<?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>IRCT20201208049649N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-07</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of intervention based on family-centered empowerment model on preventive lifestyle of cardiovascular risk factors in middle-aged women</public_title>
      <acronym></acronym>
      <scientific_title>Effect of intervention based on family-centered empowerment model on preventive lifestyle of cardiovascular risk factors in middle-aged women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52904</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The samples were randomly assigned to the experimental and control groups in the form of a random permutation block design with four blocks. Thus, the letter A was considered for the intervention and the letter B was considered for the control group. Then all the permutation compounds of letters A, A and B, B, which were 6 different compounds, were written (AABB for cultivar 1, ABBA for cultivar 2…) and from cultivars 1 to 6, one cultivar was randomly selected by substitution. For example, if the number 2 was selected, it meant that the first person in the intervention group, the next two people in the control group and the fourth person in the intervention group, and we continued this operation until the sample size reached the quorum (37 people in each group). ) Receipt.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cardiovascular diseases.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Intervention group: By forming small groups during 6 training sessions, each session will be for half an hour and will be held twice a week, the lifestyle of preventing cardiovascular disease risk factors using the model steps (perceived threat from Through group discussion, promoting self-efficacy through group problem solving, increasing self-esteem (self-confidence) through educational participation) will be taught. In two sessions, a family member will be invited to attend the sessions and participate in training and group discussions. The educational content includes (nutrition, physical activity ......) which will be based on the family self-care guide and will be designed by the esteemed deputy of health and will have a set of practical recommendations for the prevention of cardiovascular disease risk factors. Educational materials are taught according to the model (perceived threat through group discussion, promoting self-efficacy through group problem solving, increasing self-esteem (self-confidence) through educational participation): Step 1 (perceived threat): In this Step by step group discussion will be used to examine the perceived threat. Examining and evaluating the current situation, individual, environmental and behavioral differences and determining the behavioral and environmental factors that affect the change of behavior will be done in this meeting. Group discussion with the research units will be done in two sessions and each session will last for 30 minutes, in which one person will participate alone and in the next session with a family member. During the sessions, discuss their knowledge and potential solutions, then provide educational materials on the importance of self-care and prevention of cardiovascular disease and its dimensions, including care measures to prevent disease. Cardiovascular, communicating with others as a group discussion to achieve codified and effective programs, promoting self-efficacy through group problem solving, increasing self-esteem (self-esteem) through educational participation of research members and families, the nature of the disease Cardiovascular, signs and symptoms of the disease or exposure and issues related to nutrition and physical activity and blood pressure and smoking will be expressed. Step 2 (Improving self-efficacy through group problem solving): For this step, the method of showing educational videos and pamphlets in two sessions for 30 minutes will be used, so that in one of the sessions, family members with the samples studied They will participate in the meeting, and the necessary training and needs assessment in the first session will be provided to the research members through educational videos and pamphlets. Also, in the meeting in which family members also participate, the research members will be asked. To reach possible solutions to the problem and plan to implement it through group discussion with each other and with family members, through the problem solving process. At the end, a program will be prepared based on standard principles and using publicly available materials and methods and will be provided to members. All material presented from scientific sources will be valid and approved by professors. Step 3 (Increase self-esteem through educational participation): In this stage, which will be done in two sessions and each session will be for 30 minutes, the patient is asked Will participate in training their family members and encourage them to help themselves. Step 4 (Final Evaluation): In this stage, which will be eight weeks after the last family-centered empowerment session, invite the research units Will do to answer the research questionnaire as a post-test. After the completion of this process, the written and text file of the trainings presented in the previous sessions will be presented in PDF format along with the pamphlet files related to all research units (both intervention and control groups). Intervention 2: Control group: The control group will benefit from the usual programs of the center, but in order to observe ethical considerations, a training session will be held for this group at the end of the intervention, in which the training given to the intervention group will be briefly taught. .</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:
The data analysis results will be available for use by other experts and researchers after the study

When:
One month after data analysis

To whom:
Researchers, experts and professors in this field, managers, planners and other stakeholders

Conditions:
There are no special conditions for people to access

Where to obtain:
After publishing the results, they can refer to the site where the results were published

