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BreastfeedingNCT07901036

Effect of a Breastfeeding Chatbot on Mothers' Breastfeeding Attitudes, Behaviors, and Self-Efficacy

A study testing AI-Based Breastfeeding Counseling Chatbot in people with Breastfeeding and Breastfeeding Attitudes, run by Adiyaman University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This randomized controlled trial aims to evaluate the effects of an artificial intelligence (AI)-based chatbot developed to address breastfeeding problems on mothers' breastfeeding attitudes, behaviors, and self-efficacy. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breastfeeding, Breastfeeding Attitudes
What is being tested?
AI-Based Breastfeeding Counseling Chatbot
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Nov 2026to 30 May 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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Mothers aged 18 years or older.
  • Primiparous mothers.
  • Having delivered a healthy singleton infant.
  • Having a term infant born between 37+0 and 41+6 weeks of gestation.
  • Infant birth weight of at least 2500 grams.
  • No infant health condition directly preventing oral feeding or breastfeeding.
Show all 14Show fewer
  • Mother and infant staying together after delivery.
  • Breastfeeding initiated during the early postpartum period.
  • Intention to breastfeed.
  • No maternal physical condition directly preventing breastfeeding.
  • Continuing breastfeeding at hospital discharge.
  • Ability to read and write Turkish.
  • Access to a smartphone and internet connection.
  • Voluntary participation with informed consent.

Who cannot join

  • Multiple births.
  • Maternal disease or physical condition preventing breastfeeding.
  • Receipt of structured or individualized professional breastfeeding counseling beyond routine care during pregnancy.
  • Diagnosed severe mental health conditions that could substantially affect study participation or interaction with the intervention.
  • Infant admission to the neonatal intensive care unit.
  • Maternal or neonatal health conditions resulting in separation of mother and infant and preventing early initiation of breastfeeding.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

ayşegül gezer tekdal, MSc contact

05398535715

atekdal@adiyaman.edu.tr

Turkey (Türkiye)1 site
  • Adiyaman University Training and Research Hospital

    Merkez, Adıyaman Province, 02040

    ayşegül gezer tekdal, 05398535715, atekdal@adiyaman.edu.tr

    ayşegül GEZER TEKDAL, MSc, 05398535715, atekdal@adiyaman.edu.tr

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of a Chatbot Developed for Breastfeeding Problems on Mothers' Breastfeeding Attitudes, Behaviors, and Self-Efficacy

This randomized controlled trial aims to evaluate the effects of an artificial intelligence (AI)-based chatbot developed to address breastfeeding problems on mothers' breastfeeding attitudes, behaviors, and self-efficacy. The study will also assess exclusive breastfeeding rates, breastfeeding duration, and the technical performance and usability of the developed chatbot.

The study is planned to include 92 primiparous mothers allocated to intervention and control groups. The intervention involves an AI-based breastfeeding counseling chatbot developed using natural language processing (NLP) and Retrieval-Augmented Generation (RAG) technology. The chatbot will provide evidence-based breastfeeding education, information, and counseling support using an expert-reviewed breastfeeding knowledge base. The system is designed to support mothers in managing breastfeeding-related difficulties and will not provide medical diagnoses or replace healthcare professionals.

Read more

Breastfeeding attitudes, self-efficacy, and behaviors will be evaluated during the postpartum follow-up period. Assessments will be conducted at baseline and at the first, third, and sixth postpartum months. Exclusive breastfeeding rates and breastfeeding duration will also be assessed.

Additionally, the chatbot's technical performance, response reliability, medical safety, user satisfaction, and usability will be evaluated. The study aims to provide scientific evidence regarding the effectiveness and feasibility of an AI-supported, evidence-based breastfeeding counseling intervention.

Read the detailed description

Study Design and Objectives

This study is designed as a two-phase research project involving the development and evaluation of an artificial intelligence (AI)-based breastfeeding counseling chatbot. The first phase involves chatbot development, expert validation, technical testing, and pilot evaluation. The second phase involves a two-arm, parallel-group, single-blind randomized controlled trial to evaluate the effectiveness of the chatbot in supporting breastfeeding outcomes among primiparous mothers.

The study aims to evaluate the effects of the chatbot on exclusive breastfeeding, breastfeeding continuation and duration, breastfeeding self-efficacy, breastfeeding attitudes, and breastfeeding behaviors.

Development of the AI-Based Chatbot

The chatbot will be developed using natural language processing (NLP) and Retrieval-Augmented Generation (RAG) technology. Its knowledge base will contain evidence-based breastfeeding guidelines, frequently asked questions, structured educational materials, and expert-reviewed breastfeeding counseling content.

The system will use the nomic-embed-text embedding model for information retrieval and the qwen3.5 language model for response generation. Retrieved content will be used to generate contextually relevant responses grounded in the approved knowledge base.

The chatbot will provide breastfeeding education, answers to frequently asked questions, guidance on breastfeeding techniques, and access to relevant educational resources. It will not provide medical diagnoses, prescribe medications, or replace healthcare professionals. Situations requiring clinical assessment will be directed to appropriate healthcare services.

Before implementation, the system will undergo expert review, technical performance assessment, and pilot testing with 10 mothers who will not be included in the randomized controlled trial.

Participants and Randomization

The randomized controlled trial will be conducted at Adiyaman University Training and Research Hospital in Türkiye.

The study is currently planned to include 92 primiparous mothers, with 46 participants allocated to each group. Eligible participants will be aged 18 years or older, have delivered a healthy term singleton infant, intend to breastfeed, and have access to a smartphone and the internet.

