<?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>IRCT20190924044866N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-27</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of an acceptance, mindfulness and compassionate-based group intervention in overweight and obese women</public_title>
      <acronym></acronym>
      <scientific_title>Determining the efficacy of an acceptance, mindfulness and compassionate-based group intervention in overweight and obese women and its effect on metabolic syndrome components</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>51</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42417</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be a block-randomized split method, which is based on randomized block software and a randomization sequence obtained by a colleague who is not involved in the execution process. In which group (intervention or control) each individual is placed in this way, both randomization and hidden allocation are performed, Blinding description: Blindness will be a one-way blind so assessments will be made by someone who has not participated in the intervention and is not aware of the intervention, as most of the outcomes of this study are laboratory indicators. Determine who is in the intervention and control group and will measure waist circumference, weight, and blood pressure by the center staff who do not know the details of the plan.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obesity and overweight.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Obese and overweight with a body mass index (25 ≤ BMI)- Treatment protocol of acceptance, mindfulness and compassion (Kg-free) by Palmira and et al at the research center of cognitive-behavioral  University of Coimbra,  Kg-free protocol is designed based on the acceptance, mindfulness and compassion for those who are obese and overweight. This program will be 10 group sessions, weekly, 2 hours plus 2 group booster sessions conducted by a clinical psychologist with the assistance therapist. Intervention 2: Control group: Treatment as usual for the Control group including, diet and nutrition modification, temporary smoking cessation and physical activity.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Asgharzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.1 tehran psychiatric institute</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5174676800</zip>
        <telephone>+98 41 4212 5220</telephone>
        <email>ali.asgharzadeh72@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Asgharzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 1 Tehran psychiatric institute</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5174676800</zip>
        <telephone>+98 41 4212 5220</telephone>
        <email>ali.asgharzadeh72@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>BMI (25≤ BMI)
Reading and writing literacy
Age range 40-65
Lack of severe knee osteoarthritis (if possible with regular attendance at sessions)</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Medical illnesses affecting weight, such as glandular disease, including thyroid problems, diabetes,
Pregnant women, lactating
Use of drugs that change weight and appetite d)
Impossible to attend weekly sessions
Severe psychiatric illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight and obesity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Obese and overweight with a body mass index (25 ≤ BMI)- Treatment protocol of acceptance, mindfulness and compassion (Kg-free) by Palmira and et al at the research center of cognitive-behavioral  University of Coimbra,  Kg-free protocol is designed based on the acceptance, mindfulness and compassion for those who are obese and overweight. This program will be 10 group sessions, weekly, 2 hours plus 2 group booster sessions conducted by a clinical psychologist with the assistance therapist.</i_keyword>
      <i_keyword>Control group: Treatment as usual for the Control group including, diet and nutrition modification, temporary smoking cessation and physical activity.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Triglycerides levels of individuals in test. Timepoint: Per-intervention, mid intervention and post-intervention and follow up. Method of measurement: To evaluate and check-up of triglyceride participants will be introduced to the laboratory.</prim_outcome>
      <prim_outcome>Blood glucose levels of individuals in test. Timepoint: Per-intervention, mid intervention and post-intervention and follow up. Method of measurement: To evaluate and check-up of blood glucose participants will be introduced to the laboratory.</prim_outcome>
      <prim_outcome>High-density lipoprotein (HDL) levels of individuals in test. Timepoint: Per-intervention, mid intervention and post-intervention and follow up. Method of measurement: To evaluate and check-up of High-density lipoprotein (HDL) participants will be introduced to the laboratory.</prim_outcome>
      <prim_outcome>Blood pressure levels of individuals in test. Timepoint: Per-intervention, mid intervention and post-intervention and follow up. Method of measurement: To evaluate and check-up of blood pressure participants will be introduced to the laboratory.</prim_outcome>
      <prim_outcome>Thyroid levels of individuals in test. Timepoint: Per-intervention, mid intervention and post-intervention and follow up. Method of measurement: To evaluate and check-up of thyroid participants will be introduced to the laboratory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Eating. Timepoint: Per-intervention, mid intervention and post-intervention and follow up. Method of measurement: Three-Factor Eating Questionnaire.</sec_outcome>
      <sec_outcome>Acceptance and Action  for Weight-Related Difficulties. Timepoint: Per-intervention, mid intervention and post-intervention and follow up. Method of measurement: Acceptance and Action Questionnaire for Weight-Related Difficulties (AAQW).</sec_outcome>
      <sec_outcome>Quality of Life. Timepoint: Per-intervention, mid intervention and post-intervention and follow up. Method of measurement: Who Quality of Life-BREF.</sec_outcome>
      <sec_outcome>Sexual Function. Timepoint: Per-intervention, mid intervention and post-intervention and follow up. Method of measurement: Female Sexual Function Index-FSFI.</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>There is no funding available for this research and the researcher will finance it.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-24</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>No. 1,  tehran psychiatric institute Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
