NCT07426185

Brief Summary

This randomized controlled study aimed to evaluate the effect of breastfeeding counselling delivered through a smartphone application on breastfeeding self-efficacy, breastfeeding duration, and breastfeeding-related problems among primiparous women in the postpartum period. A total of 60 women were allocated to either an intervention group receiving app-based counselling and motivational messages or a control group receiving routine postpartum care. Outcomes were assessed at multiple follow-up points up to six months postpartum using validated scales. The study investigated whether continuous mHealth-based support improves breastfeeding outcomes compared with standard care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 16, 2026

Last Update Submit

February 16, 2026

Conditions

Keywords

Breastfeedingbreastfeeding problemsbreastfeeding durationself-efficacysmartphone application

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) total score

    The Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) is a validated 14-item instrument that measures maternal confidence in breastfeeding. Total scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy.

    Baseline (first postpartum day), 14 days postpartum, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum

Secondary Outcomes (2)

  • Breastfeeding Problems Evaluation Scale total Score

    Baseline (first postpartum day), 14 days postpartum, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum

  • Breastfeeding duration (Breastfeeding ContinuationRate)

    6monts postpartum

Study Arms (2)

Intervention group

OTHER

Participants received breastfeeding counselling via smartphone application including video education, motivational messages, and remote support for six months.

Behavioral: Breastfeeding counselling via smartphone application

Control Group

OTHER

Participants received routine postpartum breastfeeding care.

Other: routine postpartum breastfeeding care

Interventions

Video education,motivational messages and remote support for six months.

Intervention group

Standart postpartum breastfeedingcare provided by hospital staff.

Control Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women who can give birth
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women who agree to participate in the study,
  • Aged 18 years or older,
  • In the early postpartum period (first 24 hours),
  • Able to speak and understand Turkish,
  • Possessing a smartphone (ANDROID) and able to use it,
  • Who gave birth between 36 and 40 weeks of gestation,

You may not qualify if:

  • Women who have had a breast infection during pregnancy,
  • Women whose baby has an anomaly in the mouth region,
  • Women who have communication difficulties,
  • Women with a history of breast cancer,
  • Women who have given birth multiple times,
  • Women with multiple pregnancies,
  • Women with a premature baby,
  • Women whose baby has neonatal jaundice have been excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakırçay University Çiğli Training and Research Hospital

Izmir, 35665, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either the intervention group receiving smartphone application-based breastfeeding counselling or the control group receiving routine postpartum care. Both groups were followed concurrently for six months postpartum, and outcomes were compared between groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

February 16, 2026

First Posted

February 23, 2026

Study Start

January 15, 2022

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

The individual participant data (de-identified) that underlie the results reported in this study will be made available upon reasonable request to the corresponding author. Data will be shared after publication, in accordance with institutional policies and ethical approval, and only for scientific research purposes.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 6 months after publication and ending 5 years after publication
Access Criteria
Researchers who provide a methodologically sound proposal can access the data. Proposals should be directed to the principal investigator. Data will be shared after approval and signing a data use agreement

Locations