<?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>IRCT20220909055918N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-07</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of self-care training through WhatsApp on self-care criteria of diabetic pregnant women.</public_title>
      <acronym></acronym>
      <scientific_title>Reviewing the  effect of self-care education through social media on self-care of overweight and obese pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65822</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The size of sample group is estimated to be 120 people. Sampling is done by using the Block Design Randomization method (30 blocks of 4) and using the table of random numbers. . In general, the samples are devided in a virtual training group and a control group. In total, 60 people are in the  intervention
group and 60 people are in the control group. Thus, the samples were randomly divided into the intervention group (training through WhatsApp + routine care)and the control group (only routine care). In this way, all possible modes of placement including A: Training via WhatsApp and B: Routine care were considered in blocks of 4 with an allocation ratio of 1:1, and the number of required blocks was determined based on the number of samples.
After that, according to the required number of blocks and based on the table of random numbers, the blocks corresponding to each table were listed in order. Finally, as the samples entered the study, each person got a certain letter according to the obtained order .In order to hide the random allocation, the sealed non-transparent envelopes method with random sequence was used. In this method, first, a random sequence is created using a random number table, and based on the sample size of the research(120), 120 matte envelopes (in order to make the content of the envelope unclear)  were prepared. Each of the created random sequences was recorded on a card by a person who was unaware of the goals and topic of the study and the cards were placed in the envelopes, and finally the envelopes were sealed and placed in a box in order. At the time of sampling, the researcher, according to the order in which the qualified participants entered, opened one of the envelopes and the group of that participant was revealed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gestational Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the beginning, the people who meet the criteria for entering the study will be identified and by using the block randomization method, divided into two groups of 60 people, the control group (face-to-face training) and 60 people in the intervention group (face-to-face training and training through software. Data collection tools in this research includes: demographic information form, blood sugar test checklist, measuring mothers' weight and recording weight changes, international physical activity questionnaire, lifestyle questionnaire and diabetes self-care questionnaire. At the beginning (between 24 and 28 weeks of pregnancy) for the samples of both groups, a checklist of blood sugar tests two hours of taking 75grams glucose and fast blood sugar test  will be completed by the researcher. Then, the demographic information form and Physical activity, lifestyle and self-care questionnaires will be provided to people to complete. Then the total samples, all 120 people, the intervention group (60 people) and the control group (60 people), will receive face-to-face training, which is actually the same routine pregnancy care through health centers until delivery. In addition to face-to-face training provided by health center midwives for the intervention group training will also be provided through the software.  A group will be created on the WhatsApp social network and all the intervention group members will be joined to this group, and within 10 weeks (28-38 weeks) on even days, two educational messages will be sent in the form of written text or photos or educational videos into the group. The content provided in the educational messages will be similar to the content of face-to-face training. The content of face-to-face training sessions (routine pregnancy care) and educational messages of the software includes:  “training about gestational diabetes and its effects on the mother and the fetus, explanation of self-care methods, nutrition education including foods that a pregnant person should not consume, portion of food and having regular physical activity, benefits of exercise and physical activity during pregnancy, Regular walking, recommended exercises for pregnant women (balanced movements, stretching exercise, Pilates and special classes for pregnancy), how to eat healthily, how to use insulin correctly’. After the completion of the training in two groups (38 weeks of pregnancy), the samples will be asked to perform the fasting blood sugar test and the blood sugar test after two hours of taking 75 grams of glucose and provide the results to the sampling centers.  After reviewing the tests,  As mentioned, the results will be recorded in the blood sugar test registration checklist by the researcher, and then the questionnaires (physical activity, lifestyle and self-care) will be completed again by both groups and the amount of weight changes will be estimated. Intervention 2: Control group:  Routine care of pregnancy.</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:
Use of data for research purposes only

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

To whom:
Everyone has access to published data

Conditions:
Raw statistical data will not be published, but statistical analysis will be available

