2019
DOI: 10.3390/ijerph16020232
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Effect of a Multidimensional Physical Activity Intervention on Body Mass Index, Skinfolds and Fitness in South African Children: Results from a Cluster-Randomised Controlled Trial

Abstract: Obesity-related conditions impose a considerable and growing burden on low- and middle-income countries, including South Africa. We aimed to assess the effect of twice a 10-week multidimensional, school-based physical activity intervention on children’s health in Port Elizabeth, South Africa. A cluster-randomised controlled trial was implemented from February 2015 to May 2016 in grade 4 classes in eight disadvantaged primary schools. Interventions consisted of physical education lessons, moving-to-music classe… Show more

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Cited by 27 publications
(25 citation statements)
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References 38 publications
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“…In brief, trial schools were randomized based on a computer-generated number list either to one of four interventions or to a control condition. As described previously (29,30,48), schools were randomly allocated to one of the following intervention combinations: (i) physical activity alone; (ii) physical activity plus health and hygiene education; (iii) physical activity plus health and hygiene education plus nutrition education; and (iv) health and hygiene education plus nutrition education. Four schools served as control group and did not receive any intervention.…”
Section: Methodsmentioning
confidence: 99%
“…In brief, trial schools were randomized based on a computer-generated number list either to one of four interventions or to a control condition. As described previously (29,30,48), schools were randomly allocated to one of the following intervention combinations: (i) physical activity alone; (ii) physical activity plus health and hygiene education; (iii) physical activity plus health and hygiene education plus nutrition education; and (iv) health and hygiene education plus nutrition education. Four schools served as control group and did not receive any intervention.…”
Section: Methodsmentioning
confidence: 99%
“…64 In another case, investigators randomized one school each to 4 interventions, plus 4 no-intervention control schools. 65 A critique of the study noted that "although the number of clusters that are needed in a cluster-randomized trial is not fixed, that number is never 1," and therefore that the study "could not establish causation and, at best, only had the capacity to create the hypothesis that [the interventions] may have a favorable impact on childhood obesity." 66 In one other case, an article making similar mistakes was retracted "because the statistical analysis was not correct given the clusterrandomized design" and the "conclusion that the original paper drew about having demonstrated treatment efficacy was not supported in the corrected analysis."…”
Section: Examples Of the Errormentioning
confidence: 99%
“…In response to a subsequent critique of the same study, the original authors published a corrigendum that continued to make invalid causal conclusions about their intervention . In another case, investigators randomized one school each to four interventions, plus four no‐intervention control schools . A critique of the study noted that “although the number of clusters that are needed in a cluster‐randomized trial is not fixed, that number is never 1,” and therefore that the study “could not establish causation and, at best, only had the capacity to create the hypothesis that [the interventions] may have a favorable impact on childhood obesity.” In one other case, an article making similar mistakes was retracted “because the statistical analysis was not correct given the cluster‐randomized design” and the “conclusion that the original paper drew about having demonstrated treatment efficacy was not supported in the corrected analysis.”…”
Section: Inferential Error: Ignoring Clustering In Studies That Randomentioning
confidence: 99%