Complementary Feeding, Pediatric NurseNCT07487493
The Effect of Technology-Based Education Given to Mothers During the Transition to Complementary Feeding on Infant Development, Transition to Complementary Feeding Behavior, and Mothers' Anxiety Levels
A study testing Transition to traditional complementary feeding in people with Complementary Feeding, Pediatric Nurse, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted as a randomized controlled pre-test post-test study to determine the effects of technology-based complementary feeding training given to mothers during the transition period of babies to complementary feeding on babies' behavior and development and their mothers' anxiety levels. Read more about this study
- Who is it for?
- Ages 5 to 6 months
- Conditions the study is for
- Complementary Feeding, Pediatric Nurse
- What is being tested?
- Transition to traditional complementary feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 30 Jul 2026
- 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 5 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being over 18 years of age, Having at least a primary school diploma, Having internet access at home or at work and being able to use the internet, Being able to speak Turkish, Not having received prior training on complementary feeding. • Mothers who agree to participate in the study will be included in the research.
- The inclusion criteria for babies were:
- Born between 37-42 weeks of gestation, Birth weight between 2500-4000 grams, No congenital anomalies, No chronic or metabolic diseases, No health problems, Babies who have not yet started complementary feeding.
Who cannot join
- Mothers and infants who develop any of the exclusion criteria during the study's implementation and are unable to complete the program will be excluded from the sample.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
DİLEK KONUKBAY Study Principal Investigator, Saglik Bilimleri Universitesi contact
Turkey (Türkiye)1 site
University of Health Sciences Turkey Ankara, Turkey
Ankara
About this study
This study will be conducted as a randomized controlled pre-test post-test study to determine the effects of technology-based complementary feeding training given to mothers during the transition period of babies to complementary feeding on babies' behavior and development and their mothers' anxiety levels.
Read the detailed description
Breast milk is the most appropriate food for infant nutrition (1,2,3,4). Starting from the sixth month, complementary feeding begins with the addition of new foods, taking into account the baby's developmental characteristics and needs. The World Health Organization (WHO) recommends exclusive breastfeeding for the first six months, initiating complementary feeding in addition to breast milk from the sixth month onward, and continuing breastfeeding until the age of two and beyond (5,6,7). The World Health Organization defines complementary feeding as "the period of transition to the family table, initiated in the sixth month when exclusive breastfeeding is no longer sufficient to meet the infant's needs, and during which a variety of semi-solid and solid foods are introduced along with breast milk" (8). Nutrition in the first two years of life forms the foundation of health (9,10). Growth and developmental delays that may occur during this period are very difficult to correct in later periods (11,12). The timing of complementary feeding, the way food is prepared, and the variety and proportion of nutrients offered are among the important factors affecting the baby's health (13,14). While inadequate or incorrect practices during complementary feeding increase the baby's risk of hypertension, allergies, type 1 diabetes mellitus, obesity, and growth retardation in later life, these risks can be reduced with timely and correct complementary feeding (15,16,17). The child's emotions should be taken into account during feeding, and feeding habits should be established gradually and patiently, without forcing, and by trying different tastes. To achieve this, responsive and enjoyable complementary feeding should be prioritized (7, 18, 19, 20). In recent years, responsive complementary feeding methods such as baby-led feeding (BLW) have been recommended in addition to traditional complementary feeding methods (21, 22). The WHO emphasizes the importance of responsive feeding, as well as timely and high-quality feeding, for optimal complementary feeding (5, 6, 7, 20, 21, 23, 24). BLW feeding is a baby-friendly alternative feeding method where babies feed themselves with portions of family meals, rather than spoon-fed pureed foods offered by parents during the transition to complementary feeding. BLW feeding is becoming increasingly popular due to its advantages, including reduced risk of obesity, improved nutritional quality, positive parental attitudes toward eating behavior, and support for motor development (7,24,25,26,27,28).
Health education, once provided one-on-one or in groups, can now be delivered in the form of technology-based health education, influenced by the use of the internet (29). The ease of accessibility of technology-based education, the availability of continuous information support at any time and place, and the use of different methods (video, animation, etc.) facilitate the widespread use of these education programs (30). Nurses can effectively provide education and consulting services using web-based education methods (31). Providing mothers with the most up-to-date information and methods regarding the transition to complementary feeding, which lays the foundations for healthy nutrition, is one of the most important duties of healthcare professionals, especially nurses. The transition to complementary feeding can create anxiety in both mothers and babies. A review of the relevant literature indicates that mothers experience anxiety and difficulties during the transition to complementary feeding (32,33). It has been reported that babies of anxious mothers are more likely to experience undernourishment or overnourishment (34). Therefore, evidence-based studies examining infants' transition to complementary feeding behavior, development, and mothers' anxiety levels are needed.
The aim of the study is to determine the effects of technology-based complementary feeding training given to mothers during the transition period of babies to complementary feeding on the babies' transition behavior to complementary feeding, their development, and their mothers' anxiety levels.
