Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000531112
Ethics application status
Approved
Date submitted
30/03/2019
Date registered
3/04/2019
Date last updated
29/09/2020
Date data sharing statement initially provided
3/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A smartphone application to support breastfeeding for new mothers in Vietnam
Scientific title
Effectiveness of a smartphone application to support breastfeeding for Vietnamese women following childbirth: Randomised controlled trial
Secondary ID [1] 297841 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
caesarean section 312215 0
breastfeeding 312216 0
Condition category
Condition code
Reproductive Health and Childbirth 310759 310759 0 0
Breast feeding
Public Health 310760 310760 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial will be conducted at Dong Anh General Hospital and Hanoi Obstetrics and Gynaecology Hospital, Hanoi, Vietnam.

The Vietnamese Breastfeeding (VBF) app is a theory-based yet user-friendly smartphone application developed to support breastfeeding, with specific focus at different postnatal stages. Its purpose is to provide support and knowledge that will empower new mothers to exclusively breastfeed their babies for six months. The app content is tailored to the context of breastfeeding in Vietnam, addressing known barriers such as prelacteal feeds and emphasising early initiation of breastfeeding after birth. The VBF app will support and educate mothers about the importance of exclusive breastfeeding, build confidence in breastfeeding (e.g. correct positioning, feeding on demand) and motivate them to continue breastfeeding, by providing evidence-based information and reinforcing regular communication with health professionals to address any problem. All app materials will be culturally appropriate and sensitive to the needs of Vietnamese mothers.

Each intervention participant will receive routine care and twice weekly SMS messages from baseline until childbirth. The text messages, adapted from those of Mobile Alliance for Maternal Action (United Nations Foundation 2015), contain advice on healthy lifestyle and nutrition (e.g. to avoid anaemia) during pregnancy, sanitation, early initiation of breastfeeding and vaccinations. Participants may also request a free call back from our hospital nurse to discuss any problem or complex issue.

Within 24 hours of giving birth, mothers in the intervention group will be assisted by our trained nurses to install the VBF app and access it weekly for six months. To avoid potential contamination and information exchange with the controls, each intervention participant will be issued a unique non-sharable access code for the download of VBF app to her personal smartphone. They will be briefly trained on use of the app functions and features, and encouraged to engage/communicate with the research team for any technical issues that may arise. In addition, a built-in tutorial with explanations will be displayed on first launching of the app to familiarise users with its functions and features.

It is recommended that the intervention participants should access the VBF app twice weekly for breastfeeding information, advice and support during the six-month trial period postpartum. In addition to specific emphases at different postnatal stages, a digital “baby book” is also embedded within the VBF app, which allows a mother to upload photos, note her baby’s achievement of developmental milestones and to set reminders for vaccinations. These features will assist tailoring to individual needs and encourage mothers to set their own breastfeeding goals.
Intervention code [1] 314078 0
Behaviour
Comparator / control treatment
The control group will receive exactly the same medical treatment and nursing care at the hospital as the intervention group. However, the smartphone app and SMS messages they receive will deal with different aspects of infant health and child development. The intervention group will be provided the VBF app to support breastfeeding and infant care. The control group will receive app messages related to vaccination, injury prevention, infant care and child development.
Control group
Active

Outcomes
Primary outcome [1] 319609 0
Exclusive breastfeeding duration, as assessed by a self-reported questionnaire (Duong, Lee, Binns 2005, Journal of Paediatrics & Child Health)
Timepoint [1] 319609 0
6 months postpartum
Primary outcome [2] 319610 0
Any breastfeeding duration, as assessed by a self-reported questionnaire (Duong, Lee, Binns 2005, Journal of Paediatrics & Child Health)
Timepoint [2] 319610 0
6 months postpartum
Secondary outcome [1] 368853 0
Exclusive breastfeeding rates, as assessed by a self-reported questionnaire (Duong, Lee, Binns 2005, Journal of Paediatrics & Child Health)
Timepoint [1] 368853 0
at 1, 3 and 6 months postpartum
Secondary outcome [2] 368854 0
Any breastfeeding rates, as assessed by a self-reported questionnaire (Duong, Lee, Binns 2005, Journal of Paediatrics & Child Health)
Timepoint [2] 368854 0
at 1, 3 and 6 months postpartum
Secondary outcome [3] 368855 0
Timing of introduction of solid foods, as assessed by a self-reported questionnaire (Duong, Binns, Lee 2005, Acta Paediatrica)
Timepoint [3] 368855 0
at 3 and 6 months postpartum

Eligibility
Key inclusion criteria
Pregnant women, at around 28 weeks of gestation, will be recruited at the hospital antenatal clinic. They will be eligible to participate if they: own a smartphone, aged over 18 years, have sufficient language skills (completed junior high school education) and carrying a singleton fetus.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women will be deemed ineligible where existing medical conditions or pregnancy complications are likely to inhibit breastfeeding initiation, according to their medical doctors.

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)
Allocation is concealed by central randomisation using computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Calculation
For Vietnamese women with vaginal delivery, their exclusive breastfeeding (EBF) rate at 6 months postpartum was 17% (Bui et al 2016). We hypothesize a conservative effect size of 10% improvement in the EBF rate for the intervention group relative to the control group. The estimated sample size is n1 = 538 (269 per group) at 80% power and 5% level of significance. For Vietnamese women after caesarean section, data on EBF rates were not available from the literature. Therefore, we adopt the 6 month EBF prevalence of 12% from our multi-centre prospective cohort study (Nguyen et al 2017). Assuming that EBF rate in the intervention group will be doubled to 24%, a sample size of n2 = 374 (187 per group) is required to detect such a difference with 80% power and at 5% 2-sided alpha. The total sample size for the trial is thus n = n1 + n2 = 912 and we will recruit N = 1000 pregnant women at baseline to allow for an expected 8% loss to follow-up, as evident from our present maternal cohort. Given the average of over 6000 deliveries per year at Dong Anh General Hospital and its caesarean section rate of 40%, and the corresponding data at Hanoi Gynaecology and Obstetrics Hospital is approximately 44,000 and 53%, respectively, the consecutive quota recruitment of 1000 expectant mothers should be feasible and completed within the target time frame of six months, by anticipating that 1 out of 3 women we approach will be eligible and consent to participate.

