Breastfeeding Education Integrated With Web Portal and Mobile Application-Supported Counseling
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Gonca Buran, Assoc Prof
- Numéro de téléphone: +90 2242942481
- E-mail: gburan@uludag.edu.tr
Lieux d'étude
-
-
-
Bursa, Turquie (Türkiye)
- Recrutement
- Bursa Uludag University obstetrics and gynecology clinic
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Aucune intervention: Control
Participants will receive routine maternity care provided by the hospital.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Formulaire d'information personnelle avant l'intervention
Délai: Jour 1 (pendant le recrutement)
|
Évaluation des femmes utilisant des informations personnelles. Cet outil comprend des questions sur les caractéristiques sociodémographiques des femmes |
Jour 1 (pendant le recrutement)
|
|
Perceived Insufficient Milk Supply
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Breastfeeding Intention
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Gonca Buran, Asson Prof, Uludag University
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 18-7
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .