Trial registered on ANZCTR


Trial ID
ACTRN12615000063516
Ethics application status
Approved
Date submitted
8/01/2015
Date registered
23/01/2015
Date last updated
10/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving infant and young child feeding practices: Assessing the effectiveness of breastfeeding promotion program (randomized controlled trial) using mobile phone as a communications tools in Yangon and nearby regions, Myanmar.
Scientific title
Improving infant feeding practices of women in Yangon region: A randomized controlled trial of a mobile phone communications intervention and evaluation of its effectiveness in Myanmar.
Secondary ID [1] 285930 0
NIL
Universal Trial Number (UTN)
U1111-1165-6731
Trial acronym
M528
‘M’ means mobile/mother and the term ‘528’stands for the bonding between mother and baby in Burmese culture.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breastfeeding 293857 0
Malnutrition 293858 0
Infant and Young Child Feeding Practices 293940 0
Condition category
Condition code
Public Health 294160 294160 0 0
Health promotion/education
Reproductive Health and Childbirth 294161 294161 0 0
Breast feeding
Diet and Nutrition 294162 294162 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
M 528 intervention group.
Duration of intervention will be from 28 -34 weeks of gestation (women can be any gestation week between 28-34 weeks as per inclusion criteria) until 6 months of child age. The intervention group will receive 3 times SMS (short message service) per week to their mobile phones. The type of SMS messages and frequency received will depend on women’s enrolled group, gestation age and child age. The M528 group will receive breastfeeding promotion related SMS messages. We will monitor women delivery date by sending reminder sms once a week from 36 weeks of gestation onwards to women’s phone & women will send back message to us (interactive sms) if they deliver. Assume that not all women will reply via sms if they deliver, we will capture women delivery dates via hospital registry data or direct phone calls to women or family. Follow-up phone calls will be made to motivate/educate exclusive breast feeding practices at 1, 3 and 5months after delivery. To assess outcomes measures (both primary and secondary), phone calls will be made at 1, 3, 5 and 6 months after delivery .
Intervention code [1] 290905 0
Behaviour
Intervention code [2] 290907 0
Lifestyle
Intervention code [3] 290908 0
Prevention
Comparator / control treatment
Treatment as Usual ( TaU ) group
Duration of control group will be same as intervention group. The TaU group will receive 1 time SMS (short message service) per week to their mobile phones. TAU group will receive non breastfeeding related SMS messages involving pregnancy and child care topics. We will monitor women delivery date by sending reminder sms once a week from 36 weeks of gestation onwards to women’s phone & women will send back message to us (interactive sms) if they deliver. Assume that not all women will reply via sms if they deliver, we will capture women delivery dates via hospital registry data or direct phone calls to women or family. To assess outcomes measures (both primary and secondary), phone calls will be made at 1, 3, 5 and 6 months after delivery.
Control group
Active

Outcomes
Primary outcome [1] 293952 0
The primary outcome is exclusive breastfeeding rate of women during sixth month after delivery. Primary outcome will be measured by interview/questionnaire by monthly phone calls by trained phone callers from 1 to 6 months of child age ( each woman will receive 6 times phone callings regardless of their assigned group). The outcome data will be data collected by phone with a questionnaire and responses are recorded in the tablet. We will also assess feeding status. The qualitative data (interview or focus group discussion) will be used to understand more about the reasons for their feeding pattern. The questionnaire has been designed specifically for this study after thorough literature search. It is adopted from MICS (multiple indicator cluster survey, Myanmar), UNICEF/WHO survey, census questionnaires for some demographic questions, questionnaires used in master thesis by principal investigator, formative research study conducted by principal investigator with pregnant women at the study hospital in June2013 .
Timepoint [1] 293952 0
Time point: during the sixth month after delivery ( Pregnant women will be recruited at 28-32 weeks of gestation,estimated 8-9 months after randomization .) .

