NCT07721311

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Jul 2026Feb 2027

First Submitted

Initial submission to the registry

July 18, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

July 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2027

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 18, 2026

Last Update Submit

July 18, 2026

Conditions

Keywords

Breastfeeding educationBreastfeeding CounselingPerception of Insufficient Milk SupplyWeb Portal SupportBreastfeeding AdaptationMobile Application

Outcome Measures

Primary Outcomes (2)

  • Personal information form before intervention

    Evaluation of women using personal information. This tool includes questions on women's sociodemographic characteristics

    Day 1 (During recruitment)

  • 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.

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

Secondary Outcomes (2)

  • Breastfeeding Intention

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

  • Breastfeeding Adaptation

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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Intervention Group

Control

NO INTERVENTION

Participants will receive routine maternity care provided by the hospital.

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly pregnant women are eligible for this study because the intervention and outcome measures specifically address maternal breastfeeding intention, perceived insufficient milk supply, and breastfeeding adaptation during the perinatal and postpartum periods.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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: 24897921BACKGROUND
  • 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: 24391731BACKGROUND
  • 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

    RESULT
  • 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.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Gonca Buran, Asson Prof

    Uludag University

    STUDY DIRECTOR

Central Study Contacts

Gonca Buran, Assoc Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and care providers will not be blinded due to the nature of the intervention. Outcome assessment and statistical analysis will be performed by independent researchers blinded to group allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 18, 2026

First Posted

July 23, 2026

Study Start

July 20, 2026

Primary Completion (Estimated)

February 20, 2027

Study Completion (Estimated)

February 20, 2027

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.