Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001113448
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
24/09/2025
Date registered
Help: Date registered
13/10/2025
Date last updated
Help: Date last updated
25/03/2026
Date data sharing statement initially provided
Help: Data sharing statement date
13/10/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Mid-term effects of a parenting program on early childhood development and maternal health
Scientific title
Mid-term effects of a parenting program on early childhood development and maternal health in Vietnam: follow-up of a cluster-randomized controlled trial
Additional trial identifiers [1] 315275 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records
This study is a follow-up of ACTRN12617000442303.

Health condition
Health condition(s) studied:
Child cognitive development 338959 0
Child anthropometric indices 338961 0
Maternal cardiovascular health 338962 0
Maternal biological age 338963 0
Maternal mental health 338965 0
Maternal experience of intimate partner violence 338979 0
Condition category
Condition code
Public Health 335248 335248 0 0
Health promotion/education
Cardiovascular 335259 335259 0 0
Normal development and function of the cardiovascular system
Mental Health 335260 335260 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
This is a follow-up study to assess the effects of the intervention 'Learning Clubs' now known as ‘Early Journey of Life’ on women's health and child health and development.

Specific details of the original trial can be found in the registration record for ACTRN12617000442303. In brief, 'Early Journey of Life' comprised 20 educational modules, delivered in face-to-face groups at a community centre and in one home visit. Each session was facilitated by a member of the local Women's Union, who has had experience in conducting community programs and also received training specific to this trial. When required, a community health worker and/or a kindergarten teacher also participated. Each module aimed to increase perinatal stage-specific essential knowledge and skills through structured learning activities that were translated, culturally adapted and field-tested for salience and comprehensibility. The program was implemented in facilitated small groups of women meeting every two to four weeks in community centres from early pregnancy until the end of the first postpartum year (a total of 19 facilitated sessions) and one home visit during the first eight postpartum weeks when mothers and infants in this setting usually do not go out of the house.

Data collection of the original trial was completed in 2021 when the children were two years old. A follow-up study will be conducted to examine the mid-term effects of the intervention. We will re-enrol all mother-child dyads who participated in the original trial and still live in Ha Nam province or Hanoi in Vietnam. As this is a follow-up study, no changes have been made to the intervention. Following re-enrolment, mother-child dyads will complete a questionnaire when the child is approximately seven years old in 2026 and nine years old in 2028. Additionally, when the child is around six years old, a blood sample will be collected from the mothers.
Intervention code [1] 332040 0
Not applicable
Description of the comparator or control
The control group received the usual standard of pregnancy and postpartum health care. This included free antenatal checks, birth in a medical facility and access to the National Growth Monitoring and Expanded Immunisation Programmes in the study ACTRN12617000442303.
Control group
Active