Secondary outcome [1] 312223 0
Secondary Outcome 1: early initiation of breastfeeding rate within 1 hour after birth.
This secondary outcome will be measured by means of phone calls to women in both groups at 1 month after delivery. We will have pre- tested questionnaire to assess outcome & callers will be trained and quality assurance is ensured. The outcome data will be collected by phone interview of the mothers with a questionnaire.
The questionnaire has been designed specifically for this study after thorough literature search. It is adopted from MICS (multiple indicator cluster survey, Myanmar), UNICEF/WHO survey, census questionnaires for some demographic questions, questionnaires used in master thesis by principal investigator, formative research study conducted by principal investigator with pregnant women at the study hospital in June2013 .
Timepoint [1] 312223 0
Time point 1: at 1 month after delivery
Secondary outcome [2] 312224 0
Secondary Outcome 2: exclusive breastfeeding rate at one and three months after delivery .

This secondary outcome will be measured by means of phone calls to women in both groups at 1 and 3 months after delivery. We will have pre- tested questionnaire to assess outcome & callers will be trained and quality assurance is ensured. The outcome data will be collected by phone interview of the mothers with a questionnaire.
The questionnaire has been designed specifically for this study after thorough literature search. It is adopted from MICS (multiple indicator cluster survey, Myanmar), UNICEF/WHO survey, census questionnaires for some demographic questions, questionnaires used in master thesis by principal investigator, formative research study conducted by principal investigator with pregnant women at the study hospital in June 2013 .

Timepoint [2] 312224 0
Timepoint 2: at one and three months after delivery.
Secondary outcome [3] 312225 0
Secondary Outcome 3 median duration of exclusive breastfeeding rate.
This secondary outcome will be measured by means of phone calls to women in both groups at 5 months after delivery. We will have pre- tested questionnaire to assess outcome & callers will be trained and quality assurance is ensured. The outcome data will be collected by phone interview of the mothers with a questionnaire.
The questionnaire has been designed specifically for this study after thorough literature search. It is adopted from MICS (multiple indicator cluster survey, Myanmar), UNICEF/WHO survey, census questionnaires for some demographic questions, questionnaires used in master thesis by principal investigator, formative research study conducted by principal investigator with pregnant women at the study hospital in June2013 .

Timepoint [3] 312225 0
Timepoint3: at five months after delivery
Secondary outcome [4] 312226 0
Secondary Outcome4: predominant and other type of breastfeeding rates at one, three and five months after delivery.
This outcome is a composite outcome and will be measured by means of phone calls to women in both groups at 1,3,5 and 6 months after delivery. We will have pre- tested questionnaire to assess outcome & callers will be trained and quality assurance is ensured. The outcome data will be collected by phone interview of the mothers with a questionnaire.
The questionnaire has been designed specifically for this study after thorough literature search. It is adopted from MICS (multiple indicator cluster survey, Myanmar), UNICEF/WHO survey, census questionnaires for some demographic questions, questionnaires used in master thesis by principal investigator, formative research study conducted by principal investigator with pregnant women at the study hospital in June2013 .

Timepoint [4] 312226 0
Timepoint4: at one, three, five and six months after delivery

Secondary outcome [5] 312227 0
Secondary Outcome 5: rate of infant receiving bottle feeding at one, three, five and six months after delivery. This secondary outcome will be measured by means of phone calls to women in both groups at 1,3,5 and 6 months after delivery. We will have pre- tested questionnaire to assess outcome & callers will be trained and quality assurance is ensured. The outcome data will be collected by phone interview of the mothers with a questionnaire.
The questionnaire has been designed specifically for this study after thorough literature search. It is adopted from MICS (multiple indicator cluster survey, Myanmar), UNICEF/WHO survey, census questionnaires for some demographic questions, questionnaires used in master thesis by principal investigator, formative research study conducted by principal investigator with pregnant women at the study hospital in June2013 .

