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Recruiting NCT06647875

Complementary Feeding Education & Fathers

No phase Interventional Nutrition, Healthy Father-Child Relations

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Complementary Feeding Education.
Who it may be relevant to
Registry conditions: Nutrition, Healthy, Father-Child Relations. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Impact of Complementary Feeding Education Given to Fathers on Father-Infant Relationship and Infant Feeding Behavior

Overview

The aim of this study is to investigate the effect of complementary feeding education provided to fathers on father-infant bonding and infant feeding behavior. To assess father-infant bonding, the study will use the Father-Infant Bonding Scale and the Karitane Parenting Self-Efficacy Scale. For assessing infant feeding behavior, the Behavioral Pediatric Feeding Assessment Scale will be employed. These scales will be administered to participants both before and 3 months after the training.

Detailed description

The study aims to investigate the effects of complementary feeding education provided to fathers on father-infant bonding and infant feeding behavior.

This prospective, non-randomized controlled study was conducted with the parents of 6-month-old infants followed up at the Child Health Monitoring Polyclinic of the Department of Social Pediatrics, Department of Child Health and Diseases, Istanbul Faculty of Medicine, Istanbul University. After being informed about the study and giving written consent, the parents of the infants included in the study were stratified according to the father's education level, birth order of the child, and self-efficacy scale scores, and then in order of admission to hospital assigned to the study and control groups. Infants born at term, exclusively breastfed for the first 6 months, without chronic diseases, and whose parents lived together were included in the study. Exclusion criteria included: food allergy, developmental milestones not appropriate for age, known swallowing dysfunction, psychiatric illness of either parent, a chronic illness in a sibling, adoption, and refusal to give consent.

During the 6-month check-up, parents who agreed to participate in the study completed a demographic questionnaire, the Karitane Parenting Self-Efficacy Scale (KPSCS), the Behavioral Pediatric Feeding Assessment Scale (BPFAS), the Edinburgh Postnatal Depression Scale (EPDS), and the Generalized Anxiety Disorder-7 (GAD-7) scale. The Father-Infant Bonding Scale (FIB Scale) was administered only to fathers during the same examination.

In the study group, both mothers and fathers received complementary feeding education, while in the control group, only mothers received the education. The education was based on the WHO Guideline for Complementary Feeding of Infants and Young Children 6-23 Months of Age and was delivered both in-person and via tablet. To make the education more understandable, infographics and visuals prepared using the WHO Guideline for Complementary Feeding of Infants and Young Children 6-23 Months of Age and the Basic Information for Families on Child Health and Safety in the First 5 Years booklet of the Child Health Association. At the end of the training, participants were given a booklet containing the infographics from the "Basic Information for Families on Child Health and Safety in the First 5 Years" booklet of the TChild Health Association.

At the 9-month follow-up, the KPSCS, EPDS, BPFAS, and GAD-7 scales were administered to both mothers and fathers, and the FIB Scale was administered only to fathers.

Interventions

  • Behavioral Complementary Feeding Education
    This training program has been designed in accordance withWHO Guideline for Complementary Feeding of Infants and Young Children 6-23 Months of Age. The training will be delivered both in-person and via tablet, and will be supported by infographics and visuals created using WHO Guideline for Complementary Feeding of Infants and Young Children 6-23 Months of Age and the "Basic Information for Families on Child Health and Safety in the First 5 Years" booklet published by the Child Health Associatio

Primary outcome measures

  • Karitane Parenting Self Confidence Scale [Time frame: 6-month and 9-month infant check-ups]
  • Paternal-infant attachment scale [Time frame: 6-month and 9-month infant check-ups]
Secondary outcome measures (3)
  • The Behavioral Pediatric Feeding Assessment Scale [Time frame: 6-month and 9-month infant check-ups]
  • The Generalized Anxiety Disorder-7 [Time frame: 6-month and 9-month infant check-ups]
  • The Edinburgh Postnatal Depression Scale [Time frame: 6-month and 9-month infant check-ups]

Eligibility criteria

Inclusion criteria

  • Infant born at term (>37 weeks)
  • Exclusively breastfed for the first 6 months and has completed postnatal month 6
  • Both parents live together
  • Infant feeding is done by mother, mother and father together, grandmother, or caregiver
  • Infant has no chronic disease

Exclusion criteria

  • Infant has a chronic disease
  • Infant has a known food allergy
  • Developmental milestones are not age-appropriate
  • Known swallowing dysfunction
  • Either parent has a psychiatric illness
  • Sibling has a chronic disease if applicable
  • Child is adopted
  • Consent is not given

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul University — Istanbul

Publications

  • WHO Guideline for complementary feeding of infants and young children 6-23 months of age [Internet]. Geneva: World Health Organization; 2023. Available from http://www.ncbi.nlm.nih.gov/books/NBK596427/ PMID 37871145
  • Gökçay G, Keskindemirci G, Mutlu D, Sapmaz S. Basic Information for Families on Child Health and Safety in the First 5 Years. Healthy Nutrition, Istanbul (2021).
  • Onal S, Calık Var E, Uçar A. Adaptation Study of the Behavioral Pediatric Feeding Assessment Scale (BPFAS) into Turkish. Nevşehir Journal of Science and Technology. 2017;6(1):93-101. doi:10.17100/nevbiltek.296685
  • Engindeniz N. Validity and Reliability Study for the Turkish Version of the Edinburgh Postnatal Depression Scale. Unpublished Master's Thesis, Ege University Institute of Health Sciences; 1996.
  • Yilmaz B, Oskay Ü. Karitane Parenting Confidence Scale: Turkish Validity and Reliability Study. Cukurova Medical Journal. 2021;46(2):801-813. doi:10.17826/cumj.902521
  • Güleç D. Examination of the Validity and Reliability of the Father-Infant Attachment Scale in Turkish Society. MS Thesis. Ege University, 2010.
  • Konkan R, Senormanci O, Guclu O, Aydin E, Sungur MZ, Generalized Anxiety Disorder-7 (GAD-7) Test: Turkish Adaptation, Validity and Reliability. Archives of Neuropsychiatry/Noropsychiatri Arsivi 50.1 (2013)
  • Crist W, Dobbelsteyn C, Brousseau AM, Napier-Phillips A. Pediatric assessment scale for severe feeding problems: validity and reliability of a new scale for tube-fed children. Nutr Clin Pract. 2004 Aug;19(4):403-8. doi: 10.1177/0115426504019004403. PMID 16215132

Identifiers

NCT: NCT06647875 · IUICH_01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