BreastfeedingTELE-BFNCT07396415
Telehealth-Supported Breastfeeding Counseling in Primiparous Mothers
A study testing Telehealth-Supported Breastfeeding Counseling and Routine Postpartum Care in people with Breastfeeding and Postpartum Depression (PPD), run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Postpartum Depression (PPD), Breastfeeding Self-Efficacy
- What is being tested?
- Telehealth-Supported Breastfeeding Counseling and Routine Postpartum Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2026to 25 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Marmara University Faculty of Medicine
Istanbul
tugba atmaca, +90 216 777 07 77, tip.bilgi@marmara.edu.tr
About this study
Official title: 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.
Read the 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.
- Being tested
- Telehealth-Supported Breastfeeding Counseling, Routine Postpartum Care
- Keywords
- Breastfeeding Counseling, Telehealth, Primiparous Mothers, Postpartum Period, Randomized Controlled Trial
- Medical subject headings
- Breast Feeding, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth-Supported Breastfeeding CounselingBehavioural
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 CareOther
Participants receive routine postpartum care according to standard clinical practice, without additional telehealth-supported breastfeeding counseling.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine Postpartum Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Self-Efficacy
Change in breastfeeding self-efficacy measured using a validated breastfeeding self-efficacy scale.
Measured: 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).
Measured: From baseline (early postpartum period) to 1 month postpartum
Secondary outcomes (2)
Exclusive Breastfeeding Status
Proportion of mothers exclusively breastfeeding their infants during the follow-up period.
Measured: Up to 6 months postpartum
Breastfeeding Duration
Duration of breastfeeding measured as the length of time mothers continue any breastfeeding during the postpartum follow-up period.
Measured: Up to 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start25 Feb 2026 (estimated)
- Primary completion25 Jan 2027 (estimated)
- Study completion25 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two parallel groups: a telehealth-supported breastfeeding counseling group or a routine postpartum care group.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396415
- Sponsor's protocol ID
- MU-SBF-188-2025
- Acronym
- TELE-BF
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12171026White 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.
PubMed 449366
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telehealth-Supported Breastfeeding Counseling on Breastfeeding Duration, Self-Efficacy, and Postpartum Depressive Symptoms: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07396415
- Acronym / sponsor ID
- TELE-BF / MU-SBF-188-2025
- Keywords
- Breastfeeding Counseling, Telehealth, Primiparous Mothers, Postpartum Period, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 25 Feb 2026 (estimated)
- Primary completion
- 25 Jan 2027 (estimated)
- Study completion
- 25 Feb 2027 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two parallel groups: a telehealth-supported breastfeeding counseling group or a routine postpartum care group.
| Arm | Type | Receives |
|---|---|---|
| Telehealth-Supported Breastfeeding Counseling | Experimental | Behavioral: Telehealth-Supported Breastfeeding CounselingParticipants 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. |
| Routine Postpartum Care | Active comparator | Other: Routine Postpartum CareParticipants assigned to this arm will receive routine postpartum care according to standard clinical practice, without additional telehealth-supported breastfeeding counseling. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth-Supported Breastfeeding CounselingStructured 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. | Behavioural | Telehealth-Supported Breastfeeding Counseling |
| Routine Postpartum CareParticipants receive routine postpartum care according to standard clinical practice, without additional telehealth-supported breastfeeding counseling. | Other | Routine Postpartum Care |
Primary outcome
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.
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).
2 secondary outcomes
Exclusive Breastfeeding Status
Time frame: Up to 6 months postpartum
Breastfeeding Duration
Time frame: Up to 6 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 12171026Fetzer 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.
- Results publication: PubMed 449366White 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth-Supported Breastfeeding Counseling and Routine Postpartum Care in people with Breastfeeding and Postpartum Depression (PPD), run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tugba Atmaca Study Contact (+905364416636, tugbaatmaca20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding Self-Efficacy (time frame: From baseline (early postpartum period) to 1 month postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07396415, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.