Müller 2019.

Study characteristics
Methods	Study design: cluster‐RCT
Participants	School inclusion criteria: quintile 3 schools selected based on geographic location, representation of various target communities, and commitment to support project activities School exclusion criteria: < 100 learners in Grade 4 Student inclusion criteria  Willingness to participate Written informed consent by a parent or guardian No participation in other clinical trials during the study period Not suffering from medical conditions preventing participation in a maximum exercise test, as determined by qualified medical personnel Student exclusion criteria: — Setting: school Age group: children/adolescents Gender distribution: females and males Country where trial was performed: South Africa
Interventions	Intervention 1: PA: a multi‐dimensional PA intervention during school time developed in collaboration with education authorities, teachers, and students. 4 key components included: two 40‐minute PE lessons/week; one 40‐minute moving‐to‐music lesson/week led by students from Nelson Mandela University; in‐class activity breaks; and low‐cost school environment adaptations (e.g. activity stations, painted games) Intervention 2: PA + Health education: health education lessons were held to increase children’s awareness of intestinal parasite infections Intervention 3: PA + Health education + Nutrition: a nutrition intervention consisting of classroom‐based lessons to help increase awareness of the importance of healthy nutrition were held Comparator 1: Health education + Nutrition Comparator 2: no intervention Duration of intervention: 2 × 10‐week blocks Duration of follow‐up: 15 months Number of schools: 8 Theoretical framework: —
Outcomes	Fitness BMI
Study registration	ISRCTN68411960(retrospectively registered)
Publication details	Language of publication: English  Funding: non‐commercial funding (research funding body) Publication status: peer‐reviewed journal
Stated aim for study	"The overarching purpose of the Disease, Activity and Schoolchildren’s Health study was to investigate the dual disease burden (i.e. non‐communicable diseases and infectious diseases) among children in primary schools in disadvantaged neighbourhoods"
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: "generating the allocation sequence by a simple randomisation of the schools was carried out by the research team on the basis of a computer‐generated random number list"
Allocation concealment (selection bias)	High risk	Quote from publication: "research team allocated schools, concealment and blinding were not possible in our study design"
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote from publication: "concealment and blinding were not possible in our study design"
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote from publication: "concealment and blinding were not possible in our study design"
Incomplete outcome data (attrition bias) Anthropometrics, Fitness	High risk	Comment: 281 lost to follow‐up
Selective reporting (reporting bias)	High risk	Comment: different primary outcome reported in trial registry
Cluster RCT ‐ Recruitment bias	Low risk	Comment: individual learners were enrolled and baseline data collected before randomisation at the cluster level (of schools) [author communication]
Cluster RCT ‐ Baseline imbalance	Low risk	Quote from publication: "no significant differences in primary outcome measures, such as obesity, skin‐folds and cardiorespiratory fitness at baseline were detected, when comparing schools with and without PA intervention"
Cluster RCT ‐ Loss of clusters	Low risk	Comment: no clusters lost
Cluster RCT ‐ Incorrect analysis	Low risk	Quote from publication: "separate mixed linear regression models were employed with random intercepts for school classes, in order to adjust for cluster effects"