Physical InactivityNCT05854355
Children- Sit Less, Move More (C-SLAMM): Increasing Physical Activity and Decreasing Sedentary Behaviour in Children
A study testing C-SLAMM Study in people with Physical Inactivity and Sedentary Behavior, run by University of Ulster at 1 site in United Kingdom.
Trial summary
The Children Sit Less, Move More (C-SLAMM) study aims to test the feasibility and potential effect of a multi-component school and home-based pilot cluster randomized control trial on reducing sedentary behavior and increasing physical activity in children. Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Sedentary Behavior, Health Behavior
- What is being tested?
- C-SLAMM Study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2021to 12 Jun 2022
- 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 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary school pupil
- Year 4 (Key Stage 1) or Year 5 (Key Stage 2)
- 7-9 years
- Living in Northern Ireland
Who cannot join
- Cannot speak English
- Severe psychological or neurological condition
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ulster University
Newtownabbey, Co. Antrim, BT370QB
About this study
Official title: Reducing Sedentary Behaviour and Promoting Physical Activity in Children Aged 7-9 Years: Developing, Feasibility and Pilot Testing a Low-cost, Multi-component, School-based Classroom Intervention.
The Children Sit Less, Move More (C-SLAMM) study aims to test the feasibility and potential effect of a multi-component school and home-based pilot cluster randomized control trial on reducing sedentary behavior and increasing physical activity in children.
This pilot intervention will be an 8-week two-armed cluster RCT. Individuals (children aged 7-9 years) will be the unit of analysis and schools (cluster) randomly assigned to one of two arms: (1) Physical activity and sedentary behavior (intervention arm), or (2) current practice (control arm). The design conduct and reporting of the intervention with adhere to the Consolidation Standards of Reporting Trials (CONSORT) guidelines and is guided by the Standard Protocol Items for Randomized Trials (SPIRIT) Statement.
Read the detailed description
The C-SLAMM study is an 8-week school-and home-based feasibility, two-armed pilot cluster randomized controlled trial.
A convenience sample of primary schools in Northern Ireland will be invited to take part in the study. Baseline measurements will proceed randomization, and an identical set of measures will be taken from participants in week 8 of the intervention.
Individuals (Primary 4 and Primary 5 children, aged 7-9 years) will be the unit of analysis and schools (clusters) will be randomly assigned to one of two conditions: (1) intervention condition or (2) current practice (control condition). Given the nature of the intervention, blinding of schools and participants will not be possible following randomization. The researcher responsible for subsequent data collection and analysis will not be blinded to group allocation. Any differences between the intervention and control groups will be by chance and adjusted for in the analyses. Schools randomized to control will be offered information on the intervention and associated materials at the end of the intervention.
The intervention is, adapted from the previously tested Transform-Us! trial and informed by a qualitative study was on the perceived barriers and facilitators of physical activity within the classroom, school and/or home environment (REC/20/0033).
The C-SLAMM study will use innovative behavioral, pedological, and environmental strategies within the classroom, school, and home settings to get children moving more and sitting less. Resources include health lessons, active lessons, active breaks, active homework to do with parents, active environments, and newsletters for parents. Each week teachers will be advised to incorporate elements of the intervention within the classroom setting. Teachers will modify the delivery of at least one class lesson per week (~30 minutes) so that children will complete the lesson standing up. Teachers will be provided with a suite of standing lesson delivery methods that can be modified to any class topic. In addition, every two-hour classroom teaching block will be interrupted every 30 minutes with a 2-minute guided light-intensity activity break. This will equate to a total of six minutes interrupted sitting time every two hours. Furthermore, each class will be provided with six standing desks so that children can rotate learning activities at 'standing stations'. A novelty timer will be given to each class so that teachers can monitor 2-minute standing breaks and every 30-minutes of sitting class time.
To compare the effects of the intervention against usual practice, schools assigned to the control arm will be requested to continue with their usual practice and lesson delivery, no environmental changes will be made to their classrooms. The participants in the control schools will be asked to complete the same study measurements as those in the intervention schools at the same time points.
