Effectiveness of a smartphone based, educational intervention on breastfeeding self-efficacy and mothers’ health literacy with infants in their first six month of life in Urmia, Iran.
Assessing the impact of an educational intervention based on a smartphone application for improving maternal breastfeeding of infants in their first six months of life in Urmia, Iran.
Design
A Randomized control trial study was conducted with 40 new mothers of their first child with less than three months of age assigned to each intervention (mobile app education) and control group (usual care). Randomization was conducted using a web-based randomization tool.
Settings and conduct
The study was conducted in a health center in Urmia, Iran. Data collectors and care providers were blinded to group assignment. The researcher preparing the randomization procedure was blind to participants and had not any cooperation in the recruitment process. For avoiding the study bias it was required that the control and intervention group mothers have no access to each other.
Participants/Inclusion and exclusion criteria
Based on inclusion criteria new mothers experiencing their firstborn child with less than three months of age were selected. Subjects are excluded in conditions that if they did not have a smartphone or have a medical disorder requiring treatment.
Intervention groups
In the intervention arm, mothers have distributed a mobile application which was for educating them about the required knowledge for breastfeeding. In the control arm, mother and child pairs received routine health service treatments only.
Main outcome variables
This study results with the aim to assess the effect of a smartphone-based maternal education on breastfeeding among primiparous mothers in the relational areas of the mother knowledge, attitude, practice, and self-efficacy on breastfeeding infants, showed higher improved scores for intervention group mothers in front of the control group.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190705044103N2
Registration date:2020-09-25, 1399/07/04
Registration timing:retrospective
Last update:2020-09-25, 1399/07/04
Update count:0
Registration date
2020-09-25, 1399/07/04
Registrant information
Name
Navisa Seyyedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3345 0459
Email address
ns.seyyedi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-05-10, 1398/02/20
Actual recruitment start date
2019-01-21, 1397/11/01
Actual recruitment end date
2019-06-25, 1398/04/04
Trial completion date
2019-12-11, 1398/09/20
Scientific title
Effectiveness of a smartphone based, educational intervention on breastfeeding self-efficacy and mothers’ health literacy with infants in their first six month of life in Urmia, Iran.
Public title
An educational intervention based on a mobile phone application for improving maternal breastfeeding of infants in their first six month of life in Urmia, Iran.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
New mothers experiencing their firstborn child
Infants with less than three month of age
Exclusion criteria:
If they were not in possession of a smart phone
Having a medical disorder requiring treatment
Age
From 18 years old to 38 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Random Allocation Software 1.0 (https://random-allocation software.software.informer.com/1.0/) was utilized to allocate the mother and child pair to intervention or control groups in a 1:1 ratio.
The permuted block method of randomization for a block size of four was used. Based on the limited size of the trial, this procedure was preferred to simple randomization in order to maintain an adequate balance in the number of participants allocated to each of the study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
For avoiding the bias in this study, the control and intervention group were not accessible to each other. So the participants were recruited separately in an isolated room.
Data collectors and care providers were blinded to group assignment and they just investigated the inclusion criteria in the defined clinic.
The randomization was performed by a researcher with no access to participant information and who did not participate in the enrollment process.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Science
Street address
Urmia University of Medical Sciences, Nazloo Campus, Sero Road
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Approval date
2017-06-07, 1396/03/17
Ethics committee reference number
IR.UMSU.REC.1396.105
Health conditions studied
1
Description of health condition studied
Child growth and development
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Maternal breastfeeding self-efficacy
Timepoint
Before intervention and three months after intervention
Method of measurement
Questionnaire
2
Description
KAP (Knowledge, Attitude, Practice)
Timepoint
Before intervention and three months after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Android compatible application was developed then tested and trialed through one week with cooperating test group consists of technical experts and some usual users.The designed application is for educating mothers about the required knowledge for breastfeeding. In accordance with the Ministry of Health and Maternity Guidelines for maternal and child health in the form of a comprehensive integrated healthy child care guide have been compiled in a list of things to be taught to mothers and used in the form of an educational content in the application.In the intervention arm, mothers were distributed this application installed on their phones which was featured by a topic-oriented educational manner to facilitate discovering the solution of encountered problems through lactating process. The intervention generally was scheduled for 3 month period. The mothers were followed-up and encouraged in using the app by calling them during the intervention.
Category
Behavior
2
Description
Control group: In the control group, mother and child pairs were visited in the health center by a routine health service. The babies were vaccinated and assessed on developmental aspects based on weight, height and screening tests to determine the child abilities.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Sarallah Well-child clinic
Full name of responsible person
Navisa Seyyedi
Street address
Nazloo Campus, Sero Road
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3345 0459
Email
ns.seyyedi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Nazloo campus, Sero road
City
Urmia
Province
West Azarbaijan
Postal code
7515117175
Phone
+98 44 7557 5733
Email
mohebbi_iraj@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Bahlol Rahimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
Nazloo Campus, Sero Road
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3345 0459
Email
bahlol.rahimi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Bahlol Rahimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
Nazloo Campus, Sero Road
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3345 0459
Email
bahlol.rahimi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Bahlol Rahimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
Nazloo Campus, Sero Road
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3345 0459
Email
bahlol.rahimi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Results will be presented in an article to be published in a leading scientific journal during 2021
When the data will become available and for how long
Intention to publish date 1/1/2021
To whom data/document is available
All researchers
Under which criteria data/document could be used
Results will be presented in an article to be published in a leading scientific journal during 2021 so after publishing the data could be used
From where data/document is obtainable
Results will be presented in an article to be published in a leading scientific journal during 2021 and the applicant could use the researchers email to communicate bahlol.rahimi@gmail.com
What processes are involved for a request to access data/document
Results will be presented in an article to be published in a leading scientific journal during 2021 and the applicant could use the researchers email to communicate bahlol.rahimi@gmail.com