Supplementary appendix This appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors. Supplement to: Stewart CP, Kariger P, Fernald L, et al. Effects of water quality, sanitation, handwashing, and nutritional interventions on child development in rural Kenya (WASH Benefits Kenya): a cluster-randomised controlled trial. Lancet Child Adolesc Health 2018; published online Feb 12. http://dx.doi.org/10.1016/ S2352-4642(18)30025-7.
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Supplementary appendix Supplementary methods Extended Ages and Stages Questionnaire The child communication, gross motor, personal-social, and global development scores were derived
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Supplementary appendixThis appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors.
Supplement to: Stewart CP, Kariger P, Fernald L, et al. Effects of water quality, sanitation, handwashing, and nutritional interventions on child development in rural Kenya (WASH Benefits Kenya): a cluster-randomised controlled trial. Lancet Child Adolesc Health 2018; published online Feb 12. http://dx.doi.org/10.1016/S2352-4642(18)30025-7.
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Supplementary Information for the WASH Benefits Kenya Child Development Paper
TABLE OF CONTENTS Supplementary methods ...................................................................................................................2
Table S1: Nutrient Content of the Lipid-based Nutrient Supplement (LNS) used in WASH Benefits compared to the WHO/FAO Recommended Nutrient Intakes (RNI)1 for children 1-3 years .................................................................................................................................................3
Table S2: Uptake of target behaviors at baseline and after one and two years after the start of intervention delivery ........................................................................................................................4
Table S3: Comparison of the rate of motor milestone attainment between groups, adjusted for potential covariates ......................................................................................................................... 5 Table S4: Differences between groups in scores on the Extended Ages and Stages Questionnaire, adjusted for potential covariates ..................................................................................................... 6 Table S5: Standardized differences in scores on the communication, gross motor, and personal social scales of the Extended Ages and Stages Questionnaire using inverse probability of censoring weighted (IPCW) analysis ...............................................................................................7 Table S6: Effect modification with child gender .............................................................................8 Table S7: Effect modification with maternal parity ....................................................................... 9 Table S8: Effect modification with maternal age ......................................................................... 10 Table S9: Effect modification with maternal education ............................................................... 11 Table S10: Effect modification with food insecurity .....................................................................12 Table S11: Effect modification with socioeconomic status .......................................................... 13 Table S12: CONSORT Abstract checklist ....................................................................................14 Table S13: CONSORT Checklist (Extension for cluster designs) ............................................... 15
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Supplementary methods Extended Ages and Stages Questionnaire The child communication, gross motor, personal-social, and global development scores were derived from the Extended Ages and Stages Questionnaire adapted from Squires and Bricker1, which is primarily a parental report measure of child developmental progression. In addition, the child was also asked to demonstrate certain items. In the communication domain, this included: pointing to 7 or more body parts, pointing to one or more named pictures (e.g. “Show me the cow”), naming an action taking place in a picture (e.g. children sleeping, eating, playing, or reading a book). In the gross motor domain, this included: kicking a ball by swinging leg forward without holding onto anything for balance, throwing ball overhand. In the personal-social domain, this included: child recognizing self in the mirror, child offering toy to own image reflected in mirror. The item sets in the age ranges of the study children greatly overlapped, so that all children were directly observed performing at least one of the above items per domain. Data analysis In secondary, adjusted analyses, we pre‐screened covariates to assess whether they were associated with each outcome using the likelihood ratio test. We excluded covariates that had little variation in the study population (e.g., prevalence <5%). The variables we considered included age, sex, birth order, maternal age, height and education, number of children <18 in the household, total number of people in the compound, household food insecurity, housing materials, household asset index, animal ownership, distance to water source, month of measurement, and enumerator who administered the questionnaire as potential covariates. We also examined potential effect modification with a pre‐specified list of variables including: child sex, maternal parity (first pregnancy vs. second or greater pregnancy), maternal age (<20 years old vs. ≥ 20 years old), maternal education (low education, defined as completion of primary schooling only vs. high education, defined as secondary schooling and above), household hunger (little‐to‐no hunger vs. moderate‐to‐severe hunger), and household socioeconomic status (lowest 4 quintiles vs. highest quintile). We included interaction terms in the statistical models and have presented all results stratified by category. Because there was missing data on >20% of the enrolled study cohort, we also conducted an inverse probability of censoring-weighted analysis that reconstructs the original enrolled population.2 This enabled us to examine if there was evidence of bias in the results due to high losses to follow-up. References: 1. Squires J, Bricker D, Potter L. Revision of a parent-completed development screening tool:
Ages and Stages Questionnaires. J Pediatr Psychol 1997, 22:313-328. 2. Hernan MA, Hernandez-Diaz S, Robins JM. A structural approach to selection bias.
