Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 4:29 AM
Study NCT ID:
NCT04296669
Status:
COMPLETED
Last Update Posted:
2020-03-05
First Post:
2020-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stand Out in Class: Reducing Sitting Time in the Classroom Environment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D002652', 'term': 'Child Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Controlled trial (2 intervention groups)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2016-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-03', 'studyFirstSubmitDate': '2020-02-24', 'studyFirstSubmitQcDate': '2020-03-03', 'lastUpdatePostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Standing class fidelity', 'timeFrame': '30 minutes at 4 months', 'description': 'sitting and standing behaviour recorded via direct observation by researcher'}, {'measure': 'Experiences of using standing desks', 'timeFrame': '30 mins at 4 months', 'description': 'focus groups with pupils exploring barriers and facilitators to sitting, standing and learning in the classroom'}, {'measure': 'Experiences of teaching with standing desks', 'timeFrame': '60 mins at 4 months', 'description': 'Interviews with teachers exploring barriers and facilitators to sitting, standing and teaching in the classroom'}], 'primaryOutcomes': [{'measure': 'Sitting time (mins)', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in time spent sitting using activPAL inclinometer device'}], 'secondaryOutcomes': [{'measure': 'Standing time (mins)', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in time spent standing using activPAL inclinometer device'}, {'measure': 'Stepping time (mins)', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in time spent stepping using activPAL inclinometer device'}, {'measure': 'Steps', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in Steps using activPAL inclinometer device'}, {'measure': 'Sit to stand transitions', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in Sit to stand transitions using activPAL inclinometer device'}, {'measure': 'Total acceleration per minute', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in Counts per minute using ActiGraph accelerometer device'}, {'measure': 'Light physical activity (mins)', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in Time spent in Light physical activity (mins) using ActiGraph accelerometer device'}, {'measure': 'Moderate physical activity (mins)', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in Time spent in Moderate physical activity using ActiGraph accelerometer device'}, {'measure': 'Vigorous physical activity (mins)', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in Time spent in vigorous physical activity using ActiGraph accelerometer device'}, {'measure': 'Resting Systolic blood pressure (mmHg)', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in Resting systolic blood pressure using automated Omron device'}, {'measure': 'Resting diastolic blood pressure (mmHg)', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in Resting diastolic blood pressure using automated Omron device'}, {'measure': 'Height (m)', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in height measured with portable Stadiometer'}, {'measure': 'Weight (kg)', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in weight measured with electronic weighing scales'}, {'measure': 'Body Mass index (kg/m2)', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in BMI calculated from height and weight measures'}, {'measure': 'waist circumference (cm)', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in waist circumference measured using anthropometry tape'}, {'measure': 'Stroop test', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in Computer based cognitive function test lasting 5 mins'}, {'measure': 'Corsi block tapping test', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in Computer based cognitive function test lasting 5 mins'}, {'measure': 'Rapid visual information processing test', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in Computer based cognitive function test lasting 5 mins'}, {'measure': 'musculoskeletal discomfort', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in discomfort using a self-report paper-based survey of 7 body parts. scale of 1-5, 1 is good, 5 is bad'}, {'measure': 'Behaviour related mental health', 'timeFrame': '7 days at baseline, 4 months, 8 months', 'description': 'Change in behaviour measured with a teacher completed 25 item Strengths and Difficulties questionnaire. each item is scored either "not true", "somewhat true" or "certainly true"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sedentary Behavior', 'Child Behavior', 'Physical Activity', 'Obesity', 'Health Behavior']}, 'referencesModule': {'references': [{'pmid': '30346570', 'type': 'BACKGROUND', 'citation': 'Sherry AP, Pearson N, Ridgers ND, Barber SE, Bingham DD, Nagy LC, Clemes SA. activPAL-measured sitting levels and patterns in 9-10 years old children from a UK city. J Public Health (Oxf). 2019 Dec 20;41(4):757-764. doi: 10.1093/pubmed/fdy181.