- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04296669
Stand Out in Class: Reducing Sitting Time in the Classroom Environment (SOIC2)
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
-
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Full desk allocation
All children within this classroom received a sit-stand stand
|
An adjustable sit-stand desk design for children
|
|
EXPERIMENTAL: Partial desk allocation
six sit-stand desks were provided in this classroom.
Children were rotated between these desks and traditional desks
|
An adjustable sit-stand desk design for children
|
|
NO_INTERVENTION: Control
Traditional classroom furniture was used
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sitting time (mins)
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in time spent sitting using activPAL inclinometer device
|
7 days at baseline, 4 months, 8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Standing time (mins)
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in time spent standing using activPAL inclinometer device
|
7 days at baseline, 4 months, 8 months
|
|
Stepping time (mins)
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in time spent stepping using activPAL inclinometer device
|
7 days at baseline, 4 months, 8 months
|
|
Steps
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in Steps using activPAL inclinometer device
|
7 days at baseline, 4 months, 8 months
|
|
Sit to stand transitions
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in Sit to stand transitions using activPAL inclinometer device
|
7 days at baseline, 4 months, 8 months
|
|
Total acceleration per minute
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in Counts per minute using ActiGraph accelerometer device
|
7 days at baseline, 4 months, 8 months
|
|
Light physical activity (mins)
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in Time spent in Light physical activity (mins) using ActiGraph accelerometer device
|
7 days at baseline, 4 months, 8 months
|
|
Moderate physical activity (mins)
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in Time spent in Moderate physical activity using ActiGraph accelerometer device
|
7 days at baseline, 4 months, 8 months
|
|
Vigorous physical activity (mins)
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in Time spent in vigorous physical activity using ActiGraph accelerometer device
|
7 days at baseline, 4 months, 8 months
|
|
Resting Systolic blood pressure (mmHg)
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in Resting systolic blood pressure using automated Omron device
|
7 days at baseline, 4 months, 8 months
|
|
Resting diastolic blood pressure (mmHg)
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in Resting diastolic blood pressure using automated Omron device
|
7 days at baseline, 4 months, 8 months
|
|
Height (m)
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in height measured with portable Stadiometer
|
7 days at baseline, 4 months, 8 months
|
|
Weight (kg)
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in weight measured with electronic weighing scales
|
7 days at baseline, 4 months, 8 months
|
|
Body Mass index (kg/m2)
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in BMI calculated from height and weight measures
|
7 days at baseline, 4 months, 8 months
|
|
waist circumference (cm)
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in waist circumference measured using anthropometry tape
|
7 days at baseline, 4 months, 8 months
|
|
Stroop test
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in Computer based cognitive function test lasting 5 mins
|
7 days at baseline, 4 months, 8 months
|
|
Corsi block tapping test
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in Computer based cognitive function test lasting 5 mins
|
7 days at baseline, 4 months, 8 months
|
|
Rapid visual information processing test
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in Computer based cognitive function test lasting 5 mins
|
7 days at baseline, 4 months, 8 months
|
|
musculoskeletal discomfort
Time Frame: 7 days at baseline, 4 months, 8 months
|
Change in discomfort using a self-report paper-based survey of 7 body parts.
scale of 1-5, 1 is good, 5 is bad
|
7 days at baseline, 4 months, 8 months
|
|
Behaviour related mental health
Time Frame: 7 days at baseline, 4 months, 8 months
|
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"
|
7 days at baseline, 4 months, 8 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Standing class fidelity
Time Frame: 30 minutes at 4 months
|
sitting and standing behaviour recorded via direct observation by researcher
|
30 minutes at 4 months
|
|
Experiences of using standing desks
Time Frame: 30 mins at 4 months
|
focus groups with pupils exploring barriers and facilitators to sitting, standing and learning in the classroom
|
30 mins at 4 months
|
|
Experiences of teaching with standing desks
Time Frame: 60 mins at 4 months
|
Interviews with teachers exploring barriers and facilitators to sitting, standing and teaching in the classroom
|
60 mins at 4 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stacy A Clemes, PhD, Loughborough University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R15-P086
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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