Telehealth-Supported Breastfeeding Counseling in Primiparous Mothers

NCT07396415 | Not Yet Recruiting

• 1 other identifier: MU-SBF-188-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breastfeeding; Postpartum Depression (PPD); Breastfeeding Self-Efficacy

Keywords

Breastfeeding Counseling; Telehealth; Primiparous Mothers; Postpartum Period; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Breastfeeding Self-Efficacy

  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

  Change in postpartum depressive symptoms assessed using the Edinburgh Postnatal Depression Scale (EPDS).

  From baseline (early postpartum period) to 1 month postpartum

Secondary Outcomes (2)

• Exclusive Breastfeeding Status

  Up to 6 months postpartum

• Breastfeeding Duration

  Up to 6 months postpartum

Study Arms (2)

Telehealth-Supported Breastfeeding Counseling

EXPERIMENTAL

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

Routine Postpartum Care

ACTIVE COMPARATOR

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

Interventions

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.

Telehealth-Supported Breastfeeding Counseling

Routine Postpartum Care OTHER

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

Routine Postpartum Care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Breast Feeding; Depression, Postpartum

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Tugba Atmaca Study Contact

CONTACT

+905364416636; tugbaatmaca20@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to one of two parallel groups: a telehealth-supported breastfeeding counseling group or a routine postpartum care group.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): January 25, 2027
• Study Completion (Estimated): February 25, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)