Sedentary BehaviorNCT04280250
Can an Action-based Help-sheet Help People to Move More and Sit Less.
A study testing Volitional Help-Sheet in people with Sedentary Behavior, run by University of Manchester.
Trial summary
Implementation intentions support people to turn intentions into action, and "Volitional Help-Sheets" are a tool which helps people to form implementation intentions. The study will recruit participants from secondary and tertiary mental health services. The participants will be randomised to one of two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- Volitional Help-Sheet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Jun 2021
- 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
- 18+ years old
- Motivated to decrease sedentary behaviour (demonstrated by choosing to make contact with the researcher to indicate an interest in participation in the study
- Has capacity to consent to study
- Currently receiving support from any secondary or tertiary care mental health service
- English language ability sufficient to be able to meet the requirements of the study
- Participants will not be recruited on the basis of an assumption that they are sedentary, and participants must demonstrate a desire to increase their sedentary behaviour as indicated by choosing to make contact with the researcher to indicate an interest in participation in the study.
Who cannot join
- Cannot give informed consent
- English language not sufficient to be able to meet the requirements of the study
- Does not meet other criteria for inclusion
Trial locations and contacts
No sites are listed yet.
Chris Armitage contact
About this study
Official title: Can Implementation Intentions Help People Who Are Supported by Secondary and Tertiary Care Mental Health Services to be Less Sedentary and More Physically Active: A Feasibility and Acceptability Study.
Implementation intentions support people to turn intentions into action, and "Volitional Help-Sheets" are a tool which helps people to form implementation intentions. The study will recruit participants from secondary and tertiary mental health services. The participants will be randomised to one of two groups. Participants in Group 1, the control group, will receive the Volitional Help-Sheet (psychoeducational self-help sheet) but not form implementation intentions. Participants in Group 2, the experimental condition, will use the Volitional Help-Sheet to form implementation intentions. Participants will then complete an acceptability and feasibility measure. At follow up, participants will repeat baseline measures. The feasibility and acceptability of using a Volitional Help-Sheet to form implementation intentions to help people using secondary and tertiary care mental health services to reduce sedentary behaviour will be evaluated.
Read the detailed description
Introduction: Sedentary behaviour is risk factor for developing many health conditions. People with mental health difficulties can be more sedentary and live 10 years fewer than other populations. Implementation intentions support people to turn intentions into action, and Volitional Help-Sheets are a tool which helps people to form implementation intentions, by identifying critical situations and linking these to potential solutions. The feasibility and acceptability of using a Volitional Help-Sheet to help people using secondary and tertiary care mental health services to reduce sedentary behaviour will be evaluated. If Volitional Help-Sheets are feasible and acceptable to use in this population, this will justify further research in this area, as improving physical and psychological health could increase life expectancy.
Design: The study includes two timepoints: baseline and follow up (four weeks post baseline). Participant characteristics/demographics collected at baseline. At both baseline and follow up, all participants will be asked to complete measures of sedentary behaviour, physical activity, well-being, motivation and mental health. Participants will be randomised to one of two groups. Participants in Group 1, the control group, will receive the Volitional Help-Sheet as a psychoeducational self-help sheet, but not form implementation intentions. Participants in Group 2, the experimental condition, will use the Volitional Help-Sheet to form implementation intentions. Participants will then complete an acceptability and feasibility measure. At follow up, participants will repeat baseline measures.
Sample size: Participants will be current service users, recruited from NHS based secondary and tertiary care mental health services. The recruitment of a minimum of 24 participants and a maximum of 32 participants would be considered a feasible two-armed study.
Recruitment: Adults: 18years+, motivated to decrease sedentary behaviour (demonstrated by choosing to make contact with the researcher to indicate an interest in participation in the study), has capacity to consent to study, currently receiving support from any secondary or tertiary care mental health service and English language ability sufficient to be able to meet the requirements of the study.
