<?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>IRCT2016012626078N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-02-12</date_registration>
      <primary_sponsor>Vice chancellor for Education  of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Prevention of obesity in children</public_title>
      <acronym></acronym>
      <scientific_title>Development and evaluation of  intervention based on enabling mothers for prevention of obesity in 4 to 6 years old children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21710</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>obesity.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group (mothers), educational intervention (training classes) will be received. Educational intervention will be based on social cognitive theory and the theory of family systems (parenting skills and practices). Content, methods and number of training sessions  will be according to the analysis of the results of pre - test. Intervention 2: Control group will not receive any intervention . (For control group after completion of study, training sessions are held  based on a healthy lifestyle).</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Nejadsadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Public Health,  Poursina Street, Tehran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>141556446</zip>
        <telephone>+98 21 4293 3210</telephone>
        <email>nejadsadeghi_e@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Nejadsadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Public Health,  Street Poursina,  Tehran university of medical science</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>141556466</zip>
        <telephone>+98 21 4293 3210</telephone>
        <email>nejadsadeghi_e@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:Lack of consent to participate in the study; Mother with at least one child 4-6 years old.&#13;
Exclusion criteria:Unwillingness to continue to participate in the study; Pregnant women; Mothers of child out age 6-4 years old; Children who are 6-4 years old  but suffered a physical disability that are activities Physical moderate to severe disorder imported;A child with a weight-related medical problem; Child who has participated in other weight management programs.</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group (mothers), educational intervention (training classes) will be received. Educational intervention will be based on social cognitive theory and the theory of family systems (parenting skills and practices). Content, methods and number of training sessions  will be according to the analysis of the results of pre - test.</i_keyword>
      <i_keyword>Control group will not receive any intervention . (For control group after completion of study, training sessions are held  based on a healthy lifestyle)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Preventive behaviors of obesity in children (daily: 2 hours of physical activity, eating five portions of fruit and vegetables, eating sugar-free drinks and watching less than two hours of TV). Timepoint: Before the intervention, 3 and 6 months after intervention. Method of measurement: questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Child eating behavior (response to the food, the answer to satiety , low dining emotional, emotional overeating, an interest in wine, enjoy a meal, eat slowly and excuses food). Timepoint: Before, 3 and 6 months after the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Skills ( communication skills , monitoring, problem solving, encourage good behavior, bad behavior management). Timepoint: Before, 3 and 6 months after the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>H ow to feed the baby by the mother (the child's freedom of action, the regulation of emotions Children with food, encourage children to respect the balance and diversity in eating, control of food available to children, using food as a reward, the participation of children in meal planning, food consumption modeling, monitoring snack, Forced to eat, with the aim of limiting the child's health, weight control and nutrition training with the aim of limiting the child-to-child). Timepoint: Before, 3 and 6 months after the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Constructs of  social cognitive theory (environmental factors, expected outcomes, emotional adjustment, self-control and self-efficacy). Timepoint: Before, 3 and 6 months after the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Procedures parenting (authoritarian practices, arbitrary manner ,lax procedures). Timepoint: Before, 3 and 6 months after the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Body Mass Index. Timepoint: Before,  6 months after the intervention. Method of measurement: (Weight in kilograms) divided by (height in meters squared 2).</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>Vice chancellor for Education  of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-01-05</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences, 16 Azar Street Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
