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IRCT20140907019082N11 IRCT 2022-02-19 Tabriz University of Medical Sciences Effect of mobile application on children's undernutrition Designing a mobile application for educating mothers of preschool children with undernutrition and comparing its efficacy with the usual method of clinical education on the level of knowledge, attitude and nutritional practices of mothers and nutritional status of children aged 2 to 6 years 2022-02-05 anticipated 116 Complete https://irct.ir/trial/61592 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Individuals enter the study through convenience sampling from pediatrician's office and will be divided into two groups of intervention and control using simple randomization and will be matched based on age, sex and degree of malnutrition as well as supplementation or medication. In this study, we will use block randomization. Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process. The size of all the blocks is the same and we will have 4 blocks in this four-group experiment. The randomization tool is also used from the site www.sealedenvelope.com, which is a site for generating random sequences, in addition to simple randomization, is able to generate random sequences by blocking method. For concealment, we use allocation concealment, which is the method used to execute a random sequence on study participants, so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with a random sequence (Sequentially numbered, sealed, opaque envelopes) in which in this method each random sequence is recorded on a card and the cards are placed in the envelopes respectively. Are placed. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed, Blinding description: In this study, participants will be unaware of the type of intervention received (application or routine consultation) by each group. N/A Undernutrition. Intervention 1: Intervention group: includes face-to-face instructions in the clinic and providing nutrition education mobile application. Intervention 2: Control group: Receive only in-clinic instructions. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mahdieh Abbasalizad Farhangi
Tabriz University of Medical Sciences, Attar St. Tabriz, I.R.Iran
Tabriz Iran (Islamic Republic of) 5166614711 +98 413357580 abbasalizadm@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Mahdieh Abbasalizad Farhangi
Tabriz University of Medical Sciences, Attar St. Tabriz, I.R.Iran
Tabriz Iran (Islamic Republic of) 5166614711 +98 413357580 abbasalizadm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study and signature of written consent by mothers Smartphone accessibility Being 2 to 6 years old confirmation of being malnourished and underweight using growth charts Mother's literacy 2 years 6 years Both Reluctance to continue participation Having a specific disease that affects the results of the study R63.6 Underweight Behavior Behavior Intervention group: includes face-to-face instructions in the clinic and providing nutrition education mobile application Control group: Receive only in-clinic instructions Weight for age z-score. Timepoint: Baseline and 3 months after intervention. Method of measurement: Digital weighing scale and growth chart. Weight for height z-score. Timepoint: Baseline and 3 months after intervention. Method of measurement: Digital weighing scale, stadiometer and growth chart. Tabriz University of Medical Sciences Approved 2022-01-29 Ethics committee of Tabriz University of Medical Sciences Faculty of Nutrition and Food Sciences, Attar Neyshabouri St., Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)