Procedure: Recruitment posters will be displayed in clinical areas as part of recruitment. Care teams can advise interested participants on how to contact the researcher and support this if required. Participant information sheets will be disseminated to interested parties. Where a service user has informed the researcher of their interest in participating in the study, they will be offered a detailed participant information sheet and consent to contact forms outlining the study, the expected benefits and commitment required, and informed consent forms. Interested participants will be assessed for capacity to consent and eligibility and will begin the randomisation procedure upon booking the baseline assessment appointment. All members of the research team have experience of obtaining informed consent in research and clinical roles.
Participants will be block randomised (sampling without replacement) in blocks of four and stratified according to clinical service using an online program, into either a control group (group 1) or an experimental arm (group 2). Participants in Group 1 (control arm) will receive a Volitional Help-Sheet with an instruction to tick all situations in which they are tempted not to be active, and tick all solutions to overcome these. Participants in Group 2 (experimental arm) will use the Volitional Help-Sheet to form implementation intentions by linking situations in which they are tempted not to be physically active, with solutions to overcome these. Researchers will be unblinded, however the participants and those external to the research team where involved will remain blind to the group allocated.
Outcomes and analysis: The main study hypothesis is that forming implementation intentions using the Volitional Help-Sheet will be considered acceptable to the participants involved in the study, and that forming implementation intentions using the Volitional Help-Sheet will be considered feasible to use within a diverse range of NHS settings. An exploratory hypothesis is also that the increase in activity will be significantly greater in the treatment group than the control group. Quantitative analysis will be used to evaluate the feasibility and acceptability of using a Volitional Help-Sheet to help people using secondary and tertiary care mental health services to form implementation intentions, with the aim of a reduction in sedentary behaviour.
- Conditions
- Sedentary Behavior
- Being tested
- Volitional Help-Sheet, Control condition
- Keywords
- Implementation Intention, If-Then plan, Tertiary mental health services, Secondary mental health services
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volitional Help-SheetOther
Self-help sheet in order to form implementation intentions
Control conditionOther
Psychoeducational self-help sheet
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Active control arm: Volitional help-sheet with instruction: We want you to plan to increase your level of physical activity. Research shows that if people can identify situations in which they are likely to be tempted not to be physically active and ways to overcome temptation they are much more likely to be successful in their intention to increase their level of physical activity. On the left hand side of the page are a series of common situations in which people feel tempted not to be physically active; please tick all those that apply to you personally. On the right hand side of the page are a series of possible solutions; please tick all those that apply to you personally. Tick as many or as few situations and solutions as you like. Receives: Other: Control condition |
| Group 2 | Experimental | Experimental arm: Volitional help-sheet with instruction:
We want you to plan to increase your level of physical activity. Research shows that if people link being tempted not to be physically active with a way to overcome that temptation, they are much more likely to be successful in their intention to increase their level of physical activity. On the left hand side of the page below is the temptation not to be physically active; on the right hand side of the page are a series of possible solutions. Please draw lines linking being tempted not to be physically active (left hand side) to solutions (right hand side) that you think might work for you personally. Please make as many situation-solution links as you like. Receives: Other: Volitional Help-Sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention Measure (AIM). (Weiner et al, 2017)
Self reported acceptability measure
Measured: Change from Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)
Feasibility of Intervention Measure (FIM). (Weiner et al, 2017)
Self reported feasibility measure
Measured: Change from Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)
Intervention Appropriateness Measure (IAM). (Weiner et al, 2017)
Self reported appropriateness measure
Measured: Change from Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)
Secondary outcomes (5)
International Physical Activity Questionnaire short form (Booth, 2000)
Self reported physical activity measure
Measured: Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)
Sedentary Behaviour Questionnaire (Gardener et al, 2011)
Self reported sedentary behaviour measure
Measured: Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)
CORE-OM (Evans et al, 2000)
Self reported symptom measure
Measured: Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)
Office for National Statistics' Measure of Subjective Wellbeing (Dolan, Layard, and Metcalfe, 2011).
