<?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>IRCT20210509051229N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-30</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of online educational lifestyle intervention in the elderly</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of online educational lifestyle intervention in the elderly with type 2 diabetes in Qazvin</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>130</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56251</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In this study, a questionnaire is given to individuals before training and a questionnaire is filled out once after training. This study is performed in two groups of control and intervention, Randomization description: In this study, a multi-stage randomization method was used. So that 130 elderly people with diabetes are needed to conduct the research and there should be 65 people in each control and experimental group. At first, 4 centers were randomly selected from 13 existing health centers in Qazvin city. Then, among these 4 centers, the number of elderly people with diabetes was removed, and among all the elderly people, by random method and using the number of 130 cards, 65 control groups and 65 experimental groups were selected. and then that card was discarded. Finally, after dividing the people into two groups, the questionnaires were completed.</study_design>
      <phase>3</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: During 8 weeks, the intervention group receives training on the correct methods of food intake in people with diabetes, the effect of physical activity in controlling diabetes, and the consumption of fruits and vegetables in people with diabetes, and after 3 months of The last retraining session of the questionnaire is given to two experimental and control groups to answer the questions. Intervention 2: In the control group, at first, the questionnaire is completed by elderly people with type 2 diabetes. And after 3 months, when the relevant training were passed to the intervention group, the questionnaires will be completed again in the two groups to measure the result and impact of the training in the two groups. Finally, training and explanations about lifestyle, physical activity and food in people with diabetes are also given to the control group so that they do not benefit from the study.</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:
Some of the data related to the main outcome can be shared

When:
Access starts 6 months after the results are published.

To whom:
Data is confidential.

Conditions:
The data are examined for analysis.

Where to obtain:
Fateme Zanjanchi Nikoo

How to obtain:
Data is confidential

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Isa Mohammadi Zeidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Bahonar Blvd</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15315-34199</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>imohammadi@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Zanjanchi Nikoo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hakim Blvd</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15315-34199</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>f.zanjanchinikoo@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Literacy of reading and writing
Ownership and ability to use Android mobile or IOS system
People with diabetes
Voluntary and conscious participation of people</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from physical diseases or mental disorders that prevent proper and regular participation in any way be in research
Lack of access to the Android system and software related to What's App
Unwillingness to cooperate in further research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</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: During 8 weeks, the intervention group receives training on the correct methods of food intake in people with diabetes, the effect of physical activity in controlling diabetes, and the consumption of fruits and vegetables in people with diabetes, and after 3 months of The last retraining session of the questionnaire is given to two experimental and control groups to answer the questions.</i_keyword>
      <i_keyword>In the control group, at first, the questionnaire is completed by elderly people with type 2 diabetes. And after 3 months, when the relevant training were passed to the intervention group, the questionnaires will be completed again in the two groups to measure the result and impact of the training in the two groups. Finally, training and explanations about lifestyle, physical activity and food in people with diabetes are also given to the control group so that they do not benefit from the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Healthy lifestyle in diabetics. Timepoint: Before training-After training. Method of measurement: In this study, the questionnaire is the measurement scale. The questionnaire questions include the following: 1- Demographic information 2- Lifestyle questionnaire: This 19-item questionnaire was designed by Lipke and Zigelman in 2006. All questions in the questionnaire are scored on a Likert scale from one to four (completely false = 1 to completely true = 4). 3-Physical Activity Questionnaire: International Physical Activity Questionnaire, as an international physical activity measurement tool in Geneva by WHO. and CDC (1998) was suggested for the age group of 69-15 years. There are two forms of IPAQ 4- Health Action Questionnaire: Perceived Risk Questionnaire: (includes 6 questions related to physical activity and regular consumption of fruits and vegetables) - Self-efficacy scale: (includes 6 questions related to self-efficacy and with a 5-point Likert scale E) - Awareness scale: (yes-no answer options) - Outcome expectation scale: (the scale consists of 5 questions and with 5-point answer options) - Action planning scale - Coping plan scale - Support scale social.</prim_outcome>
      <prim_outcome>The main variable measured in this study is lifestyle items. Timepoint: Before training-After training. Method of measurement: HAPA Questionnaire.</prim_outcome>
      <prim_outcome>The main variable measured in this study is lifestyle items. Timepoint: Before training-After training. Method of measurement: Nutrition Questionnaire -.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Average perceived risk--. Timepoint: people are divided into two categories of control and intervention and are compared with each other. Method of measurement: Knowledge-Nutrition-HAPA Questionnaire.</sec_outcome>
      <sec_outcome>Average awareness-Self. Timepoint: people are divided into two categories of control and intervention and are compared with each other. Method of measurement: Knowledge-Nutrition-HAPA Questionnaire.</sec_outcome>
      <sec_outcome>Efficacy-Expectation of outcome. Timepoint: people are divided into two categories of control and intervention and are compared with each other. Method of measurement: Knowledge-Nutrition-HAPA Questionnaire.</sec_outcome>
      <sec_outcome>Social support. Timepoint: people are divided into two categories of control and intervention and are compared with each other. Method of measurement: Knowledge-Nutrition-HAPA 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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-19</approval_date>
        <contact_name>Qazvin university of medical sciences</contact_name>
        <contact_address>Shahid Bahonar Blvd Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
