<?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>IRCT20170606034339N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-08</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of education on weight changes and lifestyle self-efficacy of women in the postpartum period</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of nutrition training and physical activity on weight changes and Self-efficacy of Weight Lifestyle for Women with High Body Mass Index in Postpartum Period</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50414</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization is done by lottery, Blinding description: Among the health centers under the auspices of the university, one center is randomly selected as the intervention group using a lottery, and the nearest center in terms of distance and similarity in terms of socio-economic context is considered as the control group. The reason for choosing a separate intervention and control center to prevent the dissemination of information between the two groups. In this way, the participants do not know whether they are in the intervention or control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Overweight and Obesity after childbirth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, in addition to the standard care available in health centers, nutrition education with emphasis on four sources of self-efficacy and physical activity with pedometer by the researcher in groups of 5-7 people through lectures, group discussions and questions and answers. It is done in 4 sessions (45-60) minutes with an interval of one week. At the end of the training sessions, a healthy lifestyle booklet with the content of healthy nutrition and physical activity after childbirth will be given to mothers. Intervention 2: Control group: The control group will receive the standard care available in the 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data will be published after the individuals are unidentified

When:
Immediately after completing the plan

To whom:
All the researchers

Conditions:
People working in health centers

Where to obtain:
Hoda Naderi

How to obtain:
Initially, an application is submitted via email, then after the email is read, if possible, the data will be provid

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Crossroads Doktora, Ibn-Sina Avenue</address>
        <city>Mshhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>maryam.moradi.fu@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn Sina Street, Doctora intersection</address>
        <city>Mahshad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>00985318591511</telephone>
        <email>naderih931@mums.ac.ir</email>
        <affiliation>Mashhad 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: have written consent to participate in research; to visit the health center at 6-16 weeks after delivery; have physical activity level poor (score between 20-39) or inactive (score Less than 20); the pre-pregnancy body mass index is between (25-34/9); after delivery body mass index is between (25-34/9).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exclusion criteria: do not participate in one of the training sessions; walking has not been done in 3 continuous Sessions or 5 discontinuous sessions; in more than 5 sessions, the number of steps recorded is less than 100-120 steps per minute.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E.66.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other 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: In the intervention group, in addition to the standard care available in health centers, nutrition education with emphasis on four sources of self-efficacy and physical activity with pedometer by the researcher in groups of 5-7 people through lectures, group discussions and questions and answers. It is done in 4 sessions (45-60) minutes with an interval of one week. At the end of the training sessions, a healthy lifestyle booklet with the content of healthy nutrition and physical activity after childbirth will be given to mothers.</i_keyword>
      <i_keyword>Control group: The control group will receive the standard care available in the health centers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight chenges. Timepoint: Before the intervention, 4 weeks after the intervention, 8 weeks after the intervention. Method of measurement: Scales.</prim_outcome>
      <prim_outcome>Weight-Efficacy of Life style. Timepoint: Before intervention, 8 weeks after intervention. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physical Activity Index. Timepoint: Before the intervention, 8 weeks after the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Waist to Hip Ratio. Timepoint: Before the intervention, 4 weeks after the intervention, 8 weeks after the intervention. Method of measurement: Meter.</sec_outcome>
      <sec_outcome>Hip Circumference. Timepoint: Before the intervention, 4 weeks after the intervention, 8 weeks after the intervention. Method of measurement: Meter.</sec_outcome>
      <sec_outcome>Waist Circumference. Timepoint: Before the intervention, 4 weeks after the intervention, 8 weeks after the intervention. Method of measurement: Meter.</sec_outcome>
      <sec_outcome>Body Mass Index. Timepoint: Before the intervention, 4 weeks after the intervention, 8 weeks after the intervention. Method of measurement: Scales and Meters.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-10</approval_date>
        <contact_name>Mashhad University of Medical Sciences</contact_name>
        <contact_address>Qaryashi Building, University Street, Mashhad Holy Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