Timepoint [5] 312227 0
Timepoint5: at one, three, five and six months after delivery

Secondary outcome [6] 312228 0
Secondary Outcome 6: rate of children receiving early introduction of solid, semi-solid or soft foods at one, three and five months after delivery. This secondary outcome will be measured by means of phone calls to women in both groups at 1,3 and 5 months after delivery. We will have pre- tested questionnaire to assess outcome & callers will be trained and quality assurance is ensured. The outcome data will be collected by phone interview of the mothers with a questionnaire.
The questionnaire has been designed specifically for this study after thorough literature search. It is adopted from MICS (multiple indicator cluster survey, Myanmar), UNICEF/WHO survey, census questionnaires for some demographic questions, questionnaires used in master thesis by principal investigator, formative research study conducted by principal investigator with pregnant women at the study hospital in June2013 .

Timepoint [6] 312228 0
Time point6: at one, three and five months after delivery
Secondary outcome [7] 312408 0
Secondary Outcome 7: Proportion of women from intervention group satisfying use of mobile phone as a communication tools to receive breastfeeding promotional messages.
This secondary outcome will be measured by means of phone survey to women in intervention group at 6 months after delivery by assessing quality of user experiences. We will have pre- tested survey/interview questionnaires to assess outcome & callers will be trained and quality assurance is ensured. Qualities of user experiences will be measured as women’s acceptability, comprehension on message receive, new information learned and reported behavior changed,etc.
The questionnaire has been designed specifically for this study after thorough literature search. It is adopted from MICS (multiple indicator cluster survey, Myanmar), UNICEF/WHO survey, census questionnaires for some demographic questions, questionnaires used in master thesis by principal investigator, formative research study conducted by principal investigator with pregnant women at the study hospital in June2013 . We also adopted assessment/survey conducted on M health internationally including China, Malawi, etc.
Timepoint [7] 312408 0
Timepoint 7: at six months after delivery

Eligibility
Key inclusion criteria
- Pregnant mother visiting antenatal clinic, Central Women Hospital, Yangon, Myanmar
- 28-34 weeks gestation
- Have mobile android or java mobile phone which can read Myanmar font ( access to mobile phone)
- Have uncomplicated and single fetus,
- No known medical disease, intention to breastfeed,
- Plan to give birth at CWH,
- Able to read and write ,
- Live in Yangon or cities with mobile network coverage,
- Give consent to participate
Minimum age
15 Years
Maximum age
49 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Infant weight less than 2000 grams
- Infant with birth defect which may hinder sucking of breast milk
- Infant admit to intensive care unit (ICU) after delivery
- Women who decline to participate.

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)
Study site observation has been conducted in November, 2014 and Central Women Hospital , Yangon is chosen because it is the largest tertiary women hospital in Myanmar. Ante- natal clinic ( ANC) opens from Monday to Friday , 8-12 am and average 100-120 women visit antenatal clinic each day.
On the day of recruitment, based on inclusion criteria registration, research team will filter potential participants from attendance registry book or women antenatal care card with the help of nurses or admin staff from clinic. Then, the team will approach eligible women waiting at the waiting area of AN clinic, explain nature of study in details & give information statement written in Burmese. If women agree to participate, will take informed consent and ask questionnaires by using tablet. It is estimated that average 12-18 women could be recruited per day and we will recruit 344 women. Recruiting women will be allocated into two groups called M 528 intervention group ( M stands for mobile phone and 528 reflects the bonding between and baby) and TaU ( treatment as Usual) group.
Assignment and allocation will be randomized to reduce bias and neither of the women or research team members know who will belong to the intervention or control group. Only after enrolled woman starts answering the survey questions, a team member will open opaque and sealed envelope, draw a piece of paper which determine woman’s assigned group. Third party will prepare that envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
By using computer generated software, randomization is done. Numbers for intervention and control groups are generated in random number . We assume that average 15 women could be recruited per day and numbers are calculated and tried to be balanced for each day-i.e.; women will be assigned equally to both intervention and control group each day.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
To calculate the required sample size in determining the primary and secondary outcomes, we ran a STATA program using two sample populations test. It is assumed that the percentage of women from the intervention group exclusively breastfeeding their infants in their sixth month of life will be doubled (30%) compared to the control group receiving usual program (15%). That figure 15% is based on the national data, exclusive breastfeeding rate at 4-5 months of child age, collected in 2010 ( MICS) . To detect the difference in two groups at 80% power and 5% level of significance, a sample size of 156 subjects per group, a total of 312 participants, is needed. However, to allow for attrition and loss at follow-up, the study will recruit additional 10 percent more participants (ie. 16 participants) and this sample size will be more than sufficient. This will take the total sample to about 344 in initial recruitment. In this situation, a sample size of 172 participants per group (intervention and control) in intervention stage after taking in account of loss to follow up will be adequate to explore differences amongst the groups.
Statistical analysis,
Analysis will be by ‘Intention to Treat’ analysis. Data on screening, refusals and drop-out will be coded and reported as per standard guidelines. STATA will be used for all analyses.
Baseline characteristics between treatment groups will be examined to check that randomization and equally allocated potential confounding factors across the treatment groups. Primary analyses will compare the proportion of children exclusively breastfed at 6 months and will use chi-square tests and 95% confidence intervals to test for differences between treatment groups. Similar analyses will be done to the secondary outcomes such as early initiation of breastfeeding within 1 hour of birth and exclusive breastfeeding , predominant breastfeeding and other types of breastfeeding, bottle feeding, timing of introduction of complementary feeding at 1,3,5 and 6 months. Survival analysis will be used to compare (the duration of EBF between the treatment groups. Multiple logistic regressions will be applied to assess differences in infant feeding practices.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment outside Australia
Country [1] 6583 0
Myanmar
State/province [1] 6583 0
Yangon region

