Health PromotionNCT06044545
Effect Web Based Pregnancy Preparation Education According to Health Promotion Model in Preconceptional Period on Women
A study testing Web Based Pregnancy Preparation Education Structured According to the Health Promotion Model Knowledge Attitude and Health Behaviors in people with Health Promotion, run by Erzincan Binali Yildirim Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Preconceptional care is a very important preventive health service that gives couples the opportunity to prepare for a healthy pregnancy in a physically and psychologically healthy way, aims to identify and minimize the risks that may be present to the mother and fetus. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Health Promotion
- What is being tested?
- Web Based Pregnancy Preparation Education Structured According to the Health Promotion Model Knowledge Attitude and Health Behaviors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2023to 1 Mar 2024
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Being 18 years or older
- Being literate in Turkish
- Never been pregnant
- Pregnancy in the last year plan
- Being able to use a computer
- Computer or mobile phone at home have a phone and internet connection
Who cannot join
- Questionnaire and/or scales incomplete answer
- Withdrawing from research
- Being pregnant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzincan Binali Yıldırım University
Erzincan, 24002
Ebru BOZCU
About this study
Official title: The Effect of Web Based Pregnancy Preparation Education Structured According to the Health Promotion Model in the Preconceptional Period on Women's Knowledge Attitude and Health Behaviors
Preconceptional care is a very important preventive health service that gives couples the opportunity to prepare for a healthy pregnancy in a physically and psychologically healthy way, aims to identify and minimize the risks that may be present to the mother and fetus. Although preconceptional care is recommended for all couples of reproductive age, it is not at the desired level both in the world and in our country. In the literature, it is seen that the existing knowledge of individuals is insufficient, care is not provided for this period, and research revealing the knowledge and attitudes of individuals is very insufficient. It is thought that if the individuals in the society are informed about this issue and awareness is raised, the rate of benefiting from preconceptional care and counseling services will increase.
One of the important components of preconceptional counseling is health education. Health education aims to increase the knowledge of individuals, to create awareness and thus to gain positive health behavior. The Health Promotion Model enables individuals to make behavioral changes to create a healthy lifestyle. Based on this, this research has been planned in order to determine the effect of web-based pregnancy preparation education structured according to the health improvement model in the preconceptional period on women's knowledge, attitudes and health behaviors.
Read the detailed description
One of the global health goals is to improve maternal health and reduce child mortality. In order to reduce maternal and newborn diseases and deaths, it is necessary to focus on preconceptional health. Preconceptional care aims to prepare individuals for pregnancy, to maintain and result in a healthy pregnancy, and to ensure that future generations are composed of healthier individuals. It is important to provide the necessary education, care and counseling to women in the preconception period in achieving these goals. The World Health Organization states that initiatives taken after pregnancy occur are quite late in reducing the risks to the mother and newborn. For this reason, it is necessary to take the necessary steps during the preconceptional period in order to create the highest level of impact on health outcomes.
When evaluated in general, nowadays; preconceptional care services and the rate of benefiting from these services are low all over the world, including many developed countries. For this reason, an important part of women today she still continues to conceive with preventable risks. It is stated in the literature that the proportion of those who have heard about the concept of preconceptional care and counseling is low; knowledge and positive behaviors related to preconceptional care are insufficient. In the literature, it has been determined that especially young, illiterate women or women living in poor areas do not have adequate access to pre-pregnancy, pregnancy and birth services. From this point of view, it is necessary to ensure the awareness of society about the preconceptional period and to conduct studies on the subject. It is thought that if the individuals in the society are informed about this issue and awareness is raised, the rate of benefiting from preconceptional care and counseling services will increase.
Education is an important component of preconceptional counseling. Health education is a combination of learning experiences designed to increase individuals' knowledge, create positive attitudes and improve their health. The main purpose of education is to first create awareness (positive attitude) by providing information and to develop correct behavior or change wrong behavior. The Health Promotion Model, on the other hand, provides individuals to make behavioral changes to create a healthy lifestyle. This research has been planned in order to determine the effect of web-based pregnancy preparation education structured according to the health improvement model in the preconceptional period on women's knowledge, attitudes and health behaviors.
