Tonguet Papucci 2015.
Study characteristics | ||
Methods |
Study design: cRCT Study grouping: parallel group How were missing data handled? influence of missing data assessed using a sensitivity analysis using multiple imputation to account for missing values. Children without ≥ 2 measurements or excluded from the analysis. Authors employed ITT analysis. Randomisation ratio: 1:1 (16 control villages and 16 intervention villages) Recruitment method: initial recruitment by approaching a village representative (normally village head and his/her committee) to obtain consent for participation of village following an explanation of aims of research. Individual informed consent then sought from individual HH representatives (usually mothers) following explanation of research aim, sequence of activities and procedures, and risks and benefits of participation. Sample size justification and outcome used: Houngbe: type I error of 5%, a statistical power of 90% and a minimum follow‐up time of 24 months, assuming a 33% reduction in the cumulative incidence of wasting, a coefficient of variation K of 0.25 and an anticipated 25% dropout, 16 clusters with 50 children were required in each study group. Tonguet‐Papucci: to detect a decrease with 33% in the cumulative incidence of wasting assuming a baseline incidence rate of wasting of 0.26 per child‐year with a Type I error of 5%, a statistical power of 90% and a minimum follow‐up of 24 months, assuming a coefficient of variation K of 0.25, 16 clusters of 50 HHs per cluster were necessary per study group. This calculation accounted for an anticipated 25% drop‐out. Sampling method: villages randomly assigned to intervention and control groups during a ceremony to keep the allocation of cash transparent and fair. Representatives of each of 32 villages drew blindly from a bag 1 of the 32 identical papers with 'cash' or 'no cash' written on it. Within villages, HH participation in study was voluntary and based on inclusion criteria. How 32 villages in 3 municipalities were selected was NR. Study aim or objective: Houngbe: "to assess the impact of a cash transfer programme in reducing the incidence of acute malnutrition and morbidity and the prevalence of stunting in children aged 36 months. Study period: June 2013 to October 2015 Unit of allocation or exposure: villages |
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Participants |
Baseline characteristics Intervention or exposure
Control
Overall: NR Inclusion criteria: HHs classified as poor or very poor according to the Household Economy Approach; with ≥ 1 child aged < 1 year at time of inclusion, regardless of nutritional status; children with ≥ 2 follow‐up measurements. Exclusion criteria: NR Pretreatment: overall, baseline characteristics were balanced between groups. Children in intervention group were more likely to be 1 month younger and more wasted than children in the control group. Attrition per relevant group: Houngbe 2017: intervention group: 2.2% (14/644) of children; control group: 2.2% (14/634) of children. Intervention: 14 children LTFU at visit 2 (12 deaths and 2 left study area); excluded from analysis. Additional LTFU: 43 children LTFU between visits 3 and 9 (reasons: 35 deaths; 8 left study area); control: 14 children LTFU at visit 2 (10 deaths, 4 wrongly included); excluded from analysis. Additional LTFU: 28 LTFU between visits 3 and 9 (reasons: 22 deaths; 6 left study area). Description of subgroups measured and reported: NR Total number completed and analysed per relevant group: intervention: 630 children analysed; control: 620 children analysed Total number enrolled per relevant group: Houngbe 2017: intervention: 644 children from 602 HHs; control: 634 children from 583 HHs. Total number randomised per relevant group: total 1278 children from 32 villages randomised; intervention: 644; control: 634. |
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Interventions |
Intervention characteristics Intervention or exposure
Control
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Outcomes | Dietary diversity: DDS; MDD; minimum acceptable diet; proportion consuming iron‐rich or iron‐fortified foods Anthropometry: incidence of wasting; HAZ; WHZ; incidence of stunting; MUAC Morbidity: incidence diarrhoeal disease; incidence ARIs |
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Identification |
