Mental IllnessWORtHNCT04134871
Walking for Health: an Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in People With SMI
A study testing Group walk and one to one coaching in people with Mental Illness and Schizophrenia, run by University of Ulster at 3 sites in 2 countries.
Trial summary
People who have a severe mental illness can have poorer physical health and higher mortality rates than the general population. Their medications combined with low levels of physical activity and increased sedentary behaviour can general population and may help people with severe mental illness to be more active. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Illness, Schizophrenia, Bipolar Disorder
- What is being tested?
- Group walk and one to one coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 22 Aug 2019to 31 Dec 2022
- 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
- Inactive adults (Male or Female; aged ≥18 years)
- Diagnosis of any SMI (schizophrenia, psychosis, bipolar disorder and major depression).
Who cannot join
- Significant movement impairment
- Identified as 'Active' using the GPPAQ screening tool
- Unable to understand English or lack comprehension to understand the purpose of the study and given written informed consent.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: Walking for Health: The Feasibility of a Walking Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in People With Severe Mental Illness
People who have a severe mental illness can have poorer physical health and higher mortality rates than the general population. Their medications combined with low levels of physical activity and increased sedentary behaviour can general population and may help people with severe mental illness to be more active.
A previous feasibility study has been conducted in the UK in a large city with positive findings. The current study will be conducted in rural settings in Northern Ireland and Republic of Ireland. The intervention will last 13 weeks. People with Severe Mental Illness will be randomly assigned into one of two groups. Both groups will get information on the benefits of physical activity. In addition, one group will be shown how to use a step counter to measure their steps, be invited to a weekly group walk, and meet their coach every 2 weeks contribute to this. Walking is a good way to increase physical activity in the to see how they are getting on and to support them.
The research team are interested in finding out how willing clinicians are to recruit people into the study, how willing people are to take part, do people then stick with the programme, and if not the reasons for people dropping out. Qualitative findings will explore whether participants feel they benefited from and enjoyed the programme. Findings will be used to investigate the feasibility to conduct a larger trial like this in the future.
- Conditions
- Mental Illness, Schizophrenia, Bipolar Disorder, Major Depression, Psychosis
- Being tested
- Group walk and one to one coaching
- Medical subject headings
- Mental Disorders, Schizophrenia, Bipolar Disorder, Depressive Disorder, Major, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group walk and one to one coachingBehavioural
Participants will be invited to attend a group education session, weekly group walks and fortnightly coaching sessions
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants randomised to the intervention group will be invited to attend a group education session where they will be given a step counter and activity diary, they will be invited to weekly group walks and fortnightly coaching 1-1 sessions aimed at setting and reviewing goals to increase physical activity and reduce sedentary behaviour Receives: Behavioral: Group walk and one to one coaching |
| Control group | No intervention | Participants randomised to the control group will be given an information leaflet about being more active during a one-off 1-1 consultation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study recruitment rate
The number of participants recruited to the study in relation to the number of individuals screened along with reasons for exclusion.
Measured: Through study completion, approx. 18 months
Retention of study participants
The number of participants that complete the study intervention versus the number of dropouts will be analysed along with reasons for drop out.
Measured: Through study completion, approx. 18 months
Level of acceptability assessed by semi-structured interviews
Semi-structured interviews will involve gaining information on participants' level of overall satisfaction with the intervention
Measured: Data will be collected from participants at completion of the intervention, approx 3 months.
Secondary outcomes (3)
Change in activity levels
Participants' activity levels will be measured at baseline and end of intervention
Measured: Data will be collected at baseline and at completion of intervention, approx 3 months.
Change in body weight (kilograms)
Participants' body weight will be measured at baseline and end of intervention
Measured: Data will be collected at baseline and at completion of intervention, approx 3 months.
Change in waist circumference (cm)
Participants' waist circumference will be measured at baseline and end of intervention
Measured: Data will be collected at baseline and at completion of intervention, approx 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start22 Aug 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental IllnessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne M McDonough, PhD, Principal investigator, Ulster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134871
- Sponsor's protocol ID
- 17/0078
- Acronym
- WORtH
- Status last verified
- May 2023
- First submitted
- 6 Sep 2019
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McDonough SM, Dillon M, McDonough CM, McAuley J, Clarke M, Murphy C, Clarke M, McArdle D, Niven A, Williams J, Wilson I, Tully MA, Murphy MH, Howes SC. Randomised controlled feasibility trial of an intervention to increase activity and reduce sedentary behaviour in people with severe mental illness: Walking fOR Health (WORtH) study. BMJ Open. 2026 Jun 7;16(6):e107567. doi: 10.1136/bmjopen-2025-107567.
PubMed 42252141McDonough SM, Howes SC, Dillon M, McAuley J, Brady J, Clarke M, Clarke M, Lait E, McArdle D, O'Neill T, Wilson I, Niven A, Williams J, Tully MA, Murphy MH, McDonough CM. A study protocol for a randomised controlled feasibility trial of an intervention to increase activity and reduce sedentary behaviour in people with severe mental illness: Walking fOR Health (WORtH) Study. Pilot Feasibility Stud. 2021 Nov 15;7(1):205. doi: 10.1186/s40814-021-00938-5.
