Pellerano 2014.
Study characteristics | ||
Methods |
Study design: cRCT Study grouping: parallel How were missing data handled? HHs that were living elsewhere or unavailable for interview for other reasons were dropped from the study. Analysis was limited to panelled HHs that were observed both at baseline and follow‐up (25% of the original sample not analysed). Randomisation ratio: 1:1 (clusters = EDs) Recruitment method: field workers visited each randomly selected HH, where the head of each HH was interviewed. In case the head of the HH/carer was N/A, any knowledgeable member of the HH aged > 18 years qualified for the interview. Sample size justification and outcome used: NR Sampling method: multistage stratified random cluster sampling. Within 10 community councils, 96 EDs were randomly allocated to the CGP programme or not (primary sampling units) in public lottery events that took place in each ED. EDs that were selected for the programme were paired with EDs that were not (48 pairs). Of these, 40 pairs were randomly selected. Within each selected ED, 2 villages (or clusters) were randomly selected (secondary sampling units). In every cluster, a random sample of 20 HHs (10 eligible and 10 non‐eligible at baseline) were randomly selected and interviewed. Study aim or objective: to assess the direct impact of the CGP on the well‐being of eligible HHs. To assess the indirect impact of the CGP on non‐eligible HHs (data not extracted). Study period: 2 years; September 2011–2013 Unit of allocation or exposure: EDs (HHs within these were then selected based on eligibility criteria). |
|
Participants |
Baseline characteristics Intervention or exposure
Control
Overall: NR Inclusion criteria: ultra‐poor HHs with any child aged 0–17 years in 10 selected community councils spread across 5 districts. Ultra‐poor HHs were identified by members of their community and by collection of proxy indicators of HH wealth, captured in the National Information System for Social Assistance (NISSA – HHs had to be categorised as NISSA 1 or NISSA 2) Exclusion criteria: NR Pretreatment: baseline differences between HHs in the intervention and control group included number of children aged 0–5 years (P < 0.01), females aged 18–59 years (P < 0.05), and proportion of HHs that borrowed or received support from other family members, friends or neighbours (P < 0.05) (data included eligible and non‐eligible HHs in treatment and control groups – not disaggregated for only eligible HHs). Attrition per relevant group: intervention group: 5% (41/747); control group: (12%; 92/739); main reason for LTFU: moved outside the cluster. Description of subgroups measured and reported: none reported Total number completed and analysed per relevant group: total: 1353 HHs (91%); intervention group: 706 HHs; control group: 647 HHs. Only 75% of children were in both baseline and follow‐up surveys (attrition: 25%) Total number enrolled per relevant group: intervention group: 747 HHs; control group: 739 HHs Total number randomised per relevant group: total: 48 EDs in 5 districts. Intervention: 24 EDs; control: 24 EDs. |
|
Interventions |
Intervention characteristics Intervention or exposure
Control: no intervention |
|
Outcomes | Real monthly total consumption expenditure; monthly amount spent on food Food security: proportion of children aged 0–5 and 6–17 years with severe food deprivation (FSI); number of months in which HHs had sufficient/some shortage/extreme shortage food to meet their needs Dietary diversity: DDI; FCS; proportion of HHs with poor/borderline/acceptable food consumption Anthropometry: weight; underweight Morbidity: proportion of children ill in previous month; mean number of days children ill in previous month. Adverse event: overweight |
|
Identification |
Sponsorship source: Oxford Policy Management (OPM) was contracted by UNICEF to design and undertake an independent evaluation of Round 2 Phase 1 of the CGP pilot. Country: Lesotho Setting: rural HHs Author's name: Luca Pellerano Email: luca.pellerano@opml.co.uk Declarations of interest: NR Study or programme name and acronym: Lesotho Child Grants Programme (CGP) Type of record: report |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (Selection bias) | Low risk | Randomisation took place through public lottery events in each community council. |
Allocation concealment (Selection bias) | Low risk | Allocation was at the ED level, in public lottery events. |
Baseline characteristics similar (Selection bias) | Low risk | A number of baseline differences reported between HHs in the intervention and control group despite the matching of electoral districts (primary sampling unit), followed by random sampling of clusters (secondary sampling units). These include number of children aged 0–5 years (P < 0.01), women aged 18–59 years (P < 0.05), price of rubber boots in the community (P < 0.05), and proportion of HHs that borrowed or received support from other family members, friends or neighbours (P < 0.05). The study authors used the DID method and adjusted for baseline imbalances in their analyses. |
Baseline outcome measurements similar (Selection bias) | Low risk | HHs in both groups were similar at baseline in terms of outcome measurements such as HH food consumption, HH food security and expenditure on food. |
Blinding of participants and personnel (Performance bias) | Low risk | No blinding possible. This was unlikely to introduce performance bias. |
Blinding of outcome assessment (Detection bias) | High risk | Outcomes were measured by self‐report in questionnaire. Self‐reported outcomes could have been influenced by knowledge of treatment allocation. |
Protection against contamination (Performance bias) | Low risk | CGP administrative records indicated that no eligible HHs in control areas received the intervention. |
Incomplete outcome data (Attrition bias) | Low risk | Differential attrition (12% in control group; 8% in intervention group), mainly due to more HHs in the control group that moved outside their clusters. The study authors adjusted sampling weights for selective non‐response in their analysis by calculating the probability of HHs being retained in the sample on the basis of key HH characteristics at baseline. Loss of clusters (cRCT): low risk. No loss of complete clusters (villages) reported. |
Selective outcome reporting (Reporting bias) | Unclear risk | No study protocol available. |
Other bias | Unclear risk | Misclassification bias: low risk. Measurement bias: low risk. Trained fieldworkers. Used a 7‐day dietary recall 8 food groups at baseline and follow‐up. Incorrect analysis: low risk. Estimates adjusted for clustering. Recruitment bias: low risk. Villages (clusters) were sampled before randomisation of electoral districts to the intervention or control group. Seasonality bias: low risk. |