Where to obtain:
Responsible for clinical trial registration

How to obtain:
It will be possible with the permission of the Ethics Committee and Research Vice-Chancellor of Jundishapur University of Medical Sciences, Ahwaz

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Abbaspour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jondishapur University of Medical Sciences ,Golestan Ave, Golestan Blvd ,Ahvaz, KHuzestan province ,Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3333 3477</telephone>
        <email>abbaspoor-z@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Abbaspour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jondishapur University of Medical Sciences ,Golestan Ave, Golestan Blvd ,Ahvaz, KHuzestan province ,Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3333 3477</telephone>
        <email>abbaspoor-z@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. 24-28-week pregnant women whose gestational diabetes has been confirmed by blood sugar test Two hours after taking 75 grams of glucose. 2. Being literate.3. Having a private mobile phone.4. Having WhatsApp installed and being able to use it.5. Having the ability to attend in face-to-face .meetings and answering questions</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O24.41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gestational diabetes mellitus in pregnancy</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 beginning, the people who meet the criteria for entering the study will be identified and by using the block randomization method, divided into two groups of 60 people, the control group (face-to-face training) and 60 people in the intervention group (face-to-face training and training through software. Data collection tools in this research includes: demographic information form, blood sugar test checklist, measuring mothers' weight and recording weight changes, international physical activity questionnaire, lifestyle questionnaire and diabetes self-care questionnaire. At the beginning (between 24 and 28 weeks of pregnancy) for the samples of both groups, a checklist of blood sugar tests two hours of taking 75grams glucose and fast blood sugar test  will be completed by the researcher. Then, the demographic information form and Physical activity, lifestyle and self-care questionnaires will be provided to people to complete. Then the total samples, all 120 people, the intervention group (60 people) and the control group (60 people), will receive face-to-face training, which is actually the same routine pregnancy care through health centers until delivery. In addition to face-to-face training provided by health center midwives for the intervention group training will also be provided through the software.  A group will be created on the WhatsApp social network and all the intervention group members will be joined to this group, and within 10 weeks (28-38 weeks) on even days, two educational messages will be sent in the form of written text or photos or educational videos into the group. The content provided in the educational messages will be similar to the content of face-to-face training. The content of face-to-face training sessions (routine pregnancy care) and educational messages of the software includes:  “training about gestational diabetes and its effects on the mother and the fetus, explanation of self-care methods, nutrition education including foods that a pregnant person should not consume, portion of food and having regular physical activity, benefits of exercise and physical activity during pregnancy, Regular walking, recommended exercises for pregnant women (balanced movements, stretching exercise, Pilates and special classes for pregnancy), how to eat healthily, how to use insulin correctly’. After the completion of the training in two groups (38 weeks of pregnancy), the samples will be asked to perform the fasting blood sugar test and the blood sugar test after two hours of taking 75 grams of glucose and provide the results to the sampling centers.  After reviewing the tests,  As mentioned, the results will be recorded in the blood sugar test registration checklist by the researcher, and then the questionnaires (physical activity, lifestyle and self-care) will be completed again by both groups and the amount of weight changes will be estimated.</i_keyword>
      <i_keyword>Control group:  Routine care of pregnancy</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of self-care. Timepoint: Before and after the intervention. Method of measurement: Diabetes self-care questionnaire.</prim_outcome>
      <prim_outcome>Blood sugar. Timepoint: Before and after the intervention. Method of measurement: blood sugar test 2 hours after consuming 75 grams of glucose and fasting blood sugar test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physical activity. Timepoint: Before and after the intervention. Method of measurement: Physical activity questionnaire.</sec_outcome>
      <sec_outcome>Life style. Timepoint: Before and after the intervention. Method of measurement: Lifestyle questionnaire.</sec_outcome>
      <sec_outcome>Weight changes. Timepoint: Before and after the intervention. Method of measurement: Recording weight changes with a scale.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-03</approval_date>
        <contact_name>Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Golestan Ave,Golestan Blvd,Ahvaz,KHuzestan province,Iran Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
