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BreastfeedingNCT07721311

Breastfeeding Education Integrated With Web Portal and Mobile Application-Supported Counseling

A study testing Intervention Group in people with Breastfeeding and Breastfeeding Attitudes, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Breastfeeding provides significant benefits for maternal and infant health; however, perceived insufficient milk supply is one of the most common factors associated with early breastfeeding discontinuation. Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
What is being tested?
Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Jul 2026to 20 Feb 2027
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 18 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Pregnant women at 37-39 weeks of gestation.
  • Being 18 years of age or older.
  • Planning to give birth at the study hospital.
  • Planning to breastfeed their newborn.
  • Having a singleton pregnancy.
  • Having a healthy pregnancy without conditions requiring high-risk pregnancy management.
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  • Being able to communicate verbally and understand the study procedures.
  • Having access to a smartphone and/or internet connection to use the web portal and mobile application (for participants assigned to the intervention group).
  • Voluntarily agreeing to participate in the study and providing written informed consent.

Who cannot join

  • Having a medical condition that contraindicates breastfeeding.
  • Having a pregnancy complication requiring intensive medical follow-up or early delivery.
  • Multiple pregnancy (e.g., twins or higher-order pregnancies).
  • Planned cesarean delivery due to medical indications that may interfere with the breastfeeding initiation process (if applicable according to your protocol).
  • Having a newborn requiring neonatal intensive care admission after birth.
  • Previous participation in a structured breastfeeding education or digital breastfeeding counseling program during the current pregnancy.
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  • Inability to complete study questionnaires or participate in follow-up assessments.
  • Not having access to the required digital tools for the intervention group.
  • Withdrawal of informed consent at any stage of the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gonca Buran, Assoc Prof contact

+90 2242942481

gburan@uludag.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Bursa Uludag University obstetrics and gynecology clinic

    Bursa

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Breastfeeding Education Integrated With Web Portal and Mobile Application-Supported Counseling on Perceived Insufficient Milk Supply, Breastfeeding Intention, and Breastfeeding Adaptation: A Randomized Controlled Trial

Breastfeeding provides significant benefits for maternal and infant health; however, perceived insufficient milk supply is one of the most common factors associated with early breastfeeding discontinuation. Although the World Health Organization recommends exclusive breastfeeding for the first six months of life, breastfeeding continuation rates remain suboptimal in many countries, including Türkiye.

This randomized controlled trial aims to evaluate the effect of breastfeeding education combined with a web portal and mobile application-supported breastfeeding counseling on perceived insufficient milk supply, breastfeeding intention, and breastfeeding adaptation among pregnant women.

Read more

Women at 37-39 weeks of gestation will be randomly assigned to an intervention group or a control group. Participants in the intervention group will receive individualized breastfeeding education during pregnancy, educational materials, postpartum breastfeeding support, and web portal- and mobile application-supported breastfeeding counseling. Participants in the control group will receive routine hospital care.

Data will be collected during pregnancy (baseline), immediately after birth, and at 1-, 3-, and 6-month postpartum follow-ups using validated scales assessing perceived insufficient milk supply, breastfeeding intention, and breastfeeding adaptation. Digital platform usage data, including the counseling topics accessed and the frequency of use, will also be evaluated in the intervention group.

This study is supported as a research project and aims to develop an accessible digital breastfeeding support model that may improve breastfeeding confidence, reduce perceived insufficient milk supply, and promote breastfeeding adaptation and continuation.

Read the detailed description

Breastfeeding is a critical component of maternal and infant health, providing essential nutritional, immunological, and developmental benefits for infants while supporting maternal health and well-being. Despite the established benefits of exclusive breastfeeding during the first six months of life, as recommended by the World Health Organization, many mothers experience challenges in initiating and maintaining breastfeeding. Perceived insufficient milk supply is one of the most frequently reported concerns among breastfeeding mothers and may negatively affect breastfeeding confidence, breastfeeding intention, and continuation of breastfeeding.