Participants will be randomly allocated to the intervention or control group in a 1:1 ratio using computer-generated permuted block randomization. The randomization sequence will be generated by an independent researcher. Group allocation will occur after eligibility assessment, written informed consent, and baseline data collection.

Due to the nature of the digital intervention, participants cannot be blinded to group allocation. However, group identities will be masked during statistical analysis to reduce analytical bias.

Intervention and Control Groups

Participants in the intervention group will receive standard breastfeeding counseling provided by healthcare professionals, in addition to access to the AI-based breastfeeding counseling chatbot for six months postpartum.

The chatbot will provide evidence-based information and educational support related to breastfeeding difficulties. User interactions and system usage data will be recorded for evaluation.

Participants in the control group will receive routine breastfeeding education and counseling provided by healthcare professionals. No additional digital breastfeeding intervention will be provided as part of the study.

Data Collection and Outcome Assessment

Data will be collected at four time points:

T0: Within the first 24 hours postpartum.

T1: At one month postpartum.

T2: At three months postpartum.

T3: At six months postpartum.

Data collection instruments will include a Participant Information Form, the Iowa Infant Feeding Attitude Scale (IIFAS), the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), and a Breastfeeding Follow-up Form.

The study will evaluate exclusive breastfeeding status at six months postpartum, breastfeeding continuation and duration, breastfeeding self-efficacy, breastfeeding attitudes, and breastfeeding behaviors.

Technical Performance and Safety Evaluation The technical performance of the chatbot will be evaluated using information retrieval metrics, including Precision@5 and Recall@5, expert assessment of response accuracy, consistency with source information, response relevance, hallucination rates, appropriate referral performance, response time, and system error rates.

User satisfaction, usability, and interaction patterns will also be evaluated. The chatbot will operate within predefined safety boundaries and will provide educational and supportive information rather than diagnostic or therapeutic recommendations.

Expected Contribution This study is expected to provide evidence regarding the effectiveness, safety, usability, and feasibility of an AI-supported breastfeeding counseling system. The findings may contribute to the development of evidence-based digital interventions supporting breastfeeding practices and postpartum maternal care.

Being tested
AI-Based Breastfeeding Counseling Chatbot
Keywords
Breastfeeding Attitudes, Exclusive Breastfeeding, Artificial Intelligence, Chatbot
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI-Based Breastfeeding Counseling ChatbotBehavioural

    Participants in the intervention group will receive access to an AI-based breastfeeding counseling chatbot for six months postpartum, in addition to routine breastfeeding care. The chatbot uses natural language processing and Retrieval-Augmented Generation (RAG) technology to provide evidence-based information from an expert-reviewed breastfeeding knowledge base. It offers guidance on breastfeeding techniques, common breastfeeding difficulties, and educational resources through an interactive conversational interface. The system provides personalized educational support based on user questions and directs mothers to healthcare professionals when clinical evaluation is needed. It does not provide diagnoses or treatment recommendations. Chatbot usage and user interactions will be recorded for evaluation.

Study groups in NCT07901036
Study groupRoleWhat they receive
AI-Based Breastfeeding Chatbot GroupExperimentalParticipants in the intervention group will receive routine breastfeeding education and counseling provided by healthcare professionals, in addition to access to an artificial intelligence-based breastfeeding counseling chatbot for six months postpartum. The chatbot will provide evidence-based breastfeeding information, educational content, and support for managing breastfeeding difficulties. Participants will be able to ask breastfeeding-related questions and receive guidance based on an expert-reviewed knowledge base. When necessary, the system will direct users to appropriate healthcare professionals.
Receives: Behavioral: AI-Based Breastfeeding Counseling Chatbot
Routine Breastfeeding Counseling GroupNo interventionParticipants in the control group will receive routine breastfeeding education and counseling provided by midwives and nurses during postpartum hospital care. Following discharge, participants will continue to receive standard healthcare services without any additional digital breastfeeding intervention provided by the study. Breastfeeding outcomes will be assessed at baseline and at one, three, and six months postpartum.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exclusive Breastfeeding at Six Months Postpartum

    The proportion of infants receiving only breast milk at six months postpartum, without other foods or liquids, except oral rehydration solution, vitamins, minerals, or medications. Exclusive breastfeeding status will be assessed using the Breastfeeding Follow-up Form.

    Measured: 6 months postpartum

Secondary outcomes (1)
  1. Change in Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) Scores

    Breastfeeding self-efficacy will be assessed using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), consisting of 14 items rated on a 5-point Likert scale. Total scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy. Changes in scores will be compared between the intervention and control groups across follow-up assessments.

    Measured: Baseline (within 24 hours postpartum), 1, 3, and 6 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2026
  2. Study start2 Nov 2026 (estimated)
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a two-arm, parallel-group randomized controlled trial. Participants will be randomly assigned in a 1:1 ratio to either an intervention group receiving AI-based breastfeeding chatbot support in addition to routine breastfeeding counseling or a control group receiving routine breastfeeding counseling only. Participants will be followed for six months postpartum.
Masking
None (open label)
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07901036
Sponsor's protocol ID
154
Status last verified
Oct 2026
First submitted
22 Oct 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AI-Based Breastfeeding Counseling Chatbot in people with Breastfeeding and Breastfeeding Attitudes, run by Adiyaman 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 14 inclusion and 6 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 28 Oct 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 ayşegül gezer tekdal, MSc (05398535715, atekdal@adiyaman.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exclusive Breastfeeding at Six Months Postpartum (time frame: 6 months postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 28 Oct 2026.

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