<?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>IRCT20221026056301N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-26</date_registration>
      <primary_sponsor>Shahid Beheshti University</primary_sponsor>
      <public_title>The effect of exercise training and gamification on inhibitory control and brain activity in overweight and obese women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of 8 weeks of high-intensity functional training and gamification on inhibitory control and brain activity in overweight and obese women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66720</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obesity due to excess calories.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In this study, the control group will not receive any intervention. Also, at the beginning of the study and after 2 months, measurements of body composition, inhibitory control and brain activity will be done. Intervention 2: The first intervention group: the group of high-intensity functional training, which in this study will perform high-intensity functional exercises training  for 2 months, 3 sessions a week for 1 hour under the supervision of the researcher. Each session, participants will first warm up for 10 to 15 minutes using aerobic activities such as running and stretching, then for the main part of the training, a combination of aerobic activities (such as jumping rope), strength activities for the upper body (such as power swimming ), the lower body (such as squats) and the central part of the body (such as sit-ups) will be used for 40-45 minutes. At the end of the session, stretching movements will be used to cool down for 10 to 15 minutes to return to the initial state. Intervention 3: The second intervention group: The game group in this study will play a mobile game designed to strengthen inhibitory control daily for 20 minutes for 2 months. This game is a serious game and is designed to target inhibitory control behavior related to eating. Also, the stages of the game are varied from easy to difficult. Intervention 4: The fourth intervention group: The combined group in this study will perform high-intensity functional exercises for 2 months at the same time, 3 sessions of 1 hour per week (the details of the intervention are described in the second intervention group). Also, they will play a mobile game designed to strengthen inhibitory control for 20 minutes daily (the details of the intervention are described in the third intervention group).</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marzieh Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 919 302 4326</telephone>
        <email>mzbagheri681@gmail.com</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 919 302 4326</telephone>
        <email>mzbagheri681@gmail.com</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Body mass index greater than 25
Being right-handed
No history of using mobile and computer games for more than 2 hours per week in the past 12 months
No experience of high-intensity functional training
Not participating in a regular exercise program for more than 2 hours per week in the past12 months</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Overweight and obesity are not due to the use of medicine.
Not using weight loss programs (exercise, diet, medicine, etc.) during the last 12 months
No history of chronic disease (diabetes, blood pressure, cardiovascular diseases, etc.)
No history of neurological and psychiatric disorders (eating disorder, depression, etc.)
Absence of medical or orthopedic conditions that prohibits doing exercises.
Not during pregnancy and breastfeeding.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>چاقی به دلیل کالری اضافی</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In this study, the control group will not receive any intervention. Also, at the beginning of the study and after 2 months, measurements of body composition, inhibitory control and brain activity will be done.</i_keyword>
      <i_keyword>The first intervention group: the group of high-intensity functional training, which in this study will perform high-intensity functional exercises training  for 2 months, 3 sessions a week for 1 hour under the supervision of the researcher. Each session, participants will first warm up for 10 to 15 minutes using aerobic activities such as running and stretching, then for the main part of the training, a combination of aerobic activities (such as jumping rope), strength activities for the upper body (such as power swimming ), the lower body (such as squats) and the central part of the body (such as sit-ups) will be used for 40-45 minutes. At the end of the session, stretching movements will be used to cool down for 10 to 15 minutes to return to the initial state.</i_keyword>
      <i_keyword>The second intervention group: The game group in this study will play a mobile game designed to strengthen inhibitory control daily for 20 minutes for 2 months. This game is a serious game and is designed to target inhibitory control behavior related to eating. Also, the stages of the game are varied from easy to difficult.</i_keyword>
      <i_keyword>The fourth intervention group: The combined group in this study will perform high-intensity functional exercises for 2 months at the same time, 3 sessions of 1 hour per week (the details of the intervention are described in the second intervention group). Also, they will play a mobile game designed to strengthen inhibitory control for 20 minutes daily (the details of the intervention are described in the third intervention group).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Inhibitory control. Timepoint: At the beginning of the study and after 2 months of exercise training and cognitive training. Method of measurement: In the study "Effect of exercise and cognitive training on inhibitory control and brain activity", the method of measuring inhibitory control can be the Go/No-go task. Also, the method of measuring brain activities can be the Functional near-infrared spectroscopy method.</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>Shahid Beheshti University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-07</approval_date>
        <contact_name>Research Ethics Committees of Shahid Beheshti University</contact_name>
        <contact_address>Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
