Health Promotion and Fitness for Younger and Older Adults With SMI
InSHAPE
2 other identifiers
interventional
210
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started May 2007
Longer than P75 for not_applicable schizophrenia
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 13, 2014
CompletedFirst Posted
Study publicly available on registry
March 18, 2014
CompletedMarch 18, 2014
March 1, 2014
6 years
March 13, 2014
March 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Weight
Change in weight over time was measured at baseline, 3-, 6-, 9-, 12-, and 18-months. Measures were weight (kg) and body mass index (kg/m2).
Baseline, 3-, 6-, 9-, 12-, and 18-months
Secondary Outcomes (6)
Change in Dietary Behaviors
Baseline, 6-, 12-, and 18-months
Change in Dietary Intake
Baseline, 6-, 12-, and 18-months
Change in Serum lipids
Baseline, 6-, 12-, and 18-months
Change in Blood Pressure
Baseline, 6-, 12-, and 18-months
Change in Cardiorespiratory Fitness
Baseline, 6-, 12-, and 18-months
- +1 more secondary outcomes
Study Arms (2)
In SHAPE
EXPERIMENTALIn SHAPE 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
ACTIVE COMPARATORFitness club membership with education in using the exercise equipment.
Interventions
In SHAPE 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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Baycove Human Services
Boston, Massachusetts, 02114, United States
Massachusetts Mental Health Center
Boston, Massachusetts, 02115, United States
Vinfen
Cambridge, Massachusetts, 02141-1001, United States
Related Publications (2)
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.
PMID: 28240625DERIVEDBartels 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.
PMID: 25827032DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen J Bartels, MD, MS
Dartmouth-Hitchcock Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry, of Community and Family Medicine, and of TDI
Study Record Dates
First Submitted
March 13, 2014
First Posted
March 18, 2014
Study Start
May 1, 2007
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
March 18, 2014
Record last verified: 2014-03