<?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>IRCT2016062928697N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-07-15</date_registration>
      <primary_sponsor>Vice chancellor for research of Bushehr University of Medical Sciences</primary_sponsor>
      <public_title>The impact of distant education on physical activity in patients with diabetes.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of two methods of education including distant education multimedia and Short Message Sending (SMS) on the amount of physical activity in patients with type 2 diabetes: An application of Health Promotion Model</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23215</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Randomization is performed using random number table.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Multimedia education group will receive health promotion model-based education in the field of physical activity behavior change. Multimedia educational group receives a CD about the benefits and barriers of physical activity such as issues on physical activity during the periods of high blood sugar and educational materials on the reducion of muscle cramps after the initial increased physical activity, educating based on step by step changing of physical activity and increase it gradually over a period of 3 months, correcting people's views on the usefulness of an increase in heart rate associated with the exercise in order to improve the efficacy.  In addition, multimedia Group receives some messages twice a week up to 3 months after the educational program, in order to recall information. Intervention 2: SMS education group, receives health promotion model-based education to change physical activity behavior. The SMS group  receives multimedia content group gradually in which short messages, daily 2 messages (total per week, 12 messages from Saturday to Thursday) in the fields related to health promotion structures two weeks. In addition  SMS group receives  message  twice on the week to remind information, data structures, the time interval up to 3 months after completing the educating program will be sent. Intervention 3: control group receives clinical routine education.</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>Azita Noroozi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bushehr University of Medical Sciences, Salman Farsi Street, Bahmani, Bushehr, Iran</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7514633341</zip>
        <telephone>+98 77 3332 2081</telephone>
        <email>azitanoroozi@yahoo.com</email>
        <affiliation>Bushehr University of Medical Sciences, Bushehr</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azita Noroozi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bushehr University of Medical Sciences, Salman Farsi Street, Bahmani, Bushehr, Iran</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7514633341</zip>
        <telephone>+98 77 3332 2081</telephone>
        <email>azitanoroozi@yahoo.com</email>
        <affiliation>Bushehr University of Medical Sciences, Bushehr, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:having high school diploma; Not having diabetic foot ulcers; Willingness to participate in the study; Passing at least one year after diabetes; having a computer or CD player for multimedia group.&#13;
Exclusion criteria: Functional inability to walk without stick; inability to walk one mile (about 1.6 km) without rest according to the individual saying; inability to continue participation for at least 3 months; Having cardiovascular disease.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Multimedia education group will receive health promotion model-based education in the field of physical activity behavior change. Multimedia educational group receives a CD about the benefits and barriers of physical activity such as issues on physical activity during the periods of high blood sugar and educational materials on the reducion of muscle cramps after the initial increased physical activity, educating based on step by step changing of physical activity and increase it gradually over a period of 3 months, correcting people's views on the usefulness of an increase in heart rate associated with the exercise in order to improve the efficacy.  In addition, multimedia Group receives some messages twice a week up to 3 months after the educational program, in order to recall information.</i_keyword>
      <i_keyword>SMS education group, receives health promotion model-based education to change physical activity behavior. The SMS group  receives multimedia content group gradually in which short messages, daily 2 messages (total per week, 12 messages from Saturday to Thursday) in the fields related to health promotion structures two weeks. In addition  SMS group receives  message  twice on the week to remind information, data structures, the time interval up to 3 months after completing the educating program will be sent.</i_keyword>
      <i_keyword>control group receives clinical routine education.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Doing physical activity. Timepoint: Before education and 3 months later. Method of measurement: Seven-day physical activity recall.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Perceived benefits. Timepoint: Before, two weeks and three months after education. Method of measurement: Standard perceived benefits questionnaire.</sec_outcome>
      <sec_outcome>Perceived barriers. Timepoint: Before, two weeks and three months after education. Method of measurement: Perceived barriers questionnaire.</sec_outcome>
      <sec_outcome>Perceived Self-efficacy. Timepoint: Before, two weeks and three months after education. Method of measurement: Perceived self-efficacy questionnaire.</sec_outcome>
      <sec_outcome>Perceived health status. Timepoint: Before, two weeks and three months after education. Method of measurement: 12-Item short form health survey(SF-12).</sec_outcome>
      <sec_outcome>Perceived social support. Timepoint: Before, two weeks and three months after education. Method of measurement: Perceived Social Support Questionnaire.</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 research of Bushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-06-20</approval_date>
        <contact_name>Ethics committee of Bushehr University of Medical Sciences</contact_name>
        <contact_address>Bushehr University of Medical Sciences, Salman Farsi Street, Bahmani, Bushehr, Iran Bushehr  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
