<?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>IRCT20210722051953N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-04</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Effect of education and counseling on sedentary behaviors and fast food consumption</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of educational and counseling intervention through smartphone on awareness, sedentary behaviors and fast food consumption in women with high body mass index</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>106</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57668</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Specifications of the designed application: Profile (specifications include: age, education, occupation, family income level, number of pregnancies, number of live children, number of abortions), weight and height, fast food educational materials (what is fast food?) Mobility (includes: What is sedentary behavior? What are the disadvantages of sedentary behavior?); And there will be tips, each of which will be shown in the form of an icon.The training content will be uploaded somewhere in the application. Clicking on any of the training icons will open the content on a new page.The "Body Mass Index" icon will also include calculating body mass by writing height in centimeters and weight in kilograms. sedentary behavior training materials will be organized in four sections and in the first week, one day in between sections will be active for the user.So that after reading the contents of the first session, it will be possible to use the contents of the next training.In the first week, an individual consultation will be done with each user twice, and then during the three months that the intervention takes place, the user can request a consultation in the application at any time.For fast food, these facilities will be created in the second week.The researcher calls the user every other day (by phone or WhatsApp) to make sure she is using the APP.During the intervention, by clicking on the consultation icon, samples will be able to perform WhatsApp consultation.From the third week, a short message (notification) in the field of stimulation and consumption of fast food will be sent to the intervention group every day at a specified time.Regarding sedentary behavior at 9, 11, 16, 18, 21 hours, the message "Dear user, it is recommended to be active (get up and walk) will be sent.Regarding the consumption of fast food, every day at 12 noon, 6 pm and 9 pm, the message that "consuming fast food is harmful to health."Eat homemade food instead of fast food" is sent to people, Randomization description: Randomization is done in a simple method, individual randomization unit, using a randomization tool made of stamped envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Sedentary behaviors. Condition 2: Fast food consumption.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The modified version of the APP will be installed on the mobile phones of the intervention group in the first briefing session and how to use it will be taught in person and in practice.sedentary behavior training materials will be organized in four sections and in the first week, one day in between sections will be active for the user.So that after reading the contents of the first session, it will be possible to use the contents of the next training.In the first week, an individual consultation will be done with each user twice, and then during the three months that the intervention takes place, the user can request a consultation in the application at any time.For fast food, these facilities will be created in the second week.The researcher calls the user every other day (by phone or WhatsApp) to make sure she is using the APP.In counseling, factors that interfere with healthy eating behaviors and adequate physical activity (when, these behaviors have increased and decreased) and identifying the factors that create resistance to behavior change and how to overcome them through the rain of thoughts, explaining the correct patterns by participants Assessing self-confidence and comparing it with temptation, reviewing goals and motivators, reviewing barriers and facilitators of healthy lifestyle behavioral patterns from participants' perspectives.During the intervention, by clicking on the consultation icon, samples will be able to perform WhatsApp consultation.From the third week, a short message about the mobility and consumption of fast food will be sent to the members of the intervention group every day at the specified time.Regarding sedentary behavior at 9, 11, 16, 18, 21 hours, the message "Dear user, it is recommended to be active (get up and walk) will be sent.Regarding the consumption of fast food, every day at 12 noon, 6 pm and 9 pm, the message that "consuming fast food is harmful to health."Eat homemade food instead of fast food" is sent to people.The members of the intervention group will not be deprived of the routine care of comprehensive health centers.(First week) Educational content on sedentary behavior; Day 1: What is overweight and obesity? What causes obesity? The effect of overweight / obesity on health, fertility and pregnancy and ways to deal with it; Day 3: Definition of physical activity and exercise, the positive effects of physical activity on the body and the prevention and control of non-communicable diseases and the amount and intensity of appropriate physical activity; Day 5: What are sedentary behaviors? What are the disadvantages of sedentary behaviors?; Day 7: What are the strategies to reduce sedentary behavior at home? What are the strategies to reduce sedentary behaviors at work? Sports activities that can be done while watching TV (Week 2) Educational content about fast food; Day 1: How to get proper nutrition? What is the food pyramid? Introducing food groups; Day 3: Healthy food plate and Iranian dietary guidelines; Day 5: Nutritional recommendations in the prevention of overweight and obesity; Day 7: What is the reduction in fast food consumption? What is fast food? What are the disadvantages of consuming fast food?. Intervention 2: Control group:The control group will receive routine training from the Comprehensive Health Service Center.</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:
Publication of research results in the form of publishing a scientific article

When:
The access period starts 6 months after the publication of the article.

