- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07374159
Sit Less, Move More Program as an Integrated Service at Osonament
Severe Mental Disorders, Chronicity and Sedentary Behaviour: Usability and Effectiveness of the "Sit Less, Move More" Program as an Integrated Service at Osonament
People with severe mental illness (SMI), such as schizophrenia, bipolar disorder, or major depressive disorder, experience a life expectancy reduction of 10-20 years, largely due to chronic conditions like cardiovascular disease and type 2 diabetes. These individuals are less physically active and spend more time in sedentary behaviours (SB), which are associated with increased mortality, poor metabolic health, worse cognition, and lower quality of life. Traditional studies often rely on self-reported SB, which is unreliable, whereas objective measures like accelerometry provide more accurate data. Understanding SB patterns is essential for designing effective interventions to reduce prolonged sitting and improve health outcomes in this population.
This study aimed to describe daily SB patterns in outpatients with SMI and evaluate the feasibility of the "Sit Less, Move More" program integrated into routine care at Osonament, a community mental health center in Catalonia. The pragmatic intervention lasted 16 weeks and included two weekly contacts: face-to-face sessions for planning walking routes and strategies to increase activity, and telephone follow-ups to reinforce goals. Participants were grouped by affinity and residence to encourage autonomous walks, and the program was embedded within individual recovery plans. Ethical approval was obtained, and informed consent was secured.
Sedentary behaviour and physical activity were measured using the ActivPAL™ accelerometer, worn continuously for seven days at baseline and post-intervention. The device provided detailed data on sitting time, standing, light activity, and moderate-to-vigorous activity, as well as SB bouts categorized by duration. Self-perceived health was assessed using a visual analogue scale. From 412 potential candidates, 231 were invited, 60 enrolled, and 53 completed the program. Dropouts were due to psychiatric relapse, hospitalization, discharge, relocation, or loss of interest.
The study demonstrates the feasibility of integrating SB reduction strategies into community mental health services and highlights the importance of objective SB measurement. It provides a foundation for developing tailored interventions that break up prolonged sitting and promote movement among people with SMI, addressing a critical gap in improving physical health and reducing premature mortality in this vulnerable population.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Barcelona
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Manresa, Barcelona, Spain, 08242
- Fundació Universitaria del Bages
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being an active user of Osonament
- Having a clinical diagnosis of a severe mental illness (e.g., schizophrenia, bipolar disorder, etc) in a stable plhase of the illness
Exclusion Criteria:
- Actively using toxics substances
- Had a predominant diagnosis other than a sever mental disorder
- Presented with medical contraindication that prevented safe participation in physical activity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
|
The "Sit Less, Move More" program was implemented between February and May 2018, with a total duration of 16 weeks. The intervention was led by AG and delivered across three locations: the main Osonament center in Vic, the Estivill Camps center in Torelló, and the Mental Health Residential Home in Manlleu. Each participant received two weekly contacts: one face-to-face session and one telephone follow-up. During the face-to-face sessions, participants collaboratively selected walking routes and discussed strategies to increase daily activity at home. Educational materials and personal diaries were distributed to support self-monitoring and reflection. The telephone sessions served to reinforce behavioral agreements and encourage adherence to the weekly goals. Participants were grouped according to affinity and place of residence to facilitate autonomous group walks and improve accessibility and adherence. |
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Active Comparator: Comparator
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The intervention involve normal or standarized healthcare delivered in Osonament center
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity levels
Time Frame: From enrollment to the end of intervention at 12 weeks
|
Total physical activity levels will be measured though accelerometry using ActivPAL.
Total levels of physical activity (light or moderate-high) will be recorded in minutes
|
From enrollment to the end of intervention at 12 weeks
|
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Sedentary behaviour
Time Frame: From enrollment to the end of intervention at 12 weeks
|
Patterns of sedentary behvaiour will be measured though accelerometry using ActivPAL.
Patterns of sedentary behaviour will be recorded in minutes and bouts
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From enrollment to the end of intervention at 12 weeks
|
|
Self-perceived health
Time Frame: From enrollment to th end of intervention at 12 weeks
|
Self-perceived health was evaluated using a single-item visual analogue scale ranging from 0 to 100, where participants rated their general health status, with higher scores indicating better perceived health.
This measure was chosen for its simplicity and feasibility in populations with severe mental disorders.
|
From enrollment to th end of intervention at 12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMI25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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