Funding & Sponsors
Funding source category [1] 290517 0
University
Name [1] 290517 0
Sydney Medical School Foundation , University of Sydney
Address [1] 290517 0
Room 204, Edward Ford Building A27
The University of Sydney, NSW 2006
Australia
Country [1] 290517 0
Australia
Primary sponsor type
Individual
Name
Dr. Myat Pan Hmone @ Crystal
Address
Room128C, Edward Ford Building A27,
The University of Sydney, NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 289211 0
None
Name [1] 289211 0
Address [1] 289211 0
Country [1] 289211 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292167 0
Ethical Review Committee, Department of Medical Research( Lower Myanmar). The Government of the Republic of the Union of Myanmar, Ministry of Health.
Ethics committee address [1] 292167 0
No5, Ziawaka Road, Dagon Township, Yangon, 11191,Myanmar.
Ethics committee country [1] 292167 0
Myanmar
Date submitted for ethics approval [1] 292167 0
Approval date [1] 292167 0
11/02/2014
Ethics approval number [1] 292167 0
7/ Ethics 2014

Summary
Brief summary
Myanmar has high under –five and infant mortality rates with 56 and 50 per 1,000 live births (MICS, 2010). Under nutrition is a major cause of under-five children deaths and to practice correct infant and young child feeding (IYCF) practices is important for better nutrition outcomes. Although 76 per cent of newborns have timely initiation of breastfeeding within 1 hour after birth, only 24 percent of infants in Myanmar are exclusively breastfeed, and Myanmar has 3rd lowest exclusive breastfeeding rate in Asia-Pacific region. Scientific study and well cited literature evidences prove that appropriate exclusive breast and complementary feeding practices with high coverage could save millions of children’s lives. It is important to understand the underlying socio-economic and cultural values of pregnant women if we really want to narrow down the knowledge and practice gap and we conducted a formative study prior to RCT intervention and findings have been incorporated into the design of RCT.
The research aims to implement a breastfeeding promotion intervention using mobile phones as a communication tool & will conduct at the largest public women’s hospital in Yangon. There is no published randomized controlled trial intervention using mobile phone to promote exclusive breast feeding practices in Myanmar. This study could not be realistic two years ago where possession of mobile phone is considered a luxury asset. The study will be the first study conducted in Myanmar using mobile phone as a communications tools in health promotion intervention program and we design the study in line with changing socio- economics and political situations in Myanmar as mobile phone prices in the country have plunged from $1,000 in 2011 to $15 in 2014-15. The study has received official ethical approval from Myanmar ethical review committee and approval letter from Department of Health.
The study aims to collect high quality evidence about whether or not a mobile phone communications package that promotes appropriate breastfeeding practices, starting in late pregnancy and continuing till the child is six months of age will: Increase the rate of exclusive breastfeeding in the first 6 months of life, increase the duration of exclusive breastfeeding and the rate of early initiation of breastfeeding, reduce the rate of bottle feeding and early introduction of semi-solid foods. Our primary hypothesis is the percentage of women from the intervention group exclusively breastfeeding their infants in their sixth month of life will be doubled compared to the control group receiving usual programs. Our secondary hypotheses will be: women in the intervention group will have a higher rate of early initiation of breastfeeding, an increased median duration of exclusive breastfeeding, a decreased rate of bottle feeding, & a decreased rate of children receiving early introduction of solid, semi-solid or soft foods.
