Exploration of Sedentary Behaviour Among General Practitioners: A Mixed Methods Study

September 12, 2022 updated by: NeilHeron, Queen's University, Belfast
A sequential, mixed-methods study exploring sedentary behaviour among General Practitioners and General Practice Specialty Trainees.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Belfast, United Kingdom, BT9 7BL
        • Queen's University Belfast School of Medicine, Dentistry and Biomedical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

23 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

Participants will be General Practitioners or General Practice Specialty Trainees working in Northern Ireland, United Kingdom.

Exclusion Criteria:

Not working as a General Practitioner or General Practice Specialty Trainee in Northern Ireland, United Kingdom.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Questionnaire survey
Online questionnaire, based on the International Sedentary Assessment Tool (ISAT)
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.
Other: Questionnaire survey
Online questionnaire, based on the International Sedentary Assessment Tool (ISAT)
Device: Accelerometer study
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 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.
Other: Questionnaire survey
Online questionnaire, based on the International Sedentary Assessment Tool (ISAT)
Device: Accelerometer study
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.
Other: Semi-structured interview study
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Self-reported sedentary behaviour
Time Frame: Autumn 2020
Autumn 2020
Accelerometer measured sedentary behaviour
Time Frame: Autumn 2021
Autumn 2021
Thematic analysis of semi-structured interviews
Time Frame: Autumn 2021
Autumn 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Queen's University, Belfast

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Ulster
University of Southern Denmark
Loughborough University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Neil Heron, Centre for Public Health, Queen's University Belfast

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MHLS 20_39 - Amendment 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sharing of study protocol to optimise openness and integrity of research.

IPD Sharing Time Frame

Study protocol will be made available on commencement of the study and will be available for the duration of the study.

IPD Sharing Access Criteria

Study protocol will be submitted for open access journal publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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