<?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>IRCT20180516039690N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-16</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Designing and evaluating a retirees' health promotion program</public_title>
      <acronym></acronym>
      <scientific_title>Designing and evaluating the impact of a health promotion program on retirement adjustment and the quality of life among oil industry retirees; an application of Transactional Model of Stress and Coping embedded in the Precede-Proceed model</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63038</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Allocation concealment is not possible in the process of this study. Because the intervention is of an educational type and the participants know what content they are receiving and for what purposes. Blinding is also not possible. Because the dominant form of intervention is education, which is an obvious process. Both the participants and the researcher will be informed about the content of the intervention. Stratified randomization will be applied. The participants are divided into two categories, men and women, according to their gender. Then, in each category, random allocation to intervention and control groups will be implemented through block allocation.
The process of randomly selecting and assigning them to groups is as follows:
Retirees who are members of the Fars Oil Industry Retirement Center are divided into two categories of men and women from the list of names. Then sorted by code, and using a systematic random method, 80 women and 80 men will be selected. Then through the block randomization method using Random Allocation Software, individuals are divided into two categories of intervention and control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>retirement.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: retirees are members of the Oil Industry Retirement Center. Health promotion intervention includes education and some environmental-organizational actions. In the educational component, a training course consisting of 5 to 6 sessions of approximately 45 to 60 minutes will be implemented for this group using face-to-face, virtual, or Blended Learning. In the environmental-organizational component, training sessions will be held for key family members of the participants and officials of the retirement center (two sessions for each group) with the aim of familiarizing themselves with the needs of the retirement period and the importance of support. Data will be collected and analyzed to evaluate the intervention before, three, and six months after the intervention. Intervention 2: Control group: Participants in this group will experience the regular programs of the retirement center and only a short-term home safety training course will be held for them. Data will be collected and analyzed to evaluate the intervention before, three, and six months after the 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Hossein Kaveh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Promotion, School of health, Razi Boulvar</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7153675541</zip>
        <telephone>+98 71 3725 6216</telephone>
        <email>mhkaveh255@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Hossein Kaveh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Promotion, School of health, Razi Boulvar</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7153675541</zip>
        <telephone>+98 71 3725 6216</telephone>
        <email>mhkaveh255@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>having formal document conforming to Retirement (recruitment order)
At least one and at most 10 years have passed since their retirement.
In terms of education level, they must have at least a certificate of completion of the primary course.
Having a smartphone and the ability to use it.
Use of social networks (WhatsApp).</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Those who have physical or psychological conditions that require special medical care or are unable to participate in this study. such as heart failure, kidney failure, severe depression, and cancer.
Those who work with secondary wages after retirement.</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: retirees are members of the Oil Industry Retirement Center. Health promotion intervention includes education and some environmental-organizational actions. In the educational component, a training course consisting of 5 to 6 sessions of approximately 45 to 60 minutes will be implemented for this group using face-to-face, virtual, or Blended Learning. In the environmental-organizational component, training sessions will be held for key family members of the participants and officials of the retirement center (two sessions for each group) with the aim of familiarizing themselves with the needs of the retirement period and the importance of support. Data will be collected and analyzed to evaluate the intervention before, three, and six months after the intervention.</i_keyword>
      <i_keyword>Control group: Participants in this group will experience the regular programs of the retirement center and only a short-term home safety training course will be held for them. Data will be collected and analyzed to evaluate the intervention before, three, and six months after the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life score in the World Health Organization Quality of Life –OLD questionnaire(WHOQOL-Old). Timepoint: before, 3 and 6 months after the intervention. Method of measurement: self-administered World Health Organization Quality of Life –OLD questionnaire (WHOQoL-OLD).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Retirement adjustment score. Timepoint: Before, 3 and 6 months after the intervention. Method of measurement: The Wells' Retirement adjustment scale.</sec_outcome>
      <sec_outcome>Retirement resource score. Timepoint: Before, 3 and 6 months after the intervention. Method of measurement: The Retirement Resources Inventory.</sec_outcome>
      <sec_outcome>Coping strategies score. Timepoint: Before, 3 and 6 months after the intervention. Method of measurement: The Lazarus and Folkman Ways of Coping Questionnaire.</sec_outcome>
      <sec_outcome>Spiritual well-being score. Timepoint: Before, 3 and 6 months after the intervention. Method of measurement: The Spiritual Well-Being Scale.</sec_outcome>
      <sec_outcome>Psychological well-being score. Timepoint: Before, 3 and 6 months after the intervention. Method of measurement: The Ryff’s Scale of Psychological Well-being.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-02</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Ethics committee, Health school, Razi boulvar Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
