WebNCT06002451
Web-based Preconceptional Care and Counseling, Risk Awareness, Healthy Lifestyle Behavior
A study testing WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNG in people with Web, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Web
- What is being tested?
- WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 May 2021to 9 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Literate,
- Between the ages of 18-49, who are of childbearing age,
- Not pregnant,
- Not receiving preconceptional care and consultancy services,
- Does not have a disorder based on a psychiatric/psychological diagnosis,
- No diagnosis of menopause,
Show all 9Show fewer
- Internet access,
- Using at least one computer-tablet-smartphone,
- Communicable and language-free
Who cannot join
- Those who do not agree to participate in the research,
- under 18 years old and over 49 years old,
- pregnant,
- Receiving preconceptional care and counseling before,
- illiterate,
- No internet access,
Show all 10Show fewer
- Not having at least one computer-tablet-smartphone,
- Having a disorder based on a psychiatric/psychological diagnosis,
- Diagnosed with menopause,
- Having communication and language problems.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Community health center and family health centers affiliated to Sivas Provincial Health Directorate
Sivas, Center/ Sivas, 58000
About this study
Official title: The Effect of Web-based Preconceptional Care and Counseling on Risk Awareness and Healthy Lifestyle Behavior in Women
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.
Read the detailed description
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. .
- Conditions
- Web
- Being tested
- WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNG
- Keywords
- Risk Awareness, Web-based, Preconceptional Care, Preconceptional Counselling, Innovation, Midwifery, Training, Healthy Lifestyle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNGBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNG | Experimental | 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. Receives: Behavioral: WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNG |
| CONTROL | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
risk awareness in women
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.
Measured: 10 week
Secondary outcomes (1)
Healthy lifestyle behaviors of women
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.
Measured: 10 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start3 May 2021
- Primary completion3 May 2021
- Study completion9 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WebStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Öznur HASDEMİR, Cumhuriyet University
- Investigators
- Zeliha Burcu YURTSAL, Assoc. Prof., Study director, Sivas Cumhuriyet University, Faculty of Health Sciences, Department of Midwifery, SivasÖznur HASDEMİR, PhD, Principal investigator, PROVINCIAL HEALTH DIRECTORATE, PUBLIC HEALTH SERVICES, SİVAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002451
- Sponsor's protocol ID
- CUMHURIYET UNIVERSITY HASDEMIR
- Status last verified
- Aug 2023
- First submitted
- 13 Aug 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Hasdemir O, Yurtsal ZB. Effect of web-based preconception care and counseling on women's awareness of risk, and healthy lifestyle behaviors: an open-label randomized controlled trial. BMC Womens Health. 2026 Mar 16;26(1):216. doi: 10.1186/s12905-026-04375-5.
PubMed 41840613
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web-based Preconceptional Care and Counseling on Risk Awareness and Healthy Lifestyle Behavior in Women
- ClinicalTrials.gov ID
- NCT06002451
- Acronym / sponsor ID
- CUMHURIYET UNIVERSITY HASDEMIR
- Conditions
- Web
- Keywords
- Risk Awareness, Web-based, Preconceptional Care, Preconceptional Counselling, Innovation, Midwifery, Training, Healthy Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 9 Jul 2023 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNG | Experimental | Behavioral: WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNGAt 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. |
| CONTROL | No intervention | –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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Literate,
- Between the ages of 18-49, who are of childbearing age,
- Not pregnant,
- Not receiving preconceptional care and consultancy services,
- Does not have a disorder based on a psychiatric/psychological diagnosis,
Key exclusion criteria (10 listed)
- Those who do not agree to participate in the research,
- under 18 years old and over 49 years old,
- pregnant,
- Receiving preconceptional care and counseling before,
- illiterate,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNGA 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. | Behavioural | WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNG |
Primary outcome
risk awareness in women
Time frame: 10 week
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.
1 secondary outcome
Healthy lifestyle behaviors of women
Time frame: 10 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Derived from this study: PubMed 41840613Hasdemir O, Yurtsal ZB. Effect of web-based preconception care and counseling on women's awareness of risk, and healthy lifestyle behaviors: an open-label randomized controlled trial. BMC Womens Health. 2026 Mar 16;26(1):216. doi: 10.1186/s12905-026-04375-5.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeliha Burcu YURTSAL, Assoc. Prof. study director
Sivas Cumhuriyet University, Faculty of Health Sciences, Department of Midwifery, Sivas
Öznur HASDEMİR, PhD principal investigator
PROVINCIAL HEALTH DIRECTORATE, PUBLIC HEALTH SERVICES, SİVAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNG in people with Web, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
risk awareness in women (time frame: 10 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06002451, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.