<?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>IRCT20230715058786N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-17</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Empowering the elderly to adopt a healthy lifestyle and self-efficacy</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of empowerment interventions based on Pender's health promotion model in adopting a healthy lifestyle and self-efficacy of the elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71318</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization To apply randomization, the method of random blocks will be used with blocks of size four. The randomization unit will be individual. According to the sample size of 60 people, 24 quadruple blocks according to the statification factors including gender (male and female), age (less than 75 and 75 years and more) and literacy level (below diploma, diploma and above) using An online site (www.sealedenvelope.com) will be developed. Each sample is assigned a number that the researchers do not know about.For concealment, random allocation concealment will be used, which refers to the method used to implement a random sequence in the participants, so that the participant is unaware of his allocation in the study groups. For this purpose, based on the sequence created in the randomization software, each of the created sequences is recorded on a card, and the cards are placed inside sealed opaque envelopes, and to maintain the sequence on the outer surface of the envelopes, no. Placement is done in the same order. The lids of the envelopes are glued and placed in a box. Based on the order of entry of eligible participants to the study, the envelopes will be opened in order and the participant group will be revealed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>the old age.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The interventions will be focused on disease prevention behaviors, healthy nutritional behaviors, physical activity, stress management, and building healthy relationships with family, friends, and neighbors, and in the form of six educational intervention sessions for the elderly and the use of self-efficacy strategies, including taking steps to The behavior step and mastering the behavior, the use of verbal encouragement after the development of the desired behavior and the use of successful models of the elderly for behavioral modeling will be done. In addition, two educational intervention sessions will be held with their families. Pamphlets and educational videos will be used for training. Therefore, the content of the interventions is as follows: six training sessions based on Pender's health promotion model (one 2-hour session per week); The first session: teaching the patterns and behaviors of appropriate and adequate nutrition for the elderly, trying to change attitudes and health beliefs and convincing the people of the test group in terms of unhealthy nutritional habits in life, the second session: teaching the patterns and physical and sports activities appropriate for the elderly, increasing the sense of Self-efficacy, trying to change attitudes and health beliefs and convincing the people of the test group to physical activities suitable for the elderly, the third session: teaching the concept of communication, verbal and non-verbal communication methods, teaching problem solving style and conflict in social interactions and personal life of the elderly, session Fourth: Defining self-efficacy, teaching concepts and ways to increase the growth of self-efficacy in the elderly, helping the elderly in identifying and distinguishing between primary and secondary basic needs and valuing personal life priorities and goals, fifth session: Teaching concepts and ways to increase support in interpersonal relationships , paying attention to the present time and using 24 hours of daily life, teaching concepts and ways to increase responsibility in the field of healthy lifestyle in old age and the sixth session: teaching concepts of stress and ways to deal with it, identifying stressful life factors and learning emotional management techniques , the implementation of the post-exam stage. Also, two group discussion sessions with the families of the elderly (the first session: training on the effectiveness of implementing healthy lifestyle programs for the elderly at low risk of disease and the second session: training on increasing self-care of the elderly and having an active and healthy elderly) as well as presenting educational videos and pamphlets for the benefits It is understood that healthy behaviors are performed in the elderly.​. Intervention 2: Control group: They did not receive any intervention.</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:
Only a part of the data, such as the information related to the main outcome or the like, can be shared.

When:
The access period starts 6 months after the results are published

To whom:
All people

Conditions:
For health research purposes

Where to obtain:
Mohsen Kaziminia

How to obtain:
send mail:
mkazeminia69@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Kaziminia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Habib Vand village</address>
        <city>Sare-Pole-Zahab</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6775139177</zip>
        <telephone>+98 83 4227 2023</telephone>
        <email>mkazeminia69@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Jalali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nobahar</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714673159</zip>
        <telephone>+98 83 3838 4185</telephone>
        <email>a_jalali@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Interested in participating in the study
Full consciousness
Having the ability to perform activities of daily living
Not suffering from severe psychiatric diseases (such as Alzheimer's and dementia)
Not having serious emergency conditions
Not having hearing, vision and movement limitations
Living in Kermanshah for more than five years</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>being admitted to the hospital
Absence of more than three sessions in intervention sessions
Refusal to continue the intervention
Migration from Kermanshah city</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>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The interventions will be focused on disease prevention behaviors, healthy nutritional behaviors, physical activity, stress management, and building healthy relationships with family, friends, and neighbors, and in the form of six educational intervention sessions for the elderly and the use of self-efficacy strategies, including taking steps to The behavior step and mastering the behavior, the use of verbal encouragement after the development of the desired behavior and the use of successful models of the elderly for behavioral modeling will be done. In addition, two educational intervention sessions will be held with their families. Pamphlets and educational videos will be used for training. Therefore, the content of the interventions is as follows: six training sessions based on Pender's health promotion model (one 2-hour session per week); The first session: teaching the patterns and behaviors of appropriate and adequate nutrition for the elderly, trying to change attitudes and health beliefs and convincing the people of the test group in terms of unhealthy nutritional habits in life, the second session: teaching the patterns and physical and sports activities appropriate for the elderly, increasing the sense of Self-efficacy, trying to change attitudes and health beliefs and convincing the people of the test group to physical activities suitable for the elderly, the third session: teaching the concept of communication, verbal and non-verbal communication methods, teaching problem solving style and conflict in social interactions and personal life of the elderly, session Fourth: Defining self-efficacy, teaching concepts and ways to increase the growth of self-efficacy in the elderly, helping the elderly in identifying and distinguishing between primary and secondary basic needs and valuing personal life priorities and goals, fifth session: Teaching concepts and ways to increase support in interpersonal relationships , paying attention to the present time and using 24 hours of daily life, teaching concepts and ways to increase responsibility in the field of healthy lifestyle in old age and the sixth session: teaching concepts of stress and ways to deal with it, identifying stressful life factors and learning emotional management techniques , the implementation of the post-exam stage. Also, two group discussion sessions with the families of the elderly (the first session: training on the effectiveness of implementing healthy lifestyle programs for the elderly at low risk of disease and the second session: training on increasing self-care of the elderly and having an active and healthy elderly) as well as presenting educational videos and pamphlets for the benefits It is understood that healthy behaviors are performed in the elderly.​</i_keyword>
      <i_keyword>Control group: They did not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Healthy lifestyle. Timepoint: Before and after the intervention. Method of measurement: Healthy lifestyle questionnaire.</prim_outcome>
      <prim_outcome>Efficacy. Timepoint: Before and after the intervention. Method of measurement: Sharr self-efficacy questionnaire.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-16</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti Blvd., Medical Sciences Building No. 2 kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
