Preconceptional Period and Transtheoretically Based Education

NCT06765304 — Not applicable, Completed, 108 participants, Ankara Medipol University

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RegistryNCT06765304
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, prevention
Enrollment108 (Actual)
SponsorAnkara Medipol University (Other)
ConditionsPreconceptional Care, Education
InterventionsTranstheoretical education intervention group, Preconceptional Period Healthy Life Behaviours Classical Education Intervention Group, Placebo (Behavioral)
Datesstart 2025-11-17, primary completion 2026-01-12, completion 2026-01-12, first posted 2025-01-09, last updated 2026-01-28
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Preconceptional Care All trials for Education All trials of Transtheoretical education intervention group All trials of Preconceptional Period Healthy Life Behaviours Classical Education Intervention Group

-Summary

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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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Transtheoretically Based Education Model Intervention GroupExperimentalBehavioral: Transtheoretical education intervention group
Preconceptional Period Healthy Life Behaviours Classical Education Intervention GroupExperimentalBehavioral: Preconceptional Period Healthy Life Behaviours Classical Education Intervention Group
Placebo GroupPlacebo comparatorBehavioral: Placebo
  • 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.

+Outcome measures

Primary outcomes

  • Status of Risky Behaviours [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

+Eligibility

Sex: Female, ages: 18 Years to 49 Years, accepts healthy volunteers

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.)

+Locations (1)

FacilityCityCountryStatus
Ankara Medipol UniversityAnkaraTurkey (Türkiye)