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Trial registered on ANZCTR


Registration number
ACTRN12623000659606
Ethics application status
Approved
Date submitted
3/05/2023
Date registered
19/06/2023
Date last updated
18/09/2023
Date data sharing statement initially provided
19/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Maternal Beliefs, Mental Health, and Economic Resources on Human Capital Accumulation in Early Life
Scientific title
The Effect of Maternal Beliefs, Mental Health, and Economic Resources on Human Capital Accumulation in Early Life
Secondary ID [1] 309562 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maternal well-being 329858 0
Condition category
Condition code
Public Health 326765 326765 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will provide three interventions through the Kapasia Model of Maternal and Child Health (henceforth, Kapasia Model):
1) In treatment 1, project officers employed by the research team, who will be located in study area, will provide information over the phone to each treated household on their eligibility (yes or no) of government’s cash and food transfer programs, as well as where and how to enrol, and assistance with enrolment for eligible mothers.

Treatment 2 involves providing information to pregnant mothers and their families on the importance of the early-life environment, and especially the 9-month in utero period, in laying the foundations for a child’s lifelong success. Eligible and willing participants who would be randomly assigned to receive this treatment will be contacted by our project officers, and the officer will provide the following information over the phone:
“A healthy pregnancy, wherein mothers take care of themselves and their children during their pregnancy, is extremely important for their children health and economic outcomes. Starting from as early as the 9th week of pregnancy, mothers who eat nutritious food and think positively give birth to healthier children who grow up to be healthier adults. A healthy diet during pregnancy such as this one, (this is based on study conducted in a similar setting, see: https://bmjopen.bmj.com/content/bmjopen/7/8/e015393.full.pdf)

can protect a child against low birth weight and stunting (short height) in infancy, and psychological problems, and diabetes or hypertension in adulthood. In contrast, children of mothers who suffer from long periods of stress during pregnancy can develop future health problems when they become adults themselves. Therefore, taking nutritious food regularly, managing stress, and thinking positively from the earliest stages of pregnancy are important for the child in the near- as well as in the long-term. It’s never too early to incorporate these positive changes to your routine.”

The third intervention involves offering psychological counselling based on Cognitive Behavioural Therapy, which will be provided by trained counsellors from Moner Bondhu (https://www.monerbondhu.org/). The content will follow the World Health Organization (WHO)-adopted and evidence-based programme called Thinking Healthy, specifically focusing on only the early (pre-delivery) sessions. Thinking Healthy has already been translated and adapted to Bengali (with the full manual for the management of perinatal depression available for free from the WHO website here: https://apps.who.int/iris/bitstream/handle/10665/152936/WHO-MSD-MER-15.1-ben.pdf?ua=1&ua=1. Eligible and willing participants who would be randomly assigned to receive this treatment will be contacted by an officer from Moner Bondhu. Participants will be invited to take part in 4 group counselling sessions, each lasting approximately 1-1.5 hours. The group will consist of other pregnant women from the same village enrolled in this study. We anticipate the groups will be approximately 22 women or less. Counsellors from Moner Bondhu will identify an appropriate venue with comfortable furnishing and privacy to hold the sessions. The sessions will use narratives, or stories, to engage women and then open the floor to discussion on the issues of (1) mother’s physical health, (2) coping with stress, (3) and mother’s relationship with the people around her. They will be modelled after the Thinking Healthy Programme (THP) intervention (https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(18)30467-X/fulltext, specifically see Chapter 2 in the THP Manual, https://www.who.int/publications/i/item/WHO-MSD-MER-15.1). However, we will adapt the sessions to include a focus on identifying and coping with stressors.
Intervention code [1] 325988 0
Treatment: Other
Comparator / control treatment
The control group will receive standard care through the Kapasia Model.. This include access to free community health clinics, immunisations, and public health care.
Control group
Active

Outcomes
Primary outcome [1] 334623 0
Child’s health at birth (birth weight and low birth weight) will be collected from administrative records as well as from parents through visiting their households.
Timepoint [1] 334623 0
Eight months after the start of the interventions, the research team will visit all participants and collect this information through measuring children.
Secondary outcome [1] 421445 0
Parental investment on children (time, monetary, and warmth) will be collected from parents (mothers) by using a survey instrument designed for this study. The components will be combined in an index and will be measured as a composite index.
Timepoint [1] 421445 0
Eight months after the start of the interventions
Secondary outcome [2] 422646 0
Women's empowerment, which will be measured through a battery of questions designed to measure women's empowerment. These questions will be asked to each participating woman at the follow-up survey, which will take place after eight months of the interventions.
Timepoint [2] 422646 0
Eight months after the start of the interventions, the research team will visit all participants and collect this information from all participating women
Secondary outcome [3] 422647 0
Women mental health, which will be collected through PHQ, and GAD7.
Timepoint [3] 422647 0
Eight months after the start of the interventions, the research team will visit all participants and collect this information from all participating women
Secondary outcome [4] 422649 0
Intimate partner violence, which will be measured through a battery of questions designed to measure intimate partner violence. These questions will be asked to each participating woman at the follow-up survey, which will take place after eight months of the interventions.
Timepoint [4] 422649 0
Eight months after the start of the interventions, the research team will visit all participants and collect this information from all participating women
Secondary outcome [5] 422650 0
Stress. Participating women Hair sample will be collected. The analysis of the hair sample is subject to receive additional funding.
Timepoint [5] 422650 0
Eight months after the start of the interventions, the research team will visit all participants and collect this information from all participating women