This randomized controlled trial aims to evaluate the effect of a breastfeeding education program combined with a web portal and mobile application-supported breastfeeding counseling on perceived insufficient milk supply, breastfeeding intention, and breastfeeding adaptation among pregnant women. The study is designed to investigate whether continuous digital support, integrated with structured prenatal breastfeeding education, can provide sustained guidance and improve breastfeeding-related outcomes during the postpartum period.

Pregnant women at 37-39 weeks of gestation will be recruited and randomly allocated to either an intervention group or a control group. Participants in the intervention group will receive individualized face-to-face breastfeeding education during pregnancy. The education will include evidence-based breastfeeding information delivered through verbal instruction, question-and-answer sessions, visual educational materials, and demonstration techniques using a newborn model. Participants will also receive a written educational booklet. Following childbirth, mothers in the intervention group will receive support during the initiation of breastfeeding and continued breastfeeding counseling through a web portal and mobile application throughout the postpartum period. Participants assigned to the control group will receive routine hospital maternity care.

Data will be collected at five assessment points: during pregnancy as a baseline assessment, immediately after childbirth during the hospital stay, and at 1-, 3-, and 6-month postpartum follow-ups. Baseline maternal characteristics will be collected using a Sociodemographic Information Form, which includes demographic, socioeconomic, health-related, and breastfeeding-related characteristics. Breastfeeding-related outcomes will be assessed using validated measurement instruments, including the Infant Feeding Intention Scale, Perceived Insufficient Milk Supply Scale, Breastfeeding Adaptation Scale, and Breastfeeding Attitude Assessment Scale. These instruments will be used to evaluate changes in mothers' breastfeeding intention, perceptions regarding milk sufficiency, breastfeeding attitudes, and adaptation to breastfeeding over the follow-up period.

In addition, digital platform engagement data will be collected for participants in the intervention group. Information regarding accessed counseling topics, frequency of platform use, and participant interactions with digital breastfeeding support services will be recorded and evaluated.

By integrating face-to-face breastfeeding education with continuous digital counseling support, this study aims to provide evidence for an accessible, sustainable breastfeeding support model. The findings may contribute to the development of evidence-based digital health interventions that support breastfeeding adaptation, address breastfeeding-related concerns, and promote breastfeeding continuation among mothers.

Being tested
Intervention Group
Keywords
Breastfeeding education, Breastfeeding Counseling, Perception of Insufficient Milk Supply, Web Portal Support, Breastfeeding Adaptation, Mobile Application
Medical subject headings
Breast Feeding

What participants receive

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

  • Intervention GroupBehavioural

    The intervention consists of a structured breastfeeding education program combined with a web portal and mobile application-supported breastfeeding counseling. Pregnant women at 37-39 weeks of gestation will receive individualized face-to-face breastfeeding education, including evidence-based breastfeeding information, question-and-answer sessions, visual educational materials, and demonstration techniques using a newborn model. Participants will also receive a written booklet on breastfeeding education.

    Following childbirth, participants will receive support during the initiation of breastfeeding and continuous breastfeeding counseling through a web portal and mobile application during the 6-month postpartum follow-up period. The digital platform will provide breastfeeding-related educational resources, professional guidance, and support for breastfeeding-related concerns. Usage data, including accessed topics and frequency of platform engagement, will be recorded for evaluation.

Study groups in NCT07721311
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants will receive individualized breastfeeding education during pregnancy (37-39 weeks of gestation), postpartum breastfeeding support, and web portal- and mobile application-supported breastfeeding counseling during the postpartum period.
Receives: Behavioral: Intervention Group
ControlNo interventionParticipants will receive routine maternity care provided by the hospital.

What is being measured

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

  1. Personal information form before intervention

    Evaluation of women using personal information.

    This tool includes questions on women's sociodemographic characteristics

    Measured: Day 1 (During recruitment)

  2. Perceived Insufficient Milk Supply

    Participants' perceived milk supply will be assessed using the Perceived Insufficient Milk Supply Scale. The scale evaluates mothers' perceptions regarding breast milk adequacy and concerns about insufficient milk production. Changes in perceived insufficient milk supply between the intervention and control groups will be evaluated throughout the follow-up period.

