Study characteristics |
Methods |
Study design: controlled prospective study Study grouping: N/A How were missing data handled? to increase the accuracy of the anthropometric indices, implausible values were excluded. Unclear how much data were excluded due to this. No other missing/excluded data reported but according to table 4, data were missing for 10/3000 originally enrolled HHs (7 in intervention group; 3 in control group; both at baseline and follow‐up for each). Randomisation ratio: N/A Recruitment method: NR Sample size justification and outcome used: sample size calculation was primarily to detect meaningful levels of change in the study outcomes compared to the comparison group. Planned to sample only 1 child per HH, hence an equal sample size of 750 HHs at baseline and 750 at follow‐up was obtained in the intervention (1500) as well as the control area (1500). This sample size was adequate to show a 10% effect size for stunting (primary outcome) among children aged < 5 years at 6 years follow‐up (32.9% in the intervention vs 40% in the control) with > 80% power and 5% significance level (2‐sided test), a design effect of 2% and 5% sampling error. The sample size allowed for a 10% non‐response rate. The sample size was adequately powered to detect a 6% effect size in the prevalence of wasting at 6‐year follow‐up and to model associations between outcome and intervention, adjusted for demographics and other variables. Sampling method: the surveys were conducted using a 2‐stage cluster sampling method. The first stage involved identifying clusters (wards) within each district to be included in the study. All wards in each district were listed separately in alphabetical order by VDC. Using the 2011 population census data for each ward (cluster), a cumulative population for all wards was computed. From this cumulative list, the required number of clusters in each district was determined using the probability proportional to size sampling method. In the second stage, HHs within the selected clusters were identified for inclusion in the study. A list of HHs in each selected ward was constructed with the help of the local leaders and UNICEF staff. From the list, a HH was selected using a systematic sampling approach. Only HHs with ≥ 1 child aged < 60 months were eligible for the study. The sampling interval (X) was determined by dividing the total number of HHs in each ward with the expected sample size, and the first HH to be surveyed was randomly selected by choosing a number between 1 and X. For each selected HH, mothers/caretakers of children aged < 5 years volunteered to take part in the surveys, and the interview occurred outside the home, away from other HH members. If the selected HH was not inhabited, or there was no‐one at home, the closest neighbouring HH was used for the survey. Sampled about 30 HHs per cluster in each selected district at baseline, midline and endline surveys. For clusters where the number of HHs was < 25, the selected ward and its adjoining neighbour were merged and treated as a single cluster. In HHs with > 1 child, only 1 child was randomly selected for enumeration. Study aim or objective: to evaluate the effectiveness of the synergetic effect of child sensitive social protection programmes, augmented by a capacity building for social protection and embedded within existing government's TRTs for families on child nutritional status. Study period: 6 years: October–December 2009 (pre) to December 2014–February 2015 (post) Unit of allocation or exposure: district |
Participants |
Baseline characteristics Intervention or exposure
Age: child, mean, months: 28.66 (SD 15.36)
Place of residence: NR
Sex: proportion of girls: 44.8% (SD 49.8%); boys: 55.2% (SD 49.8%)
Ethnicity and language: ethnicity proportion: disadvantaged ethnic groups: 1.5% (SD 12.0%); Dalit Hill/Terai: 21.3% (SD 41.0%); upper caste group: 77.2% (SD 42.0%)
Occupation: NR
Education: proportion of fathers with primary education or less: 2.1% (SD 14.5%); secondary level education: 33.1% (SD 47.1%); intermediate or higher education: 64.8% (SD 47.8%). District total literacy rate: 38.5%
SES: HH Wealth Index, mean: poor: 89.1% (SD 31.2%); middle class: 9.7% (SD 29.6%); rich: 1.2% (SD 11.1%)
Social capital: NR
Nutritional status: proportion stunting: girls: 68; boys: 65.7. Proportion of wasting: girls: 9.3; boys: 15.3
Morbidities: NR
Concomitant or previous care: NR
Control
Age: child, mean, months: 28.08 (SD 15.55)
Place of residence: Bajhang District, Seti Zone
Sex: proportion of girls: 43.7% (SD 49.6%); boys: 56.3% (SD 49.6%)
Ethnicity and language: proportion: disadvantaged ethnic groups: 0.0% (SD 0.0%); Dalit Hill/Terai: 16.8% (SD 37.4%); upper caste group: 83.2% (SD 37.4%)
Occupation: NR
Education: proportion of fathers with primary education or less: 25.9% (SD 43.8%); secondary level education: 26.4% (SD 44.1%); intermediate or higher education: 47.7% (SD 50.0%). District Total literacy rate: 35.5%
SES: Household Wealth Index, mean: poor: 10.1% (SD 30.2%); middle class: 23.9% (SD 42.7%); rich: 65.9% (SD 47.4%)
Social capital: NR
Nutritional status: proportion stunting: girls: 61.9; boys: 63.7. Proportion of wasting: girls: 4.5; boys: 6.6