Epidemiology 2004; 15(5): 615-25.
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Table Supplementary Table 1. Nutrient Content of the Lipid-based Nutrient Supplement (LNS) used in WASH Benefits compared to the WHO/FAO Recommended Nutrient Intakes (RNI)1 for children 1-3 years
*RNI=Recommended Nutrient Intake; LNS=Lipid-based nutrient supplement; RDA=Recommended Dietary Allowance; WHO = World Health Organization; FAO = Food and Agriculture Organization of the United Nations ‡ In malaria endemic areas, it is recommended that the supplement be split into two 10 g servings in one day to reduce the iron consumed in a single bolus dose. Although malaria is less common in Bangladesh, we recommended that children consume two 10 g sachets per day in both trials.
§ The calcium, phosphorus, and magnesium content of LNS do not meet 100% of the RNI for technical reasons
¶ The Institute of Medicine RDA level for copper for infants 1-3 y is shown here.2 ** The RNI for iron and zinc is that assumed under a diet of low bioavailability. ‡‡ WASH Benefits Bangladesh used encapsulated ferrous sulfate, similar to other LNS products on the market. Ferrous fumarate was used in Kenya due to an interaction between ferrous sulfate and polyphenols in the commonly consumed millet flour.
References: 1. WHO and FAO, Vitamin and Mineral Requirements in Human Nutrition. Second Edition ed. 2004, Geneva, Switzerland:
World Health Organization.2. Institute of Medicine, Dietary Reference Intakes: The essential guide to nutrient requirements. 2006, Washington, DC:
National Academies Press.
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Supplementary Table 2: Uptake of target behaviors at baseline and after one and two years after the start of intervention delivery
Active Control Passive Control Water Sanitation Handwashing WSH Nutrition Nutrition+WSH
Free chlorine in drinking water and lipid-based nutrient supplement (LNS) consumption were not measured at enrollment and were only measured in a subset of arms. LNS adherence measured as
proportion of 14 sachets consumed in the past week among index children ages 6-24 months (reported). WSH: combined water, sanitation, handwashing. Data previously reported in Null C, Stewart CP, Pickering AJ, et al. Lancet Global Health, 2018 http://dx.doi.org/10.1016/S2214-109X(18)30005-6
Supplementary Table 3: Comparison of the rate of motor milestone attainment between groups, adjusted for potentialcovariates.1
Hazard Ratio Hazard Ratio Hazard Ratio
Outcome N vs. Control (95% CI) vs. WSH (95% CI) vs. Nutrition (95% CI)
Standing with assistanceActive Control 1245 Ref
Passive Control 621 0.94 (0.81, 1.10)
Water 607 1.13 (0.95, 1.34)Sanitation 585 0.96 (0.82, 1.13)
* p<0.05, ** p<0.01, *** p<0.0011Potential adjustment for child age.2Potential adjustment for Model 1 covariates as well as child sex, birth order, maternal age, maternal height,maternal education, number under 18y in household, number in compound, household hunger scale, floor material,
roof material, household asset index, cattle ownership, goat ownership, dog ownership, poultry ownership, distanceto water source, field staff interviewer, and month of measurement.
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Supplementary Table 5: Standardized differences in scores on the communication, gross motor, and personal socialscales of the Extended Ages and Stages Questionnaire using inverse probability of censoring weighted (IPCW) analysis.
