Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001526268
Ethics application status
Approved
Date submitted
6/09/2018
Date registered
12/09/2018
Date last updated
5/11/2019
Date data sharing statement initially provided
5/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Early Childhood Development Information Campaign for Mothers
Scientific title
Early Childhood Development and Parental Involvement: The role of information and maternal knowledge on developmental outcomes of children aged one to three years
Secondary ID [1] 295906 0
Nil known
Universal Trial Number (UTN)
U1111-1219-4251
Trial acronym
InfoCamp
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 309585 0
Motor skill development 309586 0
Early childhood development 309587 0
Condition category
Condition code
Public Health 308241 308241 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will run an information campaign with mothers on caring of children aged 1-3 years and examine the association between maternal knowledge on child development and developmental outcomes of their children in the short and medium run in a resource poor setting. This will be a randomized controlled trial (RCT) on early childhood development (ECD) implemented in southwestern rural Bangladesh. In particular, mothers who have children in this age range at present will be invited to participate in a set of three information sessions on rearing and caring of 1-3 years old children. Sessions will focus primarily on child nutrition and feeding, hygiene practice in child caring, and home environment favorable to child development.

The intervention will be delivered in the mode of specially developed modules of brief curricula through a set of three information sessions. Mothers will learn more about aforesaid topics, and easy and affordable way to translate those into daily practices. Briefly, the curricula will cover 1) aspects of child nutrition and feeding practice i.e. breastfeeding, complementary feeding, balance diet for infant and young and children, way of feeding (frequency, time and attention, utensils used); 2) importance of maintaining hygiene in child caring, daily cleanliness, safe food handling (cooking, serving, and storing food), and overall cleanliness in and around household; 3) immunization of children (i.e. importance and information on total course of nationally available immunization for children); and 4) home environment favorable to child development i.e. parent-child engagement (e.g. talking to, playing with, and where possible reading to children), interaction with elder siblings and other family members, and growth stimulants (e.g. toys, story books for children, physical activity for motor development, taking children out). The intervention will promote optimal and efficient utilization of existing and available resources and services.

Fortnightly half-day (four hours), face-to-face group sessions will be facilitated by locally recruited science graduates with a minimum of three years work experience in the field on behavior change communication (BCC). Three half-day (four hours), weekly, face-to-face, refresher group sessions will follow after three months since the commencement of the intervention where previously discussed topics will be revised for better retention of knowledge. Each group will include 6-10 participants. The sessions will be participatory and interactive. Participants would discuss their experience and share knowledge along with learning new information on child development.

In one of the treatment arms, informative sessions and refreshers will be complemented by fortnightly home visits by trained facilitators/fieldworkers to support mothers to put learning into practice and observe progress. Therefore, the intervention includes
Treatment A: Information sessions + Refresher sessions
Treatment B: Information sessions + Refresher sessions + fortnightly Home visits for 6 months.
Control group households will be regularly invited to participate in community based cultural events and activities to encourage them to continue their participation in the project.
Intervention code [1] 312230 0
Lifestyle
Comparator / control treatment
The proposed intervention will be a randomized controlled trial, covering 140 villages in southwestern rural Bangladesh. Randomization will be carried out at the village level. 140 villages will be randomized into treatment and control arms. One child per household will be surveyed at baseline and endline. We plan to obtain 6-12 children of 1-3 years old from each village, living in closer neighbourhoods, lottery will be used in selecting the children in villages/neighbourhood where there are more than 12 children in this age group. Thus, children in the same household will have an equal chance to be assessed. No intervention will be given in the control arm. Control arm households will be regularly invited to participate in community based cultural events and activities to encourage them to continue their participation in the project.
Control group
Active

Outcomes
Primary outcome [1] 307212 0
Change in level of maternal knowledge on child development as assessed using knowledge on child nutrition and feeding, hygiene practice in child caring, and home environment favorable to child development. Changes will be measured using questionnaire specifically designed for this study.
Timepoint [1] 307212 0
Primary outcomes will be measured in January 2020

Longer term outcomes will be measured between June and July, 2021.
Primary outcome [2] 307213 0
Age appropriate Ages and Stages Questionnaire (ASQ) will be administered to assess gross and fine motor, communication, problem solving, and personal social. This would be more appropriate in order to allow mothers some time to incorporate their newly gained knowledge into practice, and the change due to intervention to be reflected. The change in measure was reconsidered after consulting local experts working with children in that age group. The change was made after enrolling a third of the participants
Timepoint [2] 307213 0
Primary outcomes will be measured in January 2020

Longer term outcomes will be measured between June and July, 2021.
Primary outcome [3] 307214 0
Standard anthropometry as assessed by measuring height-for-age (HAZ), weight-for-age (WAZ), and weight-for-height (WHZ). Weight will be measuring using standard digital scale capable of measuring up150kg. Tared weighing will be applied for children aged less than two years of children more than two years but cannot stand. Length board, measuring in centimeter will be used to measure length of children aged less than two years and for determining height of children older than two but cannot stand. Measuring tapes will be used for measuring height of children aged two and above.
Timepoint [3] 307214 0
Primary outcomes will be measured in January 2020

