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Not yet recruitingNCT07487493Updated Mar 23, 2026

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

An interventional study of Transition to traditional complementary feeding in Complementary Feeding, Pediatric Nurse, sponsored by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 5 Months to 6 Months. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
5 Months to 6 Months
Sex
All
01

Study 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 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.

02

Conditions studied

  • Complementary Feeding, Pediatric Nurse

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Keywords

  • Complementary feeding, technology-based education, infant, pediatric nursing, baby-led feeding, mother, anxiety
03

In context

Anxiety Disorders

4,864 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.

This study's planned enrollment of 132 is above the median of 80 across 4,170 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi is the lead sponsor of 65 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Months to 6 Months
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

Inclusion criteria for mothers in the study were:

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.

Exclusion Criteria:

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.

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05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
132 participants (estimated)

Study arms

  • Experimental
    Transition to traditional complementary feeding

    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.

    Behavioral: Transition to traditional complementary feeding

  • Experimental
    transition to baby-led weaning complementary feeding

    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.

    Behavioral: Transition to traditional complementary feeding

  • Experimental
    Control group

    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.

    Behavioral: Transition to traditional complementary feeding

Interventions

  • BehavioralTransition to traditional complementary feeding

    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.

06

What researchers measure

Primary outcomes

  1. Infants' transition to complementary feeding

    The infants' transition to complementary feeding will be measured using the 'Complementary Feeding Transition Behavior Scale'.

    Time frame: 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.

    Time frame: 3 months

Other outcomes

  1. Mothers' anxiety levels during the transition to complementary feeding for their babies

    The 'State-Trait Anxiety Scale' will be administered to the mothers of the infants at the beginning and end of the study.

    Time frame: 3 months

07

Study locations

1 site
  • University of Health Sciences Turkey Ankara, Turkey
    Ankara, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — We will not be able to share the data under the personal data protection laws in our country.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07487493
Lead sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Responsible party
Dilek Konukbay (Assistant professor, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi) — Principal investigator
First posted
Mar 23, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Jul 30, 2026 (estimated)
Last update
Mar 23, 2026

Study contacts

DİLEK KONUKBAY, ASSOCIATE PROFESSOR
Contact
dilek.konukbay@yahoo.com
+90-312-304 39 39
DİLEK KONUKBAY Study Principal Investigator, Saglik Bilimleri Universitesi
Contact
dilek.konukbay@yahoo.com
+90-312-304 39 39

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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