<?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>IRCT2015070220401N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-09-05</date_registration>
      <primary_sponsor>Vice chancellor for research, yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Comparison  of  the  effect of    group    and  family based  education  on  elderly lifestyle of yasouj city.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison  of  the  effect of    group    and  family based  education  on  elderly lifestyle</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18099</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: randomization in this study is blocking method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>elderly.</hc_freetext>
      <i_freetext>Intervention 1: control group: Elderly in the control group will not receive any intervention. Intervention 2: Intervention2. Family base education: face-to-face necessary training will be presented to the elderly and key member of family by the researcher (community health nurse) and a nutritionist (in nutrition session) in 8 sessions, twice a week each session 60 minutes. Before a home visit, will be meeting with families to express the aims of the study and consent to participate in the study. Also will be specified the key person in the family, who is more important to take care of elderly. Educational session include: the first, second and third meeting: nutrition, fourth meeting: exercise and physical activity, fifth meeting: mental health, sixth meeting: personal hygiene and sexual relation, seventh meeting: Sleep hygiene and prevention of accidents, eighth meeting: oral health and limitation smoking in elderly. The new content will be taught by lecture, question and answer. Then elderly and key person will express the summery of session and also next meeting will be reminded. At the beginning of the next meeting will summarize previous expression by people. At the end of sessions, for better learning will be given educational pamphlet to Families. Intervention 3: Intervention 1. Group education: elderly will be divided in to 5 groups that each group contain 10 people. Group education program will be held in 8 session for twice a week each session 60 minutes at Home health and if it don’t have any suitable place it will be held in village mosque face by face by researcher (community health nurse) and a nutritionist (a nutrition session). Educational session include: the first, second and third meeting: nutrition, fourth meeting: exercise and physical activity, fifth meeting: mental health, sixth meeting: personal hygiene and sexual relation, seventh meeting: Sleep hygiene and prevention of accidents, eighth meeting: oral health and limitation smoking in elderly. The new content will be taught by lecture, question and answer. Then elderly will express the summery of session and also next meeting will be reminded. At the beginning of the next meeting will summarize previous expression by elderly. At the end of sessions, for better learning will be given educational pamphlet to  elderly.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Sadat shaafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Motahari Blvd, Yasouj University of Medical Sciences, yasouj, iran.</address>
        <city>yasouj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591741417</zip>
        <telephone>+98 74 3333 7251</telephone>
        <email>webda@yums.ac.ir</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nazafarin  Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Doctor Jali street,yasouj University of Medical Sciences, second floor- school of nursing and midwifery</address>
        <city>yasouj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591741417</zip>
        <telephone>+98 74 3323 5144</telephone>
        <email>hosseini.nazafarin@yums.ac.ir</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: the age of 60-75 years old؛ the average and unfavorable life style score according to  questionnaire؛ lack of physical and mental disability. Exclusion criteria: Physically and mentally disease during intervention؛ the absence of more than one session؛ taking the  life style education from other sources according to people answers.</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>34 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R54</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>senility</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>control group: Elderly in the control group will not receive any intervention</i_keyword>
      <i_keyword>Intervention2. Family base education: face-to-face necessary training will be presented to the elderly and key member of family by the researcher (community health nurse) and a nutritionist (in nutrition session) in 8 sessions, twice a week each session 60 minutes. Before a home visit, will be meeting with families to express the aims of the study and consent to participate in the study. Also will be specified the key person in the family, who is more important to take care of elderly. Educational session include: the first, second and third meeting: nutrition, fourth meeting: exercise and physical activity, fifth meeting: mental health, sixth meeting: personal hygiene and sexual relation, seventh meeting: Sleep hygiene and prevention of accidents, eighth meeting: oral health and limitation smoking in elderly. The new content will be taught by lecture, question and answer. Then elderly and key person will express the summery of session and also next meeting will be reminded. At the beginning of the next meeting will summarize previous expression by people. At the end of sessions, for better learning will be given educational pamphlet to Families</i_keyword>
      <i_keyword>Intervention 1. Group education: elderly will be divided in to 5 groups that each group contain 10 people. Group education program will be held in 8 session for twice a week each session 60 minutes at Home health and if it don’t have any suitable place it will be held in village mosque face by face by researcher (community health nurse) and a nutritionist (a nutrition session). Educational session include: the first, second and third meeting: nutrition, fourth meeting: exercise and physical activity, fifth meeting: mental health, sixth meeting: personal hygiene and sexual relation, seventh meeting: Sleep hygiene and prevention of accidents, eighth meeting: oral health and limitation smoking in elderly. The new content will be taught by lecture, question and answer. Then elderly will express the summery of session and also next meeting will be reminded. At the beginning of the next meeting will summarize previous expression by elderly. At the end of sessions, for better learning will be given educational pamphlet to  elderly.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lifestyle. Timepoint: before intervention ,one,two and three month after intervention. Method of measurement: elderly lifestyle 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>Vice chancellor for research, yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-03-16</approval_date>
        <contact_name>Ethics committee of yasouj University of Medical Sciences</contact_name>
        <contact_address>Motahari Blvd, Yasouj University of Medical Sciences, Yasouj, iran. yasouj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