Morbidities: NR
Concomitant or previous care: NR
Overall: NR Inclusion criteria: HHs with ≥ 1 child aged < 60 months. Exclusion criteria: NR Pretreatment: total literacy rate was higher in the intervention group than the control group (38.5% with intervention vs 35.5% with control). A larger percentage of HHs in the control group were in the middle class or rich categories (measured by Household Wealth Index) than the intervention group (intervention group: poor 89.1%, middle class 9.7%, rich 1.2% compared with control group: poor 10.1%, middle class 23.9%, rich 65.9%). Imbalances were adjusted for using PSM for the analyses. Attrition per relevant group: none reported. According to table 4 and initial enrolment of 1500 HHs per district: data missing for 2 control HHs at baseline and 1 control HH at follow‐up; and for 7 intervention HHs at baseline. Description of subgroups measured and reported: children's age groups: children aged < 5 years (all, girls, boys); children aged > 24 months; children aged < 24 months. Total number completed and analysed per relevant group: total HHs: baseline 1491; follow‐up 1499; control HHs: baseline 748; follow‐up 749; intervention HHs: baseline 743; follow‐up 750 Total number enrolled per relevant group: 3000 HHs; 1500 in intervention district and 1500 in control district Total number randomised per relevant group: N/A |
Interventions |
Intervention characteristics Intervention or exposure
Food access intervention category: increase buying power
Intervention type: CCG + government TRTs for families
Description: intervention district received the TRTs, augmented with a CCG programme introduced in the Government of Nepal's 2009/2010 budget and a capacity building component for social protection (Figure 1). The CCG provides NPR 200 per month for up to 2 children for poor families with children aged < 5 years in Karnali Zone (Kalikot, Jumla, Mugu, Humla and Dolpa) to complement existing social protection schemes for senior citizens, single women, endangered communities and people with disabilities. The Government of Nepal's CCG is an UCT scheme in which allowances are provided to all eligible HHs. The CCG programme has been supported and enhanced by the capacity building for social protection implemented by a UNICEF/Nepal partnership programme, whose aim has been to design and implement complementary interventions, partly funded by the Asian Development Bank through Japan Fund for Poverty Reduction (Table 1). The capacity building for social protection had 4 major components: 1. capacity development of central and local government officials; 2. system development for effective implementation and monitoring of child grant; 3. linking the child grant with nutrition; and 4. grant management, monitoring and audit. The Ministry of Federal Affairs and Local Development (the main executing agency) was responsible for the system development component and the Asia Development Bank together with the Ministry of Federal Affairs and Local Development and the Ministry of Health and Population were responsible for grant management component. (Table 1 of publication for all programme activities).
Duration of intervention period: 6 years
Frequency: assessments were completed and outcome measures recorded pre‐ (October–December 2009) and post‐ (December 2014 to February 2015) intervention. Distribution of child grants to all children aged < 5 years were done every 4 months (3 times a year). In addition, the intervention group had multiple contacts with study partners, including 1. capacity building activities to enhance capacity of local bodies to deliver the child grant, 2. network enhancing activities aimed at improving child nutrition, 3. social BCC on child nutrition, 4. awareness raising activities for timely birth registration to identify all eligible HHs and about the availability of the CCG, 5. assisting mothers/carers to identify the best possible locally available food and encouraging use of cash grant for nutritious foods and the improvement of nutritional status of children, 6. improving the knowledge and skills of CCG beneficiaries in the areas of infant and young child feeding practices, hygiene, sanitation and other key behaviours linked to child nutrition.
Number of study contacts: multiple. Repeat cross‐sectional quasi‐experimental design with measures taken pre‐ (October–December 2009) and post‐ (December 2014 to February 2015) intervention in the intervention community (Kalikot district) and comparison communities (Bajhang district).
Providers: the Ministry of Federal Affairs and Local Development (the main executing agency) was responsible for the system development component and the Asia Development Bank together with the Ministry of Federal Affairs and Local Development and the Ministry of Health and Population were responsible for grant management component. UNICEF was responsible for implementation of the capacity development and linking CCG with nutrition and supported the Government of Nepal's (Ministry of Federal Affairs and Local Development and Ministry of Health and Population) in implementing key strategies underpinning the intervention.
