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NCT Number: NCT07396415

Telehealth-Supported Breastfeeding Counseling in Primiparous Mothers

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Breastfeeding Self-Efficacy Depression, Postpartum Depressive Disorder Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Postpartum Depression (PPD) Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telehealth-Supported Breastfeeding Counseling

Behavioral

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.

Routine postpartum care

Other

Participants receive routine postpartum care according to standard clinical practice, without additional telehealth-supported breastfeeding counseling.

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. Exclusive Breastfeeding Status

    Time frame: Up to 6 months postpartum

    Proportion of mothers exclusively breastfeeding their infants during the follow-up period.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tugba Atmaca Study Contact

CONTACT

[email protected]

+905364416636

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Acronym: TELE-BF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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