Telehealth-Supported Breastfeeding Counseling in Primiparous Mothers

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Другое Routine Postpartum Care
  Participants receive routine postpartum care according to standard clinical practice, without additional telehealth-supported breastfeeding counseling.

Первичные конечные точки

• Breastfeeding Self-Efficacy [Срок оценки: From baseline (early postpartum period) to 1 month postpartum]
• Postpartum Depressive Symptoms [Срок оценки: From baseline (early postpartum period) to 1 month postpartum]

Вторичные конечные точки (2)

• Exclusive Breastfeeding Status [Срок оценки: Up to 6 months postpartum]
• Breastfeeding Duration [Срок оценки: Up to 6 months postpartum]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр

• Marmara University Faculty of Medicine — Istanbul

Публикации

• Fetzer JC. How a graduate school education can meet the needs of industrial employment. Anal Bioanal Chem. 2002 Jul;373(4-5):209-10. doi: 10.1007/s00216-002-1334-7. No abstract available. PMID 12171026
• White RA, Thames HD Jr. State vector models of the cell cycle II: The first three moments of the transit time distribution. J Theor Biol. 1979 Mar 7;77(1):141-60. doi: 10.1016/0022-5193(79)90144-9. No abstract available. PMID 449366

Идентификаторы

NCT: NCT07396415 · MU-SBF-188-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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