Smartphone-based maternal education directed at complementary feeding versus treatment as usual among malnourished children below 3 years of age in food-secure contexts: Randomized controlled trial in Urmia, Iran
The aim of this study was to assess the effect of smartphone-based maternal nutritional education directed at complementary feeding on malnourished children below 3 years of age in a food-secure context
Design
Six-month single-centre randomized controlled trial with one intervention (smartphone application) arm and one control (treatment-as-usual) arm.
Settings and conduct
The study used a randomized controlled trial design with one intervention and one control arm (n=110; 1:1 ratio). 860 children seen at one well-child clinic in Urmia, Iran, were assessed for study eligibility. An educational smartphone application was delivered to the intervention group for a 6-month period while the control group received treatment-as-usual (TAU). The primary outcome and Secondary outcome measures were pre-post intervention changes in malnutrition indices and mothers’ nutritional health literacy.
The randomization was performed by a researcher with no access to participant information and who did not participate in the enrollment process. also, the participants in control group were blinded to the smartphone application provided to the intervention group.
Participants/Inclusion and exclusion criteria
inclusion criteria
Child aged < 3 years with moderate or severe malnourishment
exclusion criteria
Child or mother diagnosed with a medical disorder requiring treatment. Mother did not possess a smartphone.
Intervention groups
in the intervention group, the application provided the mothers of newly-born children with an interactive healthy-child care guide structured into a set of learning topics. In the control arm, mother and child pairs received routine health service treatment.
Main outcome variables
weight-for-height (WFH), weight-for-age (WFA) and height-for-age (HFA) z scores
mothers nutritional health literacy (critical knowledge, feeding attitudes, and nutrition practice)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190705044103N1
Registration date:2019-07-14, 1398/04/23
Registration timing:retrospective
Last update:2019-07-14, 1398/04/23
Update count:0
Registration date
2019-07-14, 1398/04/23
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
2018-04-01, 1397/01/12
Expected recruitment end date
2018-05-15, 1397/02/25
Actual recruitment start date
2018-04-01, 1397/01/12
Actual recruitment end date
2018-05-31, 1397/03/10
Trial completion date
2018-12-31, 1397/10/10
Scientific title
Smartphone-based maternal education directed at complementary feeding versus treatment as usual among malnourished children below 3 years of age in food-secure contexts: Randomized controlled trial in Urmia, Iran
Public title
Smartphone-based maternal education directed at complementary feeding among malnourished children below 3 years of age in Urmia, Iran
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Child aged < 3 years
with moderate or severe malnourishment with regard to wasting (WFH < -2),and/or underweight (WFA < -2), and/or stunting (HFA < -2)
Exclusion criteria:
Child or mother diagnosed with a medical disorder requiring treatment
Mother diagnosed with a medical disorder requiring treatment
Mother did not possess a smartphone
Age
To 3 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Sample size
Target sample size:
110
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The mothers having consented to participate in the study were allocated using Random Allocation Software 1.0 (https://random-allocation-software.software.informer.com/1.0/) to intervention or control groups in a 1:1 ratio. The randomization was performed by a researcher with no access to participant information and who did not participate in the enrollment process. 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 study bias it is required that the control and intervention have no access to each other. because in this intervention as an educational mobile App, it is possible the control group by identifying the opposite group could access to the app however this probability is low in our study but for avoiding this bias the investigation on participants were conducted quit separately in an isolated room. (Dear admin, please let us know if this is blinding)
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
2017-12-13, 1396/09/22
Ethics committee reference number
IR.UMSU.REC.1396.291
Health conditions studied
1
Description of health condition studied
moderate malnutrition
ICD-10 code
E44.0
ICD-10 code description
Moderate protein-calorie malnutrition
2
Description of health condition studied
severe malnutrition
ICD-10 code
E41
ICD-10 code description
Nutritional marasmus
Primary outcomes
1
Description
Pre-post intervention change with regard to wasting status measured by the weight-for-height (WFH) z score (< -2 standard deviations (SDs)) indicator
Timepoint
before intervention and 6 month after intervention
Method of measurement
The weight of the child was obtained using a calibrated electronic scale and infant digital scale and stadiometer were used for measuring the height
Secondary outcomes
1
Description
Underweight status (measured by the WFA indicator), practice
Timepoint
before intervention and 6 month after intervention
Method of measurement
calibrated electronic scale
2
Description
stunting status (the HFA indicator),
Timepoint
before intervention and 6 month after intervention
Method of measurement
infant digital scale and stadiometer were used for measuring the height
3
Description
wasting caseness (WFH < -2; yes/no),
Timepoint
before intervention and 6 months after intervention
Method of measurement
(WFH < -2; yes/no)
4
Description
underweight caseness (WFA < -2; yes/no),
Timepoint
calibrated electronic scale
Method of measurement
(WFA < -2; yes/no)
5
Description
stunting caseness (HFA < -2; yes/no),
Timepoint
before intervention and 6 month after intervention
Method of measurement
(HFA < -2; yes/no)
6
Description
mothers nutritional health literacy (critical knowledge, feeding attitudes, and nutrition practice)
Timepoint
before intervention and 6 month after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: A smartphone application and educational content were developed based on the Maternity Guidelines for maternal and child health services issued by the Iranian Ministry of Health and delivered to the intervention group for a 6-month period. The application provided the mothers of newly-born children with an interactive healthy-child care guide structured into a set of learning topics. The topics included nutrition principles based on child age, behavioral methods for child feeding, child weaning time, the introduction of complementary feeding, and mother health. All learning materials in the application were cross-examined by expert nutritionists to ensure that they complied with the national guidelines on infant feeding in the first 3 years of life. The user interface and functions of the smartphone application were developed using participatory design methods involving software developers, clinicians, medical informaticians, and end users in a process where functions were step wise added and revised. Following repeated field tests, a final version of the application was implemented for the Android operative system for smartphones. The final application had two major features: (1) providing mothers with evidenced-based education of how to feed their child divided by the child’s age group, and (2) a chat function where clinicians answered the mothers’ questions regarding nutrition through the application.Mothers in the intervention arm had the application installed on their smartphones at the start of the 6 months intervention period.
Category
Behavior
2
Description
Control group:In the TAU arm, mother and child pairs received routine health service treatment.Mother and child pairs were visited by MCH clinicians for assessments to determine the age-related ability of the child. Developmental screening tests were performed by asking mothers checklist-based questions about their child’s play, learning, speech, behaviour, and motor abilities.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Well-child clinic
Full name of responsible person
Hamid Reza Farrokh Eslamlou
Street address
Urmia University of Medical Sciences, Nazloo Campus, Sero Road
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3344 5138
Email
hamidfarrokh@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
Urmia University of Medical Sciences, 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 2019
When the data will become available and for how long
Intention to publish date
15/10/2019
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 2019 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 2019 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 2019 and the applicant could use the researchers email to communicate
bahlol.rahimi@gmail.com