<?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>IRCT20180721040540N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-21</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>The Impact of Community-Based Interventions on Promoting Lifestyle</public_title>
      <acronym></acronym>
      <scientific_title>TThe Effect of Community Based Interventions on Promoting the Life Style of Elderly People with Hypertension Based on Health Belief Model in 1398</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45393</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The method of sampling was convenience method. Eligible subjects with using the Permuted block randomization will have located in the intervention or control groups. The Sex(Male and female), and level of hypertension of subjects, will consider as stratified in the inside of blocks.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Improving the lifestyle of the elderly with hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The interventions in this s  sessions based on the health belief model, The researcher teaches  the elderly and their caregivers about the importance of diet, timely use of prescribed medications and physical activity.The workshop sessions will be conducted in a workshop manner (lectures, questions and answers, and a review of the content of the previous session) along with the presentation of educational booklet with very simple content.                                       The duration of group training will be between 30 and 40 minutes in comprehensive health centers or any place where the individual and her family are available and have full satisfaction with the location of the training.Training sessions will be intervened 24 times during 3 months and will be held 2 days a week according to the conditions of the elderly studied.Individual home training will take place two weeks after group   training. In addition, the researcher will be in constant contact tudy will include trainingwith the samples in person or by phone during this period.The contents of the booklet include explanations on how to consume age-appropriate diets rich in protein, milk, and low-fat products to strengthen bones, fish consumption, andBrains such as almonds and walnuts and whole grains and fruits and vegetables as well as side effectsTheir medications and the effect of exercise on vitality and health and the effects of high blood pressure as well as the need Medical follow-up will be in collaboration with a cardiologist and nutritionist.Control group: They will receive their usual care from the health staff and at the end of the study, educational interventions will be provided to this group. Intervention 2: Control group:  the control group will receive routine services of comprehensive health 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Because of confidentiality</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Heshmatolah Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kilometr 5 Khorramabad- Boroujerd Road</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>68149-93165</zip>
        <telephone>+98 66 3312 0174</telephone>
        <email>Hidari74@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Heshmatolah Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kilometr 5 Khorramabad- Boroujerd Road</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>68149-93165</zip>
        <telephone>+98 66 1233 0174</telephone>
        <email>hidari74@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>60-84 years old
Hypertension based on the diagnosis of a specialist (duration of at least 12 months).Take at least one blood pressure lowering medication or change lifestyle for control.
Confirmation of entry for study by physician designated research centers
hypertension have (140/90 -159/99 mmHg mild hypertension)
hypertension have (160/100-179 /109 mmHg medium Hypertension)
No need for surgical treatment in recent months
No history of coronary artery disease,Kidney
Lack of physical disability or mental disorder
Minimum literacy
No mobility problems (able to perform daily activities without dependence on others)
Lack of cognitive impairment and severe disabilities in walking independently (Walker, Wheelchair Dependency)
Willingness to participate in research
Spoken in Farsi, Larry and Lucky
Lack of hearing and speech problems</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>84 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Recent history for advanced and malignant disease
Taking psychotropic drugs
Drug use</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The interventions in this s  sessions based on the health belief model, The researcher teaches  the elderly and their caregivers about the importance of diet, timely use of prescribed medications and physical activity.The workshop sessions will be conducted in a workshop manner (lectures, questions and answers, and a review of the content of the previous session) along with the presentation of educational booklet with very simple content.                                       The duration of group training will be between 30 and 40 minutes in comprehensive health centers or any place where the individual and her family are available and have full satisfaction with the location of the training.Training sessions will be intervened 24 times during 3 months and will be held 2 days a week according to the conditions of the elderly studied.Individual home training will take place two weeks after group   training. In addition, the researcher will be in constant contact tudy will include trainingwith the samples in person or by phone during this period.The contents of the booklet include explanations on how to consume age-appropriate diets rich in protein, milk, and low-fat products to strengthen bones, fish consumption, andBrains such as almonds and walnuts and whole grains and fruits and vegetables as well as side effectsTheir medications and the effect of exercise on vitality and health and the effects of high blood pressure as well as the need Medical follow-up will be in collaboration with a cardiologist and nutritionist.Control group: They will receive their usual care from the health staff and at the end of the study, educational interventions will be provided to this group.</i_keyword>
      <i_keyword>Control group:  the control group will receive routine services of comprehensive health centers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Physical activity. Timepoint: Before, one month, two months and three months later. Method of measurement: Questionnaire of Physical activity scale for the elderly.</prim_outcome>
      <prim_outcome>Nutritional perceptions. Timepoint: Before, one month, two months and three months later. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Adherence to treatment. Timepoint: Before, one month, two months and three months later. Method of measurement: Adherence to Hill-Bone High Blood Pressure Treatment.</prim_outcome>
      <prim_outcome>Self- efficacy. Timepoint: Before, one month, two months and three months later. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure changes. Timepoint: Before, one month, two months and three months later. Method of measurement: Mercury manometer.</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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-02</approval_date>
        <contact_name>Ethics Committee in Research of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Kelometr 5 Kamalvand Khoramabad- Boroujerd Road, Lorestan University Of Medical Sciences Khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
