Plain English Summary
Background and study aims
It is estimated that that 20 million low-birth-weight babies are born each year, 314 million children under 5 years of age experience mild to severe stunting, and over 200 million children are not meeting their developmental and cognitive potential. Reducing the number of Tanzanian children facing these early life adversities is vital given the large negative long-term consequences of early developmental delays in terms of individual earnings and social capital. Children experiencing in utero or early childhood adversity generally enrol later in school (if they enrol at all), perform poorly on academic tests, complete less education than their peers, and have reduced personal income later in life. Accordingly, improving early life environments will likely not only improve child growth and development in the short run, but also contribute to more educated and productive future societies. The aim of this study is to assess a child growth and development intervention package delivered by community health workers (CHWs) in Morogoro Region, Tanzania. The study also looks at whether conditional cash transfers for antenatal care and well-child clinic visits improve child growth and development.
Who can participate?
Pregnant women and mothers/caregivers of infants under 1 year of age
What does the study involve?
Participating villages are randomly allocated to one of three groups. In the first group CHWs deliver the intervention package once a month in the home. In the second group CHWs deliver the intervention package once a month in the home and also conditional cash transfers to promote antenatal care and child growth monitoring clinic visits. The third group receive standard care. Participants receive the interventions for a duration of 18 months. The total duration of follow-up is 18 months. Child development and height are assessed at 9 and 18 months.
What are the possible benefits and risks of participating?
The benefit of participating is that children may receive health and development benefits from the intervention. There are no expected risks associated with participation.
Where is the study run from?
Ifakara Health Institute (Tanzania)
When is the study starting and how long is it expected to run for?
March 2017 to February 2019
Who is funding the study?
Grand Challenges Canada
Who is the main contact?
1. Dr Honorati Masanja
2. Dr Christopher Sudfeld
Trial website
Contact information
Type
Scientific
Primary contact
Dr Honorati Masanja
ORCID ID
Contact details
Ifakara Health Institute
Plot 463
Kiko Avenue
Mikocheni
Dar es Salaam
PO Box 78 373
Tanzania
Type
Scientific
Additional contact
Dr Christopher Sudfeld
ORCID ID
Contact details
677 Huntington Ave
Boston
02115
United States of America
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R-SB-POC-1707-09024
Study information
Scientific title
Effectiveness of approaches to deliver integrated solutions for optimal child growth and development in Tanzania
Acronym
Study hypothesis
1. Community health worker (CHW) delivery of evidence-based nutrition and responsive stimulation intervention package improves child growth and development.
2. Cash transfers conditioned on antenatal care and well-child clinic visits improve child growth and development.
Ethics approval
1. Ifakara Health Institute IRB, 31/03/2017, ref: 007-2017
2. National Health Research Ethics Sub-Committee, 17/07/2017, ref: NIMR/HQ/R.8a/Vol.IX/2538
3. Harvard School of Public Health IRB, 20/07/2017, ref: IRB17-1001
Study design
Single-centre cluster-randomized trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Child growth and development
Intervention
This study is a pilot cluster-randomized trial to evaluate integrated supply and demand sided platforms to deliver a child growth and development intervention package in Morogoro Region, Tanzania. 12 villages will be randomized within strata of peri-urban (6 villages) and rural (6 villages) to one of three study arms:
1. CHWs Only: CHWs deliver a nutrition and responsive stimulation caregiver intervention package once a month in the home
2. CHWs + CCT: CHWs deliver a nutrition and responsive stimulation caregiver intervention package once a month in the home plus conditional cash transfers to promote ANC and child growth monitoring clinic visits
3. Control: Participants will receive standard of care
Villages receive the randomized treatment for a duration of 18 months. The total duration of follow-up is 18 months.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Child development measured by the Bayley Scale of Child Development, 3rd edition at 9 and 18 months
2. Child height-for-age z-score assessed at 9 and 18 months
Secondary outcome measures
1. Attendance to ANC and child health visits assessed by health cards at 9 and 18 months
2. Caregiver parenting knowledge assessed by the Caregiver Knowledge of Child Development Inventory at 9 and 18 months
3. Child weight-for-height z-score assessed at 9 and 18 months
4. Child weight-for-age z-score assessed at 9 and 18 months
Overall trial start date
01/03/2017
Overall trial end date
28/02/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. The trial will be conducted in 12 village clusters which will include ~600 mother/caregiver-infant pairs
2. During the study recruitment time period, pregnant women and mother/primary caregiver of an infant <1 year of age are eligible for enrollment
3. All mothers/primary caregivers must provide informed consent
Participant type
Healthy volunteer
Age group
Mixed
Gender
Both
Target number of participants
12 village clusters with an estimated 50 mother/caregiver-infant pairs in each cluster
Participant exclusion criteria
Infants <1 years at the time of enrollment with signs of severe physical or mental impairments
Recruitment start date
25/09/2017
Recruitment end date
10/11/2017
Locations
Countries of recruitment
Tanzania
Trial participating centre
Morogoro Region, Tanzania
-
Tanzania
Sponsor information
Organisation
Ifakara Health Institute
Sponsor details
Plot 463
Kiko Avenue Mikocheni
Dar es Salaam
PO Box 78 373
Tanzania
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Grand Challenges Canada
Alternative name(s)
Grands Défis Canada
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Canada
Results and Publications
Publication and dissemination plan
The trialists plan to publish the results in a high-impact peer reviewed journal around 1 year after trial end.
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available.
Intention to publish date
28/02/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2019 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/31132997 (added 29/05/2019)