To whom:
All people

Conditions:
For information and awareness the public about sedentary behaviors and consumption of fast food

Where to obtain:
Dr. Roghayeh Bayrami, Assistant Professor, School of Nursing and Midwifery, Urmia
 Email :rozabayrami@yahoo.com

How to obtain:
Enter the site of Urmia University of Medical Sciences and search for thesis title

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sayeh Ebrahimi Gangachin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 163 , Alley 2, Shomali Ave ,  Farhangian Town</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5716753386</zip>
        <telephone>+98 44 3382 2477</telephone>
        <email>ebrahimi.sayeh@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roghaye Bayrami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery ,Nazlu Campus , Urmia University of Medical Sciences</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115111</zip>
        <telephone>0098 44 327549614</telephone>
        <email>rozabayrami@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Married women aged 15 to 49 years
Women with a BMI above 25
Consumption fast food at least once a week
Having high sedentary behaviors
Minimum literacy (fifth grade)
Being a resident of Urmia
Not participating in any physical activity training program for the past six months
Not suffering from diseases related to physical activity
Willingness to participate in the study
Not having a mental health problem
Not having sleep disorder
Do not take slimming drugs
Non-compliance with a special diet
Lack of regular physical activity (walking three times a week for at least 30 minutes) or not participating in sports clubs
No specific disease (diabetes, thyroid disorder, pco, cardiovascular, hypertension)
Listening and speaking ability
Having a mobile phone with Android system</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Getting pregnant  during study
Occurrence of a tragic event in life (death of loved ones, accidents with disability)
Having a medical problem
Reluctance to continue cooperation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:The modified version of the APP will be installed on the mobile phones of the intervention group in the first briefing session and how to use it will be taught in person and in practice.sedentary behavior training materials will be organized in four sections and in the first week, one day in between sections will be active for the user.So that after reading the contents of the first session, it will be possible to use the contents of the next training.In the first week, an individual consultation will be done with each user twice, and then during the three months that the intervention takes place, the user can request a consultation in the application at any time.For fast food, these facilities will be created in the second week.The researcher calls the user every other day (by phone or WhatsApp) to make sure she is using the APP.In counseling, factors that interfere with healthy eating behaviors and adequate physical activity (when, these behaviors have increased and decreased) and identifying the factors that create resistance to behavior change and how to overcome them through the rain of thoughts, explaining the correct patterns by participants Assessing self-confidence and comparing it with temptation, reviewing goals and motivators, reviewing barriers and facilitators of healthy lifestyle behavioral patterns from participants' perspectives.During the intervention, by clicking on the consultation icon, samples will be able to perform WhatsApp consultation.From the third week, a short message about the mobility and consumption of fast food will be sent to the members of the intervention group every day at the specified time.Regarding sedentary behavior at 9, 11, 16, 18, 21 hours, the message "Dear user, it is recommended to be active (get up and walk) will be sent.Regarding the consumption of fast food, every day at 12 noon, 6 pm and 9 pm, the message that "consuming fast food is harmful to health."Eat homemade food instead of fast food" is sent to people.The members of the intervention group will not be deprived of the routine care of comprehensive health centers.(First week) Educational content on sedentary behavior; Day 1: What is overweight and obesity? What causes obesity? The effect of overweight / obesity on health, fertility and pregnancy and ways to deal with it; Day 3: Definition of physical activity and exercise, the positive effects of physical activity on the body and the prevention and control of non-communicable diseases and the amount and intensity of appropriate physical activity; Day 5: What are sedentary behaviors? What are the disadvantages of sedentary behaviors?; Day 7: What are the strategies to reduce sedentary behavior at home? What are the strategies to reduce sedentary behaviors at work? Sports activities that can be done while watching TV (Week 2) Educational content about fast food; Day 1: How to get proper nutrition? What is the food pyramid? Introducing food groups; Day 3: Healthy food plate and Iranian dietary guidelines; Day 5: Nutritional recommendations in the prevention of overweight and obesity; Day 7: What is the reduction in fast food consumption? What is fast food? What are the disadvantages of consuming fast food?</i_keyword>
      <i_keyword>Control group:The control group will receive routine training from the Comprehensive Health Service Center.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Women's awareness of sedentary behaviors. Timepoint: Before and three months after ending of the intervention. Method of measurement: Researcher-made questionnaire.</prim_outcome>
      <prim_outcome>Women's awareness of the fast food consumption. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Researcher-made questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Average weight. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Using digital scales (Seca, Germany).</sec_outcome>
      <sec_outcome>Sedentary behaviors. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Researcher-made questionnaire.</sec_outcome>
      <sec_outcome>Fast food consumption. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Researcher-made questionnaire.</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>2021-06-23</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Urzhans Ave , Resalat Blvd Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
