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Completed

NCT Number: NCT06765304

Preconceptional Period and Transtheoretically Based Education

This study aims to evaluate the effectiveness of transtheoretical model (TTM)-based training provided to women with risky lifestyle behaviors during the preconceptional period. The preconceptional period is a critical time for women to modify health behaviors, as addressing these risks early can prevent adverse obstetric outcomes. TTM conceptualizes behavior change as a process and identifies distinct stages individuals progress through during this process. The study examines the impact of TTM-based interventions on improving unhealthy lifestyle behaviors in women before pregnancy.

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Key information

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Medipol University

Ankara, Turkey (Türkiye)

About this study

The preconceptional period is defined as 3 months before pregnancy or at least 1-2 years before the start of unprotected sexual intercourse. Many women enter the pregnancy period with risky living conditions and behaviours including pre-existing physical and behavioural health problems, exposure to teratogenic drugs or adverse environmental conditions, genetic disorders, substance use, unhealthy diet, obesity and domestic violence. It is not possible to correct these risky behaviours which cause many adverse obstetric outcomes in the early periods when pregnancy is not yet noticed. Therefore, many modifiable risky behaviours that may adversely affect outcomes during pregnancy and are difficult to change in the short term should be addressed in the pre-pregnancy period. It is recommended that educational interventions for changing behaviour should be model-based. In this way, it is easier to determine the main factors affecting behaviour, the relationships between these factors and the elements that need to be focused on more. One of the prominent theories that can be taken as a basis for behaviour modification training is the transtheoretical model. The transtheoretical model assumes that individuals go through some stages in the process of changing their health behaviours and maintaining these changes. According to this model, behaviour change is considered as a process rather than a result. One of the prominent theories that can be taken as a basis for behaviour change training is the transtheoretical model. The transtheoretical model assumes that individuals go through some stages in the process of changing their health behaviours and maintaining these changes. According to this model, behaviour change is considered as a process rather than an outcome. This model, developed by Prochaska and DiClemente (1982), basically divides the stage at which the individual is in the change of unhealthy behaviour into five stages temporally. According to this model, people change from people who have no intention to change in adopting new behaviours (pre-planning) to people who think-design to change (planning), to activists who adopt the behaviour but have not yet changed the behaviour regularly (preparation), and to maintainers who have changed the behaviour (action) and continue this behaviour regularly (maintenance). The aim of this study was to determine the effectiveness of transtheoretical model-based training given to women with risky life behaviours in the preconceptional period.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Volunteering to participate in the research

  • Being between the ages of 18-49 and not going through menopause
  • Not having problems in speaking and understanding Turkish
  • To be able to read and write
  • Being sexually active
  • Thinking about becoming pregnant in the next 2 years
  • Having the risk score determined from the 'Preconceptional Risky Life Behaviours in Women Diagnostic Scale' to be developed by the researchers

Exclusion criteria

  • Psychiatric illness
  • Having chronic diseases (diabetes, hypertension, hypothyroidism, etc.)

Treatment and study plan

Transtheoretical education intervention group

Behavioral

The training sessions will be held over four weeks in eight consecutive sessions (two sessions per week). Each session will last 60 minutes. The content of each training module will be designed under the following headings: Week 1 - Planning, Week 2 - Preparation, Week 3 - Action, Week 4 - Sustainability.

Preconceptional Period Healthy Life Behaviours Classical Education Intervention Group

Behavioral

Participants will be provided with eight educational modules designed for the preconception period. Training sessions will be conducted twice weekly for 60 minutes over a four-week period.

Placebo

Behavioral

No procedures will be performed on participants.

Primary outcomes

  1. Status of Risky Behaviours

    Time frame: Measurements will be made before starting the study and 1 month after the end of the training intervention.As the score obtained from the scale increases, it will be determined that the woman has risky life behaviours in the preconceptional period.

    Preconceptional Risky Life Behaviours in Women will be measured using the Diagnostic Scale

Sponsors and collaborators

Lead sponsor

Ankara Medipol University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2025
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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