Effectiveness of approaches to deliver integrated solutions for optimal child growth and development in Tanzania
| ISRCTN | ISRCTN10323949 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10323949 |
| Secondary identifying numbers | R-SB-POC-1707-09024 |
- Submission date
- 01/10/2017
- Registration date
- 03/10/2017
- Last edited
- 29/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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 May 2019
Who is funding the study?
Grand Challenges Canada
Who is the main contact?
1. Dr Honorati Masanja
2. Dr Christopher Sudfeld
Contact information
Scientific
Ifakara Health Institute
Plot 463, Kiko Avenue
Mikocheni
Dar es Salaam
PO Box 78 373
Tanzania
Scientific
677 Huntington Ave
Boston
02115
United States of America
Study information
| Study design | Single-centre cluster-randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effectiveness of approaches to deliver integrated solutions for optimal child growth and development in Tanzania |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2017 |
| Completion date | 10/05/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 12 village clusters with an estimated 50 mother/caregiver-infant pairs in each cluster |
| Total final enrolment | 593 |
| Key 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 |
| Key exclusion criteria | Infants <1 years at the time of enrollment with signs of severe physical or mental impairments |
| Date of first enrolment | 14/09/2017 |
| Date of final enrolment | 31/10/2017 |
Locations
Countries of recruitment
- Tanzania
Study participating centre
Tanzania
Sponsor information
Research organisation
Plot 463, Kiko Avenue Mikocheni
Dar es Salaam
PO Box 78 373
Tanzania
| Website | http://ihi.or.tz/ |
|---|---|
"ROR" |
https://ror.org/04js17g72 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Grands Défis Canada, GCC
- Location
- Canada
Results and Publications
| Intention to publish date | 31/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The datasets generated during and/or analysed during the current study are/will be available upon request from csudfeld@hsph.harvard.edu. Deidentified individual participant data (including data dictionaries) may be made available, in addition to study protocols, the statistical analysis plan, and the informed consent form. The data may be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal and obtain the necessary ethical approvals. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/05/2019 | 29/05/2019 | Yes | No |
| Results article | results | 13/12/2020 | 02/02/2021 | Yes | No |
| Results article | 01/04/2021 | 29/04/2021 | Yes | No |
Editorial Notes
29/04/2021: Publication reference added.
02/02/2021: Publication reference, total final enrolment and IPD sharing statement added.
03/06/2020: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/06/2019 to 10/05/2019.
2. The recruitment start date was changed from 25/09/2017 to 14/09/2017.
3. The recruitment end date was changed from 10/11/2017 to 31/10/2017.
4. The intention to publish date was changed from 28/02/2020 to 31/08/2020.
11/02/2020: The overall trial end date has been changed from 28/02/2019 to 30/06/2019 and the plain English summary has been updated to reflect this change.
29/05/2019: Publication reference added.
