<?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>IRCT20250701066313N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-07-17</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of educational intervention on self-care behaviors of people with type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of educational therapy intervention based on the theory of planned behavior on self-care behaviors of people with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-07-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84539</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 will be conducted as a multi-center cluster randomized controlled trial among patients with type 2 diabetes attending urban, rural, and urban-rural comprehensive health service centers in Khorramshahr, Khuzestan Province, Iran. In this study, the comprehensive health service center will be considered the cluster and the unit of randomization. A multistage sampling method will be used. First, a list of all urban, rural, and urban–rural comprehensive health service centers in Khorramshahr will be prepared, and six centers will be selected using simple random sampling. These six centers (clusters) will then be randomly allocated by a statistician to either the intervention group (three centers) or the control group (three centers) using simple random allocation. After the allocation of clusters, the list of patients with type 2 diabetes covered by each center will be obtained and used as the sampling frame. From each center, 30 eligible participants will be selected using systematic random sampling. Additionally, a list of 30 replacement participants will be prepared to substitute individuals who do not meet the inclusion criteria or decline participation. All participants in centers allocated to the intervention group will receive the educational intervention, whereas participants in centers allocated to the control group will receive routine care provided by the health centers. In this design, all patients within each center will be assigned to the same study group according to the cluster allocation in order to prevent contamination between the intervention and control groups, Blinding description: This study is designed as a single‑blind trial. In this study, the data analyst will be blinded to the allocation of participants to the intervention and control groups as well as to the details of the intervention. Due to the educational nature of the intervention, blinding of participants is not feasible.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Participants in the control group will receive only the routine health care services provided at the comprehensive health service centers during the study period. Intervention 2: Intervention group: In the intervention group, a blended educational program consisting of face‑to‑face and virtual education will be implemented. The face‑to‑face component will be conducted through lecture sessions accompanied by question‑and‑answer discussions, while the virtual component will include educational video clips, distribution of pamphlets, and motivational educational text messages sent to the participants’ mobile phones. The intervention is designed based on the Theory of Planned Behavior and will be delivered over four weeks, including two one‑hour face‑to‑face educational sessions and four virtual sessions during the same period. After obtaining informed consent from the participants, the questionnaires will be completed and fasting blood sugar (FBS) will be measured in both the intervention and control groups before the start of the intervention. In addition, three months after completion of the educational program, follow‑up will be conducted, the questionnaires will be completed again, and fasting blood sugar will be measured by taking blood samples from patients at the comprehensive health service centers.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No further information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Marzieh Araban</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz University of Medical Sciences, School of Public Health, Department of Health Education and Promotion</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3373 8612</telephone>
        <email>araban62@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Marzieh Araban</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz University of Medical Sciences, School of Public Health, Department of Health Education and Promotion</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3373 8612</telephone>
        <email>araban62@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Doctor-confirmed type 2 diabetes
No neurological diseases or learning disorders
Informed consent to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to continue participating in this research
Not attending half of the training sessions
Changing the address and contact number where the person cannot be reached.
Death</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Participants in the control group will receive only the routine health care services provided at the comprehensive health service centers during the study period.</i_keyword>
      <i_keyword>Intervention group: In the intervention group, a blended educational program consisting of face‑to‑face and virtual education will be implemented. The face‑to‑face component will be conducted through lecture sessions accompanied by question‑and‑answer discussions, while the virtual component will include educational video clips, distribution of pamphlets, and motivational educational text messages sent to the participants’ mobile phones. The intervention is designed based on the Theory of Planned Behavior and will be delivered over four weeks, including two one‑hour face‑to‑face educational sessions and four virtual sessions during the same period. After obtaining informed consent from the participants, the questionnaires will be completed and fasting blood sugar (FBS) will be measured in both the intervention and control groups before the start of the intervention. In addition, three months after completion of the educational program, follow‑up will be conducted, the questionnaires will be completed again, and fasting blood sugar will be measured by taking blood samples from patients at the comprehensive health service centers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determining the effect of educational intervention on awareness of self-care behaviors in patients with type 2 diabetes referring to comprehensive health centers in Khorramshahr city. Timepoint: Measuring awareness of self-care behaviors in patients with type 2 diabetes before the start of the intervention and 90 days after the intervention. Method of measurement: Awareness questionnaire.</prim_outcome>
      <prim_outcome>Determining the effect of educational intervention on attitudes towards self-care behaviors in patients with type 2 diabetes. Timepoint: Measuring attitudes towards self-care behaviors in patients with type 2 diabetes before the start of the intervention and 90 days after the intervention. Method of measurement: Attitude questionnaire.</prim_outcome>
      <prim_outcome>Determining the effect of educational intervention on abstract norms towards self-care behaviors in patients with type 2 diabetes. Timepoint: Measuring abstract norms towards self-care behaviors in patients with type 2 diabetes before the start of the intervention and 90 days after the intervention. Method of measurement: Abstract Norms Questionnaire.</prim_outcome>
      <prim_outcome>Determining the effect of educational intervention on perceived behavioral control towards performing self-care behaviors in patients with type 2 diabetes. Timepoint: Measuring perceived behavioral control over self-care behaviors in patients with type 2 diabetes before the start of the intervention and 90 days after the intervention. Method of measurement: Perceived Behavioral Control Questionnaire.</prim_outcome>
      <prim_outcome>Determining the effect of educational intervention on behavioral intention to perform self-care behaviors in patients with type 2 diabetes. Timepoint: Measuring behavioral intention to perform self-care behaviors in patients with type 2 diabetes before the start of the intervention and 90 days after the intervention. Method of measurement: Behavioral Intention Questionnaire.</prim_outcome>
      <prim_outcome>Determining the effect of educational intervention on self-care behaviors in patients with type 2 diabetes. Timepoint: Measuring self-care behaviors in patients with type 2 diabetes before the start of the intervention and 90 days after the intervention. Method of measurement: Self-care Behaviors Questionnaire.</prim_outcome>
      <prim_outcome>Determining the effect of educational intervention on social support for self-care behaviors in patients with type 2 diabetes. Timepoint: Measuring social support for self-care behaviors in people with type 2 diabetes before the start of the intervention and 90 days after the intervention. Method of measurement: Social support questionnaire.</prim_outcome>
      <prim_outcome>Determining fasting blood sugar scores in people with type 2 diabetes. Timepoint: Measurement of fasting blood sugar scores in patients with type 2 diabetes before the start of the intervention and 90 days after the intervention. Method of measurement: Glucometer device.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-01-04</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>University City, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
