Condition category
Not Applicable
Date applied
01/10/2017
Date assigned
03/10/2017
Last edited
03/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 measures

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

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

http://ihi.or.tz/

Funders

Funder type

Government

Funder name

Grand Challenges Canada

Alternative name(s)

Grands Défis Canada

Funding Body Type

government organisation

Funding Body Subtype

Federal/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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes