Sedentary BehaviorSOIC2NCT04296669
Stand Out in Class: Reducing Sitting Time in the Classroom Environment
A study testing Ergotron LearnFit Sit-Stand desk in people with Sedentary Behavior and Child Behavior, run by Loughborough University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Child Behavior, Physical Activity
- What is being tested?
- Ergotron LearnFit Sit-Stand desk
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2015to 15 Jul 2016
- Phase
- Interventional
- 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 9 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- -
Who cannot join
- 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.
- 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
About this study
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.
Read the detailed description
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.
Changes 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.
The 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.
This 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
- Conditions
- Sedentary Behavior, Child Behavior, Physical Activity, Obesity, Health Behavior
- Being tested
- Ergotron LearnFit Sit-Stand desk
- Medical subject headings
- Sedentary Behavior, Child Behavior, Motor Activity, Obesity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergotron LearnFit Sit-Stand deskDevice
An adjustable sit-stand desk design for children
| Study group | Role | What they receive |
|---|---|---|
| Full desk allocation | Experimental | All children within this classroom received a sit-stand stand Receives: Device: Ergotron LearnFit Sit-Stand desk |
| Partial desk allocation | Experimental | six sit-stand desks were provided in this classroom. Children were rotated between these desks and traditional desks Receives: Device: Ergotron LearnFit Sit-Stand desk |
| Control | No intervention | Traditional classroom furniture was used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sitting time (mins)
Change in time spent sitting using activPAL inclinometer device
Measured: 7 days at baseline, 4 months, 8 months
Secondary outcomes (19)
Standing time (mins)
Change in time spent standing using activPAL inclinometer device
Measured: 7 days at baseline, 4 months, 8 months
Stepping time (mins)
Change in time spent stepping using activPAL inclinometer device
Measured: 7 days at baseline, 4 months, 8 months
Steps
Change in Steps using activPAL inclinometer device
Measured: 7 days at baseline, 4 months, 8 months
Sit to stand transitions
Change in Sit to stand transitions using activPAL inclinometer device
Measured: 7 days at baseline, 4 months, 8 months
Total acceleration per minute
Change in Counts per minute using ActiGraph accelerometer device
Measured: 7 days at baseline, 4 months, 8 months
Light physical activity (mins)
Change in Time spent in Light physical activity (mins) using ActiGraph accelerometer device
Measured: 7 days at baseline, 4 months, 8 months
Moderate physical activity (mins)
Change in Time spent in Moderate physical activity using ActiGraph accelerometer device
Measured: 7 days at baseline, 4 months, 8 months
Vigorous physical activity (mins)
Change in Time spent in vigorous physical activity using ActiGraph accelerometer device
Measured: 7 days at baseline, 4 months, 8 months
Resting Systolic blood pressure (mmHg)
Change in Resting systolic blood pressure using automated Omron device
Measured: 7 days at baseline, 4 months, 8 months
Resting diastolic blood pressure (mmHg)
Change in Resting diastolic blood pressure using automated Omron device
Measured: 7 days at baseline, 4 months, 8 months
Height (m)
Change in height measured with portable Stadiometer
Measured: 7 days at baseline, 4 months, 8 months
Weight (kg)
Change in weight measured with electronic weighing scales
Measured: 7 days at baseline, 4 months, 8 months
Body Mass index (kg/m2)
Change in BMI calculated from height and weight measures
Measured: 7 days at baseline, 4 months, 8 months
waist circumference (cm)
Change in waist circumference measured using anthropometry tape
Measured: 7 days at baseline, 4 months, 8 months
Stroop test
Change in Computer based cognitive function test lasting 5 mins
Measured: 7 days at baseline, 4 months, 8 months
Corsi block tapping test
Change in Computer based cognitive function test lasting 5 mins
Measured: 7 days at baseline, 4 months, 8 months
Rapid visual information processing test
Change in Computer based cognitive function test lasting 5 mins
Measured: 7 days at baseline, 4 months, 8 months
musculoskeletal discomfort
Change in discomfort using a self-report paper-based survey of 7 body parts. scale of 1-5, 1 is good, 5 is bad
Measured: 7 days at baseline, 4 months, 8 months
Behaviour related mental health
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"
Measured: 7 days at baseline, 4 months, 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start20 Aug 2015
- Primary completion15 Jul 2016
- Study completion15 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Controlled trial (2 intervention groups)
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- Bradford Teaching Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Stacy Clemes, Loughborough University
- Investigators
- Stacy A Clemes, PhD, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296669
- Sponsor's protocol ID
- R15-P086
- Acronym
- SOIC2
- Status last verified
- Mar 2020
- First submitted
- 24 Feb 2020
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30346570
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stand Out in Class: Reducing Sitting Time in the Classroom Environment
- ClinicalTrials.gov ID
- NCT04296669
- Acronym / sponsor ID
- SOIC2 / R15-P086
- Conditions
- Sedentary Behavior, Child Behavior, Physical Activity, Obesity, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- Bradford Teaching Hospitals NHS Foundation Trust
- Study start
- 20 Aug 2015 (actual)
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 15 Jul 2016 (actual)
- First posted
- 5 Mar 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.
