<?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>IRCT20180712040438N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-28</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of nutritional and physical activity education on obesity</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the combined effect of nutritional education based on low-calorie foods and physical activity program on treatment of obesity and overweight among primary and secondary school students: A Randomized Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>524</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66945</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The randomization method in this study is block randomization. Each of the randomly created sequences is recorded on a card and the cards are placed in the envelopes in order.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obesity or overweight.</hc_freetext>
      <i_freetext>Intervention group: In the intervention group, nutrition education will be provided to overweight and obese children for 1 hour every week during the 8 months of intervention. These trainings will be with an emphasis on the consumption of alternative and low-calorie foods and the use of a healthy food plate. Students will be advised to do sports activities 3 times a week for one hour each time under the supervision of a sports coach. Educational pamphlets in the field of nutrition and following the food pyramid, as well as sports exercises, are provided to students and their parents at the beginning of the study..</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:
Data collected for the primary outcomes will be shared

When:
Accessibility to data is possible 8 months after publication.

To whom:
The data will only be available for people working in academic institutions.

Conditions:
The data of the present study will only be accessible by other researchers, for conducting Meta analysis

Where to obtain:
Dr Jalal Moludi, Faculty of Nutrition Sciences and Food Technology, Kermanshah University of Medical Sciences, +989399516766, j.moloudi@yahoo.com

How to obtain:
Any one who request our data should provide a brief explanation of the purpose and method of their meta-analysis study. The applicant's request will be reviewed by the researchers and if all agree, the requested data will be sent to the applicant via email in the form of an Excel file. All these steps will not take more than 10 days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Jalal Moludi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kermanshah Province, Kermanshah City, Isar Square, next to Farabi Hospital, Faculty of Nutrition Sciences and Food Industry</address>
        <city>Kermanshsh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6719851552</zip>
        <telephone>+98 83 3710 2003</telephone>
        <email>jmoludi@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jalal Moludi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kermanshah Province, Kermanshah City, Isar Square, next to Farabi Hospital, Faculty of Nutrition Sciences and Food Industry</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6719851552</zip>
        <telephone>+98 83 3710 2003</telephone>
        <email>jmoludi@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Desire to cooperate
Elementary and high school students
Overweight or obese students with a high body mass index (body mass index equal to or higher than the 85th percentile)</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Have a known neurological disease
Having major systemic diseases such as malignancies
Have known liver disease
Taking medications that affect appetite and body weight, such as corticosteroids or other supplements
Any possible injury related to the intervention during the study (such as physical harm during physical activity or following the provided diet)</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>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, nutrition education will be provided to overweight and obese children for 1 hour every week during the 8 months of intervention. These trainings will be with an emphasis on the consumption of alternative and low-calorie foods and the use of a healthy food plate. Students will be advised to do sports activities 3 times a week for one hour each time under the supervision of a sports coach. Educational pamphlets in the field of nutrition and following the food pyramid, as well as sports exercises, are provided to students and their parents at the beginning of the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body mass index. Timepoint: The beginning of the study (before the start of the study), the 16th week and the end of the 32nd week. Method of measurement: Dividing weight (in kilograms) by the square of height (in meters).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Energy intake. Timepoint: The beginning of the study (before the start of the study), the 16th week and the end of the 32nd week. Method of measurement: Three-day food recording.</sec_outcome>
      <sec_outcome>Waist circumference. Timepoint: The beginning of the study (before the start of the study), the 16th week and the end of the 32nd week. Method of measurement: Tape measure.</sec_outcome>
      <sec_outcome>Hip circumference. Timepoint: The beginning of the study (before the start of the study), the 16th week and the end of the 32nd week. Method of measurement: Tape measure.</sec_outcome>
      <sec_outcome>The thickness of the skin fold in the triceps region. Timepoint: The beginning of the study (before the start of the study), the 16th week and the end of the 32nd week. Method of measurement: Caliper.</sec_outcome>
      <sec_outcome>Physical activity. Timepoint: The beginning of the study (before the start of the study), the 16th week and the end of the 32nd week. Method of measurement: International physical activity questionnaire.</sec_outcome>
      <sec_outcome>Stress, anxiety and depression. Timepoint: The beginning of the study (before the start of the study), the 16th week and the end of the 32nd week. Method of measurement: Depression anxiety stress scales.</sec_outcome>
      <sec_outcome>Sleep quality. Timepoint: The beginning of the study (before the start of the study), the 16th week and the end of the 32nd week. Method of measurement: Pittsburgh Sleep Quality Index.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-11</approval_date>
        <contact_name>Ethics Committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Kermanshah Province, Kermanshah City, Isar Square, next to Farabi Hospital, Faculty of Nutrition Sciences and Food Industry Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
