Telehealth-Supported Breastfeeding Counseling in Primiparous Mothers (TELE-BF)

February 2, 2026 updated by: Marmara University

The Effect of Telehealth-Supported Breastfeeding Counseling on Breastfeeding Duration, Self-Efficacy, and Postpartum Depressive Symptoms: A Randomized Controlled Trial

Breastfeeding is critical for infant and maternal health; however, many first-time mothers experience difficulties that may lead to early discontinuation of breastfeeding. Telehealth-supported breastfeeding counseling has the potential to provide timely, accessible, and continuous support to mothers during the postpartum period.

This randomized controlled trial aims to evaluate the effect of telehealth-supported breastfeeding counseling on breastfeeding duration, breastfeeding self-efficacy, and postpartum depressive symptoms in primiparous mothers. Participants will be randomly assigned to either a telehealth-supported breastfeeding counseling group or a routine postpartum care group.

The intervention group will receive structured breastfeeding counseling sessions delivered via telecommunication tools in addition to standard care, while the control group will receive routine postpartum care only. Outcomes will be assessed using validated questionnaires and follow-up evaluations during the postpartum period. The findings of this study may contribute to improving breastfeeding support strategies and maternal mental health outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a single-center, parallel-group, randomized controlled trial designed to investigate the effectiveness of telehealth-supported breastfeeding counseling in primiparous mothers.

Eligible participants will be primiparous women who have delivered a healthy, term, singleton infant and meet the inclusion criteria. After providing informed consent, participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group.

The intervention group will receive structured breastfeeding counseling delivered through telehealth methods, including scheduled video or telephone-based counseling sessions conducted by trained healthcare professionals, in addition to routine postpartum care. The control group will receive routine postpartum care alone.

Primary outcomes include breastfeeding self-efficacy and postpartum depressive symptoms, assessed using validated measurement tools. Secondary outcomes include breastfeeding duration and exclusive breastfeeding status during follow-up. Data will be collected at predefined time points during the postpartum period.

The study will be conducted in accordance with ethical principles and has received approval from the Marmara University Faculty of Health Sciences Non-Interventional Clinical Research Ethics Committee. The results of this study are expected to provide evidence regarding the role of telehealth-based breastfeeding support in improving maternal and infant health outcomes.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Primiparous women aged 18-45 years.
  • Mothers who have delivered a healthy, term (≥37 weeks), singleton infant.
  • Ability to communicate in Turkish.
  • Willingness to participate in the study and provide informed consent.
  • Access to a telephone or internet-enabled device for telehealth communication.

Exclusion Criteria:

  • Mothers with severe maternal medical or psychiatric conditions that may interfere with breastfeeding.
  • Infants with congenital anomalies or conditions affecting feeding.
  • Mothers who require neonatal intensive care admission for their infants.
  • Mothers who are unable to participate in telehealth follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telehealth-Supported Breastfeeding Counseling
Participants assigned to this arm will receive structured breastfeeding counseling delivered via telehealth methods, including scheduled video or telephone-based counseling sessions provided by trained healthcare professionals, in addition to routine postpartum care.
Behavioral: Telehealth-Supported Breastfeeding Counseling
Structured breastfeeding counseling delivered via telehealth methods, including scheduled video or telephone-based sessions conducted by trained healthcare professionals. The intervention is provided in addition to routine postpartum care and focuses on breastfeeding techniques, problem-solving, maternal support, and breastfeeding self-efficacy during the postpartum period.
Active Comparator: Routine Postpartum Care
Participants assigned to this arm will receive routine postpartum care according to standard clinical practice, without additional telehealth-supported breastfeeding counseling.
Other: Routine Postpartum Care
Participants receive routine postpartum care according to standard clinical practice, without additional telehealth-supported breastfeeding counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding Self-Efficacy
Time Frame: From baseline (early postpartum period) to 1 month postpartum
Change in breastfeeding self-efficacy measured using a validated breastfeeding self-efficacy scale.
From baseline (early postpartum period) to 1 month postpartum
Postpartum Depressive Symptoms
Time Frame: From baseline (early postpartum period) to 1 month postpartum
Change in postpartum depressive symptoms assessed using the Edinburgh Postnatal Depression Scale (EPDS).
From baseline (early postpartum period) to 1 month postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exclusive Breastfeeding Status
Time Frame: Up to 6 months postpartum
Proportion of mothers exclusively breastfeeding their infants during the follow-up period.
Up to 6 months postpartum
Breastfeeding Duration
Time Frame: Up to 6 months postpartum
Duration of breastfeeding measured as the length of time mothers continue any breastfeeding during the postpartum follow-up period.
Up to 6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 25, 2026

Primary Completion (Estimated)

January 25, 2027

Study Completion (Estimated)

February 25, 2027

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU-SBF-188-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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