How to obtain:
After publishing the results in the journal and the site, it is enough to search for the keywords of the research on the internet page, and also to communicate with the researcher, they can contact him through the email published in the article.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fariba Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 41, 4th and 7th floors, Sadeghi Alley, Farmanieh, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 2275 8177</telephone>
        <email>farimahosseini2015@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 41, 4th and 7th floors, Sadeghi Alley, Farmanieh, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 2275 8177</telephone>
        <email>farimahosseini2015@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 40 to 59 years
Lack of speech and hearing problems- Literacy
Do not suffer from known mental disorders (self-expression and apple system)
The person is at a moderate and higher risk of cardiovascular disease
Do not have underlying diseases other than diabetes</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>59 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Absence from more than two sessions of training sessions
Spatial displacement</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Combined systolic (congestive) and diastolic (congestive) heart failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Intervention group: By forming small groups during 6 training sessions, each session will be for half an hour and will be held twice a week, the lifestyle of preventing cardiovascular disease risk factors using the model steps (perceived threat from Through group discussion, promoting self-efficacy through group problem solving, increasing self-esteem (self-confidence) through educational participation) will be taught. In two sessions, a family member will be invited to attend the sessions and participate in training and group discussions. The educational content includes (nutrition, physical activity ......) which will be based on the family self-care guide and will be designed by the esteemed deputy of health and will have a set of practical recommendations for the prevention of cardiovascular disease risk factors. Educational materials are taught according to the model (perceived threat through group discussion, promoting self-efficacy through group problem solving, increasing self-esteem (self-confidence) through educational participation): Step 1 (perceived threat): In this Step by step group discussion will be used to examine the perceived threat. Examining and evaluating the current situation, individual, environmental and behavioral differences and determining the behavioral and environmental factors that affect the change of behavior will be done in this meeting. Group discussion with the research units will be done in two sessions and each session will last for 30 minutes, in which one person will participate alone and in the next session with a family member. During the sessions, discuss their knowledge and potential solutions, then provide educational materials on the importance of self-care and prevention of cardiovascular disease and its dimensions, including care measures to prevent disease. Cardiovascular, communicating with others as a group discussion to achieve codified and effective programs, promoting self-efficacy through group problem solving, increasing self-esteem (self-esteem) through educational participation of research members and families, the nature of the disease Cardiovascular, signs and symptoms of the disease or exposure and issues related to nutrition and physical activity and blood pressure and smoking will be expressed. Step 2 (Improving self-efficacy through group problem solving): For this step, the method of showing educational videos and pamphlets in two sessions for 30 minutes will be used, so that in one of the sessions, family members with the samples studied They will participate in the meeting, and the necessary training and needs assessment in the first session will be provided to the research members through educational videos and pamphlets. Also, in the meeting in which family members also participate, the research members will be asked. To reach possible solutions to the problem and plan to implement it through group discussion with each other and with family members, through the problem solving process. At the end, a program will be prepared based on standard principles and using publicly available materials and methods and will be provided to members. All material presented from scientific sources will be valid and approved by professors. Step 3 (Increase self-esteem through educational participation): In this stage, which will be done in two sessions and each session will be for 30 minutes, the patient is asked Will participate in training their family members and encourage them to help themselves. Step 4 (Final Evaluation): In this stage, which will be eight weeks after the last family-centered empowerment session, invite the research units Will do to answer the research questionnaire as a post-test. After the completion of this process, the written and text file of the trainings presented in the previous sessions will be presented in PDF format along with the pamphlet files related to all research units (both intervention and control groups).</i_keyword>
      <i_keyword>Control group: The control group will benefit from the usual programs of the center, but in order to observe ethical considerations, a training session will be held for this group at the end of the intervention, in which the training given to the intervention group will be briefly taught. .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Preventive lifestyle risk factors for cardiovascular disease. Timepoint: Before the intervention, two months after the end of the intervention. Method of measurement: Standard Eating Habits Questionnaire, Metabolic Health Assessment Questionnaire, Baecke Physical Activity Questionnaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-05</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat Sharghi St., Tohid Sq., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
