<?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>IRCT20191203045584N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-29</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Family-centered behavioral Modification training on Dietary habits and BMI of obese children</public_title>
      <acronym></acronym>
      <scientific_title>The effect of educational package of family-centered behavioral modification on the child and family Dietary habits and BMI percentile of school-age obese girls</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44315</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: The research population will be selected by simple randomization method without alternatives using envelopes, so that out of ten schools in one of the middle areas of Mashhad city, 2 schools will be selected as the intervention group and 2 schools as the control group. It is necessary to explain that the first and third choices will be the intervention group and the second and fourth choices will be the control group.Randomization on samples is not possible due to their inclusion in the study with special features. 80 obese girls aged 7-12 years old with a BMI percentile of more than 85 will be selected from the above 4 schools, which will be the research environment, by the available method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Dietary counselling and surveillance.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Family-centered behavioral modification educational package (contains information on obesity, motivation and skills development that is extracted from articles, book and program of Iran Eco and approved by the professors of Mashhad School of Nursing and Midwifery and nutritionist) in 7 sessions of 45 minutes will be taught for child and mother (mother presence is required in half of the sessions), at the end of the educational sessions, the educational package will be given to them and the follow-up will continue for 3 months by weekly phone call. Intervention 2: Control group: information about obesity and its complications will be given and at the end of the research, they will be given an educational package.</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 potential data can be shared after unidentifiable people

When:
Start of access period 6 months after printing results

To whom:
For researchers working only in academic and scientific institutions

Conditions:
School Health

Where to obtain:
Mashhad School of Nursing and Midwifery

How to obtain:
Immediately by visiting the library of Mashhad School of Nursing and Midwifery

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Tahereh Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebne sina St</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948959</zip>
        <telephone>+98 56 3254 1036</telephone>
        <email>Sadeghit@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Tahereh Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebne sina st</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948959</zip>
        <telephone>+98 56 3254 1036</telephone>
        <email>Sadeghit@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children with a BMI percentile greater than 85%(WHO definition of childhood overweight and obesity)
Age between 7- 12 years
Mother's attendance at the training sessions
Parent's ability to read and write
Informed consent to participate in the study
Living with both parents</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>12 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>participating in another weight control program
Having a psychiatric disorder
Exercise heart disease or shortness of breath during exercise
Medical status or use of medications for weight loss
Reaching puberty</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z71.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dietary counseling and surveillance</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Family-centered behavioral modification educational package (contains information on obesity, motivation and skills development that is extracted from articles, book and program of Iran Eco and approved by the professors of Mashhad School of Nursing and Midwifery and nutritionist) in 7 sessions of 45 minutes will be taught for child and mother (mother presence is required in half of the sessions), at the end of the educational sessions, the educational package will be given to them and the follow-up will continue for 3 months by weekly phone call.</i_keyword>
      <i_keyword>Control group: information about obesity and its complications will be given and at the end of the research, they will be given an educational package.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The rate of change in child and family eating behavior and habits. Timepoint: The first training session and at the end of the third month. Method of measurement: Child Eating Behavior Questionnaire and Duch Eating Behavior Questionnaire and Child and Family Dietary Habits Questionnaire.</prim_outcome>
      <prim_outcome>BMI percentile percentage. Timepoint: First meeting and at the end of each month for 3 months. Method of measurement: Meters and scales.</prim_outcome>
      <prim_outcome>Skin thickness. Timepoint: Before the intervention and at the end of the intervention. Method of measurement: Caliper.</prim_outcome>
      <prim_outcome>Arm circumference. Timepoint: Before the intervention and at the end of the intervention. Method of measurement: Non-stretch calibrated tape.</prim_outcome>
      <prim_outcome>Height. Timepoint: First meeting and at the end of each month for 3 months. Method of measurement: Meter.</prim_outcome>
      <prim_outcome>Weight. Timepoint: First meeting and at the end of each month for 3 months. Method of measurement: Scales.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-14</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical sciences</contact_name>
        <contact_address>Mashhad Nursing And Midwifery Schole, Ebne Sina St Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