Self reported wellbeing measure
Measured: Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)
COM-B measures (Keyworth, Epton, Goldthorpe, Calam, and Armitage, 2019)
Self reported motivation measure
Measured: Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study startMar 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Roebuck, University of Manchester
- Investigators
- Stephanie Roebuck, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280250
- Sponsor's protocol ID
- NHS00164
- Status last verified
- Feb 2020
- First submitted
- 31 Jan 2020
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Implementation Intentions Help People Who Are Supported by Secondary and Tertiary Care Mental Health Services to be Less Sedentary and More Physically Active: A Feasibility and Acceptability Study.
- ClinicalTrials.gov ID
- NCT04280250
- Acronym / sponsor ID
- NHS00164
- Conditions
- Sedentary Behavior
- Keywords
- Implementation Intention, If-Then plan, Tertiary mental health services, Secondary mental health services
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 21 Feb 2020 (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.
Implementation intentions support people to turn intentions into action, and "Volitional Help-Sheets" are a tool which helps people to form implementation intentions. The study will recruit participants from secondary and tertiary mental health services. The participants will be randomised to one of two groups. Participants in Group 1, the control group, will receive the Volitional Help-Sheet (psychoeducational self-help sheet) but not form implementation intentions. Participants in Group 2, the experimental condition, will use the Volitional Help-Sheet to form implementation intentions. Participants will then complete an acceptability and feasibility measure. At follow up, participants will repeat baseline measures. The feasibility and acceptability of using a Volitional Help-Sheet to form implementation intentions to help people using secondary and tertiary care mental health services to reduce sedentary behaviour will be evaluated.
Detailed description
Introduction: Sedentary behaviour is risk factor for developing many health conditions. People with mental health difficulties can be more sedentary and live 10 years fewer than other populations. Implementation intentions support people to turn intentions into action, and Volitional Help-Sheets are a tool which helps people to form implementation intentions, by identifying critical situations and linking these to potential solutions. The feasibility and acceptability of using a Volitional Help-Sheet to help people using secondary and tertiary care mental health services to reduce sedentary behaviour will be evaluated. If Volitional Help-Sheets are feasible and acceptable to use in this population, this will justify further research in this area, as improving physical and psychological health could increase life expectancy.
Design: The study includes two timepoints: baseline and follow up (four weeks post baseline). Participant characteristics/demographics collected at baseline. At both baseline and follow up, all participants will be asked to complete measures of sedentary behaviour, physical activity, well-being, motivation and mental health. Participants will be randomised to one of two groups. Participants in Group 1, the control group, will receive the Volitional Help-Sheet as a psychoeducational self-help sheet, but not form implementation intentions. Participants in Group 2, the experimental condition, will use the Volitional Help-Sheet to form implementation intentions. Participants will then complete an acceptability and feasibility measure. At follow up, participants will repeat baseline measures.
Sample size: Participants will be current service users, recruited from NHS based secondary and tertiary care mental health services. The recruitment of a minimum of 24 participants and a maximum of 32 participants would be considered a feasible two-armed study.
Recruitment: Adults: 18years+, motivated to decrease sedentary behaviour (demonstrated by choosing to make contact with the researcher to indicate an interest in participation in the study), has capacity to consent to study, currently receiving support from any secondary or tertiary care mental health service and English language ability sufficient to be able to meet the requirements of the study.
Procedure: Recruitment posters will be displayed in clinical areas as part of recruitment. Care teams can advise interested participants on how to contact the researcher and support this if required. Participant information sheets will be disseminated to interested parties. Where a service user has informed the researcher of their interest in participating in the study, they will be offered a detailed participant information sheet and consent to contact forms outlining the study, the expected benefits and commitment required, and informed consent forms. Interested participants will be assessed for capacity to consent and eligibility and will begin the randomisation procedure upon booking the baseline assessment appointment. All members of the research team have experience of obtaining informed consent in research and clinical roles.
Participants will be block randomised (sampling without replacement) in blocks of four and stratified according to clinical service using an online program, into either a control group (group 1) or an experimental arm (group 2). Participants in Group 1 (control arm) will receive a Volitional Help-Sheet with an instruction to tick all situations in which they are tempted not to be active, and tick all solutions to overcome these. Participants in Group 2 (experimental arm) will use the Volitional Help-Sheet to form implementation intentions by linking situations in which they are tempted not to be physically active, with solutions to overcome these. Researchers will be unblinded, however the participants and those external to the research team where involved will remain blind to the group allocated.
