<?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>IRCT20221224056911N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-18</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational program based on the Health ActionProcess Approach Model on consumption of fruit and vegetable in type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of educational program based on the Health ActionProcess Approach Model on consumption of fruit and vegetable in type 2 diabetes patients in Buin Zahra city.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69301</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Buin Zahra city includes 11 comprehensive health service centers, out of which four centers will be selected by lottery, and then the names of the patients will be extracted and a list will be prepared, and those who do not have the conditions to participate in the study will be removed from the list. Among the remaining patients, people will be selected and entered into the study in a simple way (by lottery). Also, 12 people will be allocated to the intervention group and 12 people to the control group from two centers, and 13 people will be allocated to the intervention group and 13 people to the control group from the other two centers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Status of fruit and vegetable consumption in diabetic patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For the intervention group, after completing the questionnaire and according to the results of the analysis of the path and weight of each structure and according to the standard time of a training session which is 30 to 45 minutes and will be implemented based on the training goals. In these sessions, the food pyramid and Food groups including fruits and vegetables, the benefits of consuming fruits and vegetables, alternative behaviors will be presented through group discussion, existing obstacles will be removed by the method of brainstorming and verbal encouragement of patients, the positive experiences of patients following a diet containing fruits and vegetables It will be discussed in a group, strategies for increasing access to fruits and vegetables, preparing a meal containing fruits and vegetables, and preparing a snack such as a fruit and vegetable salad will be taught. Also, a video on how to clean and disinfect fruits and vegetables will be taught. It will be distributed to patients. Intervention 2: Control group: For the control group, no special program or intervention will be considered, but in order to comply with the ethics of the research, after the final evaluation (FOLLOW UP), a group training session will be considered for all patients of the control group, and also, the training package developed in The choice of all patients and the control group will be included.</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:
All information about the main outcome can be shared.

When:
The access period will start 6 months after the results are published.

To whom:
All researchers working in academic and industrial institutions can receive it.

Conditions:
In case of confidentiality, patient information and study results should be used to improve patients' quality of life.

Where to obtain:
Email address:y.ghasemkhani60@gmail.com
Phone number:02834224170
Yahya Ghasemkhani

How to obtain:
1- Submitting an application on behalf of the applicant.
2- I received the request.
3- Sending documents to the applicant. About 2 weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yahya Ghasemkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 18,  Elaheh Ave.14 , governorship Blvd., Buin Zahra Town</address>
        <city>Buien zahra</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3451746338</zip>
        <telephone>+98 28 3422 4170</telephone>
        <email>y.ghasemkhani@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yahya Ghasemkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 18,  Elaheh Ave.14 , governorship Blvd., Buin Zahra Town</address>
        <city>Buien zahra</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3451746338</zip>
        <telephone>+98 28 3422 4170</telephone>
        <email>y.ghasemkhani@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Type 2 diabetes.
Being a volunteer
Being between 30 and 60 years old
Not having complications related to diabetes
The patient has a smart mobile phone
Be literate in reading and writing
A history of diabetes for at least one year.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from physical and mental illnesses
Having severe complications of diabetes
Having an addiction to drugs, alcohol, etc.</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>Intervention group: For the intervention group, after completing the questionnaire and according to the results of the analysis of the path and weight of each structure and according to the standard time of a training session which is 30 to 45 minutes and will be implemented based on the training goals. In these sessions, the food pyramid and Food groups including fruits and vegetables, the benefits of consuming fruits and vegetables, alternative behaviors will be presented through group discussion, existing obstacles will be removed by the method of brainstorming and verbal encouragement of patients, the positive experiences of patients following a diet containing fruits and vegetables It will be discussed in a group, strategies for increasing access to fruits and vegetables, preparing a meal containing fruits and vegetables, and preparing a snack such as a fruit and vegetable salad will be taught. Also, a video on how to clean and disinfect fruits and vegetables will be taught. It will be distributed to patients.</i_keyword>
      <i_keyword>Control group: For the control group, no special program or intervention will be considered, but in order to comply with the ethics of the research, after the final evaluation (FOLLOW UP), a group training session will be considered for all patients of the control group, and also, the training package developed in The choice of all patients and the control group will be included.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Amount of fruit and vegetable consumption. Timepoint: Before the educational intervention and one month after the educational intervention. Method of measurement: According to the self-reported questionnaire by the diabetic patients participating in the study.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-18</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>No. 18,  Elaheh Ave.14 , governorship Blvd., Buin Zahra Town Buin Zahra Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
