Wang 2007a.
Methods |
Study design: cluster‐randomized controlled trial Study grouping: parallel group Study aim: "this study used the combination of school education and family education to carry out nutrition education activities. By comparing the effects of different education methods, we (1) analyze the independent role of schools and families, [and] (2) analyze the combined effect of school and family...We followed up the changes of nutrition knowledge, attitude, and practice (KAP) before and after education in accordance with the epidemiological prospective study method" (quote) [Chinese‐English translation] Study period: 1 school term; dates not specified Total number of arms: 3 Description of intervention arms: 1. Nutrition education for children and their parents (child + caregiver); 2. Nutrition education for children (child only); 3. Nutrition education for parents (not eligible) Number of clusters per arm: 1 Average cluster size: 492.33 children Sample size justification and outcome used: to detect a 5% increase in intake of soy‐based food products with a power of 90% and an alpha level of 0.05, approximately 138 children were needed per group. In consideration of clustering, study authors aimed to include 50% more children than required per sample size calculation Unit of allocation: school Missing data handling: missing values were excluded from scoring and statistical analyses Reported limitations: 1. Children may not have fully understood the questionnaire and may not have paid attention, leading to mistakes and missing responses Randomization ratio and stratification: 1:1:1:1; no stratification Participant compensation or incentives: not reported |
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Participants |
Baseline characteristics Child + caregiver arm (intervention group)
Child‐only arm (control group)
Recruitment methods: not reported Inclusion criteria: clusters: elementary school located in Xuzhou City (schools randomly chosen); participant: child enrolled in third, fourth, or fifth grade at a participating school and caregiver Exclusion criteria: not reported Age of participating children at baseline: third to fifth grade (estimated to be 7 to 11 years old) Total number randomized by relevant group: total across all study arms: n = 1477; child + caregiver arm: n = 391; child‐only arm: n = 322 Baseline imbalances between relevant groups: not reported Total number analyzed by relevant group: number analyzed differed by outcome variable but for this review was assessed as the number of children with "behavior" data at the end of the intervention and included the following: total: n = 1091; child + caregiver arm: n = 297; child‐only arm: n = 252 Attrition by relevant group: attrition rates differed by variable but for this review were calculated by dividing the number of children without "behavior" data (which includes the habit of eating breakfast and spending on or consuming various foods) at the end of the intervention by the number of children with data at baseline: child + caregiver arm: 24.0% (94/391); child‐only arm: 21.7% (70/322) Description of sample for baseline characteristics reported above: not applicable |
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Interventions |
Intervention characteristics Child + caregiver arm (intervention group)
Child‐only arm (control group)
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Outcomes | The following instrument was used to measure outcomes relevant to this review at baseline and at end of school term (end of intervention)
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Identification |
Study name: not reported Country: China Setting: elementary schools in Xuzhuo City, China Types of reports: published journal article and Masters thesis Comments: used the following reports: Wang 2007b, as well as a thesis by Zhao 2006 Author's name: Cannan Wang Email: wcnseu@126.com Conflicts of interest: not reported Sponsorship source: Jiangsu Province Preventive Medicine Scientific Research Fund |
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Notes | Chinese‐English data extraction was completed by Yuan Chi and Andrew Ying | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation | Unclear risk | Judgment comment: information was insufficient to permit judgment |
Allocation concealment | Unclear risk | Judgment comment: methods used to conceal the allocation sequence were not described |
Blinding of participants and personnel All outcomes | Unclear risk | Judgment comment: no information on blinding of participants and personnel was provided. However, given the nature of the intervention, there would have been no way to blind participants and personnel. Also, the children were aged approximately 7 and 11 years, and their performance may or may not have been influenced by lack of blinding |
Blinding of outcome assessment All outcomes | Unclear risk | Judgment comment: no information on blinding of outcome assessors was provided. Because data were reported by study participants, outcomes may or may not have been influenced by lack of blinding |
Incomplete outcome data All outcomes | High risk | Judgment comment: we calculated attrition rates by dividing the number of participating children without behavior data at the end of the intervention by the number of children with data at baseline. Total attrition was 26.1% (386/1477) for the study overall and 22.0% (164/713) for the 2 relevant study arms. Differential attrition for the 2 relevant study arms was 2.3% (94/391 vs 70/322) |
Selective reporting | High risk | Judgment comment: the trial was not registered and no protocol was cited that could be retrieved. Although dietary outcomes were measured, they did not align with dietary outcomes analyzed in this review |
Recruitment bias | Low risk | Judgment comment: randomization was carried out after participant recruitment but before baseline data collection |
Baseline imbalance | Unclear risk | Judgment comment: not reported; however, the distribution of female‐to‐male students was similar across study arms, as was the distribution of children by grade |
Loss of clusters | Low risk | Judgment comment: no clusters were lost |
Incorrect analysis | Unclear risk | Judgment comment: information was insufficient to permit judgment |
Comparability with individually randomized trials | Unclear risk | Judgment comment: information was insufficient to permit judgment |
Other sources of bias | Low risk | Judgment comment: we detected no other sources of bias |