Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001481268
Ethics application status
Approved
Date submitted
25/08/2018
Date registered
4/09/2018
Date last updated
20/08/2019
Date data sharing statement initially provided
20/08/2019
Date results information initially provided
20/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of SMS text messaging to fathers and mothers to improve exclusive breastfeeding in Tigray region, Northern Ethiopia
Scientific title
Effectiveness of SMS text messaging to fathers and mothers to improve exclusive breastfeeding in Tigray region, Northern Ethiopia
Secondary ID [1] 295909 0
Nil Known
Universal Trial Number (UTN)
U1111-1219-4319
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exclusive Breastfeeding 309384 0
Condition category
Condition code
Public Health 308244 308244 0 0
Health promotion/education
Reproductive Health and Childbirth 308262 308262 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will have two intervention groups:
Expectant couples int the first arms: mothers and fathers receiving breastfeeding related SMS text messaging.
In the second arm: Mothers only receiving breastfeeding related SMS text messaging
Both arms receive the same SMS text messages for a total of four months, one month(last trimester) and three months (After birth).
The SMS text messages are designed to improve breastfeeding knowledge, attitude, and support, thus, to improve exclusive breastfeeding practice. This will be one month during pregnancy and three months after delivery, One SMS per week. These SMS will be sent to study participants from the research team, using the FrontlineSMS bulk SMS system, from our personal computer.

Both this arms do receive also the standard services provided at health facility

we will allocate Three health centers in to each of the arms, so that, all parents in one health centers will be allocated in to one of the arms.
Intervention code [1] 312235 0
Behaviour
Comparator / control treatment
The third (control arm): Mothers and fathers receiving standard antenatal care services- including breastfeeding provided at health facility
Control group
Active

Outcomes
Primary outcome [1] 307215 0
Exclusive Breastfeeding, which will be assessed using the World Health Organization(WHO) standard 24 hrs. recall.
Timepoint [1] 307215 0
Three months post-intervention
This will be assessed monthly (Month-1, Month-2, and Month-3) after delivery
Secondary outcome [1] 351138 0
Breastfeeding Knowledge: Mothers
This will be assessed using the tool from Food and Agricultural Organization (FAO) of the United Nations (UN) manual for assessing nutrition related knowledge
Timepoint [1] 351138 0
Before intervention: Baseline
Fourth month post-intervention
Secondary outcome [2] 351139 0
Breastfeeding Attitude: Mothers
This will be assessed using Iowa Infant Feeding attitude Scale (IIFAS) standard breastfeeding measuring tool
Timepoint [2] 351139 0
Before intervention: Baseline
Fourth month post-intervention
Secondary outcome [3] 351193 0
Breastfeeding Self-efficacy: Mothers
This is assessed using Breastfeeding Self-efficacy Scale-Short Form(BSES-SF)
Timepoint [3] 351193 0
Before intervention: Baseline
Fourth month post-intervention
Secondary outcome [4] 351262 0
Breastfeeding Knowledge:Fathers
This will be assessed using the tool from Food and Agricultural Organization (FAO) of the United Nations (UN) manual for assessing nutrition related knowledge
Timepoint [4] 351262 0
Before intervention: Baseline
Fourth month post-intervention
Secondary outcome [5] 351263 0
Breastfeeding Attitude: Fathers
This will be assessed using Iowa Infant Feeding attitude Scale (IIFAS) standard breastfeeding measuring tool
Timepoint [5] 351263 0
Before intervention: Baseline
Fourth month post-intervention

Eligibility
Key inclusion criteria
having a personal mobile phone
able to read and understand Tigrigna
living in a union until the end of the study
a singleton pregnancy
mother with no known medical problem that hinders breastfeeding
Minimum age
15 Years
Maximum age
49 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Couples who are not receiving antenatal care services at public health centers

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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
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
For the primary outcome rate of exclusive breastfeeding 1, 2, and 3 months will be analysed by regression to measure intervention effect on exclusive breastfeeding among the three categories including any baseline confounding variables. The level of significance will be using the P-value < 0.05, where the null hypothesis is there is no intervention effect. So that, if the P-value is less than 0.05 the null hypothesis will be false and we will accept the alternative hypothesis, which is there is a significance difference due to intervention. The risk of stopping exclusive breastfeeding will be expressed in terms of odds ratio with 95% CI.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/09/2018
Actual
12/09/2018
Date of last participant enrolment
Anticipated
14/09/2018
Actual
31/10/2018
Date of last data collection
Anticipated
15/01/2019
Actual
10/03/2019
Sample size
Target
318
Accrual to date
Final
256
Recruitment outside Australia
Country [1] 20801 0
Ethiopia
State/province [1] 20801 0
Tigray

Funding & Sponsors
Funding source category [1] 300502 0
University
Name [1] 300502 0
Queensland University of Technology
Country [1] 300502 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Road Kelvin Grove, QLD. 4059
Country
Australia
Secondary sponsor category [1] 299993 0
None
Name [1] 299993 0
Address [1] 299993 0
Country [1] 299993 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301298 0
Queensland university of Technology Human Research Ethics commitee
Ethics committee address [1] 301298 0
Level 4
88 Musk Avenue
Kelvin Grove
QLD. 4059
Ethics committee country [1] 301298 0
Australia
Date submitted for ethics approval [1] 301298 0
01/08/2017
Approval date [1] 301298 0
05/12/2017
Ethics approval number [1] 301298 0
1700000717

Summary
Brief summary
Taking into consideration that 27% to 43% of infants in Ethiopia are exposed to a range of foods and liquids other than breast milk in the first few months of life, the level of exclusive breastfeeding at six months could be an over-estimation. The aim of this research is to test the effectiveness of SMS text messaging on breastfeeding education to mothers and fathers to improve exclusive breastfeeding in Tigray region, Ethiopia. In the intervention, we will recruit expectant couples into one of the three arms: mothers and fathers receiving SMS text messaging, mothers only receiving SMS text messaging, mothers in the standard care. One month antenatal and three months postnatal SMS will be delivered for the intervention groups, and monthly data will be collected through face-to-face interview. The primary outcome of this research is breastfeeding exclusivity, with knowledge, attitude, and self-efficacy for breastfeeding being secondary outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86542 0
Mr Kidane Tadesse Gebremariam
Address 86542 0
Queensland University of Technology|
Victoria Park Road Kelvin Grove, QLD. 4059
O-Block Wing A Level 1
Country 86542 0
Australia
Phone 86542 0
+61405468495
Fax 86542 0
Email 86542 0
[email protected]
Contact person for public queries
Name 86543 0
Mr Kidane Tadesse Gebremariam
Address 86543 0
Queensland University of Technology|
Victoria Park Road Kelvin Grove, QLD. 4059
O-Block Wing A Level 1
Country 86543 0
Australia
Phone 86543 0
+61405468495
Fax 86543 0
Email 86543 0
[email protected]
Contact person for scientific queries
Name 86544 0
Mr Kidane Tadesse Gebremariam
Address 86544 0
Queensland University of Technology|
Victoria Park Road Kelvin Grove, QLD. 4059
O-Block Wing A Level 1
Country 86544 0
Australia
Phone 86544 0
+61405468495
Fax 86544 0
Email 86544 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
We will consider this in accordance to the rules of the Queensland UNIVERSITY OF TECHNOLOGY data sharing policy


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.