Sever Mental IllnesNCT07374159
Sit Less, Move More Program as an Integrated Service at Osonament
A study testing Sit less and move more and Actual care in people with Sever Mental Illnes, run by Fundació Universitària del Bages at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sever Mental Illnes
- What is being tested?
- Sit less and move more and Actual care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSpain
- Study dates
- 7 Feb 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Sever Mental Illnes
- Being tested
- Sit less and move more, Actual care
- Keywords
- sever mental illness, physical activity, sedentary behaviour
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sit less and move moreBehavioural
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.
Actual careOther
The intervention involve normal or standarized healthcare delivered in Osonament center
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Sit less and move more |
| Comparator | Active comparator | Not described Receives: Other: Actual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity levels
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
Measured: From enrollment to the end of intervention at 12 weeks
Sedentary behaviour
Patterns of sedentary behvaiour will be measured though accelerometry using ActivPAL. Patterns of sedentary behaviour will be recorded in minutes and bouts
Measured: From enrollment to the end of intervention at 12 weeks
Self-perceived health
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.
Measured: From enrollment to th end of intervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start7 Feb 2018
- Primary completion15 Feb 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sever Mental IllnesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Universitària del Bages
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374159
- Sponsor's protocol ID
- SMI25
- Status last verified
- Jan 2026
- First submitted
- 5 Dec 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Mental Disorders, Chronicity and Sedentary Behaviour: Usability and Effectiveness of the "Sit Less, Move More" Program as an Integrated Service at Osonament
- ClinicalTrials.gov ID
- NCT07374159
- Acronym / sponsor ID
- SMI25
- Conditions
- Sever Mental Illnes
- Keywords
- sever mental illness, physical activity, sedentary behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Fundació Universitària del BagesUniversity, hospital or other
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Sit less and move more |
| Comparator | Active comparator | Other: Actual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sit less and move moreThe "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. | Behavioural | Intervention |
| Actual careThe intervention involve normal or standarized healthcare delivered in Osonament center | Other | Comparator |
Primary outcome
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sit less and move more and Actual care in people with Sever Mental Illnes, run by Fundació Universitària del Bages at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity levels (time frame: From enrollment to the end of intervention at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.