Material and Method: This study is a randomized controlled trial. The research is planned to be conducted with women who applied for marriage to the Marriage Officer of Erzurum Metropolitan Municipality Social Services Department between February 2023 and February 2025. The sample number of the study was calculated using the G*Power 3.1.9.7 program. In the calculation, a sample calculation was performed for the t-test in independent groups (The Independent Samples T-Test) by taking into account the research design with 2 groups (Experimental Group, Control Group) and 2 measurements (pre-test - post-test). In the calculation made, the effect size was calculated as 0.80 (d = 0.80), 5% margin of error (α = 0.05) and 95% power (1-β = 0.95) and the number of samples for each group was calculated as 35. Considering the possibility of data loss, the number of samples in each group was increased by approximately 20% and determined as 42 people. In total, 84 women who applied for marriage were included in the sample.
In the collection of research data the introductory features form created by the researcher, "Preconceptional Knowledge and Attitudes Scale", "Preconception Health Behaviours Scale" will be used. In the evaluation of the data, SPSS package program will be used. Statistical significance level p<0.05 will be accepted as.
- Conditions
- Health Promotion
- Being tested
- Web Based Pregnancy Preparation Education Structured According to the Health Promotion Model Knowledge Attitude and Health Behaviors
- Keywords
- Preconceptional Period Health Promotion Pregnancy Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web Based Pregnancy Preparation Education Structured According to the Health Promotion Model Knowledge Attitude and Health BehaviorsDiagnostic test
With this research, according to the "health promotion model" for the care that should be taken during the preconceptional period (pre-pregnancy) of women who are not yet pregnant, who will marry soon and who are considering pregnancy.
It is thought that they will gain knowledge, increase their awareness and develop positive health behaviors with the "web-based pregnancy preparation training". In data collection; "Introductory Characteristics Form", "Preconceptional Knowledge and Attitudes Scale", "Preconception Health Behaviours Scale" will be used.
| Study group | Role | What they receive |
|---|---|---|
| Web Based Pregnancy Preparation Education Group | Experimental | Web Based Pregnancy Preparation Education Structured According to the Health Promotion Model Knowledge Attitude and Health Behaviors Receives: Diagnostic Test: Web Based Pregnancy Preparation Education Structured According to the Health Promotion Model Knowledge Attitude and Health Behaviors |
| Control Group | No intervention | No action will be taken. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Test Data Collection
The pre-test data of the research will be collected by the researcher between September 2023 and October 2023, in line with the voluntariness of the women who applied to the Marriage Registry Office of the Erzurum Metropolitan Municipality Social Services Department for marriage. In collecting data, people in the experimental and control groups; "Introductory Features Form", "Preconceptional Knowledge and Attitudes Scale", "Preconception Health Behaviours Scale" will be applied.
The lowest score that can be obtained from the "Preconceptional Knowledge and Attitudes Scale" is 43 and the highest score is 215. As the score obtained from the scale increases, the individual's preconceptional knowledge and attitudes also increase positively.
The highest score to be obtained from the "Preconception Health Behaviours Scale" is 36 and the lowest score is 0. The high scores obtained from the scale indicate that women's preconceptional period health behaviors are in a positive direction.
Measured: Time frame: One or two months
Collection of Post-Test Data
The women in the experimental group will be trained according to the health promotion model every week for 8 weeks. The education guide will be prepared by the researcher in line with the literature.The education content will be uploaded to the website and explained by the researcher. After the training is completed, interim test data will be collected in the experimental and control groups. After the training is completed, there will be an 8-week follow-up period and reminders will be given to the women in the experimental group.
The post-test data of the research is planned to be collected between January 2024 and February 2024. In collecting data, people in the experimental and control groups; "Introductory Features Form", "Preconceptional Knowledge and Attitudes Scale", "Preconception Health Behaviours Scale" will be applied.