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to examine the effectiveness of incorporating manually adjustable sit-stand desks in the classroom environment of 9-10 year olds in reducing sedentary behaviour at school during a full school year. Secondary aims include evaluating the effects of the intervention on health and learning outcomes as well as comparing the impact of full classroom allocation of sit-stand desks to a classroom of partial sit-stand desk allocation.', 'detailedDescription': "Rates of overweight and obesity and related chronic disease risk factors in children have increased worldwide over the past decades. Whilst it is widely acknowledged that regular physical activity provides health benefits, prolonged sedentary behaviour (sitting or reclining) has been shown to adversely affect children's health, independent of the child's physical activity levels. Adverse associations between sedentary behaviour and risk factors for disease, such as obesity, blood pressure, and high levels of cholesterol have been observed in children. In addition, prolonged sedentary behaviour has been linked to reduced cognitive development and academic achievement in children.\n\nChanges in our environment and lifestyle have resulted in children not only becoming less physically active, but also spending unnecessarily long periods of time sitting, particularly in the classroom. Sedentary behaviour is the most prevalent behaviour exhibited by children in developed countries, comprising \\>65% of waking hours. The impact of unhealthy lifestyle behaviours, such as prolonged sitting, on children's health and development is concerning given the importance of childhood for the establishment of lifestyle behaviours that can track into adulthood.\n\nThe long term vision of our research is to re-address the balance between sedentary and non-sedentary (i.e. standing and all forms of physical activity) behaviours by changing environments which are traditionally associated with prolonged periods of sedentary behaviour, such as the school classroom. This study will make environmental changes to the classrooms of Year 5 students (aged 9-10 years) from one school in Bradford, in the UK, through the provision of manually adjustable sit-stand workstations. The primary aim is to compare the effects of this novel strategy using both full desk allocation (one per child) in one classroom and partial desk allocation (six standing desks in a class along with standard desks) in a second classroom on children's classroom sitting and standing time. Comparisons will also be made between the two intervention classrooms in the one school to children's sitting and standing behaviour measured in a control school (following usual practice). Secondary aims include evaluating the effects of the two interventions on time spent in different intensities of physical activity, health, learning and cognitive function outcomes.\n\nThis study expands on the success of the nine week pilot study, conducted in 2014, by implementing the intervention over a full academic year, having an additional intervention group, including an extra school for a control group, and including more key outcome measures (blood glucose, self-reported comfort) to better understand the impact of sit-stand desks. If successful this study will support the concept of sit-stand desks as an effective long term school based intervention for benefits in health and learning in children across all demographics"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* Any child with any disabilities that prevent them from standing up for short periods of time will be requested to continue with their usual practice of sitting at their school desk.\n* Children with any disabilities or injuries/illnesses that prevent them from going about their usual routine will be excluded from the evaluation component of the intervention'}, 'identificationModule': {'nctId': 'NCT04296669', 'acronym': 'SOIC2', 'briefTitle': 'Stand Out in Class: Reducing Sitting Time in the Classroom Environment', 'organization': {'class': 'OTHER', 'fullName': 'Loughborough University'}, 'officialTitle': 'Stand Out in Class: Reducing Sitting Time in the Classroom Environment', 'orgStudyIdInfo': {'id': 'R15-P086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Full desk allocation', 'description': 'All children within this classroom received a sit-stand stand', 'interventionNames': ['Device: Ergotron LearnFit Sit-Stand desk']}, {'type': 'EXPERIMENTAL', 'label': 'Partial desk allocation', 'description': 'six sit-stand desks were provided in this classroom. Children were rotated between these desks and traditional desks', 'interventionNames': ['Device: Ergotron LearnFit Sit-Stand desk']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Traditional classroom furniture was used'}], 'interventions': [{'name': 'Ergotron LearnFit Sit-Stand desk', 'type': 'DEVICE', 'description': 'An adjustable sit-stand desk design for children', 'armGroupLabels': ['Full desk allocation', 'Partial desk allocation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Stacy A Clemes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loughborough University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loughborough University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bradford Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Stacy Clemes', 'investigatorAffiliation': 'Loughborough University'}}}}