- Conditions
- Complementary Feeding, Pediatric Nurse
- Being tested
- Transition to traditional complementary feeding
- Keywords
- Complementary feeding, technology-based education, infant, pediatric nursing, baby-led feeding, mother, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition to traditional complementary feedingBehavioural
Five-month-old babies in the complementary feeding phase will be identified. Before starting the training, mothers will fill out an introductory information form for their babies.
Anthropometric measurements of the babies will be taken by the researcher. Mothers will be administered an anxiety scale and a complementary feeding transition behavior scale.
The Denver II screening test will be administered to the babies. Then, the mothers of these babies will be registered in the web-based training system. Training modules will be uploaded to the system according to months. Mothers will complete these training modules. At the end of the training, the anxiety scale will be administered to the mothers again. The Denver II screening test will be administered to the babies again at 9 months.
| Study group | Role | What they receive |
|---|---|---|
| Transition to traditional complementary feeding | Experimental | To determine the effect of web-based traditional complementary feeding education given to mothers of infants during the transition to complementary feeding on the infants' transition behavior, development, and the anxiety levels of their mothers. Receives: Behavioral: Transition to traditional complementary feeding |
| transition to baby-led weaning complementary feeding | Experimental | To determine the effect of web-based, baby-led complementary feeding transition training given to mothers of infants during the complementary feeding transition period on the infants' complementary feeding transition behavior, development, and the anxiety levels of their mothers. Receives: Behavioral: Transition to traditional complementary feeding |
| Control group | Experimental | Five-month-old babies in the complementary feeding period will be identified. Before starting the training, mothers will fill out an introductory information form for their babies.
Anthropometric measurements of the babies will be taken by the researcher. Mothers will be administered an anxiety scale and a complementary feeding transition behavior scale.
The Denver II screening test will be administered to the babies. Then, mothers in the control group will receive routine training on transitioning to complementary feeding at the family health center according to their age in months. At the end of the training, the anxiety scale will be administered to the mothers again. The Denver II screening test will be administered to the babies again at 9 months. Receives: Behavioral: Transition to traditional complementary feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infants' transition to complementary feeding
The infants' transition to complementary feeding will be measured using the 'Complementary Feeding Transition Behavior Scale'.
Measured: 3 months
Secondary outcomes (1)
Growth and development of babies during the transition to complementary feeding.
Anthropometric measurements will be taken of the babies at 6 and 9 months.
The babies' development will be evaluated twice, at the beginning and end of the study, using the Denver II Developmental Screening Test, for which an application certificate is obtained.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complementary Feeding, Pediatric NurseStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A stratified block design was planned for randomization.The strata of the study were defined as the mother's education level and the mother's number of children. Since the study included two education groups and one control group, 3 blocks were planned.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Konukbay, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487493
- Sponsor's protocol ID
- SBU-KONUKBAY-004
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not be able to share the data under the personal data protection laws in our country.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Technology-Based Education Given to Mothers During the Transition to Complementary Feeding on Infant Development, Transition to Complementary Feeding Behavior, and Mothers' Anxiety Levels
- ClinicalTrials.gov ID
- NCT07487493
- Acronym / sponsor ID
- SBU-KONUKBAY-004
- Conditions
- Complementary Feeding, Pediatric Nurse
- Keywords
- Complementary feeding, technology-based education, infant, pediatric nursing, baby-led feeding, mother, anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 23 Mar 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.
This study will be conducted as a randomized controlled pre-test post-test study to determine the effects of technology-based complementary feeding training given to mothers during the transition period of babies to complementary feeding on babies' behavior and development and their mothers' anxiety levels.
Detailed description
Breast milk is the most appropriate food for infant nutrition (1,2,3,4). Starting from the sixth month, complementary feeding begins with the addition of new foods, taking into account the baby's developmental characteristics and needs. The World Health Organization (WHO) recommends exclusive breastfeeding for the first six months, initiating complementary feeding in addition to breast milk from the sixth month onward, and continuing breastfeeding until the age of two and beyond (5,6,7). The World Health Organization defines complementary feeding as "the period of transition to the family table, initiated in the sixth month when exclusive breastfeeding is no longer sufficient to meet the infant's needs, and during which a variety of semi-solid and solid foods are introduced along with breast milk" (8). Nutrition in the first two years of life forms the foundation of health (9,10). Growth and developmental delays that may occur during this period are very difficult to correct in later periods (11,12). The timing of complementary feeding, the way food is prepared, and the variety and proportion of nutrients offered are among the important factors affecting the baby's health (13,14). While inadequate or incorrect practices during complementary feeding increase the baby's risk of hypertension, allergies, type 1 diabetes mellitus, obesity, and growth retardation in later life, these risks can be reduced with timely and correct complementary feeding (15,16,17). The child's emotions should be taken into account during feeding, and feeding habits should be established gradually and patiently, without forcing, and by trying different tastes. To achieve this, responsive and enjoyable complementary feeding should be prioritized (7, 18, 19, 20). In recent years, responsive complementary feeding methods such as baby-led feeding (BLW) have been recommended in addition to traditional complementary feeding methods (21, 22). The WHO emphasizes the importance of responsive feeding, as well as timely and high-quality feeding, for optimal complementary feeding (5, 6, 7, 20, 21, 23, 24). BLW feeding is a baby-friendly alternative feeding method where babies feed themselves with portions of family meals, rather than spoon-fed pureed foods offered by parents during the transition to complementary feeding. BLW feeding is becoming increasingly popular due to its advantages, including reduced risk of obesity, improved nutritional quality, positive parental attitudes toward eating behavior, and support for motor development (7,24,25,26,27,28).