Outcomes
Primary outcome [1] 342850 0
Child cognitive development in middle childhood.
Timepoint [1] 342850 0
When child is 7 and 9 years old
Secondary outcome [1] 452354 0
Child emotional and behavioural development,
Timepoint [1] 452354 0
When child is 7 and 9 years old
Secondary outcome [2] 452355 0
Child quality of life
Timepoint [2] 452355 0
When child is 7 and 9 years old
Secondary outcome [3] 452356 0
Child height
Timepoint [3] 452356 0
When child is 7 and 9 years old
Secondary outcome [4] 452357 0
Child weight
Timepoint [4] 452357 0
When child is 7 and 9 years old
Secondary outcome [5] 452358 0
Child BMI
Timepoint [5] 452358 0
When child is 7 and 9 years old
Secondary outcome [6] 452359 0
Child health conditions
Timepoint [6] 452359 0
When child is 7 and 9 years old
Secondary outcome [7] 452360 0
Child screen time
Timepoint [7] 452360 0
When child is 7 and 9 years old
Secondary outcome [8] 452361 0
Child sleep time
Timepoint [8] 452361 0
When child is 7 and 9 years old
Secondary outcome [9] 452362 0
Child physical activity
Timepoint [9] 452362 0
When child is 7 and 9 years old
Secondary outcome [10] 452363 0
Healthcare practices in middle childhood
Timepoint [10] 452363 0
When child is 7 and 9 years old
Secondary outcome [11] 452364 0
Education practices in middle childhood
Timepoint [11] 452364 0
When child is 7 and 9 years old
Secondary outcome [12] 452365 0
Maternal mental health
Timepoint [12] 452365 0
When child is 7 and 9 years old
Secondary outcome [13] 452366 0
Maternal quality of life
Timepoint [13] 452366 0
When child is 7 and 9 years old
Secondary outcome [14] 452367 0
Parental warmth
Timepoint [14] 452367 0
When child is 7 and 9 years old
Secondary outcome [15] 452368 0
Parental self-efficacy
Timepoint [15] 452368 0
When child is 7 and 9 years old
Secondary outcome [16] 452369 0
Child discipline
Timepoint [16] 452369 0
When child is 7 and 9 years old
Secondary outcome [17] 452370 0
Intimate partner violence
Timepoint [17] 452370 0
When child is 7 and 9 years old
Secondary outcome [18] 452371 0
Women’s cardiovascular health
Timepoint [18] 452371 0
When child is 7 years old
Secondary outcome [19] 452501 0
Women’s biological aging
Timepoint [19] 452501 0
When child is 7 and old
Secondary outcome [20] 459535 0
Father engagement
Timepoint [20] 459535 0
When child is 7 and 9 years old

Eligibility
Key inclusion criteria
Mother-child dyads who completed the baseline survey of the original trial (ACTRN12617000442303) and whose children are alive and residing in Ha Nam or Hanoi will be eligible to participate in the follow-up study.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Children who have died will be recorded and excluded.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2025
Actual
21/03/2026
Date of last participant enrolment
Anticipated
28/06/2026
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
1168
Accrual to date
30
Final
Recruitment outside Australia
Country [1] 27369 0
Viet Nam
State/province [1] 27369 0
Ha Nam Province

Funding & Sponsors
Funding source category [1] 319845 0
Charities/Societies/Foundations
Name [1] 319845 0
The LEGO Foundation
Country [1] 319845 0
Denmark
Funding source category [2] 320010 0
Charities/Societies/Foundations
Name [2] 320010 0
The Society for Research in Child Development (SRCD)
Country [2] 320010 0
United States of America
Funding source category [3] 320034 0
Other
Name [3] 320034 0
Burroughs Wellcome Fund
Country [3] 320034 0
United States of America
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 322555 0
Other Collaborative groups
Name [1] 322555 0
Research and Training Centre for Community Development
Address [1] 322555 0
Country [1] 322555 0
Viet Nam
Secondary sponsor category [2] 322585 0
University
Name [2] 322585 0
Yale University
Address [2] 322585 0
Country [2] 322585 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318401 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 318401 0
Ethics committee country [1] 318401 0
Australia
Date submitted for ethics approval [1] 318401 0
26/04/2025
Approval date [1] 318401 0
22/05/2025
Ethics approval number [1] 318401 0
2025-46034-128639

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

Contacts
Principal investigator
Name 144066 0
Prof Jane Fisher
Address 144066 0
Monash University Level 4, 553 St Kilda Road, Melbourne VIC 3004
Country 144066 0
Australia
Phone 144066 0
+61 3 9903 0290
Fax 144066 0
Email 144066 0
[email protected]
Contact person for public queries
Name 144067 0
Jane Fisher
Address 144067 0
Monash University Level 4, 553 St Kilda Road, Melbourne VIC 3004
Country 144067 0
Australia
Phone 144067 0
+61 3 9903 0290
Fax 144067 0
Email 144067 0
[email protected]
Contact person for scientific queries
Name 144068 0
Yeji Baek
Address 144068 0
Monash University Level 4, 553 St Kilda Road, Melbourne VIC 3004
Country 144068 0
Australia
Phone 144068 0
+61 3 9903 0066
Fax 144068 0
Email 144068 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


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.