Sedentary BehaviorNCT04556695
Exploration of Sedentary Behaviour Among General Practitioners: A Mixed Methods Study
An observational study of Sedentary Behavior, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
A sequential, mixed-methods study exploring sedentary behaviour among General Practitioners and General Practice Specialty Trainees. Read more about this study
- Who is it for?
- Ages 23 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- Questionnaire survey, Accelerometer study and Semi-structured interview study
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Sep 2020to 1 Oct 2021
- Phase
- Observational
- 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 23 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General Practice Specialty Trainees (GPSTs) and General Practitioners (GPs) throughout Northern Ireland. GPs and GPSTs in Northern Ireland provide care for patients as part of the UK NHS, with working conditions similar to GPs and GPSTs throughout the rest of the UK.
Who may be able to join
- Participants will be General Practitioners or General Practice Specialty Trainees working in Northern Ireland, United Kingdom.
Who cannot join
- Not working as a General Practitioner or General Practice Specialty Trainee in Northern Ireland, United Kingdom.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen's University Belfast School of Medicine, Dentistry and Biomedical Sciences
Belfast, BT9 7BL
About this study
A sequential, mixed-methods study exploring sedentary behaviour among General Practitioners and General Practice Specialty Trainees.
Read the detailed description
The study follows a sequential, mixed-methods model involving three stages. The first stage will involve the dissemination of a questionnaire survey, in which participants will self-estimate their sedentary behaviour on a working day and on a non-working day. The second stage will involve the use of thigh-worn accelerometers and a sleep/work log to obtain objective data regarding sedentary behaviour among a purposive subset of participants who responded to the questionnaire. The third stage will involve semi-structured interviews with a purposive subset of participants who wore the accelerometers, which will be analysed with the application of a theoretical framework regarding the acceptability of healthcare interventions.
- Conditions
- Sedentary Behavior
- Being tested
- Questionnaire survey, Accelerometer study, Semi-structured interview study
- Keywords
- General Practitioner, Primary Care, Sedentary Behaviour, Physical Activity
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire surveyOther
Online questionnaire, based on the International Sedentary Assessment Tool (ISAT)
Accelerometer studyDevice
Consenting participants will be asked to wear an accelerometer on the lateral aspect of the middle of the right thigh (over the midpoint of the iliotibial band), continuously over a seven-day period.
Semi-structured interview studyOther
Semi-structured interviews will take place via telephone or webcam. Participants will be given feedback regarding their accelerometer data relating to their levels of physical activity and sedentary behaviour. Questions will examine participants' thoughts and opinions regarding sedentary behaviour and physical activity in the General Practice setting. Further questions will explore participants' experiences of wearing accelerometers, their knowledge of and attitudes towards physical activity and sedentary behaviour and their thoughts or suggestions on interventions to reduce sedentary behaviour among GPs and GPSTs.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire survey | An initial online questionnaire, based on the International Sedentary Assessment Tool (ISAT), will be distributed to General Practice Specialty Trainees (GPSTs) and General Practitioners (GPs) throughout Northern Ireland. Receives: Other: Questionnaire survey | |
| Accelerometer study | A purposive sample of questionnaire respondents will be asked to participate in the accelerometer study. This purposive sample will be based on responses to the online questionnaire. The aim will be to obtain a varied sample, based on questionnaire responses, by selecting individuals with a range of demographic characteristics and self-reported levels of sedentary behaviour. Some participants will also be asked to complete a further online survey, while wearing the accelerometer, regarding their health, wellbeing, burnout and fatigue. Receives: Other: Questionnaire survey; Device: Accelerometer study | |
| Semi-structured interview study | A purposive sample comprising participants of the accelerometer study will be asked to participate in semi-structured interviews. This purposive sample will be based on the accelerometer data. The aim will be to obtain a varied sample, based on accelerometer data, by selecting individuals with a range of different levels of sedentary behaviour, demographic and workplace characteristics. The final number of participants will depend on the saturation of information. Receives: Other: Questionnaire survey; Device: Accelerometer study; Other: Semi-structured interview study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported sedentary behaviour
Measured: Autumn 2020
Accelerometer measured sedentary behaviour
Measured: Autumn 2021
Thematic analysis of semi-structured interviews
Measured: Autumn 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start2 Sep 2020
- Primary completion1 Jan 2021
- Study completion1 Oct 2021
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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulster, University of Southern Denmark, Loughborough University
- Responsible party
- Principal investigator, NeilHeron, Queen's University, Belfast
- Investigators
- Neil Heron, Principal investigator, Centre for Public Health, Queen's University Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556695
- Sponsor's protocol ID
- MHLS 20_39 - Amendment 1
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2020
- Last updated
- 13 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of study protocol to optimise openness and integrity of research.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Sedentary Behaviour Among General Practitioners: A Mixed Methods Study
- ClinicalTrials.gov ID
- NCT04556695
- Acronym / sponsor ID
- MHLS 20_39 - Amendment 1
- Conditions
- Sedentary Behavior
- Keywords
- General Practitioner, Primary Care, Sedentary Behaviour, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- University of Ulster, University of Southern Denmark, Loughborough University
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 21 Sep 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.
