Preconceptional CareNCT06765304
Preconceptional Period and Transtheoretically Based Education
A study testing Transtheoretical education intervention group and Preconceptional Period Healthy Life Behaviours Classical Education Intervention Group in people with Preconceptional Care and Education, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preconceptional Care, Education
- What is being tested?
- Transtheoretical education intervention group and Preconceptional Period Healthy Life Behaviours Classical Education Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Nov 2025to 12 Jan 2026
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Psychiatric illness
- Having chronic diseases (diabetes, hypertension, hypothyroidism, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Preconceptional Care, Education
- Being tested
- Transtheoretical education intervention group, Preconceptional Period Healthy Life Behaviours Classical Education Intervention Group, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transtheoretical education intervention groupBehavioural
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 GroupBehavioural
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.
PlaceboBehavioural
No procedures will be performed on participants.
| Study group | Role | What they receive |
|---|---|---|
| Transtheoretically Based Education Model Intervention Group | Experimental | Not described Receives: Behavioral: Transtheoretical education intervention group |
| Preconceptional Period Healthy Life Behaviours Classical Education Intervention Group | Experimental | Not described Receives: Behavioral: Preconceptional Period Healthy Life Behaviours Classical Education Intervention Group |
| Placebo Group | Placebo comparator | Not described Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Status of Risky Behaviours
Preconceptional Risky Life Behaviours in Women will be measured using the Diagnostic Scale
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start17 Nov 2025
- Primary completion12 Jan 2026
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preconceptional CareStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şerife İrem DÖNER, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765304
- Sponsor's protocol ID
- DönerKarahan24
- Status last verified
- Nov 2025
- First submitted
- 20 Dec 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preconceptional Period and Transtheoretically Based Education
- ClinicalTrials.gov ID
- NCT06765304
- Acronym / sponsor ID
- DönerKarahan24
- Conditions
- Preconceptional Care, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 9 Jan 2025 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transtheoretically Based Education Model Intervention Group | Experimental | Behavioral: Transtheoretical education intervention group |
| Preconceptional Period Healthy Life Behaviours Classical Education Intervention Group | Experimental | Behavioral: Preconceptional Period Healthy Life Behaviours Classical Education Intervention Group |
| Placebo Group | Placebo comparator | Behavioral: Placebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Psychiatric illness
- Having chronic diseases (diabetes, hypertension, hypothyroidism, etc.)
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 |
|---|---|---|
| Transtheoretical education intervention groupThe 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. | Behavioural | Transtheoretically Based Education Model Intervention Group |
| Preconceptional Period Healthy Life Behaviours Classical Education Intervention GroupParticipants 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. | Behavioural | Preconceptional Period Healthy Life Behaviours Classical Education Intervention Group |
| PlaceboNo procedures will be performed on participants. | Behavioural | Placebo Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Preconceptional Care
Not yet recruiting
The Impact of a Mobile Application-based Support and Counseling Program on Women's Knowledge, Attitudes and Self-efficacy in the Preconceptional Period
Preconception Period
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transtheoretical education intervention group and Preconceptional Period Healthy Life Behaviours Classical Education Intervention Group in people with Preconceptional Care and Education, run by Ankara Medipol University 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 7 inclusion and 2 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: finished, as of the sponsor's last update on 28 Jan 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 28 Jan 2026.