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.
Detailed description
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.
Changes 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.
The 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.
This 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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Controlled trial (2 intervention groups)
| Arm | Type | Receives |
|---|---|---|
| Full desk allocation | Experimental | Device: Ergotron LearnFit Sit-Stand deskAll children within this classroom received a sit-stand stand |
| Partial desk allocation | Experimental | Device: Ergotron LearnFit Sit-Stand desksix sit-stand desks were provided in this classroom. Children were rotated between these desks and traditional desks |
| Control | No intervention | –Traditional classroom furniture was used |
Who may qualify
- Ages
- 9 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (2 listed)
- 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.
- 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
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 |
|---|---|---|
| Ergotron LearnFit Sit-Stand deskAn adjustable sit-stand desk design for children | Device | Full desk allocation, Partial desk allocation |
Primary outcome
Sitting time (mins)
Time frame: 7 days at baseline, 4 months, 8 months
Change in time spent sitting using activPAL inclinometer device
19 secondary outcomes
Standing time (mins)
Time frame: 7 days at baseline, 4 months, 8 months
Stepping time (mins)
Time frame: 7 days at baseline, 4 months, 8 months
Steps
Time frame: 7 days at baseline, 4 months, 8 months
Sit to stand transitions
Time frame: 7 days at baseline, 4 months, 8 months
Total acceleration per minute
Time frame: 7 days at baseline, 4 months, 8 months
Light physical activity (mins)
Time frame: 7 days at baseline, 4 months, 8 months
Moderate physical activity (mins)
Time frame: 7 days at baseline, 4 months, 8 months
Vigorous physical activity (mins)
Time frame: 7 days at baseline, 4 months, 8 months
Resting Systolic blood pressure (mmHg)
Time frame: 7 days at baseline, 4 months, 8 months
Resting diastolic blood pressure (mmHg)
Time frame: 7 days at baseline, 4 months, 8 months
Height (m)
Time frame: 7 days at baseline, 4 months, 8 months
Weight (kg)
Time frame: 7 days at baseline, 4 months, 8 months
Body Mass index (kg/m2)
Time frame: 7 days at baseline, 4 months, 8 months
waist circumference (cm)
Time frame: 7 days at baseline, 4 months, 8 months
Stroop test
Time frame: 7 days at baseline, 4 months, 8 months
Corsi block tapping test
Time frame: 7 days at baseline, 4 months, 8 months
Rapid visual information processing test
Time frame: 7 days at baseline, 4 months, 8 months
musculoskeletal discomfort
Time frame: 7 days at baseline, 4 months, 8 months
Behaviour related mental health
Time frame: 7 days at baseline, 4 months, 8 months
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 5 Mar 2020.
- Background: PubMed 30346570Sherry 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.
- Individual participant dataSharing planned: No
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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.
Stacy A Clemes, PhD principal investigator
Loughborough University
Questions about this trial
What is this clinical trial studying?
A study testing Ergotron LearnFit Sit-Stand desk in people with Sedentary Behavior and Child Behavior, run by Loughborough University.
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 2 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 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Sitting time (mins) (time frame: 7 days at baseline, 4 months, 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04296669, which also lists 1 linked publication.
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 5 Mar 2020.