Eligibility
Key inclusion criteria
Eligibility criteria for inclusion:
1. Listed in the digital database of Kapasia Model
2. Permanent residence of any of the two subdistricts of Gazipur district in Bangladesh
3. Newly married women
4. Pregnant women
5. Mothers with young children aged 6 months or younger
To be eligible, women must fulfill the first and the second criteria, any of the criteria from 3 to 5 must be fulfilled.
Minimum age
16 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.. Non-residents of Gazipur district
2. Not enrolled in the digital database of Kapasia Model

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/09/2023
Actual
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
2640
Accrual to date
Final
Recruitment outside Australia
Country [1] 25425 0
Bangladesh
State/province [1] 25425 0

Funding & Sponsors
Funding source category [1] 313752 0
University
Name [1] 313752 0
J-PAL/EPoD SPI, Research Grant, Massachusetts Institute of Technology, USA
Country [1] 313752 0
United States of America
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, Camperdown, NSW 2006, Australia
Country
Australia
Secondary sponsor category [1] 315571 0
Charities/Societies/Foundations
Name [1] 315571 0
Moner Bondhu
Address [1] 315571 0
2/16, Block B (8th floor), Lalmatia, Dhaka, Bangladesh
Country [1] 315571 0
Bangladesh

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312923 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 312923 0
Research Integrity & Ethics Administration
Research Portfolio
Level 3, F23 Administrative Building
The University of Sydney
NSW 2006, Australia
Ethics committee country [1] 312923 0
Australia
Date submitted for ethics approval [1] 312923 0
Approval date [1] 312923 0
15/03/2023
Ethics approval number [1] 312923 0
2023/004

Summary
Brief summary
Using a novel locally grown health service delivery model in rural Bangladesh that tracks the universe of newly married couples and connects them to local health services, we aim to study whether targeting mothers early in pregnancy with three complementary interventions -- individually or in combination -- can improve their own wellbeing as well as their children’s developmental outcomes. The three interventions that we plan to pilot in a randomized controlled trial are: (1) information on the importance of early life conditions on future outcomes; (2) information and enrolment support to relevant government programs (including health services, cash- and food-transfers); and (3) psychological counselling. Our outcomes of interest include women’s empowerment, parental inputs, physical and mental health, and children’s health and development. Our partnership with the relevant government ministry in Bangladesh and an NGO offers a unique opportunity to implement evidence-based policy at scale.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126350 0
Prof Shyamal Chowdhury
Address 126350 0
Social Sciences Building (A02), Room 548
The University of Sydney
NSW 2006, Australia
Country 126350 0
Australia
Phone 126350 0
+61293517893
Fax 126350 0
Email 126350 0
shyamal.chowdhury@sydney.edu.au
Contact person for public queries
Name 126351 0
Prof Shyamal Chowdhury
Address 126351 0
Social Sciences Building (A02), Room 548
The University of Sydney
NSW 2006, Australia
Country 126351 0
Australia
Phone 126351 0
+61293517893
Fax 126351 0
Email 126351 0
shyamal.chowdhury@sydney.edu.au
Contact person for scientific queries
Name 126352 0
Prof Shyamal Chowdhury
Address 126352 0
Social Sciences Building (A02), Room 548
The University of Sydney
NSW 2006, Australia
Country 126352 0
Australia
Phone 126352 0
+61293517893
Fax 126352 0
Email 126352 0
shyamal.chowdhury@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data collected, after removing the individual and local identifiers, will be made available for research and replication purposes.
When will data be available (start and end dates)?
Once the main results are published in a peer reviewed outlet. The data will remain available in perpetuity.
Available to whom?
Data will be made available to researchers interested in replicating the results.
Available for what types of analyses?
Replication studies.
How or where can data be obtained?
Data will be made available through journals. Most economics journals require to make the data available for replication purposes, and we will comply to that.

After journal publication, data will be made available to researchers if requested. Such request should be sent to the following email address: shyamal.chowdhury@sydney.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19037Study protocol    385823-(Uploaded-01-05-2023-19-38-06)-Study-related document.pdf
19038Ethical approval    385823-(Uploaded-01-05-2023-19-38-41)-Study-related document.pdf
19039Informed consent form    385823-(Uploaded-01-05-2023-19-39-37)-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.