The impact of pre-emptive home delivery of ORS + zinc on treatment for child diarrhea: a randomized controlled in Bauchi, Nigeria

Last registered on April 02, 2024


Trial Information

General Information

The impact of pre-emptive home delivery of ORS + zinc on treatment for child diarrhea: a randomized controlled in Bauchi, Nigeria
Initial registration date
April 01, 2024

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
April 02, 2024, 12:51 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.



Primary Investigator


Other Primary Investigator(s)

PI Affiliation
PI Affiliation
PI Affiliation
University of Benin

Additional Trial Information

In development
Start date
End date
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
We will use a cluster randomized controlled trail to measure the effect of delivering oral rehydration salts (ORS) and zinc –– highly effective and WHO recommended treatments for child diarrhea –– to homes with children under the age of 5 years in Bauchi, Nigeria. Half of the 323 wards in Bauchi will be randomly assigned to receive the free deliveries and the other half will be the control group. We will collect data through household surveys continuously for 12 months following the deliveries. The primary outcome will be the probability that a diarrhea cases that occurred within 4 weeks of survey was treated with ORS. We will measure the average effect on ORS use over 6-months, over 12-months, and monthly. Results will be used to inform whether this intervention should be scaled-up nationwide and in other settings, and also how frequently deliveries should take place to maximize cost-effectiveness.
External Link(s)

Registration Citation

Bonds, Stephanie et al. 2024. "The impact of pre-emptive home delivery of ORS + zinc on treatment for child diarrhea: a randomized controlled in Bauchi, Nigeria." AEA RCT Registry. April 02.
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Experimental Details


The intervention will involve pre-emptive distribution of two co-packs of ORS+zinc per child to every household with at least one child under the age of five. Each co-pack includes two sachets of ORS and one strip of 10 zinc tablets, enough to be able to treat two cases of child diarrhea. This research will evaluate the impact of one round of deliveries.
Intervention Start Date
Intervention End Date

Primary Outcomes

Primary Outcomes (end points)
The primary outcome for the study is self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks. We will measure this outcome average over 6 months, 12 months, and monthly.
Primary Outcomes (explanation)
This will be measured through a series of survey questions which ask caretakers who reported having a child who had a diarrhea episode in the past 4 weeks the following set of questions:
1. “Did you give [child name] anything to treat the Diarrhea?”
2. If yes to Q1, “can you tell me or show me what treatments you gave [child name] either home-prepared or from outside of home?” Do not prompt responses.
3. If ORS not mentioned in Q2, “did you give the child any ORS to treat the diarrhea?”
Our main outcome variable will be a binary variable that is set to 1 if the respondent reports that they used ORS in 2 or 3 and to 0 if they reported that they did not use ORS in 2 and 3 or if they reported that they gave no treatment to the child in (1). We will conduct a sensitivity analysis where we use only the unprompted response from (2) to create our ORS use variable.

Secondary Outcomes

Secondary Outcomes (end points)
Zinc + ORS use
Antibiotic use
Zinc use alone
Time to ORS initiation
Exposure to unsafe drinking water
Willingness to purchase new ORS packets
Child mortality; all cause and from diarrhea
Hospitalization from diarrhea
Number of diarrhea episodes
Care seeking outside the home
Wastage of ORS and zinc packets
Receipt of ORS and zinc delivery
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
We will randomize wards to treatment or control groups before baseline data are collected. We will randomly assign wards to either of the two groups listed below, and let the randomization dictate which of the two groups end up with an extra ward:
• Group 1 – Delayed-Start Control (cN = ~162): No intervention will take place until after endline data collection in completed, after which the wards in the Control group will receive the intervention. During the study period, the caregivers in this group will have standard access to ORS and zinc at local health facilities and pharmacies. Some community health workers (called Community Health Influencers and Promoters, and Services or CHIPS(16)) in control villages could make household visits; however, we do not expect any delivery of ORS or zinc in the control group as CHIPS are generally not the source of diarrhea treatment.(12)
• Group 2 – Household Visit + Information + Free pre-emptive distribution of ORS (cN = ~162): Campaigners recruited by CHAI will be paid NGN40 for each household visited in their catchment area that contain a child under 5 years old at the beginning of the study. During the distribution visits, the campaigners will train caregivers on the dangers of diarrhea and the importance of ORS and zinc use, among other things (including how to prepare, use, and store ORS/zinc, benefits of the treatments, recommended health behaviors such as seeking care, and encouraging basic handwashing and hygiene practices). The caregivers will also receive a flyer describing the same information in their local language, for future reference. Campaigners will then distribute 2 ORS and zinc co-packs (each co-pack contains 2 sachets of ORS and 10 tablets of zinc) for free for each child under the age of five in the household.

The participant and the intervention implementer will not be blinded to the random assignment due to the nature of the intervention.
Experimental Design Details
Not available
Randomization Method
in office by computer
Randomization Unit
Ward (sub-state geographic regions)
Was the treatment clustered?

Experiment Characteristics

Sample size: planned number of clusters
Sample size: planned number of observations
68000 households. We expect 13% diarrhea prevalence in the previous 4 weeks which would give ~9000 diarrhea cases.
Sample size (or number of clusters) by treatment arms
161 clusters per arm
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Assuming a cRCT design with two-point data collection, a diarrhea prevalence rate of 13% (for a conservative MDE estimation) with an expected number of diarrhea cases per cluster of roughly 14 at endline, a control endline ORS use rate of 40%,(13) and a conservative intra-class correlation (ICC) of 0.2, we will be sufficiently powered to detect a minimum difference of 7.8 percentage points in ORS use between control and intervention groups over months 1-6.(19) Under the same assumptions, the study will be sufficiently powered to detect a minimum difference of 7.3 p.p. in ORS use between the two groups over the study period (12 months). The pooled estimate of the impact over six months and twelve months will be our primary analysis, but we will also conduct analyses to assess the impact in each month. However, since we will sample only 288 EAs per month, and to maximize power, we will expect to sample 288 wards, these parameters will allow for a minimum detectable effect (MDE) in each of the twelve months following the deliveries of 11.2 p.p. per month. Table 2 shows what MDEs will be if the ICC is 0.15 or 0.1 instead of 0.2.

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number
Analysis Plan

Analysis Plan Documents

ORS Study Protocol v1.2_2024.03.14_clean.pdf

MD5: a3ae0829c62145954f705beed87924e4

SHA1: 72a345f47a6050f61066d39807e134ada5c92f79

Uploaded At: April 01, 2024