Mean Difference Mean Difference Mean Difference
Outcome N Mean (SD) vs. Control (95% CI) vs. WSH (95% CI) vs. Nutrition (95% CI)
Item Standard Checklist item Extension for cluster trials Reported in section:
Title Identification of study as randomised
Identification of study as cluster randomised
In Title
Trial design Description of the trial design (e.g. parallel, cluster, non-inferiority)
In Methods
Methods Participants Eligibility criteria for participants
and the settings where the data were collected
Eligibility criteria for clusters In Methods
Interventions Interventions intended for each group
In Methods
Objective Specific objective or hypothesis Whether objective or hypothesis pertains to the cluster level, the individual participant level or both
In Background
Outcome Clearly defined primary outcome for this report
Whether the primary outcome pertains to the cluster level, the individual participant level or both
In Methods
Randomization How participants were allocated to interventions
How clusters were allocated to interventions
In Methods
Blinding (masking) Whether or not participants, care givers, and those assessing the outcomes were blinded to group assignment
In Methods
Results Numbers randomized Number of participants randomized
to each group Number of clusters randomized to each group
In Findings
Numbers analysed Number of participants analysed in each group
Number of clusters analysed in each group
In Findings
Outcome For the primary outcome, a result for each group and the estimated effect size and its precision
Results at the cluster or individual participant level as applicable for each primary outcome
In Findings
Harms Harms or side effects Not applicable Conclusions General interpretation of the results In Interpretation Trial registration Registration number and name of
trial register In Methods
Funding Source of funding In Funding
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Supplementary Table 13: CONSORT Checklist
Section/Topic Item No
Standard Checklist item Extension for cluster designs Reported in section:
Title and abstract 1a Identification as a randomised
trial in the title Identification as a cluster randomised trial in the title
Title
1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)
See table 2 Abstract
Introduction Background and objectives
2a Scientific background and explanation of rationale
Rationale for using a cluster design
Introduction
2b Specific objectives or hypotheses
Whether objectives pertain to the the cluster level, the individual participant level or both
Introduction, last paragraph
Methods Trial design 3a Description of trial design
(such as parallel, factorial) including allocation ratio
Definition of cluster and description of how the design features apply to the clusters
Methods (Study design)
3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons
Methods (Procedures, Last sentence of 3rd paragraph)
Participants 4a Eligibility criteria for participants
Eligibility criteria for clusters Methods (Participants)
4b Settings and locations where the data were collected
Methods (Study design)
Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered
Whether interventions pertain to the cluster level, the individual participant level or both
Methods (Procedures)
Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed
Whether outcome measures pertain to the cluster level, the individual participant level or both
Methods (Outcomes)
6b Any changes to trial outcomes after the trial commenced, with reasons
Sample size 7a How sample size was determined
Method of calculation, number of clusters(s) (and whether equal or unequal cluster sizes are assumed), cluster size, a coefficient of intracluster correlation (ICC or k), and an indication of its uncertainty
Methods (Statistical analysis, 1st paragraph)
7b When applicable, explanation of any interim analyses and stopping guidelines
Not applicable
Randomisation: Sequence generation
8a Method used to generate the random allocation sequence
Methods (Randomization and masking)
8b Type of randomisation; details of any restriction (such as blocking and block size)
Details of stratification or matching if used
Methods (Randomization and masking)
Allocation concealment mechanism
9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned
Specification that allocation was based on clusters rather than individuals and whether allocation concealment (if any) was at the cluster level, the individual participant level or both
Methods (Randomization and masking)
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Implementation
10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions
Replace by 10a, 10b and 10c
10a
Who generated the random allocation sequence, who enrolled clusters, and who assigned clusters to interventions
Methods (Randomization and masking)
10b
Mechanism by which individual participants were included in clusters for the purposes of the trial (such as complete enumeration, random sampling)
Methods (Participants)
10c
From whom consent was sought (representatives of the cluster, or individual cluster members, or both), and whether consent was sought before or after randomisation
Methods (Study design, last paragraph)
Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how
Methods (Randomization and masking)
11b If relevant, description of the similarity of interventions
Methods (Procedures)
Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes
How clustering was taken into account
Methods (Statistical analysis, 2nd and 3rd paragraphs)
12b Methods for additional analyses, such as subgroup analyses and adjusted analyses
Methods (Statistical analysis, 3rd paragraph) Supplemental material
Results Participant flow (a diagram is strongly recommended)
13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome
For each group, the numbers of clusters that were randomly assigned, received intended treatment, and were analysed for the primary outcome
Figure 1
13b For each group, losses and exclusions after randomisation, together with reasons
For each group, losses and exclusions for both clusters and individual cluster members
Figure 1
Recruitment 14a Dates defining the periods of recruitment and follow-up
Results, 1st paragraph
14b Why the trial ended or was stopped
Not applicable
Baseline data 15 A table showing baseline demographic and clinical characteristics for each group
Baseline characteristics for the individual and cluster levels as applicable for each group
Table 1
Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups
For each group, number of clusters included in each analysis
Figure 1
Outcomes and estimation
17a For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)
Results at the individual or cluster level as applicable and a coefficient of intracluster correlation (ICC or k) for each primary outcome
Results 4th and 5th paragraphs Tables 2-4 Figure 2
17b For binary outcomes, presentation of both absolute
Not applicable
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and relative effect sizes is recommended
Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory
Supplementary material
Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)