A cluster-randomized controlled trial to reduce sedentary behavior and promote physical activity and health of 8-9 year olds: The Transform-Us! Study

Abstract

BackgroundPhysical activity (PA) is associated with positive cardio-metabolic health and emerging evidence suggests sedentary behavior (SB) may be detrimental to children's health independent of PA. The primary aim of the Transform-Us! study is to determine whether an 18-month, behavioral and environmental intervention in the school and family settings results in higher levels of PA and lower rates of SB among 8-9 year old children compared with usual practice (post-intervention and 12-months follow-up). The secondary aims are to determine the independent and combined effects of PA and SB on children's cardio-metabolic health risk factors; identify the factors that mediate the success of the intervention; and determine whether the intervention is cost-effective.Methods/designA four-arm cluster-randomized controlled trial (RCT) with a 2 × 2 factorial design, with schools as the unit of randomization. Twenty schools will be allocated to one of four intervention groups, sedentary behavior (SB-I), physical activity (PA-I), combined SB and PA (SB+PA-I) or current practice control (C), which will be evaluated among approximately 600 children aged 8-9 years in school year 3 living in Melbourne, Australia. All children in year 3 at intervention schools in 2010 (8-9 years) will receive the intervention over an 18-month period with a maintenance 'booster' delivered in 2012 and children at all schools will be invited to participate in the evaluation assessments. To maximize the sample and to capture new students arriving at intervention and control schools, recruitment will be on-going up to the post-intervention time point. Primary outcomes are time spent sitting and in PA assessed via accelerometers and inclinometers and survey.DiscussionTo our knowledge, Transform-Us! is the first RCT to examine the effectiveness of intervention strategies for reducing children's overall sedentary time, promoting PA and optimizing health outcomes. The integration of consistent strategies and messages to children from teachers and parents in both school and family settings is a critical component of this study, and if shown to be effective, may have a significant impact on educational policies as well as on pedagogical and parenting practices.Trial registrationACTRN12609000715279; Current Controlled Trials ISRCTN83725066

Economic evaluation alongside factorial trials: a systematic review of empirical studies

“…It is also worth stating that, unlike clinical outcomes that are generally normally distributed, economic outcomes generally follow a skewed distribution and are associated with a higher variance, which impact on the way they should be analysed [31,32]. Therefore, even if the trial is adequately powered to detect the main difference in clinical outcome, it will be typically underpowered for the analysis of economic outcomes.…”

Reducing children's classroom sitting time using sit-to-stand desks: findings from pilot studies in UK and Australian primary schools

“…Information on the benefits of reducing sedentary behaviour and classroom sitting time reduction strategies, based on materials adapted from a previous cluster-randomized controlled study, were also provided. 15 No environmental or other changes were made to the control classroom (home to 28 students), their teacher continued with normal lesson delivery.…”

“…As in the UK study, the intervention teacher received training on desk use and the same classroom sitting time reduction strategies. 15 The control classroom involved 22 students and had no environmental or other changes, with the teacher continuing their usual lesson delivery.…”

“…14 Moreover, children sit for longer during school hours compared to non-school hours on school days. 11,14 Due to the contextually driven nature of sedentary behaviour, interventions in children have begun to target reductions in classroom sitting, [15][16][17][18][19][20][21] with initial studies demonstrating the feasibility of incorporating sit-to-stand desks in primary school classrooms. 16,20,22 Evidence suggests the use of sit-to-stand desks in primary schools are effective in increasing energy expenditure 17,21 and standing and movement during the school day.…”

Implementing Sport, Physical Activity and Physical Education in New South Wales, Australia, primary schools

“…In contrast, healthy eating and physical activity are key factors in maintaining quality of life and preventing diabetes, heart disease, arthritis, stroke and some cancers across all life stages. (New South Wales Government, 2015) Governments and policy makers need to be innovative and to be open to opportunities that contribute to the overall health and well-being of citizens, especially primary school students (Salmon, Arundell, Hume, Brown, Hesketh, Dunstan, & Crawford, 2011). The early development of children should be considered as part of the urban planning goals so that healthy outcomes such as the long-term benefits of exercise are encouraged, the social and affective outcomes of movement are part of a healthy life and the negative impact of obesity are minimised.…”