<?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>IRCT20240429061582N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-22</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of community-based social marketing campaign on social support, self-efficacy and physical activity of the elderly</public_title>
      <acronym>SMC</acronym>
      <scientific_title>Designing and assessing the effectiveness of a community-based social marketing campaign on the social support, self-efficacy and physical activity of the elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-11-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>500</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76535</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: A community-based campaign, Randomization description: Using the block randomization table, centers are randomly assigned to intervention and control. Out of 16 centers, 8 will be intervention centers and 8 will be control centers. The number of participants in the group will be the same. Centers A will be the intervention and B will be the control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Inactivity in the elderly.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 65 to 75-year-olds are residents of Rasht city, and based on the decisions of the campaign committee, interventions such as educational sessions, festivals, public walks, group discussion sessions, etc. are carried out for them. The elderly group in this committee includes 10 people are neighborhood health liaisons and elderly health ambassadors, each of whom will be responsible for 25 elderly people. The survey will be carried out in a period of 3 months with the method (3 messages, 3 times, 3 methods per month). The contents will be prepared in printed and electronic form from the source of physical activity guide in the old age of the Ministry of Health and Medical Education. Intervention 2: Control group: will only receive the routine elderly care of the Ministry of Health.</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:
The entire data can potentially be shared after de-identifying people or, for example, only part of the data, such as 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:
The data/document will be available for researchers working in academic and scientific institutions and policymakers in the field of aging.

Conditions:
It will be possible for the planners in the field of aging of the Ministry of Health to use the data with the consent of the researcher.

Where to obtain:
Seyyed Roghayeh Safavi. PhD Candidate of Tehran University of Medical Sciences. Email: Roghayehsafavi@yahoo.com. Contact number: 09114560649. Address: Rasht, Farhang Square, Azadegan Street. Gilan Province Health Deputy

How to obtain:
Documents and files will be sent by e-mail within 5 working days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyyed Roghayeh Safavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab St., Qods St., Porsina St., Faculty of Health</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417613151</zip>
        <telephone>+98 21 4293 3261</telephone>
        <email>Roghayehsafavi@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Roya Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab St., Qods St., Porsina St., Faculty of Health</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417613151</zip>
        <telephone>+98 21 4293 3333</telephone>
        <email>Sadeghir@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having the desire and consent to participate in the research
Age 65 to 75 years (based on the information registered in the Sib system)
Absence of cognitive problems such as dementia and Alzheimer's (based on the information registered in the Sib system)
Absence of diagnosed severe osteoporosis (based on the information recorded in the Sib system and asking the individual)
having minimum reading and writing literacy to complete the questionnaire</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to continue participating in the study
Elderly people with mobility problems related to wheelchairs
Migration
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>Intervention group: 65 to 75-year-olds are residents of Rasht city, and based on the decisions of the campaign committee, interventions such as educational sessions, festivals, public walks, group discussion sessions, etc. are carried out for them. The elderly group in this committee includes 10 people are neighborhood health liaisons and elderly health ambassadors, each of whom will be responsible for 25 elderly people. The survey will be carried out in a period of 3 months with the method (3 messages, 3 times, 3 methods per month). The contents will be prepared in printed and electronic form from the source of physical activity guide in the old age of the Ministry of Health and Medical Education.</i_keyword>
      <i_keyword>Control group: will only receive the routine elderly care of the Ministry of Health.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social support. Timepoint: 3 Month. Method of measurement: Questionnaire of social support for physical activity by Sallis et al.</prim_outcome>
      <prim_outcome>Self-Efficacy. Timepoint: 3 months. Method of measurement: Physical Activity Self-Efficacy Questionnaire for the Elderly, Shamsalinia et al.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physical activity. Timepoint: 6 months. Method of measurement: Short Form Physical Activity Questionnaire, Lee et al.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-04-28</approval_date>
        <contact_name>Working group of Ethics Committee in Research Faculty of Health and Paramedicine-Tehran University</contact_name>
        <contact_address>Enghelab St., Quds St., Porsina St., Faculty of Health Tehran Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