- Conditions
- Physical Inactivity, Sedentary Behavior, Health Behavior, Child Behavior, Physical Activity
- Being tested
- C-SLAMM Study
- Medical subject headings
- Sedentary Behavior, Health Behavior, Child Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-SLAMM StudyOther
The intervention arm includes using innovative behavioural, pedagogical, and environmental strategies within the classroom, school, and home settings to get children moving more and sitting less. The strategies were based on strategies used in Transform-Us! involved incorporating movement into everyday class lessons - the delivery of the lesson changes, not the content. Resources included health lessons, active lessons, active breaks, active homework to do with parents, active environments, and newsletters for parents.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This group received the multi-component school and home-based intervention (physical activity programme (aimed to increase children's physical activity and decrease sedentary behaviour) Receives: Other: C-SLAMM Study |
| Control | No intervention | The primary school children in the control group did not receive the intervention. The control arm continued with their usual practice and lesson delivery, no environmental changes were made to their classrooms. |
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 and at follow-up (8 weeks)
Secondary outcomes (7)
Standing time (mins)
Change in time spent standing using activPAL inclinometer device
Measured: 7 days at baseline and at follow-up (8 weeks)
Stepping time (mins)
Change in time spent stepping using activPAL inclinometer device
Measured: 7 days at baseline and at follow-up (8 weeks)
Steps
Changes in Steps using activPAL inclinometer device
Measured: 7 days at baseline and at follow-up (8 weeks)
Sit to stand transitions
Changes in Sit to stand transitions using activPAL inclinometer device
Measured: 7 days at baseline and at follow-up (8 weeks)
Height (m)
Change in height measured with portable Stadiometer
Measured: 7 days at baseline and at follow-up (8 weeks)
Weight (kg)
Change in weight measured with electronic weighing scales
Measured: 7 days at baseline and at follow-up (8 weeks)
Body Mass index (kg/m2)
Change in BMI calculated from height and weight measures
Measured: 7 days at baseline and at follow-up (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Sep 2021
- Primary completion13 Apr 2022
- Study completion12 Jun 2022
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 Physical InactivityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four schools allocated to receive the intervention; four schools allocated to the control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Ireland Chest Heart and Stroke
- Responsible party
- Sponsor
- Investigators
- Marie Murphy, PhD, Principal investigator, University of Ulster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854355
- Sponsor's protocol ID
- REC.21.0027
- Status last verified
- May 2023
- First submitted
- 30 Mar 2023
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nally S, Carlin A, Gallagher AM, Wilson JJ, Lahart IM, Salmon J, Murphy MH. The Children - Sit Less, Move More (C-SLAMM) pilot intervention: Feasibility and acceptability of a multi-component school and home-based intervention to promote physical activity. PLoS One. 2025 Nov 19;20(11):e0335933. doi: 10.1371/journal.pone.0335933. eCollection 2025.
PubMed 41259385
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Sedentary Behaviour and Promoting Physical Activity in Children Aged 7-9 Years: Developing, Feasibility and Pilot Testing a Low-cost, Multi-component, School-based Classroom Intervention.
- ClinicalTrials.gov ID
- NCT05854355
- Acronym / sponsor ID
- REC.21.0027
- Conditions
- Physical Inactivity, Sedentary Behavior, Health Behavior, Child Behavior, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Northern Ireland Chest Heart and Stroke
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 13 Apr 2022 (actual)
- Study completion
- 12 Jun 2022 (actual)
- First posted
- 11 May 2023 (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 Children Sit Less, Move More (C-SLAMM) study aims to test the feasibility and potential effect of a multi-component school and home-based pilot cluster randomized control trial on reducing sedentary behavior and increasing physical activity in children.
This pilot intervention will be an 8-week two-armed cluster RCT. Individuals (children aged 7-9 years) will be the unit of analysis and schools (cluster) randomly assigned to one of two arms: (1) Physical activity and sedentary behavior (intervention arm), or (2) current practice (control arm). The design conduct and reporting of the intervention with adhere to the Consolidation Standards of Reporting Trials (CONSORT) guidelines and is guided by the Standard Protocol Items for Randomized Trials (SPIRIT) Statement.
Detailed description
The C-SLAMM study is an 8-week school-and home-based feasibility, two-armed pilot cluster randomized controlled trial.
A convenience sample of primary schools in Northern Ireland will be invited to take part in the study. Baseline measurements will proceed randomization, and an identical set of measures will be taken from participants in week 8 of the intervention.
