 Aug;205(8):634-640. doi: 10.1097/NMD.0000000000000669.
citation: Bartels SJ, Pratt SI, Aschbrenner KA, Barre LK, Naslund JA, Wolfe R, Xie H, McHugo GJ, Jimenez DE, Jue K, Feldman J, Bird BL. Pragmatic replication trial of health promotion coaching for obesity in serious mental illness and maintenance of outcomes. Am J Psychiatry. 2015 Apr;172(4):344-52. doi: 10.1176/appi.ajp.2014.14030357. Epub 2014 Dec 12.