<?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>IRCT20110423006261N21</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-04-26</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of a “My Plate” nutrition training program on anthropometric indices, muscular strength and function, and quality of life among older adults with overweight and/or obesity; application of Health Belief Model</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of a “My Plate” nutrition training program on anthropometric indices, muscular strength and function, and quality of life among older adults with overweight and/or obesity; application of Health Belief Model</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76367</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: In order to be able to generalize the results of the study and to reduce the socio-economic differences as much as possible, the samples of the two control and experimental groups from 4 comprehensive urban health centers located in Jahrom city, completely randomly and in a cluster, 2 centers and two bases from each center are selected and randomly two bases will be selected as the control group and two bases as the intervention group. In the selected centers, the names of eligible people include the elderly in both sexes, according to the different proportion of women and men in terms of obesity, which according to statistics, about 60% of women and about 40% of men have a body mass index above 25. 60% of the samples are women. And 40% are men Therefore, separate lists of men and women were prepared from the Sib system, and then 25 elderly people who met the study entry criteria were selected from each center by regular random method, Blinding description: None of the participants will be given an explanation about which group, intervention or control group they are in, while the control group will also receive a healthy eating brochure.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Overweight and/or obesity in the elderly.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Two groups of 25 people from two different comprehensive health centers, that is, a total of 50 people, who will receive training on the My Plate method and the necessary exercise as an intervention. Intervention 2: Control group:  two groups of 25 people from two sub-bases of the same comprehensive health center as the intervention group were sampled. This group will only receive healthy eating brochures.</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:
Participants' data, including height and weight, anthropometric measurements, and muscle strength and function, will be shared after de-identification and after the end of the study.

When:
The access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions and the Ministry of Health and Industry can apply for them.

Conditions:
People who deal with the elderly or the elderly themselves

Where to obtain:
Mr. Dr. Mohammad Hossein Kaveh: Mhkaveh255@gmail.com
Elham Foroodi: elhamforoodi@yahoo.com

How to obtain:
First, write the reason for the need for the data in a word, and then send an email, and the data will be sent after 30 days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Hossein Kaveh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Blvd., in front of the Electrical Club of the Faculty of Health</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7153675541</zip>
        <telephone>+98 71 3725 1001</telephone>
        <email>Mhkaveh255@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Hossein Kaveh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Street, Faculty of Health</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7153675541</zip>
        <telephone>+98 71 3725 1001</telephone>
        <email>Mhkaveh255@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Body mass index of 25 and above.
They have not used any type of protein supplement in the past 6 months
Be able to walk and be able to go to the health center without the help of others.
At least have reading and writing literacy (completion of the third grade).
Do not suffer from chronic diseases such as kidney disease and diabetes that require special diet and care.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Have an injury or an acute illness that requires special care.
To withdraw from continuing to participate in the study for any reason (disability, personal preference, illness).
Absent more than two sessions from training sessions
Their questionnaires are very distorted and incompletely completed (they have not answered more than 30% of the questions).</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight and obesity</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: Two groups of 25 people from two different comprehensive health centers, that is, a total of 50 people, who will receive training on the My Plate method and the necessary exercise as an intervention.</i_keyword>
      <i_keyword>Control group:  two groups of 25 people from two sub-bases of the same comprehensive health center as the intervention group were sampled. This group will only receive healthy eating brochures.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight is measured using a scale. Timepoint: At the beginning of the study (before the start of the intervention) and 3 months after the initial measurements. Method of measurement: The weight of the elderly is measured with a Seka scale, with an accuracy of 0.1 kg, and with minimal clothes and no shoes in the morning.</prim_outcome>
      <prim_outcome>Muscle strength. Timepoint: At the beginning of the study (before the start of the intervention) and 3 months after the initial measurements. Method of measurement: We will use Sammons Preston Hand Dynamometer, JAMAR Plus) hydraulic hand dynamometer.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: At the beginning of the study (before the start of the intervention) and 3 months after the initial measurements. Method of measurement: Quality of Life Questionnaire for the Elderly (World Health Organization).</prim_outcome>
      <prim_outcome>Muscle function. Timepoint: At the beginning of the study (before the start of the intervention) and 3 months after the initial measurements. Method of measurement: Balance test with balance test TUG.</prim_outcome>
      <prim_outcome>Around the waist around the hips WHR. Timepoint: At the beginning of the study (before the start of the intervention) and 3 months after the initial measurements. Method of measurement: It is measured with an inflexible tape measure with an accuracy of 0.1 cm.</prim_outcome>
      <prim_outcome>Physical activity. Timepoint: At the beginning of the study (before the start of the intervention) and 3 months after the initial measurements. Method of measurement: Physical activity measurement questionnaire IPAQ-SF.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Constructs of health belief model. Timepoint: Three months after the initial measurements, the measurements will be repeated in both groups. Method of measurement: A researcher-made questionnaire to measure the constructs of the health belief model.</sec_outcome>
      <sec_outcome>24-hour food reminder. Timepoint: First, before the start of the study, it is measured on two different days and three months later, it is measured again on two different days. Method of measurement: Questionnaire learned 24 hours of food.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-03-13</approval_date>
        <contact_name>Research Ethics Committees of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand Street Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