Individuals (Primary 4 and Primary 5 children, aged 7-9 years) will be the unit of analysis and schools (clusters) will be randomly assigned to one of two conditions: (1) intervention condition or (2) current practice (control condition). Given the nature of the intervention, blinding of schools and participants will not be possible following randomization. The researcher responsible for subsequent data collection and analysis will not be blinded to group allocation. Any differences between the intervention and control groups will be by chance and adjusted for in the analyses. Schools randomized to control will be offered information on the intervention and associated materials at the end of the intervention.
The intervention is, adapted from the previously tested Transform-Us! trial and informed by a qualitative study was on the perceived barriers and facilitators of physical activity within the classroom, school and/or home environment (REC/20/0033).
The C-SLAMM study will use innovative behavioral, pedological, and environmental strategies within the classroom, school, and home settings to get children moving more and sitting less. Resources include health lessons, active lessons, active breaks, active homework to do with parents, active environments, and newsletters for parents. Each week teachers will be advised to incorporate elements of the intervention within the classroom setting. Teachers will modify the delivery of at least one class lesson per week (~30 minutes) so that children will complete the lesson standing up. Teachers will be provided with a suite of standing lesson delivery methods that can be modified to any class topic. In addition, every two-hour classroom teaching block will be interrupted every 30 minutes with a 2-minute guided light-intensity activity break. This will equate to a total of six minutes interrupted sitting time every two hours. Furthermore, each class will be provided with six standing desks so that children can rotate learning activities at 'standing stations'. A novelty timer will be given to each class so that teachers can monitor 2-minute standing breaks and every 30-minutes of sitting class time.
To compare the effects of the intervention against usual practice, schools assigned to the control arm will be requested to continue with their usual practice and lesson delivery, no environmental changes will be made to their classrooms. The participants in the control schools will be asked to complete the same study measurements as those in the intervention schools at the same time points.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Four schools allocated to receive the intervention; four schools allocated to the control group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: C-SLAMM StudyThis group received the multi-component school and home-based intervention (physical activity programme (aimed to increase children's physical activity and decrease sedentary behaviour) |
| Control | No intervention | –The primary school children in the control group did not receive the intervention. The control arm continued with their usual practice and lesson delivery, no environmental changes were made to their classrooms. |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Primary school pupil
- Year 4 (Key Stage 1) or Year 5 (Key Stage 2)
- 7-9 years
- Living in Northern Ireland
Key exclusion criteria (2 listed)
- Cannot speak English
- Severe psychological or neurological condition
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 |
|---|---|---|
| C-SLAMM StudyThe intervention arm includes using innovative behavioural, pedagogical, and environmental strategies within the classroom, school, and home settings to get children moving more and sitting less. The strategies were based on strategies used in Transform-Us! involved incorporating movement into everyday class lessons - the delivery of the lesson changes, not the content. Resources included health lessons, active lessons, active breaks, active homework to do with parents, active environments, and newsletters for parents. | Other | Intervention |
Primary outcome
Sitting time (mins)
Time frame: 7 days at baseline and at follow-up (8 weeks)
Change in time spent sitting using activPAL inclinometer device
7 secondary outcomes
Standing time (mins)
Time frame: 7 days at baseline and at follow-up (8 weeks)
Stepping time (mins)
Time frame: 7 days at baseline and at follow-up (8 weeks)
Steps
Time frame: 7 days at baseline and at follow-up (8 weeks)
Sit to stand transitions
Time frame: 7 days at baseline and at follow-up (8 weeks)
Height (m)
Time frame: 7 days at baseline and at follow-up (8 weeks)
Weight (kg)
Time frame: 7 days at baseline and at follow-up (8 weeks)
Body Mass index (kg/m2)
Time frame: 7 days at baseline and at follow-up (8 weeks)
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 11 May 2023.
- Derived from this study: PubMed 41259385Nally S, Carlin A, Gallagher AM, Wilson JJ, Lahart IM, Salmon J, Murphy MH. The Children - Sit Less, Move More (C-SLAMM) pilot intervention: Feasibility and acceptability of a multi-component school and home-based intervention to promote physical activity. PLoS One. 2025 Nov 19;20(11):e0335933. doi: 10.1371/journal.pone.0335933. eCollection 2025.
- 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.
Marie Murphy, PhD principal investigator
University of Ulster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-SLAMM Study in people with Physical Inactivity and Sedentary Behavior, run by University of Ulster at 1 site in United Kingdom.
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 4 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 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 and at follow-up (8 weeks)). 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 NCT05854355, 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 11 May 2023.