<?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>IRCT20210824052278N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-23</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The effect of education  based on health belief model on knowledge ,belief and performance of weight management of women with high body mass index in the before pregnancy period .</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of education intervention based on health belief model on knowledge ,belief and performance of weight management of women with high body mass index in the before pregnancy period in patients referred to comprehensive health centers in Bokan</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58318</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Before sampling, comprehensive urban health service centers will be classified into three levels: high, medium and low based on social and economic status.
The sampling method will be multi-step.
 First, based on socio-economic levels, two health centers will be selected from each level. One center for the experimental group and one center for the control group will be randomly selected.
Randomization is based on even and odd numbers and through lotteries. The even number is considered for the experimental group and the odd number is considered for the control group.
We will have a total of 6 centers. Then, in each of the centers, 11 women who refer to the Comprehensive Health Service Center, who are in the pre-pregnancy stage and have the criteria to enter the intervention, will be available. 12 people will be selected in two centers.
A total of 68 people (34 in the control group and 34 in the experimental group) will be included in the study based on the inclusion criteria, Blinding description: In the present study, the control group was kept blind from receiving educational intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obesity and overweight in women in the before pregnancy stage.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, 4 training sessions will be held in groups of 6-7 people once a week.  The duration of the sessions will be 90-60 minutes.  Educational content will be prepared based on credible sources based on needs assessment of the subjects.The trainings will be provided online once a week at a pre-determined time in the form of chat, voice, video and video, and questions and answers.  People in the control group will receive only routine pre-pregnancy care. The first session, introduction to the definition of obesity and overweight, explaining some of the major causes of weight gain and obesity. Session 2, Familiarity with the effects of obesity and overweight for the mother, fetus and pregnancy consequences. Session 3, Familiarity with the benefits of weight control in reducing the complications of obesity and weight gain; Obstacles to weight control and solutions to overcome these obstacles. The fourth session, the existing recommendations to change the diet and increase physical activity will be presented according to the National Curriculum Guide to Nutritional Care before Pregnancy of the Ministry of Health. Intervention 2: Control group: Receive routine care in comprehensive health service centers.</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:
Extract the results related to the main outcome and compile the final design report and write the article

When:
Access period starts 6 months after the results are published

To whom:
The data will be available only to researchers working in academic and scientific institutions

Conditions:
If you need a questionnaire or an educational intervention file, provided you refer to the article

Where to obtain:
Author of the article or final report, Jila Rashidi,
rashidi.zhila81@gmail.com

How to obtain:
After receiving the email stating that the data has been sent and coordinating with the research team, the data will be sent for at least one month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zilla Rashidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bukan Comprehensive Health Service Centers</address>
        <city>Bokan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6681718568</zip>
        <telephone>+98 87 3623 3327</telephone>
        <email>rashidi.zhila81@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zhila Rashidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bukan Comprehensive Health Service Centers</address>
        <city>Bukan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6681718568</zip>
        <telephone>+98 87 3623 3327</telephone>
        <email>rashidi.zhila81@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Indigenous 
Having written consent
Have a fifth grade and higher literacy
Having a smartphone and whats app messenger
Body mass index above 25 kg per cubic meter
No chronic diseases
No stressful events in the last six months in the individual or family</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy
Illiteracy
Over 50 years old
Having physical activity related diseases such as cardiovascular disease
Having weight management activities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other obesity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, 4 training sessions will be held in groups of 6-7 people once a week.  The duration of the sessions will be 90-60 minutes.  Educational content will be prepared based on credible sources based on needs assessment of the subjects.The trainings will be provided online once a week at a pre-determined time in the form of chat, voice, video and video, and questions and answers.  People in the control group will receive only routine pre-pregnancy care. The first session, introduction to the definition of obesity and overweight, explaining some of the major causes of weight gain and obesity. Session 2, Familiarity with the effects of obesity and overweight for the mother, fetus and pregnancy consequences. Session 3, Familiarity with the benefits of weight control in reducing the complications of obesity and weight gain; Obstacles to weight control and solutions to overcome these obstacles. The fourth session, the existing recommendations to change the diet and increase physical activity will be presented according to the National Curriculum Guide to Nutritional Care before Pregnancy of the Ministry of Health.</i_keyword>
      <i_keyword>Control group: Receive routine care in comprehensive health service centers</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight management in women with higher-than-normal pre-pregnancy body mass index. Timepoint: One month and three months after the intervention. Method of measurement: Using a researcher-made questionnaire based on health belief model and three-factor eating questionnaire and short form physical activity questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight Loss. Timepoint: Three months after the intervention. Method of measurement: Weight measurement with accurate and controlled scales with control weights.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-25</approval_date>
        <contact_name>Ethics committee of urmia university of Medical sciences</contact_name>
        <contact_address>no.36,Shafaet Alley ,Shohada street saqqez Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
