Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:53 AM
Study NCT ID:
NCT07487493
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "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."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-17', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Mothers' anxiety levels during the transition to complementary feeding for their babies", 'timeFrame': '3 months', 'description': "The 'State-Trait Anxiety Scale' will be administered to the mothers of the infants at the beginning and end of the study."}], 'primaryOutcomes': [{'measure': "Infants' transition to complementary feeding", 'timeFrame': '3 months', 'description': "The infants' transition to complementary feeding will be measured using the 'Complementary Feeding Transition Behavior Scale'."}], 'secondaryOutcomes': [{'measure': 'Growth and development of babies during the transition to complementary feeding.', 'timeFrame': '3 months', 'description': "Anthropometric measurements will be taken of the babies at 6 and 9 months.\n\nThe 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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Complementary feeding, technology-based education, infant, pediatric nursing, baby-led feeding, mother, anxiety'], 'conditions': ['Complementary Feeding, Pediatric Nurse']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/28027215/', 'label': 'Related Info'}, {'url': 'https://pdf.journalagent.com/jaren/pdfs/JAREN-80775-ORIGINAL_RESEARCH-SENER_TAPLAK.pdf', 'label': 'Related Info'}, {'url': 'https://www.google.com/search?client=safari&rls=en&q=Şener+Taplak+A%2C+Polat+S%2C+Erdem+E%2C+Taplak+M.+Annelerin+tamamlayıcı+beslenmeye+geçiş+sürecinde+yaşadıkları+güçlükler%3A+Niteliksel+çalışma.+Jaren.+2020%3B6(2)%3A300-8.&ie=UTF-8&oe=UTF-8', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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).\n\nHealth 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '5 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nInclusion criteria for mothers in the study were:\n\nBeing 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.\n\nThe inclusion criteria for babies were:\n\nBorn 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.\n\nExclusion Criteria:\n\nMothers 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.\n\n\\-"}, 'identificationModule': {'nctId': 'NCT07487493', 'briefTitle': "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", 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'SBU-KONUKBAY-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transition to traditional complementary feeding', 'description': "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.", 'interventionNames': ['Behavioral: Transition to traditional complementary feeding']}, {'type': 'EXPERIMENTAL', 'label': 'transition to baby-led weaning complementary feeding', 'description': "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.", 'interventionNames': ['Behavioral: Transition to traditional complementary feeding']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': '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.\n\nAnthropometric measurements of the babies will be taken by the researcher. Mothers will be administered an anxiety scale and a complementary feeding transition behavior scale.\n\nThe 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.', 'interventionNames': ['Behavioral: Transition to traditional complementary feeding']}], 'interventions': [{'name': 'Transition to traditional complementary feeding', 'type': 'BEHAVIORAL', 'description': '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.\n\nAnthropometric measurements of the babies will be taken by the researcher. Mothers will be administered an anxiety scale and a complementary feeding transition behavior scale.\n\nThe 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.', 'armGroupLabels': ['Control group', 'Transition to traditional complementary feeding', 'transition to baby-led weaning complementary feeding']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'University of Health Sciences Turkey Ankara, Turkey', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'DİLEK KONUKBAY, ASSOCIATE PROFESSOR', 'role': 'CONTACT', 'email': 'dilek.konukbay@yahoo.com', 'phone': '+90-312-304 39 39'}, {'name': 'DİLEK KONUKBAY Study Principal Investigator, Saglik Bilimleri Universitesi', 'role': 'CONTACT', 'email': 'dilek.konukbay@yahoo.com', 'phone': '+90-312-304 39 39'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will not be able to share the data under the personal data protection laws in our country.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Dilek Konukbay', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi'}}}}