The primary outcome will be exclusive breastfeeding rate of women during the sixth month after delivery. The secondary outcomes will be early initiation of breastfeeding rate within 1 hour after birth, exclusive breastfeeding rate at one and three months after delivery, median duration of exclusive breastfeeding rate, predominant and other type of breastfeeding rates at one, three, five and six months after delivery, rate of infant receiving bottle feeding at one, three , five and six months , rate of children receiving early introduction of solid, semi-solid or soft foods at one, three, five and six months and proportion of women in intervention group satisfying use of mobile phone as a communication tools to receive breastfeeding promotional messages.
We will recruit pregnant women in their 3rd trimester and follow- up till child reach 6 months of age. We will collect baseline questionnaires such as socio-economics, past breastfeeding history, breastfeeding knowledge, intention and confidence, and self-efficiency scale by using tablet. We will have two groups called intervention and control groups where former group will receive breast feeding related health promotional messages via SMS ( short message services) and the latter group will receive non-breastfeeding related health promotional messages and message contents will be more on mother and child health care. Intervention group will receive reminder phone calls at 1, 3 and 5 months after delivery and during phone calls, will provide women to have an opportunity to discuss their challenges. Outcomes will be measured at 1,3 , 5 and 6 months after delivery to both groups based on which outcome we would like to measure. The study is called ‘M528 project’ where ‘M’ refers to mobile phone or mother and ‘528’stands for the bonding between mother and baby in Myanmar culture. After the study outcomes will be measured between two groups and we expect to scale up the mentioned study design in future, not limited to breastfeeding promotion alone.
Trial website
Trial related presentations / publications
Hmone MP, Dibley MJ, Li M, Alam A: A formative study to inform mHealth based randomized controlled trial intervention to promote exclusive breastfeeding practices in Myanmar: incorporating qualitative study findings. BMC Medical Informatics and Decision Making 2016, 16(1):60.

( Note: this is the formative study publication to inform the trial design, not the results from the trial).
Public notes
Attachments [1] 272 272 0 0
http://www.anzctr.org.au/AnzctrAttachments/367704-DMR ethical approval _page1.docx

Contacts
Principal investigator
Name 53874 0
Dr Myat Pan Hmone
Address 53874 0
Room 128 C, Edward Ford Building, A 27. School of Public Health, Sydney Medical School.
The University of Sydney , NSW ,2006, AUSTRALIA
Country 53874 0
Australia
Phone 53874 0
+612 93514803
Fax 53874 0
Email 53874 0
mphmone@gmail.com
Contact person for public queries
Name 53875 0
Dr Myat Pan Hmone
Address 53875 0
Room 128 C, Edward Ford Building, A 27. School of Public Health, Sydney Medical School.

The University of Sydney , NSW ,2006, AUSTRALIA
Country 53875 0
Australia
Phone 53875 0
+612 93514803
Fax 53875 0
Email 53875 0
mphmone@gmail.com
Contact person for scientific queries
Name 53876 0
Prof Michael J Dibley
Address 53876 0
Room 307A, Edward Ford Building (A27) , School of Public Health, Sydney Medical School.
The University of Sydney , NSW ,2006, AUSTRALIA

Country 53876 0
Australia
Phone 53876 0
+61 2 9351 3620
Fax 53876 0
+61 2 9351 5049
Email 53876 0
michael.dibley@sydney.edu.au