<?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>IRCT20220218054053N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-10</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effectiveness of Emotion Focused Group Therapy in Obese people with Binge Eating Disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of Emotion-Focused Group Therapy and Diet Therapy Combined with Exercise on Impulse Control, Night Eating Syndrome and Difficulty in Emotion Regulation in Obese people with Binge Eating Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66081</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sample people were assigned in three groups (including two intervention groups and one control group) by block randomization method. Randomization was done using the website https://www.sealedenvelope.com/. According to the number of groups (3 groups), the size of the blocks was considered 6 and it is fixed. A total of 9 blocks were obtained. Thus, in each block, 2 people were assigned to the first intervention group, 2 people to the second intervention group, and 2 people to the control group, Blinding description: Interventions of the intervention and control group are kept blind without the subjects knowing about the control or intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obesity with Binge eating disorder.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group (group intervention focused on emotion and diet therapy combined with exercise): The intervention focused on emotion in the present study is carried out using the intervention sessions provided by Greenberg (2015) and includes 10 two-hour sessions that are implemented weekly. In short, the sessions include awareness of emotions, emotional experience, and reaching primary maladaptive emotions and changing them to primary adaptive emotions. Intervention 2: The second intervention group: In this research, it includes diet therapy along with aerobic exercise, the amount of calories needed by all clients in this group and the first group was calculated according to height, age, and gender, and the daily diet was reduced by 500 kilo-calories. With the share of 60-65% carbohydrates, 20-25% protein and the rest fat was prescribed, 30-45 minutes of aerobic exercise such as moderate intensity walking was considered daily. Weighing and determination of body mass index were done before and after. Seka scale is used as a standard scale. Intervention 3: Control group: Control group does not receive any intervention.</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 data on measured variables can be shared after de-identifying individuals.

When:
After printing the article

To whom:
The data will be available to academic and scientific researchers

Conditions:
Scientific use in improvement and comparison with other research is allowed.

Where to obtain:
Correspond with javadchehraghi@gmail.com.

How to obtain:
The applicant must send the reason for using the documents by e-mail.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mir Javad Chehraghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 150, Entrance 14, Block A2, Phase 1, Ekbatan Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1394933454</zip>
        <telephone>+98 21 4464 5096</telephone>
        <email>javadchehraghi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mir Javad Chehraghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 150, Entrance 14, Block A2, Phase 1, Ekbatan Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1394933454</zip>
        <telephone>+98 21 4464 5096</telephone>
        <email>javadchehraghi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Informed consent in research
Age range 30 to 55 years
Body mass index above 30
Absence of drugs and alcoholic beverages addiction  (According to the comments of the participants in the research and their medical records in the Obesity clinic of Sina Hospital
Obtaining a diagnosis of Binge Eating Disorder based on the medical records available in the Obesity clinic of Sina Hospital
No received psychological disorders other than Binge Eating Disorder based on medical records in the Obesity Clinic of Sina Hospital</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Body mass index under 30
People with Bulimia Nervosa</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group (group intervention focused on emotion and diet therapy combined with exercise): The intervention focused on emotion in the present study is carried out using the intervention sessions provided by Greenberg (2015) and includes 10 two-hour sessions that are implemented weekly. In short, the sessions include awareness of emotions, emotional experience, and reaching primary maladaptive emotions and changing them to primary adaptive emotions.</i_keyword>
      <i_keyword>The second intervention group: In this research, it includes diet therapy along with aerobic exercise, the amount of calories needed by all clients in this group and the first group was calculated according to height, age, and gender, and the daily diet was reduced by 500 kilo-calories. With the share of 60-65% carbohydrates, 20-25% protein and the rest fat was prescribed, 30-45 minutes of aerobic exercise such as moderate intensity walking was considered daily. Weighing and determination of body mass index were done before and after. Seka scale is used as a standard scale.</i_keyword>
      <i_keyword>Control group: Control group does not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Obesity, which is calculated by measuring the body mass index; Impulse control by Bart Impulsivity Questionnaire; Night eating syndrome by the Night Eating Questionnaire (NEQ) by Allison et al. (2008); Emotion regulation by the scale of difficulty in emotion regulation (Gertz and Roemer, 2004). Timepoint: The time periods of measurement are at the beginning of the trial, second time after the completion of the interventions and third time two months after the completion of the interventions. Method of measurement: Obesity, which is calculated by measuring the body mass index (BMI) using a scale and height measurement tool based on meters, which should be above 30; Impulse control by Bart Impulsivity Questionnaire; Night eating syndrome by the Night Eating Questionnaire (NEQ) by Allison et al. (2008); Emotion regulation by the scale of difficulty in emotion regulation (Gertz and Roemer, 2004).</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>Islamic Azad University, Karaj Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-31</approval_date>
        <contact_name>Ethics committee of Islamic Azad University of Karaj Branch</contact_name>
        <contact_address>Cross at esteghlal and Moazen Blvd, Rajaii shahr karaj Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
