Preconceptional Period and Transtheoretically Based Education

NCT06765304 | Completed

• 1 other identifier: DönerKarahan24
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preconceptional Care; Education

Outcome Measures

Primary Outcomes (1)

• Status of Risky Behaviours

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

  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.

Study Arms (3)

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

Interventions

Placebo BEHAVIORAL

No procedures will be performed on participants.

Placebo Group

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.

Preconceptional Period Healthy Life Behaviours Classical Education Intervention Group

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.

Transtheoretically Based Education Model Intervention Group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara Medipol University: lead

Study Sites (1)

Ankara Medipol University

Ankara, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 9, 2025
• Study Start: November 17, 2025
• Primary Completion: January 12, 2026
• Study Completion: January 12, 2026
• Last Updated: January 28, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)