    Measured: Baseline (during pregnancy at 37-39 weeks of gestation), and at 1-, 3-, and 6-month postpartum follow-ups

Secondary outcomes (2)
  1. Breastfeeding Intention

    Breastfeeding intention will be assessed using the Infant Feeding Intention Scale. This measure assesses mothers' intentions regarding infant feeding practices and the planned duration of breastfeeding. Changes in breastfeeding intention between the intervention and control groups will be evaluated during the study period.

    Measured: Baseline (during pregnancy at 37-39 weeks of gestation), and at 1-, 3-, and 6-month postpartum follow-ups

  2. Breastfeeding Adaptation

    Breastfeeding adaptation will be assessed using the Breastfeeding Adaptation Scale. This measure evaluates mothers' adaptation to the breastfeeding process, including breastfeeding-related experiences, confidence, and adjustment during the postpartum period. Changes in breastfeeding adaptation scores between the intervention and control groups will be evaluated throughout the follow-up period.

    Measured: At 1-, 3-, and 6-month postpartum follow-ups

Timeline

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

  1. First posted23 Jul 2026
  2. Study start20 Jul 2026
  3. Primary completion20 Feb 2027 (estimated)
  4. Study completion20 Feb 2027 (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
Model description
Participants will be randomly assigned in a parallel-group design to either the intervention group or the control group. The intervention group will receive individualized breastfeeding education during pregnancy, postpartum breastfeeding support, and web portal- and mobile application-supported breastfeeding counseling. The control group will receive routine maternity care provided by the hospital. Outcomes will be assessed at baseline during pregnancy, immediately after childbirth, and at 1-, 3-, and 6-month postpartum follow-up assessments.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07721311
Sponsor's protocol ID
18-7
Status last verified
Aug 2026
First submitted
18 Jul 2026
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared with other researchers. The collected data will be used only for the purposes specified in the study protocol. Participant confidentiality and data protection will be maintained in accordance with ethical requirements and applicable regulations.

Publications

  • Alus Tokat M, Sercekus P, Yenal K, Okumus H. Early postpartum breast-feeding outcomes and breast-feeding self-efficacy in Turkish mothers undergoing vaginal birth or cesarean birth with different types of anesthesia. Int J Nurs Knowl. 2015 Apr;26(2):73-9. doi: 10.1111/2047-3095.12037. Epub 2014 Jun 5.

    PubMed 24897921
  • Stockdale J, Sinclair M, Kernohan G, McCrum-Gardner E, Keller J. Sensitivity of the breastfeeding motivational measurement scale: a known group analysis of first time mothers. PLoS One. 2013 Dec 31;8(12):e82976. doi: 10.1371/journal.pone.0082976. eCollection 2013.

    PubMed 24391731
  • Li, X., Wang, Y., Chen, L., & Zhang, H. (2021). Effect of antenatal breastfeeding education on maternal breastfeeding self-efficacy and perception of milk insufficiency: A randomized controlled trial. International Breastfeeding Journal, 16(1), 55. https://doi.org/10.1186/s13006-021-00399-5

  • McCarter-Spaulding DE, Kearney MH. Parenting self-efficacy and perception of insufficient breast milk. J Obstet Gynecol Neonatal Nurs. 2001 Sep-Oct;30(5):515-22. doi: 10.1111/j.1552-6909.2001.tb01571.x.

    PubMed 11572532

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Group in people with Breastfeeding and Breastfeeding Attitudes, run by Aydin Adnan Menderes 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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 20 Aug 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. 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?

Contact Gonca Buran, Assoc Prof (+90 2242942481, gburan@uludag.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Personal information form before intervention (time frame: Day 1 (During recruitment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07721311, which also lists 4 linked publications.

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 20 Aug 2026.

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