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

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

Overview

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.

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.

Interventions

• Behavioral Intervention Group
  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 e

Primary outcome measures

• Personal information form before intervention [Time frame: Day 1 (During recruitment)]
• Perceived Insufficient Milk Supply [Time frame: Baseline (during pregnancy at 37-39 weeks of gestation), and at 1-, 3-, and 6-month postpartum follow-ups]

Secondary outcome measures (2)

• Breastfeeding Intention [Time frame: Baseline (during pregnancy at 37-39 weeks of gestation), and at 1-, 3-, and 6-month postpartum follow-ups]
• Breastfeeding Adaptation [Time frame: At 1-, 3-, and 6-month postpartum follow-ups]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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. PMID 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. PMID 11572532

Identifiers

NCT: NCT07721311 · 18-7

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