NCT06002451

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2021

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

Same day

First QC Date

August 13, 2023

Last Update Submit

August 19, 2023

Conditions

Keywords

Risk AwarenessWeb-basedPreconceptional CarePreconceptional CounsellingInnovationMidwiferyTrainingHealthy Lifestyle

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 week

Secondary Outcomes (1)

  • Healthy lifestyle behaviors of women

    10 week

Study Arms (2)

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.

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.

Interventions

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.

WEB-BASED PRECONCEPTİONAL CARE AND COUNSELİNG

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIt covers women of childbearing age between the ages of 18-49.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community health center and family health centers affiliated to Sivas Provincial Health Directorate

Sivas, Center/ Sivas, 58000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Zeliha Burcu YURTSAL, Assoc. Prof.

    Sivas Cumhuriyet University, Faculty of Health Sciences, Department of Midwifery, Sivas

    STUDY DIRECTOR
  • Öznur HASDEMİR, PhD

    PROVINCIAL HEALTH DIRECTORATE, PUBLIC HEALTH SERVICES, SİVAS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
midwife

Study Record Dates

First Submitted

August 13, 2023

First Posted

August 21, 2023

Study Start

May 3, 2021

Primary Completion

May 3, 2021

Study Completion

July 9, 2023

Last Updated

August 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

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.

Locations