Sponsorship source: Houngbe et al 2017: Action Against Hunger France and the CDC, European Commission's Humanitarian Aid and Civil Protection department, USAID (through the Technical Operational Performance Support programme) and Foundation Action Against Hunger (France) for research and innovation supported research uptake and the dissemination of results. The cash transfer programme was funded by European Commission's Humanitarian Aid and Civil Protection department. 1 study author supported by the CGIAR Research Program on Agriculture for Nutrition and Health (A4NH), led by the International Food Policy Research Institute. Tonguet‐Papucci: study funded by Actino Contre la Faim – France and the Center for Disease Control. The cash transfer programme was made possible thanks to ECHO funds. The cost‐effectiveness analysis is co‐funded by Action Contre la Faim and the Nutrition Embedding Evaluation Program (NEEP, PATH‐DFID). Country: Burkina Faso Setting: poor and very poor rural HHs in eastern Burkina Faso Comments: registered at clinicaltrials.gov as NCT01866124. Authors' names: F Houngbe; A Tonguet‐Papucci Email: fhoungbe@actioncontrelafaim.org; apapucci@actioncontrelafaim.org Declarations of interest: yes; Houngbe: "J‐FH, LH, and PK, no conflicts of interest. FH, AT‐P, CA, and MA‐A are employed by Action Against Hunger France, which implemented the MAM'Out study." Tonguet‐Papucci: "The authors declare that they have no competing interests." Study or programme name and acronym: Moderate Acute Malnutrition Out (MAM'Out) research project/study Type of record: Houngbe: journal article. Tonguet‐Papucci: study protocol |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (Selection bias) | Low risk | Quote: "Villages were randomly assigned to the intervention and control groups during a ceremony in order to keep the allocation of cash transparent and fair. Representatives of each of the 32 villages drew blindly from a bag one of the 32 identical papers with "cash" or "no cash" written on it." |
Allocation concealment (Selection bias) | Low risk | Allocation to intervention groups was by village at the beginning of the study. |
Baseline characteristics similar (Selection bias) | Low risk | Quote: "Overall, baseline characteristics were balanced between the intervention and the control groups (Table 1)." Comment: intervention group had more young children (aged < 6 years) compared to control group but all analyses adjusted for child's age at baseline. In addition, Houngbe 2017 reported that adjustment had been done for important prognostic covariates. |
Baseline outcome measurements similar (Selection bias) | Low risk | Children in intervention group were more likely to be wasted. No morbidity outcomes measured at baseline. Analysis adjusted for morbidity status and WHZ at baseline. |
Blinding of participants and personnel (Performance bias) | Low risk | No blinding possible but this was unlikely to affect participant behaviour. |
Blinding of outcome assessment (Detection bias) | High risk | Outcome assessors were not blinded to treatment assignment. Morbidity outcomes were recalled by mothers and these could have been influenced by knowledge of treatment allocation. |
Protection against contamination (Performance bias) | Low risk | Allocation was by village and it was unlikely that control villages received treatment. Given the cluster randomised design of the study combined with poor and very poor participants who likely did not travel to other villages often, the risk of contamination was not judged to be appreciable. |
Incomplete outcome data (Attrition bias) | Low risk | Attrition was not high: 99/1278 (7.8%) children enrolled LTFU, due to either death or leaving the study area. 57/644 (8.9%) children in intervention group and 42/634 (6.6%) children in control group LTFU from visits 1 to 9. Data from children with < 2 measurements were excluded: 14 (2.2%) children in intervention group (2.2%) and 14 (2.2%) children in control group were excluded. |
Selective outcome reporting (Reporting bias) | High risk | Some morbidity outcomes reported in the protocol were NR in published paper (oedema and measles). |
Other bias | Unclear risk | Misclassification bias: unlikely. Measurement bias: unlikely. Incorrect analysis: unclear. Adjusted for clustering. Poisson regression model adjusted for clustering by village, household and child. The payment ('compensations') for the time control participants spent on the study may have resulted in volunteer bias, which may have altered effect sizes. Furthermore, the payment in itself was not meaningfully different from the intervention (though no values were specified) and may have influenced outcomes as well. |