Clinical trial NCT06647875: Complementary Feeding Education & Fathers
Official title: The Impact of Complementary Feeding Education Given to Fathers on Father-Infant Relationship and Infant Feeding Behavior
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nutrition, Healthy
Father-Child Relations
Keywords: complementary feeding, father-child relationship
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

Brief summary: 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.

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

Primary outcomes:
measure: Karitane Parenting Self Confidence Scale
timeFrame: 6-month and 9-month infant check-ups
measure: Paternal-infant attachment scale
timeFrame: 6-month and 9-month infant check-ups
Secondary outcomes:
measure: The Behavioral Pediatric Feeding Assessment Scale
timeFrame: 6-month and 9-month infant check-ups
measure: The Generalized Anxiety Disorder-7
timeFrame: 6-month and 9-month infant check-ups
measure: The Edinburgh Postnatal Depression Scale
timeFrame: 6-month and 9-month infant check-ups
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
References:
citation: 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/
citation: 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).
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citation: Condon, J. T., Corkindale, C. J., & Boyce, P., (2008). Assessment of postnatal paternal-infant attachment: development of a questionnaire instrument. Journal of Reproductive and Infant Psychology, 26(3), 195-210. https://doi.org/10.1080/02646830701691335