Outcomes and analysis: The main study hypothesis is that forming implementation intentions using the Volitional Help-Sheet will be considered acceptable to the participants involved in the study, and that forming implementation intentions using the Volitional Help-Sheet will be considered feasible to use within a diverse range of NHS settings. An exploratory hypothesis is also that the increase in activity will be significantly greater in the treatment group than the control group. Quantitative analysis will be used to evaluate the feasibility and acceptability of using a Volitional Help-Sheet to help people using secondary and tertiary care mental health services to form implementation intentions, with the aim of a reduction in sedentary behaviour.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Control conditionActive control arm: Volitional help-sheet with instruction: We want you to plan to increase your level of physical activity. Research shows that if people can identify situations in which they are likely to be tempted not to be physically active and ways to overcome temptation they are much more likely to be successful in their intention to increase their level of physical activity. On the left hand side of the page are a series of common situations in which people feel tempted not to be physically active; please tick all those that apply to you personally. On the right hand side of the page are a series of possible solutions; please tick all those that apply to you personally. Tick as many or as few situations and solutions as you like. |
| Group 2 | Experimental | Other: Volitional Help-SheetExperimental arm: Volitional help-sheet with instruction: We want you to plan to increase your level of physical activity. Research shows that if people link being tempted not to be physically active with a way to overcome that temptation, they are much more likely to be successful in their intention to increase their level of physical activity. On the left hand side of the page below is the temptation not to be physically active; on the right hand side of the page are a series of possible solutions. Please draw lines linking being tempted not to be physically active (left hand side) to solutions (right hand side) that you think might work for you personally. Please make as many situation-solution links as you like. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18+ years old
- Motivated to decrease sedentary behaviour (demonstrated by choosing to make contact with the researcher to indicate an interest in participation in the study
- Has capacity to consent to study
- Currently receiving support from any secondary or tertiary care mental health service
- English language ability sufficient to be able to meet the requirements of the study
Key exclusion criteria (3 listed)
- Cannot give informed consent
- English language not sufficient to be able to meet the requirements of the study
- Does not meet other criteria for inclusion
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 |
|---|---|---|
| Volitional Help-SheetSelf-help sheet in order to form implementation intentions | Other | Group 2 |
| Control conditionPsychoeducational self-help sheet | Other | Group 1 |
Primary outcome
Acceptability of Intervention Measure (AIM). (Weiner et al, 2017)
Time frame: Change from Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)
Self reported acceptability measure
Feasibility of Intervention Measure (FIM). (Weiner et al, 2017)
Time frame: Change from Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)
Self reported feasibility measure
Intervention Appropriateness Measure (IAM). (Weiner et al, 2017)
Time frame: Change from Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)
Self reported appropriateness measure
5 secondary outcomes
International Physical Activity Questionnaire short form (Booth, 2000)
Time frame: Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)
Sedentary Behaviour Questionnaire (Gardener et al, 2011)
Time frame: Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)
CORE-OM (Evans et al, 2000)
Time frame: Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)
Office for National Statistics' Measure of Subjective Wellbeing (Dolan, Layard, and Metcalfe, 2011).
Time frame: Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)
COM-B measures (Keyworth, Epton, Goldthorpe, Calam, and Armitage, 2019)
Time frame: Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Wearable Ankle Power Training (WearAPT) for Enhanced Mobility in Aging
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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.
Chris Armitage contact
Stephanie Roebuck principal investigator
University of Manchester
Questions about this trial
What is this clinical trial studying?
A study testing Volitional Help-Sheet in people with Sedentary Behavior, run by University of Manchester.
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 6 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: status not confirmed, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Roebuck (01613060400, stephanie.roebuck@postgrad.manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (AIM). (Weiner et al, 2017) (time frame: Change from Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)). 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 21 Feb 2020.