<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20201229049874N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-23</date_registration>
      <primary_sponsor>Esfarayen University of Medical Sciences</primary_sponsor>
      <public_title>Social Media Intervention for Improve Water Drinking Behaviour among students in Yasuj, Iran</public_title>
      <acronym></acronym>
      <scientific_title>Designing and Assessing Effects of a Social Media Intervention for Improve Water Drinking Behaviour Among Grade 7 to 9 Female Students of Yasuj, Iran</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>388</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53385</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: This study is a field trial (Before and after study with a randomized comparison group) with 194 people in each group (water intervention and comparison group). Using simple randomization method, two school will be selected out from the list of secondary schools in Yasuj, where the number of seventh to ninth grade students is calculated equal to the sample size. Out of two schools, one is randomly assigned to experimental group and the other to the comparison group. All seventh to ninth grade students from these two schools enter the study, Blinding description: Both intervention and comparison groups receive training through a social media, but participants are unaware of the content and structure of the tailored education (based on a selective framework) or general. In other words, they do not know which group they belong to.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Water consumption.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 7th to 9th grade female students in the secondary school of Yasuj, which has been selected as the intervention school. The selection of intervention components, behavioral change strategies, and educational methods and materials is mainly based on social cognitive theory. Students in the intervention group receive one of the interventions each week for three months through one of the social networks and online. Interventions in this group include providing the desired content through text messages, videos, audio and short text files, providing individual advice and feedback, publishing successful and unsuccessful experiences in the group, starring students who drank more water during the last week, help students to set short-term and long-term goals, verbally encourage students, encourage students to self-reward, use reminders to record the volume of water consumed, and develop a water drinking commitment letter and approval by students. The required content and media will be compiled by the researcher. Forming a group and presenting all the interventions is done by Stars in each class who has been trained to do this, and in this way the influence of peers is used to improve the drinking behavior of students. The researcher supervises the leadership of the group and the implementation of interventions by the stars, the discussions and the participation of all members of each group. Coordination and planning will be done with the school principal before the intervention. Intervention 2: Control group: 7th to 9th grade female students in the secondary school of Yasuj, which has been selected as the control school. The comparison school will only receive a series of general and background information on the subject through the researcher, and peers will have no role in this group. Educational content will be provided to them after the end of the study.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data related to the main outputs of the study

When:
One year after the publication of the study results

To whom:
Researchers working in universities and scientific institutes

Conditions:
Conducting meta analysis

Where to obtain:
Refer to the site of Isfahan University of Medical Sciences Vice Chancellor for Research
Call Dr. Ahmad Ali Eslami or send a request email to him

How to obtain:
Send the request email and respond to it by the responsible person

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ahmad Ali Eslami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar-jarib St.,</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3668 8138</telephone>
        <email>eslamiaa@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Ali Eslami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar-Jerib St.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3668 8138</telephone>
        <email>eslamiaa@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Residence in Yasuj
Lack of diet and history of regular medication
No cardiovascular, renal, hepatic diseases, diabetes, and hypertension</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>15 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>No tendency to participation in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 7th to 9th grade female students in the secondary school of Yasuj, which has been selected as the intervention school. The selection of intervention components, behavioral change strategies, and educational methods and materials is mainly based on social cognitive theory. Students in the intervention group receive one of the interventions each week for three months through one of the social networks and online. Interventions in this group include providing the desired content through text messages, videos, audio and short text files, providing individual advice and feedback, publishing successful and unsuccessful experiences in the group, starring students who drank more water during the last week, help students to set short-term and long-term goals, verbally encourage students, encourage students to self-reward, use reminders to record the volume of water consumed, and develop a water drinking commitment letter and approval by students. The required content and media will be compiled by the researcher. Forming a group and presenting all the interventions is done by Stars in each class who has been trained to do this, and in this way the influence of peers is used to improve the drinking behavior of students. The researcher supervises the leadership of the group and the implementation of interventions by the stars, the discussions and the participation of all members of each group. Coordination and planning will be done with the school principal before the intervention.</i_keyword>
      <i_keyword>Control group: 7th to 9th grade female students in the secondary school of Yasuj, which has been selected as the control school. The comparison school will only receive a series of general and background information on the subject through the researcher, and peers will have no role in this group. Educational content will be provided to them after the end of the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean Volume of daily water consumption. Timepoint: At the beginning of the study (before the intervention), during the intervention, immediately after the intervention, one month and three months after the intervention. Method of measurement: Recording the volume of daily water consumption as a self-report by Liq in 7.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Habit to regular water consumption during day. Timepoint: Before the intervention, one month and three months after the intervention. Method of measurement: Self-reported by The Self-Report Habit Index.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Esfarayen University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-27</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar-Jerib St. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
