Chen 2019.
Study characteristics | ||
Methods |
Study design: cRCT Study grouping: parallel group How were missing data handled? data from non‐boarding students and from boarding students who did not have Hb concentration, height and weight measurements were excluded from the analysis. Randomisation ratio: 1:1:2 (nutrition subsidy intervention:nutrition subsidy + monetary incentive intervention:control) Recruitment method: in each 1 of 30 townships, with the necessary permission from the Chinese government, schools were chosen if they offered fourth and fifth grade classes and accommodated ≥ 400 students. Once schools were selected, written assent was requested from students and their parents. Written consent was also requested from the students' legal guardians at school (schoolmasters and head teachers). Sample size justification and outcome used: NR Sampling method: 30 townships were randomly selected from 2 provincial‐level administration units, Qinghai Province and Ningxia Autonomous Region. Schools were selected from these townships and all fourth and fifth graders from these schools with assent and consent were included. Study aim or objective: how does the provision of nutrition subsidies translate into observed nutritional and health outcomes? Will policy targets with different levels of specificity, e.g. general ones such as malnutrition prevention and specific ones such as anaemia reduction, lead to different behavioural responses and, thus, nutritional and health outcomes, partly through different incentives attached to these policy targets (since certain incentives are presumably needed to achieve any specific policy target)? Study period: October 2009–May 2010 Unit of allocation or exposure: cluster: elementary schools |
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Participants |
Baseline characteristics Nutrition subsidy
Nutrition subsidy + monetary incentive
Control
Overall: NR Inclusion criteria: townships: located in Qinghai Province or Ningxia Autonomous Region. Schools: offering fourth and fifth grade classes; accommodating ≥ 400 students. Children: fourth or fifth grade students; written assent provided; consent from guardians provided; boarding (to be included in analysis). Exclusion criteria: NR Pretreatment: baseline characteristics and outcome variables presented in Table A1 and 2. Table A1: most variables were quite balanced across groups, with minor differences due to sampling errors, suggesting that the random group assignments were done reasonably well. However, due to the modest number (i.e. 59) of project schools, some student or school characteristics may have been balanced across the 3 groups (Appendix A Table A1), even under randomised group assignments. To address this issue, the authors modified the estimating equation. Quote: "Unless otherwise stated, all estimates presented below are obtained after controlling for the full set of covariates reported in Appendix A Table A1." Attrition per relevant group: 61% of boarding students (who were considered in the analysis) were not analysed because they did not have health information collected due to budgetary reasons. Considering the full sample of 6994, attrition was 88%. Description of subgroups measured and reported: NR Total number completed and analysed per relevant group: to fully capture the impacts of the treatments, the authors' analysis focused only on the 2199 boarding students in the sample (of 6994 students). Due to budgetary reasons, while dietary information was collected from all (boarding) students, health information was collected only from about half of them: 1020 boarding students had information on Hb concentration level, 952 had height and weight information, and 866 had both sets of information. Thus, the final analytical sample comprised 866 boarding students with information available on all 3 dimensions. Students: 219/582 (38%) for nutrition subsidy; 210/563 (36%) for nutrition subsidy + monetary incentive; 437/1550 (28%) for control group. Total number enrolled per relevant group: total sample 6994. Not clear per group, as only reported on those with Hb and height/weight information. Total number randomised per relevant group: total of 15 schools for nutrition subsidy, 15 for nutrition subsidy + monetary incentive and 29 for control group. |
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Interventions |
Intervention characteristics Nutrition subsidy (treatment group 1)
Nutrition subsidy + monetary incentive (treatment group 2)
Control: no intervention |
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Outcomes | DDS (0–10) Anthropometry: BMZ; proportion underweight (BMZ < –2SD) Biochemical: Hb concentration Morbidity: proportion anaemic |
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Identification |
Sponsorship source: National Natural Science Foundation of China [grant number 71603261]; Humanities and Social Science Fund of the Ministry of Education of China [grant numbers 16YJC880107, 18YJC790010]; The Fundamental Research Funds for the Central Universities [grant number 2019TC110]. Country: China Setting: fourth and fifth graders enrolled in elementary schools in rural Qinghai and Ningxia Authors' names: Qihui Chen; corresponding: Qiran Zhao Email: zhaoqiran@cau.edu.cn Declarations of interest: yes; no conflicts of interest. Study or programme name and acronym: NR Type of record: journal article |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (Selection bias) | Unclear risk | No information provided how the random sequence generation is done. Only (quote): "schools were randomly assigned into three groups." |
Allocation concealment (Selection bias) | Low risk | Unit of allocation was by school; all assignments were done at start of study. |
Baseline characteristics similar (Selection bias) | Unclear risk | Low for the analysed group, but no data available for the entire group. Quote: "Due to both randomisation plus taking this into account during the analysis. Baseline characteristics and outcome variables presented in Table A1 and 2. Table A1: Most of these variables are quite balanced across groups, with minor differences due to sampling errors, suggesting that the random group assignments were done reasonably well." "However, due to the modest number (i.e., 59) of project schools, some student or school characteristics may not be perfectly balanced across the three groups (Appendix A Table A1), even under randomized group assignments. To address this issue, we modify the estimating equation (1) in two ways." "Unless otherwise stated, all estimates presented below are obtained after controlling for the full set of covariates reported in Appendix A Table A1." |
Baseline outcome measurements similar (Selection bias) | Unclear risk | Low for the analysed group, but no data available for the entire group. Quote: "Due to both randomisation plus taking this into account during the analysis. Baseline characteristics and outcome variables presented in Table A1 and 2. Table A1: Most of these variables are quite balanced across groups, with minor differences due to sampling errors, suggesting that the random group assignments were done reasonably well." "However, due to the modest number (i.e., 59) of project schools, some student or school characteristics may not be perfectly balanced across the three groups (Appendix A Table A1), even under randomized group assignments. To address this issue, we modify the estimating equation (1) in two ways." "Unless otherwise stated, all estimates presented below are obtained after controlling for the full set of covariates reported in Appendix A Table A1." |
Blinding of participants and personnel (Performance bias) | High risk | Not explicitly reported whether students and school staff were blinded to assignment. Given the integral role of the schoolmaster in administering the intervention and their access to information on anaemia; however, it is not possible that these people could be blinded. The lack of blinding may have resulted in considerable performance bias, specifically in the group of schoolmasters not receiving incentives. |
Blinding of outcome assessment (Detection bias) | High risk | NR whether the medical professionals who assessed some outcomes were blinded. Most outcomes were objective and not prone to detection bias, but outcomes such as dietary diversity may have been affected by unblinded self‐report from participants. |
Protection against contamination (Performance bias) | Low risk | Since payment was made into the school account and information was provided to the headmasters, contamination at school level was not expected. Furthermore, only boarders were analysed: boarding arrangement ensures that almost all the food consumed by boarding students came from the intervention. |
Incomplete outcome data (Attrition bias) | High risk | Very high levels of attrition among students: 363/582 (62%) for nutrition subsidy; 353/563 (64%) for nutrition subsidy + monetary incentive; 1113/1550 (72%) for control group. This is predominantly due to only including boarding students with Hb and anthropometric data, as well as the loss of 1 control cluster. Attrition appears to be differential for the control group versus the intervention groups. |
Selective outcome reporting (Reporting bias) | Unclear risk | No study protocol available. |
Other bias | Unclear risk | Recruitment bias: randomisation of schools occurred after students had been recruited; low risk. Incorrect analysis: adjustment for clustering NR, but robust SEs used; unclear risk. |