Measuring the Impact of Touch Health’s watotoCare on Medium to High Risk Newborns in Tanzania

Last registered on June 22, 2026
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Pre-Trial

Trial Information

General Information

Title
Measuring the Impact of Touch Health’s watotoCare on Medium to High Risk Newborns in Tanzania
RCT ID
AEARCTR-0018936
Initial registration date
June 15, 2026

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
June 22, 2026, 6:41 AM EDT

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

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Primary Investigator

Name
Alix Bonargent
Affiliation
IDinsight
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Other Primary Investigator(s)

PI Name
Alison Connor
PI Affiliation
IDinsight
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PI Name
Martha Mkony
PI Affiliation
MUHAS
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PI Name
Grace Muriithi
PI Affiliation
IDinsight
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PI Name
Catherine Wambura
PI Affiliation
IDinsight
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Additional Trial Information

Status
In development
Start date
2026-10-05
End date
2028-02-29
Keywords
Behavior, Health
Additional Keywords
neonatal health, postnatal care, post-discharge follow-up, newborn survival, telehealth, mHealth, early child development
JEL code(s)
Primary: I12 (Health Behavior); I15 (Health and Economic Development); I18 (Health: Government Policy, Regulation, Public Health); J13 (Children; Youth) ; C93 (Field Experiments)
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Tanzania records 24 neonatal deaths per 1,000 live births. Rising facility delivery (skilled attendance up from 66% to 85%, 2015–2022) has not produced a matching fall in newborn deaths. The gap is sharpest after discharge: the postnatal period carries the most newborn deaths but the lowest care coverage, and structured contact with the health system is often lost once mother and baby leave the facility.

watotoCare (Touch Health) is a post-discharge support programme that matches follow-up intensity to clinical risk, through three components: Educate: a pre-discharge knowledge session for all mothers. Telehealth: home-based teleconsultations for medium- and high-risk newborns. Transports: subsidised facility transport for high-risk infants. The evaluation aims to determine whether the program leads to improved health outcomes for medium and high-risk neonates to inform the delivery of postnatal care in Tanzania. This will be done through an individually-randomised controlled trial (1:1) across four district hospitals.

Outcomes: Primary outcomes are interval growth and head circumference. Secondary outcomes include PNC completion, age-appropriate immunisation, exclusive breastfeeding, caretaker-infant interaction, caretaker knowledge of neonatal danger signs and early child development.
External Link(s)

Registration Citation

Citation
Bonargent, Alix et al. 2026. "Measuring the Impact of Touch Health’s watotoCare on Medium to High Risk Newborns in Tanzania ." AEA RCT Registry. June 22. https://doi.org/10.1257/rct.18936-1.0
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Experimental Details

Interventions

Intervention(s)
watotoCare is a tiered, post-discharge support programme delivered by clinical risk. It has three components: Educate, a pre-discharge knowledge session for all mothers; Telehealth, home-based teleconsultations facilitated by community drivers for medium- and high-risk newborns; and Transports, subsidised facility transport for high-risk infants. The treatment arm is offered the full package by risk level; the control arm receives the standard of care plus the universal Educate session.
Intervention Start Date
2026-10-05
Intervention End Date
2027-10-01

Primary Outcomes

Primary Outcomes (end points)
(1) interval growth, measured as weight-for-age and length-for-age Z-scores; (2) head circumference-for-age Z-score (HCAZ). Measured at the 49-day and 3-4 month follow-ups.
Primary Outcomes (explanation)
All anthropometric outcomes are expressed as age-standardised Z-scores using WHO growth standards. Interval growth is the change in weight and length between measurement points. Exact age at measurement is recorded, and all analyses are age-adjusted.

Secondary Outcomes

Secondary Outcomes (end points)
PNC completion (at least four visits); exclusive breastfeeding; maternal-infant interaction; maternal knowledge of neonatal danger signs; appropriate care-seeking; completion of age-appropriate immunisations; and early child development.
Secondary Outcomes (explanation)
PNC completion will be obtained through caregiver report, with a subset complemented by facility-register verification.
Exclusive breastfeeding is measured through maternal report using the DHS-style recall. Maternal-infant interaction: a postnatal bonding and interaction screen.
Danger-sign knowledge through prompted and unprompted recall of a list of danger-signs from the WHO-recommended PNC knowledge list.
Immunisation obtained from the child health card plus maternal report, with register verification. Early child development is measured through the Short Global Scales for Early Development (Short GSED), as age-standardised Z-scores. Most are measured at 49 days, except for immunisation and early child development, which will be measured at 3–4 months.

Experimental Design

Experimental Design
A prospective, individually-randomised controlled trial with 1:1 allocation, stratified by facility and risk classification at discharge, across four public district hospitals. Eligible participants are neonates classified as medium- or high-risk at discharge, together with their mothers.
Experimental Design Details
Not available
Randomization Method
Computer-generated, using pre-generated randomisation sequences. Assignment is applied automatically at enrolment through a tablet-based system, so caregivers, health facility providers, and enrolment officers cannot influence allocation.
Randomization Unit
Individual (mother-neonate pair), stratified by facility and risk classification
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
0
Sample size: planned number of observations
approximately 2,134 mother-neonate pairs in total (two arms at 1:1)
Sample size (or number of clusters) by treatment arms
1,067 per arm under the primary scenario
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Power calculations were done for individual participants, assuming a two-sided test with a 5% significance level and 80% power. We plan to enrol 1,067 participants per arm, with a scenario of 10% loss to follow-up by the second visit. For the main continuous outcome, head circumference for age Z-score at 42, we can detect a difference of about 0.13 SD. For binary outcomes, exclusive breastfeeding and immunisation, the design can detect about a 7 percentage point difference. For postnatal care completion, the study can detect about a 6 percentage point difference. These detectable effects are consistent with effect sizes seen in similar maternal and newborn health programs in low- and middle-income countries.
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number
Analysis Plan