Fairclough 2013.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: within pre‐defined geographical units known as Neighbourhood Management Areas, 1 high and 1 low socioeconomic status school (defined as percentage of students per school eligible to receive free school meals) were randomly selected School exclusion criteria: — Student inclusion criteria: all children within Year 6 (10 to 11 years old) Student exclusion criteria: — Setting: school Age group: children Gender distribution: females and males Country/Countries where trial was performed: UK |
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| Interventions |
Intervention: Children’s Health, Activity and Nutrition: Get Educated! curriculum consisted of 20 weekly lesson plans, worksheets, homework tasks, lesson resources, and a CD‐ROM. Lessons provided an opportunity for children to discuss, explore, and understand the meaning and practicalities of PA and nutrition as key elements of healthy lifestyles. The core message of the PA and sedentary behaviour components was “move more, sit less” with no specific prescription given as to what forms of PA the children should do. Nutrition components focused on topics such as energy balance, macronutrients, and eating behaviours. Homework tasks involved the whole family because formative work emphasised the importance of family support Comparator: classes in the comparison schools received normal instruction. This did not involve a specific unit of Personal, Social, and Health Education focused on healthy eating and PA, but concepts related to these areas may have been touched on informally during other lessons Duration of intervention: 20 weeks Duration of follow‐up: 8 months Number of schools: 12 Theoretical framework: social cognitive theory |
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| Outcomes | PA duration Sedentary time Fitness BMI |
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| Study registration | ISRCTN03863885 (retrospectively registered) | |
| Publication details |
Language of publication: English Funding: — Publication status: peer‐reviewed journal |
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| Stated aim for study | "The Children’s Health, Activity and Nutrition: Get Educated! intervention was designed to promote healthy weight in primary school children through a teacher‐delivered curriculum‐based intervention with family involvement, focused on PA and dietary behaviour. The aim of this pragmatic evaluation was to assess the effectiveness of the Children’s Health, Activity and Nutrition: Get Educated! intervention on measures of body size, PA, and food intake" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: random number generator used |
| Allocation concealment (selection bias) | High risk | Comment: not described |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: students not blinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: outcome assessors not blinded [author communication] |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | High risk | Comment: large loss to follow‐up, bigger in intervention group |
| Incomplete outcome data (attrition bias) Physical activity and sedentary time | High risk | Comment: large loss to follow‐up, bigger in intervention group |
| Selective reporting (reporting bias) | Low risk | Comment: outcomes match with trial registry |
| Cluster RCT ‐ Recruitment bias | High risk | Comment: randomisation conducted prior to baseline measures |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: baseline differences adjusted for in analyses |
| Cluster RCT ‐ Loss of clusters | High risk | Comment: 1 school lost from intervention group |
| Cluster RCT ‐ Incorrect analysis | Low risk | Quote from publication: "multilevel models can analyse the hierarchical nature of non‐independent, nested data by taking into account the dependency of observations. Children were defined as the first level unit of analysis, and school was the second level unit of analysis" |