<?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>IRCT20180627040254N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-30</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of a Behavioral Self-Regulation Education on Weight Changes in Hemodialysis Patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of a Behavioral Self-Regulation Education on Weight Changes in Hemodialysis Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33621</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: An easy and accessible sampling method was used. Therefore people who come to the dialysis unit will be selected and by completing the weighing table two weeks before the intervention and average calculating for 6 consecutive dialysis sessions, identified peoples who are not following the limitations of fluid intake and if have the criteria for entering the study, the informed consent form and the form of the demographic information will be completed by samples. Qualified persons will be placed in two groups randomly (odd or even days). By coin tossing the test and comparison groups (test group with letter A and comparison group with letter B) will be specified.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic kidney disease.</hc_freetext>
      <i_freetext>Intervention 1: In the experimental group, self-regulatory behavior training based on the Kanfer framework included self-observation, self-assessment, and self-enhancement of a target behavior. In the form of face-to-face training, with the presence of a researcher and a psychologist of behavioral science for 7 weeks, each week, an hour of meeting with the subjects will be performed.Trainings are more about discussing people's problems and leading to solving problems. The content of each session will be determined by the progress of each session and the individual's requirements. First session: introduction of self-regulation practices and its relationship with the regime of dialysis treatment. Brief overview of fluids and long-term complications and noncompliance will be done. Second session: An overview of the relationship between self-regulatory processes of behavior (eg self-observation, self-assessment, self-esteem) and goal behavior. Session 3: Self-reflection will be reviewed and discussed. Session Four: Self-monitoring skills and the beginning of night-time assignments include their own monitoring of daily fluid intake, mood, and behaviors that lead to over-consumption of fluid in the setting of fluid intake and people will set goals for fluid intake. Fifth Session: Finding you’re Strengthening Strategies. Sixth Session: Learning about controlling stimulus behaviors. Seventh session: review and evaluation of experiences Group. Intervention 2: Comparison Group: In the comparison group, with the collaboration of a nursing staff member of the Shahid Hasheminejad Hospital's Dialysis Hospital, (Training routine will be repeated) regular training will be provided for 7 weeks, each meeting will receive an appointment with a nurse for one hour. It includes: The first session will be a public discussion of how hemodialysis will be treated. Second Session: Why behavior change (including fluid intake) is important for success and quality of life. Third Session: How the disease affects family members and relatives. Fourth Session: The importance of active participation in Dialysis Sessions. Fifth Session: The importance of patient’s interaction and dialysis providers to provide dialysis schedules to set dialysis programs. Sixth Session: logistical problems related to dialysis (for example: patients who are traveling). Seventh session: Completion of the meeting will be discussed with an overview of the discussions.</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:
All the potential data can be shared after unidentifiable people

When:
After paper publication that is taken from article

To whom:
Academic researchers

Conditions:
Academic research that mentioned to cite this article

Where to obtain:
E-mail responsible for the general response to the trial

How to obtain:
A month after the receipt of the email will be sent

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeinab Afshar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rashid Yasemi st. Vale asr Aven.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 8820 1978</telephone>
        <email>zeinabafshar94@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jaleh mohammad- aliha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rashid Yasemi St. Valeasr Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 8820 1978</telephone>
        <email>mohammadaliha.j@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>More than 18 years
Have studying and writing skill
Should be hemodialized for at least 3 months
The average weight gain of 6 sessions of dialysis is more than 2.5 kg
Non-participation in the study or training in relation to compliance with fluid restriction simultaneously with the impact of Self-regulation training
No kidney transplant history and no psychological problems
Awareness of time, place and person</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Have no desire to attend in the study
Be hospitalized
Participants in the study died
Do not attend in 2 sessions of training</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the experimental group, self-regulatory behavior training based on the Kanfer framework included self-observation, self-assessment, and self-enhancement of a target behavior. In the form of face-to-face training, with the presence of a researcher and a psychologist of behavioral science for 7 weeks, each week, an hour of meeting with the subjects will be performed.Trainings are more about discussing people's problems and leading to solving problems. The content of each session will be determined by the progress of each session and the individual's requirements. First session: introduction of self-regulation practices and its relationship with the regime of dialysis treatment. Brief overview of fluids and long-term complications and noncompliance will be done. Second session: An overview of the relationship between self-regulatory processes of behavior (eg self-observation, self-assessment, self-esteem) and goal behavior. Session 3: Self-reflection will be reviewed and discussed. Session Four: Self-monitoring skills and the beginning of night-time assignments include their own monitoring of daily fluid intake, mood, and behaviors that lead to over-consumption of fluid in the setting of fluid intake and people will set goals for fluid intake. Fifth Session: Finding you’re Strengthening Strategies. Sixth Session: Learning about controlling stimulus behaviors. Seventh session: review and evaluation of experiences Group.</i_keyword>
      <i_keyword>Comparison Group: In the comparison group, with the collaboration of a nursing staff member of the Shahid Hasheminejad Hospital's Dialysis Hospital, (Training routine will be repeated) regular training will be provided for 7 weeks, each meeting will receive an appointment with a nurse for one hour. It includes: The first session will be a public discussion of how hemodialysis will be treated. Second Session: Why behavior change (including fluid intake) is important for success and quality of life. Third Session: How the disease affects family members and relatives. Fourth Session: The importance of active participation in Dialysis Sessions. Fifth Session: The importance of patient’s interaction and dialysis providers to provide dialysis schedules to set dialysis programs. Sixth Session: logistical problems related to dialysis (for example: patients who are traveling). Seventh session: Completion of the meeting will be discussed with an overview of the discussions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight Changes of undergoing hemodialysis patients. Timepoint: Two weeks before the intervention, 2 weeks and 3 months after the intervention. Method of measurement: Weight was measured by calibrated digital weighing scales.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-10</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
