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IRCT20190705044103N1 IRCT 2019-07-14 Oroumia University of Medical Sciences Smartphone-based maternal education directed at complementary feeding among malnourished children below 3 years of age in Urmia, Iran 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 2018-04-01 anticipated 110 Complete https://irct.ir/trial/40612 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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 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. N/A Condition 1: moderate malnutrition. Condition 2: severe malnutrition. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Results will be presented in an article to be published in a leading scientific journal during 2019 When: Intention to publish date 15/10/2019 To whom: All researchers Conditions: 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 Where to obtain: 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 How to obtain: 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 Comments:
public Bahlol Rahimi
Nazloo Campus, Sero Road
Urmia Iran (Islamic Republic of) 571478334 +98 44 3345 0459 bahlol.rahimi@gmail.com Oroumia University of Medical Sciences scientific Bahlol Rahimi
Nazloo Campus, Sero Road
Urmia Iran (Islamic Republic of) 571478334 +98 44 3345 0459 bahlol.rahimi@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) 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) no limit 3 years Both Child or mother diagnosed with a medical disorder requiring treatment Mother diagnosed with a medical disorder requiring treatment Mother did not possess a smartphone E44.0 E41 Moderate protein-calorie malnutrition Nutritional marasmus Behavior Behavior 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. 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. 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. Underweight status (measured by the WFA indicator), practice. Timepoint: before intervention and 6 month after intervention. Method of measurement: calibrated electronic scale. 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. Wasting caseness (WFH < -2; yes/no),. Timepoint: before intervention and 6 months after intervention. Method of measurement: (WFH < -2; yes/no). Underweight caseness (WFA < -2; yes/no),. Timepoint: calibrated electronic scale. Method of measurement: (WFA < -2; yes/no). Stunting caseness (HFA < -2; yes/no),. Timepoint: before intervention and 6 month after intervention. Method of measurement: (HFA < -2; yes/no). Mothers nutritional health literacy (critical knowledge, feeding attitudes, and nutrition practice). Timepoint: before intervention and 6 month after intervention. Method of measurement: questionnaire. Oroumia University of Medical Sciences Approved 2017-12-13 Ethics committee of Urmia University of Medical Science Urmia University of Medical Sciences, Nazloo Campus, Sero Road Urmia West Azarbaijan Iran (Islamic Republic of)