xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06002451</url>
    </required_header>
    <id_info>
      <org_study_id>CUMHURIYET UNIVERSITY HASDEMIR</org_study_id>
      <nct_id>NCT06002451</nct_id>
    </id_info>
    <brief_title>Web-based Preconceptional Care and Counseling, Risk Awareness, Healthy Lifestyle Behavior</brief_title>
    <official_title>The Effect of Web-based Preconceptional Care and Counseling on Risk Awareness and Healthy Lifestyle Behavior in Women</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cumhuriyet University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cumhuriyet University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Preconceptional (pre-pregnancy) care; It is a primary care preventive health service that&#xD;
        aims to prepare individuals for pregnancy, to maintain and result in a healthy pregnancy&#xD;
        process, and thus to contribute to the formation of new generations from healthier&#xD;
        individuals. The purpose of preconceptional care; identifying the risk factors present in the&#xD;
        woman is to eliminate or reduce the adverse effects of these risk factors in the pregnancy&#xD;
        process, improve health, improve mother and child health in the short and long term.&#xD;
        Preconception counseling (PC), on the other hand, is to provide training on the best way to&#xD;
        achieve a healthy pregnancy by addressing women's existing health problems and modifiable&#xD;
        risk factors. When performing PC and care, it is necessary to maintain a system based on&#xD;
        evidence and to assess women's holistic and create risk awareness. The creation of risk&#xD;
        awareness in women should begin with the determination of the risk factors present before&#xD;
        pregnancy. It is also very important to identify pre-pregnancy risk factors and to provide&#xD;
        healthy lifestyle behaviors. Today, web-based training is known to be used to adapt&#xD;
        individuals to new situations and to improve the health of individuals, to improve positive&#xD;
        behavior changes.This research was conducted to determine the effect of web-based&#xD;
        preconceptional care and counseling on risk awareness and healthy lifestyle behavior in&#xD;
        women.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Planning fertility with evidence-based management while providing preconceptional care and&#xD;
        counseling; advanced maternal and paternal age; family history, genetic history and diseases;&#xD;
        physical activity, body mass index; nutrition; vaccination; sexually transmitted infections;&#xD;
        chronic diseases; drugs ;harmful habits and exposure; Psychosocial sub-dimensions of women&#xD;
        should be evaluated holistically and risk awareness should be created.As a matter of fact,&#xD;
        creating risk awareness in women should start with the identification of risk factors that&#xD;
        exist before pregnancy. It is possible to gain healthy lifestyle behaviors with the&#xD;
        determination of these risk factors and taking the necessary precautions.Studies have shown&#xD;
        that preconception care and counseling services provide cost-effectiveness while improving&#xD;
        maternal and child health; It is emphasized that health institutions that are inadequate in&#xD;
        providing this service should develop strategies to encourage preconceptional care and&#xD;
        counseling at the community level, especially for women.Recommendations of reputable&#xD;
        organizations such as CDC, ACOG, WHO; It has been concluded that preconceptional care and&#xD;
        counseling services should be expanded more effectively and quickly in line with the results&#xD;
        and recommendations of the researches; It is thought that this widespread effect can be&#xD;
        achieved by using the internet and web-based trainings, which are a part of our lives.It is&#xD;
        reported in the literature that web-based trainings are seen as an appropriate intervention&#xD;
        area in reaching women of childbearing age who need preconceptional care and&#xD;
        counseling.Although there are studies in the world that web-based PC and care services are&#xD;
        provided and that they affect health positively; No studies on web-based PC and maintenance&#xD;
        services have been found in our country.The results obtained from this study; establishing a&#xD;
        comprehensive evidence-based standard PC and maintenance program; improving risk awareness&#xD;
        and healthy lifestyle behaviors of women of childbearing age; It is thought that it will lead&#xD;
        to the encouragement of the use of modern technology areas in the field of PC and care&#xD;
        services, to the development of all health personnel, especially midwives, who want to&#xD;
        provide comprehensive services in this field, to use web-based PC and maintenance program in&#xD;
        field applications, and to contribute to the midwifery literature in the planning of advanced&#xD;
        studies. .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 3, 2021</start_date>
    <completion_date type="Actual">July 9, 2023</completion_date>
    <primary_completion_date type="Actual">May 3, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>risk awareness in women</measure>
      <time_frame>10 week</time_frame>
