Web-based Preconceptional Care and Counseling, Risk Awareness, Healthy Lifestyle Behavior

August 19, 2023 updated by: Öznur HASDEMİR, Cumhuriyet University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Center/ Sivas
      • Sivas, Center/ Sivas, Turkey, 58000
        • Community health center and family health centers affiliated to Sivas Provincial Health Directorate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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,
  • Internet access,
  • Using at least one computer-tablet-smartphone,
  • Communicable and language-free

Exclusion Criteria:

  • 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,
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNG
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.
Behavioral: WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNG
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.
No Intervention: CONTROL
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
10 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Healthy lifestyle behaviors of 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. 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.
10 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cumhuriyet University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Zeliha Burcu YURTSAL, Assoc. Prof., Sivas Cumhuriyet University, Faculty of Health Sciences, Department of Midwifery, Sivas
  • Principal Investigator: Öznur HASDEMİR, PhD, PROVINCIAL HEALTH DIRECTORATE, PUBLIC HEALTH SERVICES, SİVAS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 9, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CUMHURIYET UNIVERSITY HASDEMIR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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