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Breastfeeding EducationNCT07244783

Effectiveness of an IMB Model-Based Web Breastfeeding Education Program

A study testing Web-Based Breastfeeding Education Program in people with Breastfeeding Education and Web Education, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breastfeeding Education, Web Education
What is being tested?
Web-Based Breastfeeding Education Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2025to 30 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 19 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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:
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gazi University Hospital

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effectiveness of a Web-Based Breastfeeding Education Program Based on the Information-Motivation-Behavioral Skills (IMB) Model

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.

Read more

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.

Read the detailed description

This study is designed to evaluate the effectiveness of a Web-Based Breastfeeding Education Program based on the Information-Motivation-Behavioral Skills (IMB) Model among primiparous women. The research aims to assess the program's impact on breastfeeding self-efficacy, maternal motivation, breastfeeding-related problems, and exclusive breastfeeding rates.

Background

Although breastfeeding is universally recognized as the optimal and natural method of infant nutrition, both global and national rates remain below desired levels. According to the 2018 Turkey Demographic and Health Survey (TDHS), breastfeeding is initiated at high rates within the first hour postpartum; however, continuation of exclusive breastfeeding until six months remains limited. Key barriers include inadequate maternal knowledge, insufficient social support, and limited access to professional counseling. Nurses play a pivotal role in supporting breastfeeding through education and counseling, yet time constraints, limited staff availability, and accessibility challenges restrict face-to-face counseling. With the rapid expansion of digital technologies, web-based interventions have become promising alternatives for delivering breastfeeding education. Prior studies have shown that technology-assisted interventions improve maternal knowledge, motivation, and breastfeeding outcomes.

Objectives and Hypotheses

The primary objective of this study is to evaluate the effectiveness of a web-based breastfeeding education program structured according to the IMB Model. It is hypothesized that the program will improve maternal breastfeeding knowledge, motivation, self-efficacy, and exclusive breastfeeding rates while reducing breastfeeding-related problems compared to routine care.

Study Design

The study will be conducted in two phases:

Phase 1 - Development of the Breastfeeding Knowledge Test (ASEBT):

A 30-item multiple-choice test will be developed to assess breastfeeding knowledge.

Test items will be prepared based on literature review, Bloom's cognitive taxonomy, and expert consultation.

Content validity will be evaluated through expert review (n=9). The test will be administered to 300 pregnant women meeting the inclusion criteria.

Reliability will be assessed using the Kuder-Richardson (KR-20) coefficient; items with KR-20 below 0.60 will be excluded.

Phase 2 - Randomized Controlled Trial (RCT):

Sample and Randomization: A total of 80 primiparous pregnant women (≥32 weeks gestation, ≥19 years, literate, with access to internet-enabled devices) will be recruited from a university hospital's obstetrics outpatient clinic. Participants will be randomly assigned to intervention (n=35) and control (n=35) groups using a computer-generated randomization schedule. Exclusion criteria include mental or sensory impairments, psychiatric diagnoses, high-risk pregnancies, or prior structured breastfeeding education.

Intervention Group: Participants will complete a five-module web-based breastfeeding education program based on the IMB Model, which includes:

The Importance of Breastfeeding and Breast Milk

Understanding Infant Needs and Breastfeeding Techniques

Common Breastfeeding Problems and Management

Mother-Infant Bonding and Secure Attachment

Stress Management during the Breastfeeding Process The program incorporates interactive educational videos, digital breastfeeding guides, mini knowledge tests, motivational messages, virtual badges, and digital achievement certificates. Modules must be completed sequentially by 37 weeks of gestation.

Control Group: Participants will receive routine hospital-based breastfeeding education only. After study completion, the web-based program will be made available to the control group.

Follow-Up and Assessments:

Baseline (32-34 weeks): Individual Information Form, ASEBT (pre-test), Antenatal Breastfeeding Self-Efficacy Scale, Visual Analog Scale (VAS-Motivation).

37 weeks gestation: ASEBT (post-test), Antenatal Breastfeeding Self-Efficacy Scale, VAS-Motivation.

Within 48 hours postpartum: Postnatal Breastfeeding Self-Efficacy Scale, Breastfeeding Motivation Scale, Breastfeeding Problems Assessment Scale, Postpartum Follow-up Form 1.

1 month postpartum: ASEBT, Postnatal Breastfeeding Self-Efficacy Scale, Breastfeeding Motivation Scale, Breastfeeding Problems Assessment Scale, Postpartum Follow-up Form 2, exclusive breastfeeding status.

Data Collection Tools

Breastfeeding Knowledge Test (ASEBT) - developed in Phase 1. Antenatal and Postnatal Breastfeeding Self-Efficacy Scales Visual Analog Scale (VAS) for Motivation - to measure antenatal motivation. Breastfeeding Motivation Scale - adapted for Turkish mothers Breastfeeding Problems Assessment Scale - validated Turkish version Postpartum Follow-up Forms - developed based on current literature. Statistical Analysis

Data will be analyzed using SPSS 22.0. Normality will be tested prior to analysis. Descriptive statistics (mean, SD, frequency, percentage) will be calculated. Independent samples t-tests will be used to compare group means, and Pearson correlation will assess relationships between variables. Results will be evaluated at a 95% confidence interval with a significance level of p<0.05.

Ethical Considerations

Ethical approval have been obtained from Ankara Yıldırım Beyazıt University Ethics Committee and institutional permissions have been secured. Permissions for the use of all scales have been requested from the original authors. Participation will be voluntary, and written informed consent will be obtained from all participants. The principles of confidentiality, respect for autonomy, and beneficence/non-maleficence will be strictly observed.

Expected Contributions

This study is expected to provide evidence on the effectiveness of web-based, IMB model-guided breastfeeding education in improving maternal knowledge, motivation, and self-efficacy while reducing breastfeeding problems. By supporting exclusive breastfeeding practices, the intervention may contribute to improved maternal and child health outcomes. Findings are anticipated to guide the integration of technology-assisted interventions into routine nursing practice and to promote the wider dissemination of digital breastfeeding education programs.

Being tested
Web-Based Breastfeeding Education Program
Keywords
Web-Based Breastfeeding Education, breast milk, breastfeeding, Information-Motivation-Behavioral Skills (IMB) Model
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web-Based Breastfeeding Education ProgramBehavioural

    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.

Study groups in NCT07244783
Study groupRoleWhat they receive
Participants in the IMB-based web breastfeeding education programActive comparatorThis 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.
Receives: Behavioral: Web-Based Breastfeeding Education Program
Participants receiving routine hospital-based breastfeeding educationNo interventionParticipants in the control group will receive the standard hospital-based breastfeeding education routinely provided by healthcare professionals.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2025
  2. Study start1 Apr 2025
  3. Primary completion15 Nov 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07244783
Sponsor's protocol ID
E-84892257-300-292373
Status last verified
Nov 2025
First submitted
18 Aug 2025
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Web-Based Breastfeeding Education Program in people with Breastfeeding Education and Web Education, run by Ankara Yildirim Beyazıt 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 10 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: under way, not looking for participants, as of the sponsor's last update on 24 Nov 2025. 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

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 (time frame: 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). 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 24 Nov 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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