NCT07244783

Brief Summary

This study is designed to evaluate the effectiveness of a Web-Based Breastfeeding Education Program based on the Information-Motivation-Behavioral Skills (IMB) Model. The study aims to examine the effects of the program on breastfeeding self-efficacy, motivation, problems encountered, and exclusive breastfeeding status among primiparous women. Although breastfeeding is the most appropriate and natural form of infant nutrition, breastfeeding rates are still below the desired level both worldwide and in Turkey. According to the 2018 Turkey Demographic and Health Survey, breastfeeding is initiated at a high rate in the immediate postpartum period; however, continuation rates remain low. The main reasons for this include lack of maternal knowledge, limited social support, and restricted access to professional counseling. The recent increase in digital opportunities has introduced web-based interventions in breastfeeding education. Studies in the literature have shown that technology-assisted interventions improve maternal knowledge and motivation and contribute to sustaining breastfeeding. In the first stage of this study, the Breastfeeding Knowledge Test (ASEBT) will be developed and its reliability assessed. The test, prepared based on a literature review and expert opinions, will consist of 30 multiple-choice questions. Reliability and validity analyses will be conducted using the KR-20 coefficient. The second stage will be conducted as a randomized controlled trial. The sample will consist of 70 primiparous pregnant women who meet the inclusion criteria. Participants will be randomly assigned to intervention and control groups. The intervention group will receive a five-module web-based education program structured according to the IMB model. The modules will cover the importance of breastfeeding, breastfeeding techniques, common problems, mother-infant bonding, and stress management. The program will be supported with digital guides, mini quizzes, virtual badges, motivational messages, and achievement certificates. The control group will only receive routine hospital education. Data will be collected using the Individual Information Form, ASEBT, Antenatal and Postnatal Breastfeeding Self-Efficacy Scales, Visual Analog Scale for Motivation, Breastfeeding Motivation Scale, Breastfeeding Problems Assessment Scale, and postpartum follow-up forms. All data will be analyzed using SPSS 22.0 software. After testing normality assumptions, descriptive statistics, independent sample t-tests, and Pearson correlation analyses will be applied. Results will be evaluated at a 95% confidence interval and a significance level of p\<0.05. Ethical approval and institutional permissions will be obtained prior to implementation. In addition, permissions for the use of the scales will be secured from the original authors. Participation will be voluntary, and informed consent will be obtained from all participants. Throughout the study, ethical principles including confidentiality, respect for autonomy, and non-maleficence/beneficence will be observed. This study aims to introduce a digital-based approach to enhance behavioral outcomes related to breastfeeding. The web-based education program structured according to the IMB Model is expected to improve maternal knowledge and motivation, strengthen breastfeeding self-efficacy, and contribute to longer durations of exclusive breastfeeding. The study is anticipated to provide evidence to support the development and dissemination of technology-assisted educational programs in nursing practice.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

August 18, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

Web-Based Breastfeeding Educationbreast milkbreastfeedingInformation-Motivation-Behavioral Skills (IMB) Model

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding status: The proportion of infants exclusively receiving breast milk will be assessed in both the intervention and control groups at birth and at 1 month postpartum

    The proportion of infants exclusively receiving breast milk will be assessed in both the intervention and control groups at birth and at 1 month postpartum

    The proportion of infants exclusively receiving breast milk will be assessed in both the intervention and control groups at birth and at 1 month postpartum

Study Arms (2)

Participants in the IMB-based web breastfeeding education program

ACTIVE COMPARATOR

This study evaluates a web-based breastfeeding education program structured according to the Information-Motivation-Behavioral Skills (IMB) model. The intervention group will receive a five-module program covering the importance of breastfeeding, breastfeeding techniques, common problems, mother-infant bonding, and stress management. The program includes educational texts, videos, digital guides, quizzes, and interactive tools. Motivation will be supported through virtual badges, motivational messages, and a certificate of participation. Behavioral skills will be assessed via web-based questionnaires and self-assessment scales.

Behavioral: Web-Based Breastfeeding Education Program

Participants receiving routine hospital-based breastfeeding education

NO INTERVENTION

Participants in the control group will receive the standard hospital-based breastfeeding education routinely provided by healthcare professionals.

Interventions

his study evaluates a web-based breastfeeding education program structured according to the Information-Motivation-Behavioral Skills (IMB) model. The intervention group will receive a five-module program covering the importance of breastfeeding.The program includes educational texts, videos, digital guides, quizzes, and interactive tools. Motivation will be supported through virtual badges, motivational messages, and a certificate of participation. Behavioral skills will be assessed via web-based questionnaires and self-assessment scales.

Participants in the IMB-based web breastfeeding education program

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be included if they meet all of the following criteria:
  • Able to communicate in Turkish
  • Literate (able to read and write)
  • At 32 weeks of gestation or more
  • Primiparous (first-time mother)
  • Aged 19 years or older
  • Have access to a device (smartphone or computer) with an internet connection, compatible with Android or iOS operating systems

You may not qualify if:

  • Have conditions that may cause communication difficulties (e.g., mental, visual, or hearing impairments)
  • Have a diagnosed psychiatric disorder (e.g., bipolar disorder, schizophrenia)
  • Have a high-risk pregnancy (e.g., gestational diabetes, preeclampsia, multiple pregnancy, pregnancy after in vitro fertilization)
  • Have previously received structured breastfeeding or breast milk education outside the hospital
  • Withdrawal Criteria:
  • Participants will be removed from the study if they meet any of the following:
  • Choose to withdraw from the study at any stage
  • Do not complete the web-based education modules after enrollment
  • The newborn requires intensive care after birth
  • The mother requires intensive care before or after birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Hospital

Ankara, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sub-Investigator / Researcher

Study Record Dates

First Submitted

August 18, 2025

First Posted

November 24, 2025

Study Start

April 1, 2025

Primary Completion

November 15, 2025

Study Completion

December 30, 2025

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations