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

19 sierpnia 2026 zaktualizowane przez: Gonca Buran, Aydin Adnan Menderes University

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.

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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

62

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

      • Bursa, Turcja (Türkiye)
        • Rekrutacyjny
        • Bursa Uludag University obstetrics and gynecology clinic

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Intervention Group
Participants 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.

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.

Brak interwencji: Control
Participants will receive routine maternity care provided by the hospital.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Formularz danych osobowych przed interwencją
Ramy czasowe: Dzień 1 (podczas rekrutacji)

Ocena kobiet wykorzystujących dane osobowe.

To narzędzie zawiera pytania dotyczące cech socjodemograficznych kobiet

Dzień 1 (podczas rekrutacji)
Perceived Insufficient Milk Supply
Ramy czasowe: Baseline (during pregnancy at 37-39 weeks of gestation), and at 1-, 3-, and 6-month postpartum follow-ups
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.
Baseline (during pregnancy at 37-39 weeks of gestation), and at 1-, 3-, and 6-month postpartum follow-ups

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Breastfeeding Intention
Ramy czasowe: Baseline (during pregnancy at 37-39 weeks of gestation), and at 1-, 3-, and 6-month postpartum follow-ups
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.
Baseline (during pregnancy at 37-39 weeks of gestation), and at 1-, 3-, and 6-month postpartum follow-ups
Breastfeeding Adaptation
Ramy czasowe: At 1-, 3-, and 6-month postpartum follow-ups
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.
At 1-, 3-, and 6-month postpartum follow-ups

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Dyrektor Studium: Gonca Buran, Asson Prof, Uludag University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

20 lipca 2026

Zakończenie podstawowe (Szacowany)

20 lutego 2027

Ukończenie studiów (Szacowany)

20 lutego 2027

Daty rejestracji na studia

Pierwszy przesłany

18 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 lipca 2026

Pierwszy wysłany (Rzeczywisty)

23 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

20 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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