Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2026-01-01 @ 9:26 AM
Study NCT ID:
NCT04556695
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2020-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploration of Sedentary Behaviour Among General Practitioners: A Mixed Methods Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-12', 'studyFirstSubmitDate': '2020-09-14', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported sedentary behaviour', 'timeFrame': 'Autumn 2020'}, {'measure': 'Accelerometer measured sedentary behaviour', 'timeFrame': 'Autumn 2021'}, {'measure': 'Thematic analysis of semi-structured interviews', 'timeFrame': 'Autumn 2021'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['General Practitioner', 'Primary Care', 'Sedentary Behaviour', 'Physical Activity'], 'conditions': ['Sedentary Behavior']}, 'descriptionModule': {'briefSummary': 'A sequential, mixed-methods study exploring sedentary behaviour among General Practitioners and General Practice Specialty Trainees.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '23 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants will be General Practitioners or General Practice Specialty Trainees working in Northern Ireland, United Kingdom.\n\nExclusion Criteria:\n\nNot working as a General Practitioner or General Practice Specialty Trainee in Northern Ireland, United Kingdom.'}, 'identificationModule': {'nctId': 'NCT04556695', 'briefTitle': 'Exploration of Sedentary Behaviour Among General Practitioners: A Mixed Methods Study', 'organization': {'class': 'OTHER', 'fullName': "Queen's University, Belfast"}, 'officialTitle': 'Exploration of Sedentary Behaviour Among General Practitioners: A Mixed Methods Study', 'orgStudyIdInfo': {'id': 'MHLS 20_39 - Amendment 1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Questionnaire survey', 'description': '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.', 'interventionNames': ['Other: Questionnaire survey']}, {'label': 'Accelerometer study', 'description': '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.', 'interventionNames': ['Other: Questionnaire survey', 'Device: Accelerometer study']}, {'label': 'Semi-structured interview study', 'description': '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.', 'interventionNames': ['Other: Questionnaire survey', 'Device: Accelerometer study', 'Other: Semi-structured interview study']}], 'interventions': [{'name': 'Questionnaire survey', 'type': 'OTHER', 'description': 'Online questionnaire, based on the International Sedentary Assessment Tool (ISAT)', 'armGroupLabels': ['Accelerometer study', 'Questionnaire survey', 'Semi-structured interview study']}, {'name': 'Accelerometer study', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Accelerometer study', 'Semi-structured interview study']}, {'name': 'Semi-structured interview study', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Semi-structured interview study']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT9 7BL', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': "Queen's University Belfast School of Medicine, Dentistry and Biomedical Sciences", 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'overallOfficials': [{'name': 'Neil Heron', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre for Public Health, Queen's University Belfast"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Study protocol will be made available on commencement of the study and will be available for the duration of the study.', 'ipdSharing': 'YES', 'description': 'Sharing of study protocol to optimise openness and integrity of research.', 'accessCriteria': 'Study protocol will be submitted for open access journal publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University, Belfast", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Ulster', 'class': 'OTHER'}, {'name': 'University of Southern Denmark', 'class': 'OTHER'}, {'name': 'Loughborough University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Lecturer in GP', 'investigatorFullName': 'NeilHeron', 'investigatorAffiliation': "Queen's University, Belfast"}}}}