Measured: Time frame: Four or five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start20 Sep 2023 (estimated)
- Primary completion20 Oct 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health PromotionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 84 people, 42 in the experimental group and 42 in the control group, will be included in the study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan Binali Yildirim Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Principal investigator, Ebru BOZCU, Erzincan Binali Yildirim Universitesi
- Investigators
- Ebru BOZCU, Doctorate, Principal investigator, Erzincan Binali Yildirim Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044545
- Sponsor's protocol ID
- Ebru1
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web Based Pregnancy Preparation Education Structured According to the Health Promotion Model in the Preconceptional Period on Women's Knowledge Attitude and Health Behaviors
- ClinicalTrials.gov ID
- NCT06044545
- Acronym / sponsor ID
- Ebru1
- Conditions
- Health Promotion
- Keywords
- Preconceptional Period Health Promotion Pregnancy Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Erzincan Binali Yildirim UniversitesiUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 20 Sep 2023 (estimated)
- Primary completion
- 20 Oct 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 21 Sep 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 care is a very important preventive health service that gives couples the opportunity to prepare for a healthy pregnancy in a physically and psychologically healthy way, aims to identify and minimize the risks that may be present to the mother and fetus. Although preconceptional care is recommended for all couples of reproductive age, it is not at the desired level both in the world and in our country. In the literature, it is seen that the existing knowledge of individuals is insufficient, care is not provided for this period, and research revealing the knowledge and attitudes of individuals is very insufficient. It is thought that if the individuals in the society are informed about this issue and awareness is raised, the rate of benefiting from preconceptional care and counseling services will increase.
One of the important components of preconceptional counseling is health education. Health education aims to increase the knowledge of individuals, to create awareness and thus to gain positive health behavior. The Health Promotion Model enables individuals to make behavioral changes to create a healthy lifestyle. Based on this, this research has been planned in order to determine the effect of web-based pregnancy preparation education structured according to the health improvement model in the preconceptional period on women's knowledge, attitudes and health behaviors.
Detailed description
One of the global health goals is to improve maternal health and reduce child mortality. In order to reduce maternal and newborn diseases and deaths, it is necessary to focus on preconceptional health. Preconceptional care aims to prepare individuals for pregnancy, to maintain and result in a healthy pregnancy, and to ensure that future generations are composed of healthier individuals. It is important to provide the necessary education, care and counseling to women in the preconception period in achieving these goals. The World Health Organization states that initiatives taken after pregnancy occur are quite late in reducing the risks to the mother and newborn. For this reason, it is necessary to take the necessary steps during the preconceptional period in order to create the highest level of impact on health outcomes.
When evaluated in general, nowadays; preconceptional care services and the rate of benefiting from these services are low all over the world, including many developed countries. For this reason, an important part of women today she still continues to conceive with preventable risks. It is stated in the literature that the proportion of those who have heard about the concept of preconceptional care and counseling is low; knowledge and positive behaviors related to preconceptional care are insufficient. In the literature, it has been determined that especially young, illiterate women or women living in poor areas do not have adequate access to pre-pregnancy, pregnancy and birth services. From this point of view, it is necessary to ensure the awareness of society about the preconceptional period and to conduct studies on the subject. It is thought that if the individuals in the society are informed about this issue and awareness is raised, the rate of benefiting from preconceptional care and counseling services will increase.
Education is an important component of preconceptional counseling. Health education is a combination of learning experiences designed to increase individuals' knowledge, create positive attitudes and improve their health. The main purpose of education is to first create awareness (positive attitude) by providing information and to develop correct behavior or change wrong behavior. The Health Promotion Model, on the other hand, provides individuals to make behavioral changes to create a healthy lifestyle. This research has been planned in order to determine the effect of web-based pregnancy preparation education structured according to the health improvement model in the preconceptional period on women's knowledge, attitudes and health behaviors.
