<?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>IRCT2014083118989N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-02</date_registration>
      <primary_sponsor>Vice Chansellor for Research,Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of the New Technologies-based Education  on the life style and Obesity of Employees</public_title>
      <acronym></acronym>
      <scientific_title>Development and Evaluation of the Effectiveness of an Intervention Based on New Communication Technologies and the Social-Cognitive Theory on the Weight Control and Lifestyle of the Employees With Overweight and Obesity</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>435</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17095</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Obesity. Condition 2: lifestyle.</hc_freetext>
      <i_freetext>Intervention 1: Phone intervention:&#13;
The intervention starts when the personal&#13;
counsellor first calls the participant. The ”lifestyle programe” consists of 10 modules (lessons) that provide the participants with information on the nutrition and physical activity. The assignments teach the participants how to use the strategies in their daily lives. The intervention will be continued for 6 months. Subjects in the telephone- assisted group  will be received the lessons via the SMS. Telephone consultations will be provided at the end of every two weeks. Intervention 2: Internet intervention: A website is developed for the intervention,With unique username and password for each participants. The employee is asked to fill out some personal details for the counselor .The &#13;
‘lifestyle programe” consists of 10 modules (lessons) that provide the participants with information on the nutrition and physical activity. The intervention will be continued for 6 months. Subjects in the web- assisted group will be received the lessons via the web  &#13;
. E-mail consultations will be provided at the end of every two weeks. Intervention 3: Control group: The control group will be received general brochures about lifestyle and overweight although they do not receive the lifestyle program.</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>Jalal Abdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Education and Promotion, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 3821 4519</telephone>
        <email>j-abdi@razi.tums.ac.ir</email>
        <affiliation>Department of Health Education and Promotion, School of Public Health, Tehran University of Medical </affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hassan Eftekhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Education and Promotion, School of Public Health, Tehran University of Medical  Science, Poorsina Street, Engelab Square, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8895 5888</telephone>
        <email>Eftkhara@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences, Tehran, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The most important inclusion criteria are:&#13;
Body Mass Index(BMI)&gt;25kg/m2;  working for at least 8 hours per week; having computer and to be familiar with working with computer ;  access to the telephone, cell phone, and the Internet, and familiarity with working with these technologies;   and age above 18 years. The exclusion criteria are pregnancy; depression; and other disorders leading to physical inactivity</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.0</hc_code>
      <hc_code>z72</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity due to excess calories</hc_keyword>
      <hc_keyword>Problems related to lifestyle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Phone intervention:&#13;
The intervention starts when the personal&#13;
counsellor first calls the participant. The ”lifestyle programe” consists of 10 modules (lessons) that provide the participants with information on the nutrition and physical activity. The assignments teach the participants how to use the strategies in their daily lives. The intervention will be continued for 6 months. Subjects in the telephone- assisted group  will be received the lessons via the SMS. Telephone consultations will be provided at the end of every two weeks.</i_keyword>
      <i_keyword>Internet intervention: A website is developed for the intervention,With unique username and password for each participants. The employee is asked to fill out some personal details for the counselor .The &#13;
‘lifestyle programe” consists of 10 modules (lessons) that provide the participants with information on the nutrition and physical activity. The intervention will be continued for 6 months. Subjects in the web- assisted group will be received the lessons via the web  &#13;
. E-mail consultations will be provided at the end of every two weeks.</i_keyword>
      <i_keyword>Control group: The control group will be received general brochures about lifestyle and overweight although they do not receive the lifestyle program.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body Mass Index. Timepoint: basline.6 and 9 months after. Method of measurement: digital scale (kg) ,Tape(cm).</prim_outcome>
      <prim_outcome>Lifestyle. Timepoint: basline.6 and 9 months after. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Social -cognitive theory constructs. Timepoint: basline.6 and 9 months after. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood Pressure. Timepoint: Baseline,6 and9 months after intervention. Method of measurement: sphygmomanometer(mmHg).</sec_outcome>
      <sec_outcome>Waist circumference. Timepoint: Baseline,6 and9 months after intervention. Method of measurement: Tape(cm).</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 Chansellor for Research,Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-08-13</approval_date>
        <contact_name>Vice Chancellor for Research, Tehran University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research, Tehran University of Medical Sciences, Keshavarz Boulevard, Engelab Square.Tehran,Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