PubMed 34782018
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking for Health: The Feasibility of a Walking Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in People With Severe Mental Illness
- ClinicalTrials.gov ID
- NCT04134871
- Acronym / sponsor ID
- WORtH / 17/0078
- Conditions
- Mental Illness, Schizophrenia, Bipolar Disorder, Major Depression, Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Oct 2019 (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 who have a severe mental illness can have poorer physical health and higher mortality rates than the general population. Their medications combined with low levels of physical activity and increased sedentary behaviour can general population and may help people with severe mental illness to be more active.
A previous feasibility study has been conducted in the UK in a large city with positive findings. The current study will be conducted in rural settings in Northern Ireland and Republic of Ireland. The intervention will last 13 weeks. People with Severe Mental Illness will be randomly assigned into one of two groups. Both groups will get information on the benefits of physical activity. In addition, one group will be shown how to use a step counter to measure their steps, be invited to a weekly group walk, and meet their coach every 2 weeks contribute to this. Walking is a good way to increase physical activity in the to see how they are getting on and to support them.
The research team are interested in finding out how willing clinicians are to recruit people into the study, how willing people are to take part, do people then stick with the programme, and if not the reasons for people dropping out. Qualitative findings will explore whether participants feel they benefited from and enjoyed the programme. Findings will be used to investigate the feasibility to conduct a larger trial like this in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Group walk and one to one coachingParticipants randomised to the intervention group will be invited to attend a group education session where they will be given a step counter and activity diary, they will be invited to weekly group walks and fortnightly coaching 1-1 sessions aimed at setting and reviewing goals to increase physical activity and reduce sedentary behaviour |
| Control group | No intervention | –Participants randomised to the control group will be given an information leaflet about being more active during a one-off 1-1 consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inactive adults (Male or Female; aged ≥18 years)
- Diagnosis of any SMI (schizophrenia, psychosis, bipolar disorder and major depression).
Key exclusion criteria (3 listed)
- Significant movement impairment
- Identified as 'Active' using the GPPAQ screening tool
- Unable to understand English or lack comprehension to understand the purpose of the study and given written informed consent.
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 |
|---|---|---|
| Group walk and one to one coachingParticipants will be invited to attend a group education session, weekly group walks and fortnightly coaching sessions | Behavioural | Intervention group |
Primary outcome
Study recruitment rate
Time frame: Through study completion, approx. 18 months
The number of participants recruited to the study in relation to the number of individuals screened along with reasons for exclusion.
Retention of study participants
Time frame: Through study completion, approx. 18 months
The number of participants that complete the study intervention versus the number of dropouts will be analysed along with reasons for drop out.
Level of acceptability assessed by semi-structured interviews
Time frame: Data will be collected from participants at completion of the intervention, approx 3 months.
Semi-structured interviews will involve gaining information on participants' level of overall satisfaction with the intervention
3 secondary outcomes
Change in activity levels
Time frame: Data will be collected at baseline and at completion of intervention, approx 3 months.
Change in body weight (kilograms)
Time frame: Data will be collected at baseline and at completion of intervention, approx 3 months.
Change in waist circumference (cm)
Time frame: Data will be collected at baseline and at completion of intervention, approx 3 months.
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 11 May 2023.
- Derived from this study: PubMed 42252141McDonough SM, Dillon M, McDonough CM, McAuley J, Clarke M, Murphy C, Clarke M, McArdle D, Niven A, Williams J, Wilson I, Tully MA, Murphy MH, Howes SC. Randomised controlled feasibility trial of an intervention to increase activity and reduce sedentary behaviour in people with severe mental illness: Walking fOR Health (WORtH) study. BMJ Open. 2026 Jun 7;16(6):e107567. doi: 10.1136/bmjopen-2025-107567.
- Derived from this study: PubMed 34782018McDonough SM, Howes SC, Dillon M, McAuley J, Brady J, Clarke M, Clarke M, Lait E, McArdle D, O'Neill T, Wilson I, Niven A, Williams J, Tully MA, Murphy MH, McDonough CM. A study protocol for a randomised controlled feasibility trial of an intervention to increase activity and reduce sedentary behaviour in people with severe mental illness: Walking fOR Health (WORtH) Study. Pilot Feasibility Stud. 2021 Nov 15;7(1):205. doi: 10.1186/s40814-021-00938-5.
- Individual participant dataSharing planned: No
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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.
Suzanne M McDonough, PhD principal investigator
Ulster University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group walk and one to one coaching in people with Mental Illness and Schizophrenia, run by University of Ulster at 3 sites in 2 countries.
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 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Ireland. 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?
Study recruitment rate (time frame: Through study completion, approx. 18 months). 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?
On the ClinicalTrials.gov record for NCT04134871, which also lists 2 linked publications.
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 11 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.