<?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>IRCT20140518017736N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-05</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of family-centered empowerment, collaborative care model and motivational interviewing techniques on blood sugar control and eating behaviors</public_title>
      <acronym></acronym>
      <scientific_title>Study and comparison the effectiveness of family-centered empowerment, collaborative care model and motivational interviewing techniques on blood sugar control and eating behaviors based on BASNEF model among patients with diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34852</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, a multi-stage cluster sampling method will be used. At first, 80 Health Houses will be selected and then, three health houses will be selected using the simple sampling method. Randomization will be done using SPSS (version 18) software, Blinding description: There is no blinding process at present study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes type 2.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Collaborative Care. It consists of four stages: 1) motivation, 2) preparation, 3) engagement and 4) evaluation. These four steps will be conducted in the form of two phases of collaborative educational visits and collaborative follow-up visits. Interventions for all visits will be conducted for 2 groups of 15 (30 in total) independently (each session duration is 60-45 minutes on average). Intervention 2: Intervention group 2: Family-based Empowerment.It consists of four stages of perceived threat, self-efficacy, self-esteem and evaluation. All stages are delivered through two 30-45 minute sessions. Each group has 15 people (2 groups of 15). Intervention 3: Intervention group 3: Motivational Interviewing. It consists of four basic principles: expressing empathy, developing discrepancy, rolling with resistance and self-efficacy support. Each group consists of 10 patients. The training will be delivered through 5 30-45 minute sessions.,. Intervention 4: Control group: This group only receives common training about diabetes in the health centers through 5 30-45 minute sessions. Each group has 15 patients (2 groups of 15).</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:
Information on the main outcomes of the study will provide for decision makers and authorities of Health Deputy

When:
The study will be conducted in November 1397 and results will be presented after one year

To whom:
All  academic researchers will have access to the results

Conditions:
In addition to publishing results in valid journals, the results will be available to officials working in the provincial health center

Where to obtain:
Dr Seyyed Kamaladdin Mirkarimi, Assistant Professor, Department of Public Health, Golestan University of Medical Sciences, Mobile number 09112731646 and email k.mirkarimi@goums.ac.ir

How to obtain:
Results, questionnaire and study tools will be available to all researchers   (after publication of the paper) through the telephone and email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyyed Kamaladdin Mirkarimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan University of Medical Sciences, 4th Kilometer of Gorgan-Sari Road</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4917848183</zip>
        <telephone>+98 17 3216 0330</telephone>
        <email>k.mirkarimi@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyed Kamaladdin Mirkarimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan University of Medical Sciences, 4th Kilometer of Gorgan-Sari Road</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4917848183</zip>
        <telephone>+98 17 3216 0330</telephone>
        <email>k.mirkarimi@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with type 2 diabetes diagnosed by a physician
Patients who have been registered and have records in health houses in Gorgan
Not participating in other family-based empowerment training classes, collaborative care model and motivational interviewing
Reading and writing literacy</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Consumption of medications which have possible interaction with type 2 diabetes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Collaborative Care. It consists of four stages: 1) motivation, 2) preparation, 3) engagement and 4) evaluation. These four steps will be conducted in the form of two phases of collaborative educational visits and collaborative follow-up visits. Interventions for all visits will be conducted for 2 groups of 15 (30 in total) independently (each session duration is 60-45 minutes on average).</i_keyword>
      <i_keyword>Intervention group 2: Family-based Empowerment.It consists of four stages of perceived threat, self-efficacy, self-esteem and evaluation. All stages are delivered through two 30-45 minute sessions. Each group has 15 people (2 groups of 15).</i_keyword>
      <i_keyword>Intervention group 3: Motivational Interviewing. It consists of four basic principles: expressing empathy, developing discrepancy, rolling with resistance and self-efficacy support. Each group consists of 10 patients. The training will be delivered through 5 30-45 minute sessions.,</i_keyword>
      <i_keyword>Control group: This group only receives common training about diabetes in the health centers through 5 30-45 minute sessions. Each group has 15 patients (2 groups of 15)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood sugar. Timepoint: Pre-intervention, 2, 6 and 12 months after intervention. Method of measurement: Fasting blood sugar test and HbA1C for measuring blood sugar.</prim_outcome>
      <prim_outcome>Nutritional behaviors. Timepoint: Pre-intervention, 2, 6 and 12 months after intervention. Method of measurement: Standardized questionnaire of food frequency for measuring eating behaviors.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-18</approval_date>
        <contact_name>Ethics Committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>4th Kilometer of Gorgan-Sari Road Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