      <description>The research is an experimentally planned randomized controlled trial. The sample of the study consists of women between the ages of 18-49 who are in the reproductive age. Women's risk awareness was evaluated with the Preconceptional period risk awareness scale, which was developed in line with preconceptional care and counseling. All statements of the scale, which consists of 37 items in total, are positive. The lowest score obtained from the scale is 37, and the highest score is 185. The scale has no breakpoints. The total score of the scale determines the preconceptional period risk awareness score. As the scores obtained from the scale increase, women's preconceptional period risk awareness levels increase. The Cronbach Alpha coefficient of the scale is 0.90 and it has a high degree of reliability.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Healthy lifestyle behaviors of women</measure>
      <time_frame>10 week</time_frame>
      <description>The research is an experimentally planned randomized controlled trial. The sample of the study consists of women between the ages of 18-49 who are in the reproductive age. Health-promoting behaviors of women in relation to a healthy lifestyle were evaluated with the Healthy Lifestyle Behaviors Scale-II. The lowest score for the whole scale is 52, and the highest score is 208. The scale has no breakpoints. The total score of the scale determines the healthy lifestyle behaviors score. The Cronbach Alpha coefficient of the scale is 0.92 and it has a high degree of reliability.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">84</enrollment>
    <condition>Web</condition>
    <arm_group>
      <arm_group_label>WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNG</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>At the beginning of the study, Pre-test Forms were applied and data were obtained.A total of 9 Module Trainings for PC and maintenance were given over the Web Base for 2 weeks. While the trainings were continuing, the modules were monitored from the Admin Panel and reminder messages were sent to the people who did not watch the modules regularly. During the training, PD and care services were provided via the communication. At the end of the 10th week, the post-test forms were applied and the data were obtained. that they can reach 24/7 for a total of 10 weeks, 2 weeks and the following 8 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CONTROL</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Pre-test Forms were applied and data were obtained.No attempt has been made. This group received routine training and follow-ups at the family health center and premarital counseling unit.At the end of the 10th week, the post-test forms were applied and the data were obtained.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNG</intervention_name>
      <description>A web-based preconceptional care and consultancy training platform has been developed. In line with the literature, a comprehensive preconceptional care and counseling training content was prepared for women between the ages of 18-49. Web-based training consists of a total of 9 modules.The videos created for uploading to the website were shot in a professional studio environment with professional equipment.Each video was shot and recorded by dividing the training content according to its subsections, with an average of at least 6 minutes and a maximum of 16 minutes. Each of the module videos is based on giving the main messages in line with the purpose and objectives of the presentation.women were allowed to watch all the videos within 2 weeks. A dialog box is opened on the website where women can communicate with their midwives 24/7. During and after the training, preconceptional care and counseling training was given in this area for a total of 10 weeks.</description>
      <arm_group_label>WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNG</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Literate,&#xD;
  &#xD;
            -  Between the ages of 18-49, who are of childbearing age,&#xD;
  &#xD;
            -  Not pregnant,&#xD;
  &#xD;
            -  Not receiving preconceptional care and consultancy services,&#xD;
  &#xD;
            -  Does not have a disorder based on a psychiatric/psychological diagnosis,&#xD;
  &#xD;
            -  No diagnosis of menopause,&#xD;
  &#xD;
            -  Internet access,&#xD;
  &#xD;
            -  Using at least one computer-tablet-smartphone,&#xD;
  &#xD;
            -  Communicable and language-free&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who do not agree to participate in the research,&#xD;
  &#xD;
            -  under 18 years old and over 49 years old,&#xD;
  &#xD;
            -  pregnant,&#xD;
  &#xD;
            -  Receiving preconceptional care and counseling before,&#xD;
  &#xD;
            -  illiterate,&#xD;
  &#xD;
            -  No internet access,&#xD;
  &#xD;
            -  Not having at least one computer-tablet-smartphone,&#xD;
  &#xD;
            -  Having a disorder based on a psychiatric/psychological diagnosis,&#xD;
  &#xD;
            -  Diagnosed with menopause,&#xD;
  &#xD;
            -  Having communication and language problems.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>It covers women of childbearing age between the ages of 18-49.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>49 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zeliha Burcu YURTSAL, Assoc. Prof.</last_name>
      <role>Study Director</role>
