<?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>IRCT20200717048124N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-05</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of motivation on physical activity</public_title>
      <acronym></acronym>
      <scientific_title>The effect of motivational intervention on promoting physical activity in middle-aged Iranian women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49771</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>physical inactivity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A number of behavioral change models, including trans-theoretical model (TTM), precede-proceed model (PPM), health belief model (HBM), beliefs, attitudes, subjective norms and enabling factors (BASNEF) model, and health promotion model (HPM), were considered to evaluate the best PA-promoting model after the literature review and unstructured face-to-face interview with the panel of experts. They included twenty specialists (sports medicine, community medicine, psychiatrists, health education, and genetics) with long-term executive backgrounds in the field of health system management and program directors. Before conducting the interview, the interview purpose and content as well as how to record and collect information were first examined. With open questions, the experts were then asked to comment on the different PA behavior change models, the most important factors hindering PA in IMGW, and possible ways to improve their PA level. The interviewees were completely free to express their views. All the recorded and written data were consequently summarized without any individual judgment. Results of the experts' comments showed that the HBM was the best initial model to improve PA in IMGW. Accordingly, individuals in the intervention group completed the HBM-based questionnaire to find the most important solutions in promoting IMGW' PA. The intervention was both face-to-face and virtual. Face-to-face interventions were fulfilled once a month for 90 days and each time for an hour and a half. Aerobics video tutorial for women with useful knowledge for 80 min was provided to all members of the intervention group in the first face-to-face session. In this DVD, aerobic movements using stretch band, cardio fit ball, and 1-2 kg dumbbells from beginner to advanced were trained to strengthen muscles and keep the body in shape. A social group called “Success” was made by registering all individuals in the intervention group and followed by the virtual intervention for three months. In the first and second months of the intervention, the voice book of "goals! how to get everything you want faster than you ever thought possible" written by Brian Tracy, and the voice file of “unlimited power: the new science of personal achievement” from Anthony Robbins were respectively presented. After highlighting the key points of these books, an algorithm including the following steps was designed in the intervention group: (i) inspire change and motivate excellence, (ii) decisive decision-making, (iii) write goals clearly, (iv) focus on the goal, and (v) plan to achieve the goal. Finally, the practical program to achieve the goal was implemented based on comprehensive studies of the health system and available resources. Intervention 2: Control group: only some brochures and routine recommendations of healthcare centers on PA were presented to the control group.</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:
data of primary and secondary outcome is available.

When:
6 month after pablication

To whom:
Academic researchers

Conditions:
Formal request for statistical analysis only

Where to obtain:
corresponding author:
f-khatamik@tums.ac.ir

How to obtain:
Request from corresponding author, decision in the council of the research team - if agreed, the data will be send

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farnaz Khatami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kargar Ave., Poursina Ave., Tehran University of Medical Education</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1447935575</zip>
        <telephone>+98 21 8896 2357</telephone>
        <email>f-khatamik@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farnaz Khatami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kargar Ave., Poursina Ave., Tehran University of Medical Education</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1447935575</zip>
        <telephone>+98 21 8896 2357</telephone>
        <email>f-khatamik@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>middle-age group (30-59 years)
having a middle-school literacy level or above
having an inactive lifestyle (less than 90 min of moderate-intensity PA (brisk walking, jogging) per week according to the instructions of the PA promotion program of Iran Package of Essential Non-communicable Disease
completing the consent form to participate in the study</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>59 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>having some serious diseases such as CVDs, uncontrolled diabetes and hypertension, as well as chronic kidney disease</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>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: A number of behavioral change models, including trans-theoretical model (TTM), precede-proceed model (PPM), health belief model (HBM), beliefs, attitudes, subjective norms and enabling factors (BASNEF) model, and health promotion model (HPM), were considered to evaluate the best PA-promoting model after the literature review and unstructured face-to-face interview with the panel of experts. They included twenty specialists (sports medicine, community medicine, psychiatrists, health education, and genetics) with long-term executive backgrounds in the field of health system management and program directors. Before conducting the interview, the interview purpose and content as well as how to record and collect information were first examined. With open questions, the experts were then asked to comment on the different PA behavior change models, the most important factors hindering PA in IMGW, and possible ways to improve their PA level. The interviewees were completely free to express their views. All the recorded and written data were consequently summarized without any individual judgment. Results of the experts' comments showed that the HBM was the best initial model to improve PA in IMGW. Accordingly, individuals in the intervention group completed the HBM-based questionnaire to find the most important solutions in promoting IMGW' PA. The intervention was both face-to-face and virtual. Face-to-face interventions were fulfilled once a month for 90 days and each time for an hour and a half. Aerobics video tutorial for women with useful knowledge for 80 min was provided to all members of the intervention group in the first face-to-face session. In this DVD, aerobic movements using stretch band, cardio fit ball, and 1-2 kg dumbbells from beginner to advanced were trained to strengthen muscles and keep the body in shape. A social group called “Success” was made by registering all individuals in the intervention group and followed by the virtual intervention for three months. In the first and second months of the intervention, the voice book of "goals! how to get everything you want faster than you ever thought possible" written by Brian Tracy, and the voice file of “unlimited power: the new science of personal achievement” from Anthony Robbins were respectively presented. After highlighting the key points of these books, an algorithm including the following steps was designed in the intervention group: (i) inspire change and motivate excellence, (ii) decisive decision-making, (iii) write goals clearly, (iv) focus on the goal, and (v) plan to achieve the goal. Finally, the practical program to achieve the goal was implemented based on comprehensive studies of the health system and available resources</i_keyword>
      <i_keyword>Control group: only some brochures and routine recommendations of healthcare centers on PA were presented to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Physical activity. Timepoint: before and 3 month after. Method of measurement: four-question form of PA vital sign according to the IraPEN instruction.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body Mass Index. Timepoint: before and 3 month after intervention. Method of measurement: height with stadiometer , weight with SECA 768611 balance scale.</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>2017-10-08</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Community medicine department, medical school of ums, Kargar Ave., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
