Can an Action-based Help-sheet Help People to Move More and Sit Less.
NCT ID: NCT04280250
Last Updated: 2020-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
32 participants
INTERVENTIONAL
2020-03-31
2021-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Group 1
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.
Control condition
Psychoeducational self-help sheet
Group 2
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.
Volitional Help-Sheet
Self-help sheet in order to form implementation intentions
Interventions
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Volitional Help-Sheet
Self-help sheet in order to form implementation intentions
Control condition
Psychoeducational self-help sheet
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* English language not sufficient to be able to meet the requirements of the study
* Does not meet other criteria for inclusion
18 Years
ALL
No
Sponsors
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University of Manchester
OTHER
Responsible Party
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Stephanie Roebuck
Trainee Clinical Psychologist
Principal Investigators
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Stephanie Roebuck
Role: PRINCIPAL_INVESTIGATOR
University of Manchester
Central Contacts
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Chris Armitage
Role: CONTACT
Other Identifiers
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NHS00164
Identifier Type: -
Identifier Source: org_study_id
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