Material and Method: This study is a randomized controlled trial. The research is planned to be conducted with women who applied for marriage to the Marriage Officer of Erzurum Metropolitan Municipality Social Services Department between February 2023 and February 2025. The sample number of the study was calculated using the G*Power 3.1.9.7 program. In the calculation, a sample calculation was performed for the t-test in independent groups (The Independent Samples T-Test) by taking into account the research design with 2 groups (Experimental Group, Control Group) and 2 measurements (pre-test - post-test). In the calculation made, the effect size was calculated as 0.80 (d = 0.80), 5% margin of error (α = 0.05) and 95% power (1-β = 0.95) and the number of samples for each group was calculated as 35. Considering the possibility of data loss, the number of samples in each group was increased by approximately 20% and determined as 42 people. In total, 84 women who applied for marriage were included in the sample.
In the collection of research data the introductory features form created by the researcher, "Preconceptional Knowledge and Attitudes Scale", "Preconception Health Behaviours Scale" will be used. In the evaluation of the data, SPSS package program will be used. Statistical significance level p<0.05 will be accepted as.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 84 people, 42 in the experimental group and 42 in the control group, will be included in the study.
| Arm | Type | Receives |
|---|---|---|
| Web Based Pregnancy Preparation Education Group | Experimental | Diagnostic Test: Web Based Pregnancy Preparation Education Structured According to the Health Promotion Model Knowledge Attitude and Health BehaviorsWeb Based Pregnancy Preparation Education Structured According to the Health Promotion Model Knowledge Attitude and Health Behaviors |
| Control Group | No intervention | –No action will be taken. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being 18 years or older
- Being literate in Turkish
- Never been pregnant
- Pregnancy in the last year plan
- Being able to use a computer
Key exclusion criteria (3 listed)
- Questionnaire and/or scales incomplete answer
- Withdrawing from research
- Being pregnant
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 Pregnancy Preparation Education Structured According to the Health Promotion Model Knowledge Attitude and Health BehaviorsWith this research, according to the "health promotion model" for the care that should be taken during the preconceptional period (pre-pregnancy) of women who are not yet pregnant, who will marry soon and who are considering pregnancy. It is thought that they will gain knowledge, increase their awareness and develop positive health behaviors with the "web-based pregnancy preparation training". In data collection; "Introductory Characteristics Form", "Preconceptional Knowledge and Attitudes Scale", "Preconception Health Behaviours Scale" will be used. | Diagnostic test | Web Based Pregnancy Preparation Education Group |
Primary outcome
Pre-Test Data Collection
Time frame: Time frame: One or two months
The pre-test data of the research will be collected by the researcher between September 2023 and October 2023, in line with the voluntariness of the women who applied to the Marriage Registry Office of the Erzurum Metropolitan Municipality Social Services Department for marriage. In collecting data, people in the experimental and control groups; "Introductory Features Form", "Preconceptional Knowledge and Attitudes Scale", "Preconception Health Behaviours Scale" will be applied. The lowest score that can be obtained from the "Preconceptional Knowledge and Attitudes Scale" is 43 and the highest score is 215. As the score obtained from the scale increases, the individual's preconceptional knowledge and attitudes also increase positively. The highest score to be obtained from the "Preconception Health Behaviours Scale" is 36 and the lowest score is 0. The high scores obtained from the scale indicate that women's preconceptional period health behaviors are in a positive direction.
Collection of Post-Test Data
Time frame: Time frame: Four or five months
The women in the experimental group will be trained according to the health promotion model every week for 8 weeks. The education guide will be prepared by the researcher in line with the literature.The education content will be uploaded to the website and explained by the researcher. After the training is completed, interim test data will be collected in the experimental and control groups. After the training is completed, there will be an 8-week follow-up period and reminders will be given to the women in the experimental group. The post-test data of the research is planned to be collected between January 2024 and February 2024. In collecting data, people in the experimental and control groups; "Introductory Features Form", "Preconceptional Knowledge and Attitudes Scale", "Preconception Health Behaviours Scale" will be applied.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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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.
Ebru BOZCU, Doctorate principal investigator
Erzincan Binali Yildirim Universitesi
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 Pregnancy Preparation Education Structured According to the Health Promotion Model Knowledge Attitude and Health Behaviors in people with Health Promotion, run by Erzincan Binali Yildirim Universitesi 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebru BOZCU, Doktora (05345927358, ebozcu2500@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-Test Data Collection (time frame: Time frame: One or two months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2023.