Children- Sit Less, Move More (C-SLAMM): Increasing Physical Activity and Decreasing Sedentary Behaviour in Children

NCT ID: NCT05854355

Last Updated: 2023-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-06-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Physical Inactivity Sedentary Behavior Health Behavior Child Behavior Physical Activity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Four schools allocated to receive the intervention; four schools allocated to the control group
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

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)

Group Type EXPERIMENTAL

C-SLAMM Study

Intervention Type OTHER

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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

C-SLAMM Study

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Primary school pupil
* Year 4 (Key Stage 1) or Year 5 (Key Stage 2)
* 7-9 years
* Living in Northern Ireland

Exclusion Criteria

* Cannot speak English
* Severe psychological or neurological condition
Minimum Eligible Age

7 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Northern Ireland Chest Heart and Stroke

OTHER

Sponsor Role collaborator

University of Ulster

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marie Murphy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ulster

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ulster University

Newtownabbey, Co. Antrim, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC.21.0027

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.