<?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>IRCT20190528043738N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-06</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Lifestyle modification of patient with sleeve gasterectomy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of lifestyle modification on The control of gastrointestinal complications and psychological disorders post sleeve gastrectomy surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39912</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants were selected through available sampling, so that eligible patients were included in the study process and divided into groups A and B. Group A was the control group and group B was the test group. For this division, the blocking method was used, in which 35 cards called A and 35 cards called B were placed in an envelope. When the patient entered to the study, the patients took one of the cards and were placed in the control or test group according to the card they took (A or B). After taking each card by the patient, the card was discarded. In this way, all patients had the same chance to enter both control and test groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>life style modification in patients with sleeve gastrectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Life style training content to patient with sleeve gastrectomy surgery is done through face-to-face and by using an educational pamphlet during four one-hour sessions (two sessions before surgery and two sessions after surgery)  in the clinic's training room.The content of the training includes lifestyle modification in four dimensions: physical health and nutrition (diet and achieving and maintaining optimal weight), exercise and physical activity, mental health and mental health, which is prepared and based on the evidence and opinion of experts in this field. It will also be evaluated by the research team and will be implemented after approval. Intervention 2: Control group: Routine training into setting to patient with sleeve gastrectomy  surgery is given through Face to face once or twice for  fifteen minutes and also an educational pamphlet is given while discharing.The content of routine training into setting includes following a diet and how to take care of nutrition and how to physical activity and referal time to therapeutic doctor.</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 part of data related to cheif consequences will be shared after unrecognization of patients.

When:
6 month after results publuishing in dissertation booklet.

To whom:
Student, Researchers,Patients and their Families.

Conditions:
Written request to the research and Obtaining a license, can access to the part of data from researcher. Also, datas can just be used for scientific and research goals.

Where to obtain:
Refer to researcher of research project  with Email address:zkamali1358@gmail.com.

How to obtain:
Accomplish written Request to research assistant in university and department and after that reviewing by Research Team, and decision will make about that.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Doctor Robabe Khalli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nosrati alley., South Sheikh Bahaei ave.,vanak square.,Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>0098 21 8755535</telephone>
        <email>khalili1120@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Doctor Robabe Khalili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nosrati alley., South Sheikh Bahaei ave.,vanak square.,Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8755 5535</telephone>
        <email>khalili1120@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients who  have had a sleeve gastrectomy by the method of laparoscopic surgery
Patient  to be have age group between 18 to 50
participants do not have drug addiction
Participants to be have the minimum literacy and communication skills
patient not to  have drug addiction
Patients who have got  a final score of 0 to 59 according to  DASS 21  (normal to moderate).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who taking weight-loss medications concurrently.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K95</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Complications of bariatric procedures</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: Life style training content to patient with sleeve gastrectomy surgery is done through face-to-face and by using an educational pamphlet during four one-hour sessions (two sessions before surgery and two sessions after surgery)  in the clinic's training room.The content of the training includes lifestyle modification in four dimensions: physical health and nutrition (diet and achieving and maintaining optimal weight), exercise and physical activity, mental health and mental health, which is prepared and based on the evidence and opinion of experts in this field. It will also be evaluated by the research team and will be implemented after approval.</i_keyword>
      <i_keyword>Control group: Routine training into setting to patient with sleeve gastrectomy  surgery is given through Face to face once or twice for  fifteen minutes and also an educational pamphlet is given while discharing.The content of routine training into setting includes following a diet and how to take care of nutrition and how to physical activity and referal time to therapeutic doctor.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The percentage of Gastrointestinal Complications (nausea, vomite, dumping syndrom, constipation) after sleeve gasterectomy. Timepoint: Pre and 2 month after educational intervention. Method of measurement: researcher made Questionnaire of Gastrointestinal Complications.</prim_outcome>
      <prim_outcome>The score of Psychological complication (stress, anxiety, depression) after sleeve gasterectomy. Timepoint: Pre and 2 month after educational intervention. Method of measurement: The Depression, Anxiety and Stress Scale - 21 Items (DAS S21).</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-02</approval_date>
        <contact_name>Ethics committee of Baqiyatllah University of Medical Sciences</contact_name>
        <contact_address>Nosrati alley., South Sheikh Bahaei ave.,vanak square.,Tehran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
