Currently submitted to: JMIR Research Protocols
Date Submitted: Mar 3, 2020
Open Peer Review Period: Mar 3, 2020 - Apr 28, 2020
(currently open for review)
Sedentariness and back health in Western Cape school learners: a study protocol for pragmatic stepped wedge randomised feasibility trial.
Despite growing evidence of deleterious health outcomes associated with sedentary behaviour, prolonged static sitting in classrooms remains ubiquitous in primary school classrooms. Sedentary behaviour is associated with the development of cardio-metabolic conditions and poor back health. Preventative strategies to reduce sedentary behaviour and its negative health effects may be required in a resource-constrained environment such as South Africa.
Primary: To assess the feasibility of conducting a full trial to evaluate the effects of a multi-faceted intervention comprising novel multi-functional classroom furniture and a video-based curriculum versus usual care on sedentary behaviour among students aged between 10 and 11 years old in primary schools. Secondary: To assess the preliminary effects of the intervention on sedentary behaviour and postural dynamism.
Participants: Eighty grade 5 or 6 learners, aged 10 and 11 years old, in mixed-gender, schools within the Cape Metro urban area are eligible to participate. Data to be collected at the schools. Intervention: The intervention will comprise multi-functional classroom furniture that allows for sitting and standing as well as a video-based curriculum on sedentary behaviour. Usual practice is the absence of the intervention. Setting: Western Cape Metropolitan Urban Area in South Africa. Trial design: A pilot cluster stepped-wedge trial design with classrooms as the unit of randomisation. Outcome: Primary: i) adherence to the intervention, and ii) project pragmatics. Secondary: i) sedentariness measured using activPAL3 micro sensors, and ii) postural dynamism measured using Noraxon Myomotion IMUs. Randomization: We randomized the school to the first or second start of the intervention. Blinding: This is an open-label trial and therefore not possible to blind any group. Analysis: Descriptive analysis of the feasibility and physiological outcomes will be presented. We will report the preliminary estimates of effects on sedentariness and postural dynamism using mean difference and 95% confidence interval.
At time of submission, two classrooms were recruited into the study. Baseline physical activity and postural dynamism data was collected from 10 participants from each class.
The results of this feasibility stepped-wedge cluster randomised controlled trial will be useful in informing the design on the main trial to assess whether this multifaceted intervention of multi-functional classroom furniture that allows for sitting and standing as well as a video-based curriculum versus usual care has any effects on sedentary behaviour in a low resource setting primary schools. Clinical Trial: PACTR201811799476016
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