Delivery: the CCG programme was administered and paid for by the Government of Nepal and supported and enhanced by capacity building for social protection implemented by a UNICEF/Nepal partnership programme. UNICEF was responsible for implementation of the capacity development and linking CCGs with nutrition and supported the Government of Nepal (Ministry of Federal Affairs and Local Development and Ministry of Health and Population) in implementing key strategies underpinning the intervention (training, workshops, group meetings, radio messages, campaigns, technical support). The Ministry of Federal Affairs and Local Development (the main executing agency) was responsible for the system development component and the Asia Development Bank together with the Ministry of Federal Affairs and Local Development and the Ministry of Health and Population were responsible for grant management component. The capacity building component was partly funded by the Asian Development Bank through Japan Fund for Poverty Reduction. The intervention was embedded within existing universal social transfer programmes hence ensuring continuity of participation and preventing the disruption in disbursements. The implementation of the intervention involved too many stakeholders with differing expectations and competing objectives, which might have hampered the effective implementation of the project. This challenge was overcome by having clear role and responsibilities and a focal co‐ordinating committee overseen by the Government of Nepal.
Co‐interventions: TRTs
Resource requirements: NR
Economic indicators: NR
Control
Food access intervention category: increase buying power (weaker)
Intervention type: government TRTs for families
Description: government's funded TRTs for families. The TRTs included senior citizens allowance for all people aged ≥ 70 years (NPR 500/month), single women's and widow allowance (NPR 500/month), disability allowance for all people with disability aged ≥ 16 years (NPR 1000/month for total disability and NPR 300/month for partial disability), endangered ethnicities allowance (all HH members receive NPR 500/month), and maternity incentive scheme for pregnant women (NPR 500 in Tarai, NPR 1000 in Hills and NPR 1500 in mountains as transportation costs + NPR 300 provided to health professionals and NPR 1000 reimbursement to facilities + free delivery care).
Duration of intervention period: 6 years
Frequency: monthly transfers across all programmes.
Number of study contacts: repeat cross‐sectional quasi‐experimental design with measures taken pre‐ (October–December 2009) and post‐ (December 2014–February 2015) intervention in the intervention community (Kalikot district) and control communities (Bajhang district).
Providers: government of Nepal
Delivery: government of Nepal
Co‐interventions: TRTs
Resource requirements: NR
Economic indicators: NR
|
Outcomes |
Anthropometry: HAZ; WHZ; WAZ; stunting; wasting; underweight |
Identification |
Sponsorship source: designed and implemented by UNICEF Nepal. The capacity building for social protection element was partly funded by the Asian Development Bank through Japan Fund for Poverty Reduction. The CCG programme introduced in the Government of Nepal's 2009/2010 budget Country: Nepal Setting: poor communities and HHs in 2 districts in Nepal (Bajhang District and Kalikot District) Comments: the study was approved by the Nepal Health Research Council Ethical Review Board (Approval No. 2071‐12‐18; Reg No. 29/2015). Author's name: Andre MN Renzaho Institution: N/A Email: Andre.Renzaho@westernsydney.edu.au Address: N/A Declarations of interest: yes; no conflict of interest. Study or programme name and acronym: Child Cash Grant (CCG) Type of record: journal article |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (Selection bias) |
High risk |
PCS; no randomisation done. |
Allocation concealment (Selection bias) |
High risk |
PCS; no randomisation done. |
Baseline characteristics similar (Selection bias) |
Low risk |
High variability at baseline for some characteristics such as Household Wealth Index (control wealthier than intervention), ethnicity (control group with slightly higher proportion of people from upper caste group whereas intervention group had more people from more disadvantaged ethnic groups), and education (intervention group had higher schooling than comparison group). However, PSM was used for analysis. |
Baseline outcome measurements similar (Selection bias) |
High risk |
Higher proportions of stunting, underweight and wasting in the intervention group at baseline. This was not adjusted for in the analysis. |
Blinding of participants and personnel (Performance bias) |
Low risk |
There was no blinding, but the outcomes were unlikely to be influenced by the lack of blinding. |
Blinding of outcome assessment (Detection bias) |
Low risk |
No blinding possible. Outcomes were objective and not susceptible to influence due to lack of blinding. |
Protection against contamination (Performance bias) |
Low risk |
Allocation at district level and the distance between them acted as a buffer zone, hence minimising the risk of contamination. |
Incomplete outcome data (Attrition bias) |
Low risk |
No missing data reported but they excluded anthropometric data that was biologically implausible. According to table 4 of the publication and initial enrolment of 1500 HHs per district: data missing for 2 control HHs at baseline and 1 control follow‐up; and for 7 intervention HHs at baseline. |
Selective outcome reporting (Reporting bias) |
Unclear risk |
No protocol mentioned. |
Other bias |
Low risk |
Misclassification bias of exposure: low risk; intervention assigned by government. Measurement bias: low risk. |