Health education, once provided one-on-one or in groups, can now be delivered in the form of technology-based health education, influenced by the use of the internet (29). The ease of accessibility of technology-based education, the availability of continuous information support at any time and place, and the use of different methods (video, animation, etc.) facilitate the widespread use of these education programs (30). Nurses can effectively provide education and consulting services using web-based education methods (31). Providing mothers with the most up-to-date information and methods regarding the transition to complementary feeding, which lays the foundations for healthy nutrition, is one of the most important duties of healthcare professionals, especially nurses. The transition to complementary feeding can create anxiety in both mothers and babies. A review of the relevant literature indicates that mothers experience anxiety and difficulties during the transition to complementary feeding (32,33). It has been reported that babies of anxious mothers are more likely to experience undernourishment or overnourishment (34). Therefore, evidence-based studies examining infants' transition to complementary feeding behavior, development, and mothers' anxiety levels are needed.
The aim of the study is to determine the effects of technology-based complementary feeding training given to mothers during the transition period of babies to complementary feeding on the babies' transition behavior to complementary feeding, their development, and their mothers' anxiety levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- A stratified block design was planned for randomization.The strata of the study were defined as the mother's education level and the mother's number of children. Since the study included two education groups and one control group, 3 blocks were planned.
| Arm | Type | Receives |
|---|---|---|
| Transition to traditional complementary feeding | Experimental | Behavioral: Transition to traditional complementary feedingTo determine the effect of web-based traditional complementary feeding education given to mothers of infants during the transition to complementary feeding on the infants' transition behavior, development, and the anxiety levels of their mothers. |
| transition to baby-led weaning complementary feeding | Experimental | Behavioral: Transition to traditional complementary feedingTo determine the effect of web-based, baby-led complementary feeding transition training given to mothers of infants during the complementary feeding transition period on the infants' complementary feeding transition behavior, development, and the anxiety levels of their mothers. |
| Control group | Experimental | Behavioral: Transition to traditional complementary feedingFive-month-old babies in the complementary feeding period will be identified. Before starting the training, mothers will fill out an introductory information form for their babies. Anthropometric measurements of the babies will be taken by the researcher. Mothers will be administered an anxiety scale and a complementary feeding transition behavior scale. The Denver II screening test will be administered to the babies. Then, mothers in the control group will receive routine training on transitioning to complementary feeding at the family health center according to their age in months. At the end of the training, the anxiety scale will be administered to the mothers again. The Denver II screening test will be administered to the babies again at 9 months. |
Who may qualify
- Ages
- 5 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Being over 18 years of age, Having at least a primary school diploma, Having internet access at home or at work and being able to use the internet, Being able to speak Turkish, Not having received prior training on complementary feeding. • Mothers who agree to participate in the study will be included in the research.
- Born between 37-42 weeks of gestation, Birth weight between 2500-4000 grams, No congenital anomalies, No chronic or metabolic diseases, No health problems, Babies who have not yet started complementary feeding.
Key exclusion criteria (2 listed)
- Mothers and infants who develop any of the exclusion criteria during the study's implementation and are unable to complete the program will be excluded from the sample.
- -
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 |
|---|---|---|
| Transition to traditional complementary feedingFive-month-old babies in the complementary feeding phase will be identified. Before starting the training, mothers will fill out an introductory information form for their babies. Anthropometric measurements of the babies will be taken by the researcher. Mothers will be administered an anxiety scale and a complementary feeding transition behavior scale. The Denver II screening test will be administered to the babies. Then, the mothers of these babies will be registered in the web-based training system. Training modules will be uploaded to the system according to months. Mothers will complete these training modules. At the end of the training, the anxiety scale will be administered to the mothers again. The Denver II screening test will be administered to the babies again at 9 months. | Behavioural | Control group, Transition to traditional complementary feeding, transition to baby-led weaning complementary feeding |
Primary outcome
Infants' transition to complementary feeding
Time frame: 3 months
The infants' transition to complementary feeding will be measured using the 'Complementary Feeding Transition Behavior Scale'.
1 secondary outcome
Growth and development of babies during the transition to complementary feeding.
Time frame: 3 months
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 23 Mar 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. We will not be able to share the data under the personal data protection laws in our country.
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.
DİLEK KONUKBAY Study Principal Investigator, Saglik Bilimleri Universitesi contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transition to traditional complementary feeding in people with Complementary Feeding, Pediatric Nurse, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi 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 3 inclusion and 2 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 23 Mar 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 DİLEK KONUKBAY, ASSOCIATE PROFESSOR (+90-312-304 39 39, dilek.konukbay@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infants' transition to complementary feeding (time frame: 3 months). 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 23 Mar 2026.