A sequential, mixed-methods study exploring sedentary behaviour among General Practitioners and General Practice Specialty Trainees.
Detailed description
The study follows a sequential, mixed-methods model involving three stages. The first stage will involve the dissemination of a questionnaire survey, in which participants will self-estimate their sedentary behaviour on a working day and on a non-working day. The second stage will involve the use of thigh-worn accelerometers and a sleep/work log to obtain objective data regarding sedentary behaviour among a purposive subset of participants who responded to the questionnaire. The third stage will involve semi-structured interviews with a purposive subset of participants who wore the accelerometers, which will be analysed with the application of a theoretical framework regarding the acceptability of healthcare interventions.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Questionnaire survey | – | Other: Questionnaire surveyAn initial online questionnaire, based on the International Sedentary Assessment Tool (ISAT), will be distributed to General Practice Specialty Trainees (GPSTs) and General Practitioners (GPs) throughout Northern Ireland. |
| Accelerometer study | – | Other: Questionnaire survey, Device: Accelerometer studyA purposive sample of questionnaire respondents will be asked to participate in the accelerometer study. This purposive sample will be based on responses to the online questionnaire. The aim will be to obtain a varied sample, based on questionnaire responses, by selecting individuals with a range of demographic characteristics and self-reported levels of sedentary behaviour. Some participants will also be asked to complete a further online survey, while wearing the accelerometer, regarding their health, wellbeing, burnout and fatigue. |
| Semi-structured interview study | – | Other: Questionnaire survey, Device: Accelerometer study, Other: Semi-structured interview studyA purposive sample comprising participants of the accelerometer study will be asked to participate in semi-structured interviews. This purposive sample will be based on the accelerometer data. The aim will be to obtain a varied sample, based on accelerometer data, by selecting individuals with a range of different levels of sedentary behaviour, demographic and workplace characteristics. The final number of participants will depend on the saturation of information. |
Who may qualify
- Ages
- 23 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General Practice Specialty Trainees (GPSTs) and General Practitioners (GPs) throughout Northern Ireland. GPs and GPSTs in Northern Ireland provide care for patients as part of the UK NHS, with working conditions similar to GPs and GPSTs throughout the rest of the UK.
Key inclusion criteria (1 listed)
- Participants will be General Practitioners or General Practice Specialty Trainees working in Northern Ireland, United Kingdom.
Key exclusion criteria (1 listed)
- Not working as a General Practitioner or General Practice Specialty Trainee in Northern Ireland, United Kingdom.
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 |
|---|---|---|
| Questionnaire surveyOnline questionnaire, based on the International Sedentary Assessment Tool (ISAT) | Other | Accelerometer study, Questionnaire survey, Semi-structured interview study |
| Accelerometer studyConsenting participants will be asked to wear an accelerometer on the lateral aspect of the middle of the right thigh (over the midpoint of the iliotibial band), continuously over a seven-day period. | Device | Accelerometer study, Semi-structured interview study |
| Semi-structured interview studySemi-structured interviews will take place via telephone or webcam. Participants will be given feedback regarding their accelerometer data relating to their levels of physical activity and sedentary behaviour. Questions will examine participants' thoughts and opinions regarding sedentary behaviour and physical activity in the General Practice setting. Further questions will explore participants' experiences of wearing accelerometers, their knowledge of and attitudes towards physical activity and sedentary behaviour and their thoughts or suggestions on interventions to reduce sedentary behaviour among GPs and GPSTs. | Other | Semi-structured interview study |
Primary outcome
Self-reported sedentary behaviour
Time frame: Autumn 2020
Accelerometer measured sedentary behaviour
Time frame: Autumn 2021
Thematic analysis of semi-structured interviews
Time frame: Autumn 2021
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 13 Sep 2022.
- Individual participant dataSharing planned: Yes. Sharing of study protocol to optimise openness and integrity of research.
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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.
Neil Heron principal investigator
Centre for Public Health, Queen's University Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedentary Behavior, run by Queen's University, Belfast at 1 site in United Kingdom.
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 1 inclusion and 1 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 13 Sep 2022. 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 United Kingdom. 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?
Self-reported sedentary behaviour (time frame: Autumn 2020). 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 13 Sep 2022.