Statistical Analysis
In the presence of censoring data, survival analysis will be used to compare the breastfeeding duration between the intervention and control groups, with Kaplan-Meier curves for estimating the median breastfeeding times, and assessment of differences using the log-rank test. The hazard ratios for EBF and any BF cessation will be estimated through a Cox's proportional hazards regression model, adjusting for baseline demographic characteristics and other plausible biomedical and psychosocial factors such as sex of newborn and early return to work. Multivariable logistic regression will be applied to determine the effectiveness of the intervention on the breastfeeding prevalence at 6 months accounting for delivery method and other confounding factors. Similar analyses will be performed for quantifying the hazard of complementary food introduction. Sub-group analyses will also be undertaken to assess the intervention effects on vaginal delivery and caesarean section subgroups separately. The principal of Intention-to-treat will be followed in the analysis with missing data imputation based on the best-case and worst-case scenarios to assess the robustness of the statistical inferences to the expected attrition and withdrawal of participants from the study. All statistical analyses will be performed in the STATA package Release 14.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2020
Actual
9/03/2020
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
30/10/2021
Actual
Sample size
Target
1000
Accrual to date
5
Final
Recruitment outside Australia
Country [1] 21380 0
Viet Nam
State/province [1] 21380 0
Hanoi

Funding & Sponsors
Funding source category [1] 302364 0
Government body
Name [1] 302364 0
National Health and Medical Research Council
Country [1] 302364 0
Australia
Funding source category [2] 302368 0
Government body
Name [2] 302368 0
National Foundation for Science & Technology Development
Country [2] 302368 0
Viet Nam
Primary sponsor type
Individual
Name
Professor Colin Binns
Address
School of Public Health, Curtin University, GPO Box U 1987, Perth, WA 6845
Country
Australia
Secondary sponsor category [1] 302252 0
Individual
Name [1] 302252 0
Professor Andy Lee
Address [1] 302252 0
School of Public Health, Curtin University, GPO Box U 1987, Perth, WA 6845
Country [1] 302252 0
Australia
Secondary sponsor category [2] 302255 0
Individual
Name [2] 302255 0
Associate Professor Dinh Thi Phuong Hoa
Address [2] 302255 0
Hanoi University of Public Health, 1A Duc Thang, Bac Tu Liem, Hanoi
Country [2] 302255 0
Viet Nam
Secondary sponsor category [3] 302256 0
Individual
Name [3] 302256 0
Professor Bui Thi Thu Ha
Address [3] 302256 0
Hanoi University of Public Health, 1A Duc Thang, Bac Tu Liem, Hanoi
Country [3] 302256 0
Viet Nam
Other collaborator category [1] 280623 0
Individual
Name [1] 280623 0
Dr Ngoc Minh Pham
Address [1] 280623 0
School of Public Health, Curtin University, GPO Box U 1987, Perth, WA 6845
Country [1] 280623 0
Australia
Other collaborator category [2] 280624 0
Individual
Name [2] 280624 0
Doan Thi Thuy Duong
Address [2] 280624 0
Hanoi University of Public Health, 1A Duc Thang, Bac Tu Liem, Hanoi
Country [2] 280624 0
Viet Nam

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303040 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 303040 0
Ethics committee country [1] 303040 0
Australia
Date submitted for ethics approval [1] 303040 0
21/01/2019
Approval date [1] 303040 0
22/03/2019
Ethics approval number [1] 303040 0
HRE2019-0143
Ethics committee name [2] 303043 0
Ethical Review Board for Biomedical Research, Hanoi University of Public Health
Ethics committee address [2] 303043 0
Ethics committee country [2] 303043 0
Viet Nam
Date submitted for ethics approval [2] 303043 0
01/02/2019
Approval date [2] 303043 0
01/03/2019
Ethics approval number [2] 303043 0
28/2019/YTCC-HD3

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

Contacts
Principal investigator
Name 92254 0
Prof Colin Binns
Address 92254 0
School of Public Health, Curtin University, GPO Box U 1987, Perth, WA 6845
Country 92254 0
Australia
Phone 92254 0
+61 8 9266 2952
Fax 92254 0
Email 92254 0
[email protected]
Contact person for public queries
Name 92255 0
Colin Binns
Address 92255 0
School of Public Health, Curtin University, GPO Box U 1987, Perth, WA 6845
Country 92255 0
Australia
Phone 92255 0
+61 8 9266 2952
Fax 92255 0
Email 92255 0
[email protected]
Contact person for scientific queries
Name 92256 0
Colin Binns
Address 92256 0
School of Public Health, Curtin University, GPO Box U 1987, Perth, WA 6845
Country 92256 0
Australia
Phone 92256 0
+61 8 9266 2952
Fax 92256 0
Email 92256 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Agreement with Hanoi Gynaecology and Obstetrics Hospital, Vietnam that individual participant data cannot be released to the public, with the exception of aggregated statistical summaries being reported.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of a Mobile Application on Breastfeeding Rates Among Mothers Who Have Cesarean Deliveries: A Randomized Controlled Trial.2022https://dx.doi.org/10.1089/bfm.2022.0088
N.B. These documents automatically identified may not have been verified by the study sponsor.