Salmon 2008.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: convenience sample of 3 government primary schools located on 4 campuses in low socioeconomic status areas (based on socioeconomic index for area scores) in metropolitan Melbourne was recruited to the study School exclusion criteria: — Student inclusion criteria: all Grade 5 (approximately 10 to 11 years old) students at selected schools were eligible to participate and were invited to take part in the study Student exclusion criteria: — Setting: school, urban Age group: children Gender distribution: females and males Country/Countries where trial was performed: Australia |
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| Interventions |
Students were assigned to 1 of 4 conditions: a Behavioural Modification group, a Fundamental Motor Skillsgroup, a combined Behavioural Modification and Fundamental Motor Skills group, or a control group. Components of the intervention programme were developed by the study team, with others adapted from previous interventions (SPARK), concepts outlined in Robinson's study, from Planet Health, and from the Victorian Fundamental Motor Skills programme Intervention 1: behavioural modification: included 19 sessions of 40 to 50 minutes over 3 school terms by intervention specialist teacher, with different aims for each set of lessons (e.g. increasing awareness of time use, health benefits of PA, self‐monitoring time spent in sedentary behaviours and PA, raising awareness of home and community environments in relation to choices and opportunities, decision‐making skills, developing their own PAs and games, 'intelligent viewing', a 'Switch‐off Challenge', intermittent reinforcement schedule with a small reward) Intervention 2: fundamental motor skills: 19 sessions of 40 to 50 minutes over 3 school terms taught by the same intervention specialist teacher who delivered the behavioural modification intervention. The fundamental motor skills intervention focused on 6 skills, including 3 object control skills and 3 locomotor skills. Skills were taught with emphasis on fun through games and maximum involvement for all children. Most lessons focused on at least 2 skills, and each skill was a focus lesson in at least 6 sessions Intervention 3: behavioural modification and fundamental motor skills Comparator: usual classroom lessons Duration of intervention: 1 school year Duration of follow‐up: 2 years Number of schools: 3 Theoretical framework: social marketing theory and behavioural choice theory |
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| Outcomes | PA duration BMI |
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| Study registration | — | |
| Publication details |
Language of publication: English Funding: non‐commercial funding (Victorian Health Promotion Foundation) Publication status: peer‐reviewed journal |
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| Stated aim for study | "The primary aims of this study were to evaluate the effectiveness of an intervention designed to prevent excess weight gain (beyond gains associated with normal growth and maturation), reduce the likelihood of being overweight or obese, reduce time spent in recreational screen behaviours (TV, computer, and electronic games) and promote PA participation among 10‐year‐old children" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Comment: participants selected a ticket from a container, which specified group allocation |
| Allocation concealment (selection bias) | High risk | Comment: allocation was concealed from parents and teachers until after baseline data collection [author communication] |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: participants and study personnel were not blinded [author communication] |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: 2 trained staff members not blinded to group assignment took measurements |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | High risk | Comment: incomplete outcome data; not adequately addressed |
| Incomplete outcome data (attrition bias) Physical activity and sedentary time | High risk | Comment: incomplete outcome data; not adequately addressed |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes identified a priori were reported on |
| Cluster RCT ‐ Recruitment bias | Low risk | Comment: school classes randomised after recruitment |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: baseline differences between groups, but confounders adjusted for in secondary analyses |
| Cluster RCT ‐ Loss of clusters | Low risk | Comment: no clusters lost |
| Cluster RCT ‐ Incorrect analysis | Low risk | Comment: clustering accounted for in analysis |