<?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>IRCT20191102045309N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-13</date_registration>
      <primary_sponsor>Kharazmi University</primary_sponsor>
      <public_title>Examining the Effectiveness of the Acceptance and Commitment Therapy Matrix on Health Behaviors</public_title>
      <acronym></acronym>
      <scientific_title>Examining the Effectiveness of  the Acceptance and Commitment Therapy Matrix for Health Behaviors on Obese People</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>4</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44314</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention group: In a multiple baseline design across individuals with follow-up, four obese people participated. The 12 session intervention was conduct weekly, individually, and online. The intervention was developed based on the six-step approach of the Acceptance and Commitment Therapy Matrix..</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:
After deleting the confidential information, participants' data file in this study, including demographic and intervention information, is sharing with other researchers and practitioners.

When:
Access period starts 3 months after publishing the results

To whom:
The data is only available to colleagues and other researchers and practitioners.

Conditions:
The data can be used for publication in scientific journals. Researchers are not allowed to do any analysis, and they can only view and receive the data. Researchers are also required to make a written commitment not to publish the data file.

Where to obtain:
Send an email to Saman Nonahal: Nonahal.Saman@gmail.com

How to obtain:
After sending an email to Saman Nonahal, confirming the identity of the applicant, and the final confirmation of the colleagues, the data will be sent to them. The approximate time will be 2 to 3 months

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saman Nonahal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor 2, Farda Bldg, Neshat 4 alley, Edalat 81 Ave</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4917838991</zip>
        <telephone>+98 17 3252 9260</telephone>
        <email>Nonahal.Saman@gmail.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saman Nonahal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor 2, Farda Bldg, Neshat 4 alley, Edalat 81 Ave</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4917838991</zip>
        <telephone>+98 17 3252 9260</telephone>
        <email>Nonahal.Saman@gmail.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People aged 18-50
Body Mass Index (BMI) ≥ 30
Diploma and higher education</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>suffering from mood disorders
suffering from anxiety disorders
suffering from eating disorders
using psychiatric drugs and/or fat burner supplements
suffering from cardiovascular disease
suffering from diabetes
suffering from thyroid problems
suffering from respiratory problems
suffering from gastroenteric problems
receiving psychotherapy or other program for weight loss
Pregnancy
Planning for pregnancy
Menopause
Dietary Choices (DC) subscale score &gt; 1.2
Physical Activity (PA) subscale score &gt; 1.2</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity due to excess calories</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In a multiple baseline design across individuals with follow-up, four obese people participated. The 12 session intervention was conduct weekly, individually, and online. The intervention was developed based on the six-step approach of the Acceptance and Commitment Therapy Matrix.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Healthy Eating Behavior Score in the Weight Control Strategies Scale. Timepoint: 3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase. Method of measurement: Dietary Choices subscale in the Weight Control Strategies Scale.</prim_outcome>
      <prim_outcome>Exercise Behavior Score in the Weight Control Strategies Scale. Timepoint: 3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase. Method of measurement: Physical Activity subscale in the Weight Control Strategies Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Emotional Eating Score in the Three Factor Eating Questionnaire-R18. Timepoint: 3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase. Method of measurement: Emotional Eating subscale in the Three Factor Eating Questionnaire-R18.</sec_outcome>
      <sec_outcome>External Eating Score in the Dutch Eating Behaviour Questionnaire. Timepoint: 3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase. Method of measurement: External Eating subscale in the Dutch Eating Behaviour Questionnaire.</sec_outcome>
      <sec_outcome>Food Craving Acceptance Score in the Food Craving Acceptance and Action Questionnaire. Timepoint: 3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase. Method of measurement: Acceptance subscale in the Food Craving Acceptance and Action Questionnaire.</sec_outcome>
      <sec_outcome>Healthy Eating with Willingness Score in the Food Craving Acceptance and Action Questionnaire. Timepoint: 3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase. Method of measurement: Willingness subscale in the Food Craving Acceptance and Action Questionnaire.</sec_outcome>
      <sec_outcome>Physical Activity Acceptance Score in the Physical Activity Acceptance Questionnaire. Timepoint: 3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase. Method of measurement: Cognitive Acceptance subscale in the Physical Activity Acceptance Questionnaire.</sec_outcome>
      <sec_outcome>Physical Activity Commitment Score in the Physical Activity Acceptance Questionnaire. Timepoint: 3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase. Method of measurement: Behavioral Commitment subscale in the Physical Activity Acceptance Questionnaire.</sec_outcome>
      <sec_outcome>Self-Compassion Score in the Self-Compassion Scale. Timepoint: 3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase. Method of measurement: Self-Compassion Scale.</sec_outcome>
      <sec_outcome>Valued Living Score in the Valuing Questionnaire. Timepoint: 3-6 times weekly during the baseline phase, before session 3, session 5, session 7, session 9, session 11, and after session 12 during the intervention phase, and one and three months after the intervention during the follow-up phase. Method of measurement: Valuing Questionnaire.</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>Kharazmi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-26</approval_date>
        <contact_name>Kharazmi University</contact_name>
        <contact_address>No.43, South Mofatteh Ave. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