      <affiliation>Sivas Cumhuriyet University, Faculty of Health Sciences, Department of Midwifery, Sivas</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Öznur HASDEMİR, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>PROVINCIAL HEALTH DIRECTORATE, PUBLIC HEALTH SERVICES, SİVAS</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Community health center and family health centers affiliated to Sivas Provincial Health Directorate</name>
        <address>
          <city>Sivas</city>
          <state>Center/ Sivas</state>
          <zip>58000</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cumhuriyet University</investigator_affiliation>
      <investigator_full_name>Öznur HASDEMİR</investigator_full_name>
      <investigator_title>midwife</investigator_title>
    </responsible_party>
    <keyword>Risk Awareness</keyword>
    <keyword>Web-based</keyword>
    <keyword>Preconceptional Care</keyword>
    <keyword>Preconceptional Counselling</keyword>
    <keyword>Innovation</keyword>
    <keyword>Midwifery</keyword>
    <keyword>Training</keyword>
    <keyword>Healthy Lifestyle</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The women were informed about the research subject and purpose, and their written and verbal informed consent was obtained. The study was conducted in accordance with the Principles of the Declaration of Helsinki.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06002451
  org study id: CUMHURIYET UNIVERSITY HASDEMIR
  nct id: NCT06002451
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Preconceptional (pre-pregnancy) care; It is a primary care preventive health service that
        aims to prepare individuals for pregnancy, to maintain and result in a healthy pregnancy
        process, and thus to contribute to the formation of new generations from healthier
        individuals. The purpose of preconceptional care; identifying the risk factors present in the
        woman is to eliminate or reduce the adverse effects of these risk factors in the pregnancy
        process, improve health, improve mother and child health in the short and long term.
        Preconception counseling (PC), on the other hand, is to provide training on the best way to
        achieve a healthy pregnancy by addressing women's existing health problems and modifiable
        risk factors. When performing PC and care, it is necessary to maintain a system based on
        evidence and to assess women's holistic and create risk awareness. The creation of risk
        awareness in women should begin with the determination of the risk factors present before
        pregnancy. It is also very important to identify pre-pregnancy risk factors and to provide
        healthy lifestyle behaviors. Today, web-based training is known to be used to adapt
        individuals to new situations and to improve the health of individuals, to improve positive
        behavior changes.This research was conducted to determine the effect of web-based
        preconceptional care and counseling on risk awareness and healthy lifestyle behavior in
        women.
  Planning fertility with evidence-based management while providing preconceptional care and
        counseling; advanced maternal and paternal age; family history, genetic history and diseases;
        physical activity, body mass index; nutrition; vaccination; sexually transmitted infections;
        chronic diseases; drugs ;harmful habits and exposure; Psychosocial sub-dimensions of women
        should be evaluated holistically and risk awareness should be created.As a matter of fact,
        creating risk awareness in women should start with the identification of risk factors that
        exist before pregnancy. It is possible to gain healthy lifestyle behaviors with the
        determination of these risk factors and taking the necessary precautions.Studies have shown
        that preconception care and counseling services provide cost-effectiveness while improving
        maternal and child health; It is emphasized that health institutions that are inadequate in
        providing this service should develop strategies to encourage preconceptional care and
        counseling at the community level, especially for women.Recommendations of reputable
        organizations such as CDC, ACOG, WHO; It has been concluded that preconceptional care and
        counseling services should be expanded more effectively and quickly in line with the results
        and recommendations of the researches; It is thought that this widespread effect can be
        achieved by using the internet and web-based trainings, which are a part of our lives.It is
        reported in the literature that web-based trainings are seen as an appropriate intervention
        area in reaching women of childbearing age who need preconceptional care and
        counseling.Although there are studies in the world that web-based PC and care services are
        provided and that they affect health positively; No studies on web-based PC and maintenance
        services have been found in our country.The results obtained from this study; establishing a
        comprehensive evidence-based standard PC and maintenance program; improving risk awareness
        and healthy lifestyle behaviors of women of childbearing age; It is thought that it will lead
        to the encouragement of the use of modern technology areas in the field of PC and care
        services, to the development of all health personnel, especially midwives, who want to
        provide comprehensive services in this field, to use web-based PC and maintenance program in
        field applications, and to contribute to the midwifery literature in the planning of advanced
        studies. .