Longer term outcomes will be measured between June and July, 2021.
Secondary outcome [1] 351135 0
Change of attitude towards child immunization both targeted and older children in the households in short and medium run. Changes will be assessed using a questionnaire specifically developed for the study.
Timepoint [1] 351135 0
Six months and two years after completion of intervention.
Secondary outcome [2] 351136 0
Change of pattern of health care expenditure on children both targeted and older children in the households in short and medium run. Changes will be assessed using a questionnaire specifically developed for the study.
Timepoint [2] 351136 0
Secondary outcomes will be measured in January 2020

Longer term outcomes will be measured between June and July, 2021.

Eligibility
Key inclusion criteria
Female and male children aged 1-3 years and their mothers living in 140 study villages randomized into two treatment and one control arm will have the opportunity to be included in the intervention. Children in the same age group from households randomized into control arm (containing 60 villages) will be considered as control group.
Minimum age
1 Years
Maximum age
48 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Female and male children aged less than a year (or 12 months) and more than three years (or 36 months) and their mothers will be excluded from the intervention.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization using computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using Stata (version 14).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistical analyses and logistic regression models will be used in analyzing the effects of the intervention on children’s health and developmental outcomes.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
12/11/2018
Actual
19/10/2018
Date of last participant enrolment
Anticipated
Actual
22/11/2018
Date of last data collection
Anticipated
31/01/2020
Actual
Sample size
Target
1000
Accrual to date
Final
1802
Recruitment outside Australia
Country [1] 20802 0
Bangladesh
State/province [1] 20802 0
Khulna

Funding & Sponsors
Funding source category [1] 300498 0
University
Name [1] 300498 0
Monash University
Country [1] 300498 0
Australia
Funding source category [2] 300504 0
University
Name [2] 300504 0
Economic and Social Research Council of United Kingdom
Country [2] 300504 0
United Kingdom
Funding source category [3] 300505 0
Government body
Name [3] 300505 0
Global Development & Research Initiative
Country [3] 300505 0
Bangladesh
Primary sponsor type
Individual
Name
Dr Asadul Islam
Address
Monash Business School
Monash University
Building H, Room # H4.37, Caulfield Campus
Caulfield East VIC 3145
Australia

Country
Australia
Secondary sponsor category [1] 299974 0
University
Name [1] 299974 0
Monash University
Address [1] 299974 0
Monash University
Caulfield East VIC 3145
Melbourne
Australia
Country [1] 299974 0
Australia
Secondary sponsor category [2] 299980 0
Individual
Name [2] 299980 0
Dr. Ummul Ruthbah
Address [2] 299980 0
Centre for Development Economics and Sustainability (CDES)
Monash University
Caulfield East VIC 3145
Country [2] 299980 0
Australia
Other collaborator category [1] 280323 0
Individual
Name [1] 280323 0
Tabassum Rahman
Address [1] 280323 0
School of Medicine and Public Health
University of Newcastle, Callaghan Campus, NSW 2308
Country [1] 280323 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301295 0
Monash University Human Research Ethics Committee [MUHREC]
Ethics committee address [1] 301295 0
Ethics committee country [1] 301295 0
Australia
Date submitted for ethics approval [1] 301295 0
06/09/2018
Approval date [1] 301295 0
17/10/2018
Ethics approval number [1] 301295 0
2018-16911-24520

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86530 0
Prof Asadul Islam
Address 86530 0
Professor Asadul Islam, PhD
Monash Business School
Room # H4.37, Building H
Monash University
Caulfield Campus
Caulfield East VIC 3145 Australia
Country 86530 0
Australia
Phone 86530 0
+61 3 9903 2783
Fax 86530 0
+61 3 990 31128
Email 86530 0
[email protected]
Contact person for public queries
Name 86531 0
Asadul Islam
Address 86531 0
Professor Asadul Islam, PhD
Monash Business School
Room # H4.37, Building H
Monash University
Caulfield Campus
Caulfield East VIC 3145 Australia
Country 86531 0
Australia
Phone 86531 0
+61 3 9903 2783
Fax 86531 0
+61 3 990 31128
Email 86531 0
[email protected]
Contact person for scientific queries
Name 86532 0
Asadul Islam
Address 86532 0
Professor Asadul Islam, PhD
Monash Business School
Room # H4.37, Building H
Monash University
Caulfield Campus
Caulfield East VIC 3145 Australia
Country 86532 0
Australia
Phone 86532 0
+61 3 9903 2783
Fax 86532 0
+61 3 990 31128
Email 86532 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data of published results only.
When will data be available (start and end dates)?
Immediately after publication, no date to be decided.
Available to whom?
Only researchers who provide a methodologically sound proposal, and case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5557Ethical approval    375868-(Uploaded-22-10-2019-23-36-29)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.