<?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>IRCT20210811052148N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-17</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational intervention based on the theory of planned behavior through social networks (WhatsApp) on health-promoting behaviors in overweight women after childbirth</public_title>
      <acronym></acronym>
      <scientific_title>The effect of educational intervention based on the theory of planned behavior through social networks (WhatsApp) on health-promoting behaviors in overweight women after childbirth referred to the comprehensive health service centers in Urmia in 1399</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>104</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58178</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Samples will be selected by the quota sampling method. Thus, from each geographical area (north, south, east, and west) of Urmia, one center and a total of four comprehensive health service centers were selected. The north and south centers will be selected as the intervention group and the east and west centers as the control group. According to the number of files in each center, the files that meet the inclusion criteria will be selected and numbered in order. Using the site www.random.ir
And the numbers obtained from this site will be selected as 52 cases as intervention group and 52 cases as the control group, respectively.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Postpartum overweight.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Women in the intervention group will be asked to provide the contact number to the researcher, and then the people in the WhatsApp messaging group will be added. Moreover, they will receive the educational content once a week in absentia and a WhatsApp group for 90-60 minutes. The intervention will be done for six weeks; the sessions will be weekly, each session will be for 90-60 minutes. Training sessions will be self-fulfilling and create a positive attitude with communication, health responsibility, stress management, and physical activity. 1 and 3 months after the intervention, again the knowledge, beliefs, health-promoting behaviors (lifestyle) of individuals in both groups will be evaluated through previous questionnaires and the results will be compared and reported between the two study groups. Intervention 2: Control group: Individuals in the control group will not be exposed to weekly training in the intervention group and will only receive their routine care. 1 and 3 months later, both groups' knowledge, beliefs, and health-promoting behaviors (lifestyle) will be re-evaluated through the previous questionnaires, and the results will be compared and reported between the two study groups.</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:
Use of data only for research purposes

When:
Access period starts 6 months after the results are published

To whom:
همه افراد اجازه دسترسی به داده های منتشر شده دارند

Conditions:
Raw statistical data will not be published but statistical analysis will be available

Where to obtain:
Responsible for registering clinical trials

How to obtain:
It will be possible with the permission of the Ethics Committee and the Vice Chancellor for Research of Urmia University of Medical Sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>fatemeh moghaddam tabrizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Resalat Boulevard, Emergency Alley</address>
        <city>urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3223 4897</telephone>
        <email>fmtabrizi@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>fatemeh moghaddam tabrizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Resalat Boulevard, Emergency Alley</address>
        <city>urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>571478334</zip>
        <telephone>+98 44 3223 4897</telephone>
        <email>fmtabrizi@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a full-term pregnancy 42-37 weeks
No hospitalization of the Neonate
Non-participation in training courses
Not having a high-risk pregnancy
Lack of psychiatric disease
Having overweight after giving birth
Having literacy
Smartphone access</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>42 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Reluctance to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight</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: Women in the intervention group will be asked to provide the contact number to the researcher, and then the people in the WhatsApp messaging group will be added. Moreover, they will receive the educational content once a week in absentia and a WhatsApp group for 90-60 minutes. The intervention will be done for six weeks; the sessions will be weekly, each session will be for 90-60 minutes. Training sessions will be self-fulfilling and create a positive attitude with communication, health responsibility, stress management, and physical activity. 1 and 3 months after the intervention, again the knowledge, beliefs, health-promoting behaviors (lifestyle) of individuals in both groups will be evaluated through previous questionnaires and the results will be compared and reported between the two study groups.</i_keyword>
      <i_keyword>Control group: Individuals in the control group will not be exposed to weekly training in the intervention group and will only receive their routine care. 1 and 3 months later, both groups' knowledge, beliefs, and health-promoting behaviors (lifestyle) will be re-evaluated through the previous questionnaires, and the results will be compared and reported between the two study groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Women's Awareness Score of Pregnancy, Postpartum Care, and Health-Promoting Behaviors. Timepoint: Before and after of invention. Method of measurement: Health-Promoting Lifestyle Profile (HPLP-II).</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-30</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Resalat Boulevard, Emergency Alley Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