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: risk awareness in women
  time frame: 10 week
  description: The research is an experimentally planned randomized controlled trial. The sample of the study consists of women between the ages of 18-49 who are in the reproductive age. Women's risk awareness was evaluated with the Preconceptional period risk awareness scale, which was developed in line with preconceptional care and counseling. All statements of the scale, which consists of 37 items in total, are positive. The lowest score obtained from the scale is 37, and the highest score is 185. The scale has no breakpoints. The total score of the scale determines the preconceptional period risk awareness score. As the scores obtained from the scale increase, women's preconceptional period risk awareness levels increase. The Cronbach Alpha coefficient of the scale is 0.90 and it has a high degree of reliability.
  measure: Healthy lifestyle behaviors of women
  time frame: 10 week
  description: The research is an experimentally planned randomized controlled trial. The sample of the study consists of women between the ages of 18-49 who are in the reproductive age. Health-promoting behaviors of women in relation to a healthy lifestyle were evaluated with the Healthy Lifestyle Behaviors Scale-II. The lowest score for the whole scale is 52, and the highest score is 208. The scale has no breakpoints. The total score of the scale determines the healthy lifestyle behaviors score. The Cronbach Alpha coefficient of the scale is 0.92 and it has a high degree of reliability.
  arm group label: WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNG
  arm group type: Experimental
  description: At the beginning of the study, Pre-test Forms were applied and data were obtained.A total of 9 Module Trainings for PC and maintenance were given over the Web Base for 2 weeks. While the trainings were continuing, the modules were monitored from the Admin Panel and reminder messages were sent to the people who did not watch the modules regularly. During the training, PD and care services were provided via the communication. At the end of the 10th week, the post-test forms were applied and the data were obtained. that they can reach 24/7 for a total of 10 weeks, 2 weeks and the following 8 weeks.
  arm group label: CONTROL
  arm group type: No Intervention
  description: Pre-test Forms were applied and data were obtained.No attempt has been made. This group received routine training and follow-ups at the family health center and premarital counseling unit.At the end of the 10th week, the post-test forms were applied and the data were obtained.
  intervention type: Behavioral
  intervention name: WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNG
  description: A web-based preconceptional care and consultancy training platform has been developed. In line with the literature, a comprehensive preconceptional care and counseling training content was prepared for women between the ages of 18-49. Web-based training consists of a total of 9 modules.The videos created for uploading to the website were shot in a professional studio environment with professional equipment.Each video was shot and recorded by dividing the training content according to its subsections, with an average of at least 6 minutes and a maximum of 16 minutes. Each of the module videos is based on giving the main messages in line with the purpose and objectives of the presentation.women were allowed to watch all the videos within 2 weeks. A dialog box is opened on the website where women can communicate with their midwives 24/7. During and after the training, preconceptional care and counseling training was given in this area for a total of 10 weeks.
  arm group label: WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNG
  criteria: 
  gender: Female
  gender based: Yes
  gender description: It covers women of childbearing age between the ages of 18-49.
  minimum age: 18 Years
  maximum age: 49 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Zeliha Burcu YURTSAL, Assoc. Prof.
  role: Study Director
  affiliation: Sivas Cumhuriyet University, Faculty of Health Sciences, Department of Midwifery, Sivas
  last name: Öznur HASDEMİR, PhD
  role: Principal Investigator
  affiliation: PROVINCIAL HEALTH DIRECTORATE, PUBLIC HEALTH SERVICES, SİVAS
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Cumhuriyet University
  investigator full name: Öznur HASDEMİR
  investigator title: midwife
  sharing ipd: No
  ipd description: The women were informed about the research subject and purpose, and their written and verbal informed consent was obtained. The study was conducted in accordance with the Principles of the Declaration of Helsinki.