Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05854355 |
Other study ID # |
REC.21.0027 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 1, 2021 |
Est. completion date |
June 12, 2022 |
Study information
Verified date |
May 2023 |
Source |
University of Ulster |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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.
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.
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.