An interventional study of AI-Based Breastfeeding Counseling Chatbot in Breastfeeding and Breastfeeding Attitudes, sponsored by Adiyaman University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Adiyaman University · Not applicable, Interventional, and Supportive care
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.
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.
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.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's planned enrollment of 92 is close to the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →Adiyaman University is the lead sponsor of 31 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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 .
Exclusion Criteria:
- 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Behavioral: AI-Based Breastfeeding Counseling Chatbot
Participants 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.
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.
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.
Time frame: 6 months postpartum
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.
Time frame: Baseline (within 24 hours postpartum), 1, 3, and 6 months postpartum
Change in Iowa Infant Feeding Attitude Scale (IIFAS) Scores
Breastfeeding attitudes will be assessed using the Iowa Infant Feeding Attitude Scale (IIFAS), consisting of 17 items rated on a 5-point Likert scale. Total scores range from 17 to 85, with higher scores indicating more favorable attitudes toward breastfeeding. Changes in IIFAS scores will be compared between the intervention and control groups across the follow-up assessments.
Time frame: Baseline (within 24 hours postpartum), 1, 3, and 6 months postpartum
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.
Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 6 months is below that.
Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Adiyaman University