<?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>IRCT2015070423055N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-02-05</date_registration>
      <primary_sponsor>Vice Chancellor for research of Babol University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effectiveness of lifestyle modification interventions</public_title>
      <acronym>-</acronym>
      <scientific_title>Comparison the effectiveness of lifestyle modification interventions ( nutrition and physical activity) in comparison with lifestyle education on nutritional behaviors, physical activity, anthropometric measurements, fasting blood sugar and serum lipid profile in the adults aged 40-60 years</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19769</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: Randomization in study population will be performed with random allocation of subjects in the age group of 40- 60 years old  in the three groups by random numbers table.</study_design>
      <phase>2</phase>
      <hc_freetext>Life-style (Factors influencing health status and contact with health services).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:  For 4 months (16 weeks), weekly group training about nutrition and physical activity, individualized nutrition counseling, providing educational materials and weekly free aerobic exercises. The content of nutrition classes is adapted from nutritional principles which Ministry of Health and Medical Education of Iran has released. The trainer is an expert nutritionist. The duration of each class is 45 minutes, classes will be taken as group discussion and approximate number of participants is 25-30 persons. Intervention 2: Intervention group 2: For 16 weeks, weekly group training about nutrition and physical activity, individualized nutrition counseling and providing educational materials. Intervention 3: Control group: Only educational package included booklet, CD, pamphlet and papers about lifestyle especially improving nutrition and physical activity.</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>Simin Mouodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ganjafrooz Avenue, Babol University of Medical Sciences, Babol</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4136747176</zip>
        <telephone>+98 11 3219 0624</telephone>
        <email>dr.mouodi@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Reza Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ganjafrooz Ave, Babol University of Medical Sciences, Babol</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4136747176</zip>
        <telephone>+98 11 3219 7667</telephone>
        <email>dr.mouodi@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Age 40-60 years; Living in Amirkola Babol; Desire to participate in the study, fill out and sign the informed consent form of the research&#13;
Exclusion Criteria: Unable to read and write; Pregnancy or child breast feeding; Severe physical or mental disease which make them disable; Probable migration from Amirkola in 10 months</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z40,Z41,Z4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Persons encountering health services for specific procedures and health care</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1:  For 4 months (16 weeks), weekly group training about nutrition and physical activity, individualized nutrition counseling, providing educational materials and weekly free aerobic exercises. The content of nutrition classes is adapted from nutritional principles which Ministry of Health and Medical Education of Iran has released. The trainer is an expert nutritionist. The duration of each class is 45 minutes, classes will be taken as group discussion and approximate number of participants is 25-30 persons.</i_keyword>
      <i_keyword>Intervention group 2: For 16 weeks, weekly group training about nutrition and physical activity, individualized nutrition counseling and providing educational materials.</i_keyword>
      <i_keyword>Control group: Only educational package included booklet, CD, pamphlet and papers about lifestyle especially improving nutrition and physical activity.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Life style status. Timepoint: Before ( 0 week) and after the intervention (16th week). Method of measurement: HPLP-II questionnaire (Health-Promoting Life Style Profile-II).</prim_outcome>
      <prim_outcome>Main dietary pattern. Timepoint: Before ( 0 week) and after the intervention (16th week). Method of measurement: Food Recall Questionnaire.</prim_outcome>
      <prim_outcome>Physical activity status. Timepoint: Before ( 0 week) and after the intervention (16th week). Method of measurement: IPAQ:International Physical Activity Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anthropometric measures. Timepoint: Before (0 week) and after the intervention (16 th week). Method of measurement: Physical examination.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before (0 week) and after the intervention (16 th week). Method of measurement: Physical examination.</sec_outcome>
      <sec_outcome>Fasting blood glucose. Timepoint: Before ( 0 week) and after the intervention (16 th week). Method of measurement: Blood sample.</sec_outcome>
      <sec_outcome>Serum lipid profile. Timepoint: Before ( 0 week) and after the intervention (16 th week). Method of measurement: Blood sample.</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 of Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-06-02</approval_date>
        <contact_name>Ethics committee of Babol University of Medical Sciences</contact_name>
        <contact_address>Ganjafrooz Avenue, Babol Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
