The Impact of a Mobile Application-based Support and Counseling Program on Women's Knowledge, Attitudes and Self-efficacy in the Preconceptional Period

This randomized controlled trial aims to evaluate the effect of a mobile application-based support and counseling program on women in the preconception period. The study includes women aged 18 to 49 who plan to conceive within two years and meet the eligibility criteria. Participants are randomly assigned to an intervention group receiving structured preconception counseling through a mobile application or a control group receiving standard information via a booklet. The intervention consists of weekly educational modules delivered over four weeks, followed by follow-up assessments at 4 and 12 weeks. Primary outcomes include changes in preconception knowledge, attitudes, and self-efficacy. The study seeks to determine whether mobile health-based counseling enhances preconception preparedness compared with standard information.

Study Overview

• Status: Not yet recruiting
• Conditions: Preconception Period
• Intervention / Treatment: Behavioral: Mobile Application-Based Preconception Counseling Program; Behavioral: Standard Preconception Information Booklet

Detailed Description

This randomized controlled trial investigates the effectiveness of a structured mobile application-based support and counseling program designed for women in the preconception period. Preconception care plays a critical role in improving maternal and fetal outcomes by addressing biomedical, behavioral, and psychosocial risk factors before pregnancy. Despite increasing global use of mobile health technologies, there is no comprehensive mobile application-based preconception counseling program developed and evaluated in Türkiye. This study aims to address this gap by implementing a digitally delivered intervention grounded in established guidelines from the CDC and WHO.

The study includes women aged 18 to 49 who are in the preconception period, have never been pregnant, plan to conceive within two years, can use a smartphone, and have internet access. Women who are currently pregnant, health professionals, those with diagnosed psychiatric conditions, or those who have previously received preconception counseling are excluded. A total of 110 eligible participants are enrolled and randomly assigned to intervention or control groups using a simple randomization procedure generated through an online randomization system (random.org). Because the intervention requires participant engagement with content, the study is conducted as a single-blind design, with participants unaware of their group allocation.

The intervention group receives a four-week mobile application-based counseling program developed using the ADDIE (Analysis, Design, Development, Implementation, Evaluation) instructional design model. The application delivers weekly modules covering preconception care concepts, risk assessment, nutrition, supplementation, physical activity, immunization, sexually transmitted infections, environmental exposures, oral and dental health, psychosocial well-being, reproductive planning, and lifestyle behaviors such as tobacco, alcohol, and medication use. Each module includes structured educational content, reminders, and communication tools enabling researcher-participant interaction. Participants receive weekly follow-ups via messaging to identify difficulties, support adherence, and address questions. The application also includes built-in progress tracking and notification functions.

The control group receives a printed booklet containing standardized preconception information aligned with the topics covered in the intervention modules. Control group participants do not receive digital follow-up but participate in the same assessment schedule as the intervention group.

Data are collected at baseline, at week 4, and at week 12 after the start of the study. Instruments include: a descriptive information form, the Preconception Knowledge and Attitudes Scale, the General Self-Efficacy Scale, a preconception risk assessment form, and for the intervention group, the Mobile Application Usability Scale. Baseline assessments include sociodemographic characteristics, lifestyle indicators, and preconception risk factors. Week 4 assessments measure short-term changes in knowledge, attitudes, and self-efficacy. Week 12 assessments evaluate persistence of intervention effects and longer-term retention of gains.

The primary outcomes are changes in preconception knowledge, attitudes, and self-efficacy. Secondary outcomes include user-reported usability and acceptability of the mobile application. The study evaluates whether a mobile health-based digital counseling approach provides measurable benefits beyond conventional booklet-based information and whether its effects persist beyond the immediate intervention period.

The findings are expected to contribute to the development of evidence-based, scalable, digital preconception care strategies appropriate for primary health care settings, particularly in contexts where accessibility, continuity, and standardization of preconception counseling services are limited.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Selinay Aktaş Demir, RN, PhD Student; Phone Number: +905387307340; Email: selinayaktas7@outlook.com
• Study Contact Backup: Name: Ümran Oskay, PhD, Prof.; Email: umran.oskay@iuc.edu.tr

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Bayrampaşa İlçe Sağlık Müdürlüğü Aile Sağlığı Merkezleri
    • Contact: Selinay Aktaş Demir, Phd Student, RN; Phone Number: +90 538 730 7340; Email: selinayaktas7@outlook.com
    • Contact: Ümran Oskay, PhD, Prof.; Phone Number: +90 212 414 30 00; Email: umran.oskay@iuc.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Women aged 18 to 49 years.
2. In the preconception period and planning to conceive within the next two years.
3. Never been pregnant.
4. Able to read and understand Turkish.
5. Having a smartphone and internet access.
6. Willing to participate and provide informed consent.

Exclusion Criteria:

1. Currently pregnant.
2. Having a diagnosed psychiatric disorder that may interfere with participation.
3. Previous participation in structured preconception counseling or training.
4. Being a health professional or a student in a health-related field.
5. Inability to use a mobile application due to cognitive, visual, or physical limitations.
6. Participation in another ongoing research study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Women receive a four-week mobile application-based preconception counseling program including weekly modules, reminders, and messaging support.	Behavioral: Mobile Application-Based Preconception Counseling Program; A structured digital education and counseling program delivered through a mobile application, including weekly modules, reminders, and in-app messaging support.
Active Comparator: Control Group; Women receive a standard preconception information booklet containing guideline-based educational content.	Behavioral: Standard Preconception Information Booklet; A printed booklet providing standard guideline-based preconception information without digital follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Preconception Knowledge Score	Preconception knowledge is assessed using the Preconception Knowledge and Attitudes Scale. The primary outcome is the change in total knowledge score from baseline to week 4 and week 12. Higher scores indicate higher preconception knowledge.	Baseline, Week 4, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Preconception Attitudes Score	Attitudes toward preconception health are measured using the attitude subscale of the Preconception Knowledge and Attitudes Scale. Change in attitude score is evaluated between baseline, week 4, and week 12.	Baseline, Week 4, Week 12
Change in Self-Efficacy Score	Self-efficacy is assessed using the General Self-Efficacy Scale. The outcome measure is the change in total self-efficacy score across baseline, week 4, and week 12.	Baseline, Week 4, Week 12
Mobile Application Usability Score	Usability of the mobile application is assessed using a validated usability scale. Usability is measured at week 4 among participants in the intervention group.	Week 4

Collaborators and Investigators

• Sponsor: Selinay Aktaş Demir
• Investigators: Principal Investigator: Selinay Aktaş Demir, RN, PhD Student, Atlas Üniversitesi; Study Chair: Ümran Oskay, PhD, Prof., Istanbul University - Cerrahpasa

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Women's Health; Digital Health Intervention; Self-Efficacy; Reproductive Health; Mobile Health (mHealth); Preconception Counseling; Preconception Care
• Other Study ID Numbers: ATLASU-AKTASDEMIR-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No