A Cluster Randomized Control Trial Evaluating the Effectiveness of an Integrated Sanitation and Nutrition Program in Kitui County, Kenya.
Last registered on March 12, 2019

Pre-Trial

Trial Information
General Information
Title
A Cluster Randomized Control Trial Evaluating the Effectiveness of an Integrated Sanitation and Nutrition Program in Kitui County, Kenya.
RCT ID
AEARCTR-0002019
Initial registration date
February 21, 2017
Last updated
March 12, 2019 9:55 AM EDT
Location(s)
Region
Primary Investigator
Affiliation
IDinsight
Other Primary Investigator(s)
PI Affiliation
IDinsight
Additional Trial Information
Status
Completed
Start date
2016-08-01
End date
2017-12-31
Secondary IDs
Bill & Melinda Gates Foundation Grant Investment ID: OPP1124645, KEMRI Protocol No. Non-KEMRI 547
Abstract
While sanitation and nutrition interventions are both associated with better sanitation and nutrition outcomes, these interventions are usually implemented separately. There is limited evidence of programming that has jointly impacted both sanitation and nutrition outcomes. This study seeks to identify the causal impact of an integrated sanitation and nutrition program on knowledge and practices of sanitation and nutrition behaviours in Kitui County, Kenya. Villages will be randomly assigned to either receive the standard Community Led Total Sanitation (CLTS) program or an integrated CLTS+Nutrition intervention. Outcomes of interest include household-level observations of: 1) sanitation practices, including toilet use, handwashing, courtyard cleanliness, child diarrhoea and correct disposal of child faeces; and 2) nutrition practices, including proper breastfeeding, and visits to health facilities.
External Link(s)
Registration Citation
Citation
Gimaiyo, Gerishom and Lilian Lehmann. 2019. "A Cluster Randomized Control Trial Evaluating the Effectiveness of an Integrated Sanitation and Nutrition Program in Kitui County, Kenya. ." AEA RCT Registry. March 12. https://www.socialscienceregistry.org/trials/2019/history/43199
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
The Sannut (Sanitation-Nutrition) intervention is a modified form of the Kenya National Protocol for Community Led Total Sanitation (CLTS). The intervention clarifies with the community the link between open defecation and child malnutrition through (1) the addition of two interactive meetings that sensitize caregivers on proper toddler hygiene and nutrition, and (2) household visits that reinforce these messages. The evaluation is testing the hypothesis of whether additional focus on toddler hygiene and nutrition with community level messaging leads to change in caregiver behaviours/practices that will ultimately reduce the risk of a child becoming malnourished during their first 1000 days.
CLTS activities, which are occurring in both treatment and control villages, consist of the following steps:
1. Pre-trigger involving community mobilization
2. Trigger involving a community meeting where the community is taken through their open defecation practices with the aim of eliciting shame and disgust as part of the realization that members of the community are ingesting each other’s feces. This is intended to compel community members to build and use hand washing stations and latrines.
3. Household follow-ups by designated community members to ensure that each household is adhering to the agreed upon commitments
4. The community claims to have stopped open defecation
5. External evaluators verify that the community is indeed not openly defecating
6. The community is then certified Open Defecation Free (ODF) if the above is confirmed and a celebration is held to laud this status.
The supplemental activities of Sannut (occurring only in the treatment group) that are overlaid on top of traditional CLTS are summarized below:
1. Addition of two caregiver gatherings following the CLTS trigger session to sensitize mothers and other caregivers of children under 2 on the importance of toddler hygiene and nutrition for the health of their children.
2. Household follow-up visits that include, in addition to standard CLTS messaging, the supplemental messages covered in the two caregiver meetings.
Intervention Start Date
2016-08-01
Intervention End Date
2017-04-01
Primary Outcomes
Primary Outcomes (end points)
1. Latrine Use
2. Latrine Structure maintenance
3. Courtyard cleanliness
4. Self-reported Disposal of Child Feces
5. Proper Breastfeeding Practice
6. Health Facility Visits
7. Handwashing infrastructure
8. Handwashing practice
9. Child Diarrhea
10. Sanitation Knowledge
11. Nutrition Knowledge
Primary Outcomes (explanation)
1. Latrine Use. Binary outcome for whether the respondent uses latrine
2. Latrine Structure Maintenance. Score based on observer’s checklist, standardized by control group mean and SD.
3. Courtyard cleanliness. Score based on observer’s checklist, standardized by control group mean and SD.
4. Self-reported Disposal of Child Feces. Binary outcome for whether child feces are disposed of correctly.
5. Proper Breastfeeding Practice. Binary outcome for whether caregiver is properly breastfeeding toddler based on toddler age.
6. Health Facility Visits. (1) Health facility visit in past 2 months, (2) youngest child has received Vitamin A supplement in past 6 months, (3) youngest child has received deworming treatment in past 6 months.
7. Handwashing infrastructure. Binary outcome for whether household has a stocked handwashing facility next to latrine.
8. Handwashing practice. Binary outcome for whether respondent and children are following proper handwashing practice.
9. Child Diarrhea. Each household is assigned a percentage (between 0 and 1) based on the fraction of the children older than 6 months in the household that showed symptoms of diarrhea in the past 2 weeks.
10. Sanitation Knowledge. Score based on observer’s checklist, standardized by control group mean and SD.
11. Nutrition Knowledge. Score based on observer’s checklist, standardized by control group mean and SD.
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
A cluster Randomized Control Trial (RCT) at the level of the village (“kijiji”), where key outcome indicators in the intervention group (receiving supplemental sanitation and nutrition messaging, as an add-on to the standard CLTS) will be compared to a control group (receiving only standard CLTS). Knowledge and practices of both sanitation and nutrition behaviours will be measured. The RCT will yield rigorous, causal estimates of the impact of supplemental nutrition messaging on outcomes of interest. Kijijis are stratified at ward level (unit of administration below the county and above the kijiji).
Experimental Design Details
Randomization Method
Randomization done using Stata software
Randomization Unit
Village
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
627 villages
Sample size: planned number of observations
There will be a maximum of 8 households per cluster for a possible total of 5,016 individuals.
Sample size (or number of clusters) by treatment arms
317 treatment villages and 310 control villages
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
0.175 standard deviations (8.5pp difference between treatment and control in self-reported proper breastfeeding)
Supporting Documents and Materials

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IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Kenya Medical Research Institute
IRB Approval Date
2016-10-31
IRB Approval Number
KEMRI/RES/7/3/1
Analysis Plan
Analysis Plan Documents
Sannut Pre-Analysis Plan

MD5: 2f3a570d8feabd50344fc6ac7ee85ea8

SHA1: 8b2ab5b29c5e01fecf300f9bb4599e05e7b43fbd

Uploaded At: February 17, 2017

Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
Yes
Intervention Completion Date
April 30, 2017, 12:00 AM +00:00
Is data collection complete?
Yes
Data Collection Completion Date
July 05, 2017, 12:00 AM +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
604 villages
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
4,436
Final Sample Size (or Number of Clusters) by Treatment Arms
309 treatment villages and 295 control villages
Data Publication
Data Publication
Is public data available?
No

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Program Files
Program Files
No
Reports and Papers
Preliminary Reports
Relevant Papers
Abstract
Citation
Gimaiyo G, McManus J, Yarri M, et al Can child-focused sanitation and nutrition programming improve health practices and outcomes? Evidence from a randomised controlled trial in Kitui County, Kenya BMJ Global Health 2019;4:e000973.