Complementary Feeding Education & Fathers

NCT06647875 | Recruiting

• 1 other identifier: IUICH_01
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition, Healthy; Father-Child Relations

Keywords

complementary feeding, father-child relationship

Outcome Measures

Primary Outcomes (2)

• Karitane Parenting Self Confidence Scale

  The Karitane Parenting Self-Confidence Scale (KPSCS), developed by Crncec et al. in 2008 and adapted into Turkish by Yılmaz and Oskay in 2021, is a 15-item scale designed to assess parenting self-efficacy in parents of infants aged 0-12 months. Each item is rated on a 4-point Likert scale ranging from 0 (No, not at all) to 3 (Yes, very often). Higher total scores indicate greater parenting self-efficacy.

  6-month and 9-month infant check-ups

• Paternal-infant attachment scale

  The Father-Infant Bonding Scale (FIB Scale), developed by Condon et al. in 2008 and adapted into Turkish by Güleç et al. in 2010, is a 19-item scale designed to measure the strength of the father-infant bond. The scale consists of three subscales: patience and tolerance, enjoyment of interaction, and love and pride. Each item is rated on a 5-point Likert scale. The scale includes reverse-scored items (items 4, 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 16). Higher total scores indicate a stronger father-infant bond.

  6-month and 9-month infant check-ups

Secondary Outcomes (3)

• The Behavioral Pediatric Feeding Assessment Scale

  6-month and 9-month infant check-ups

• The Generalized Anxiety Disorder-7

  6-month and 9-month infant check-ups

• The Edinburgh Postnatal Depression Scale

  6-month and 9-month infant check-ups

Study Arms (2)

Intervention Group

EXPERIMENTAL

During their infants' 6-month check-up, parents will be administered a demographic survey, the Karitane Parental Self-Efficacy Scale, the Behavioral Pediatric Feeding Assessment Scale, the Edinburgh Postnatal Depression Scale, and the Generalized Anxiety Disorder-7 scale. The Father-Infant Bonding Scale will be administered exclusively to fathers during the same visit. Subsequently, both mothers and fathers in this group will receive complementary feeding education.

Behavioral: Complementary Feeding Education

Control Group

ACTIVE COMPARATOR

During their infants' 6-month check-up, parents will be administered a demographic survey, the Karitane Parental Self-Efficacy Scale, the Behavioral Pediatric Feeding Assessment Scale, the Edinburgh Postnatal Depression Scale, and the Generalized Anxiety Disorder-7 scale. The Father-Infant Bonding Scale will be administered exclusively to fathers during the same visit. Subsequently, only mothers in this group will receive complementary feeding education.

Behavioral: Complementary Feeding Education

Interventions

Complementary Feeding Education BEHAVIORAL

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 Association, specifically the section on "Healthy Eating." At the end of the training, participants will be provided with a booklet containing the "Healthy Eating" section of the Child Health Association's booklet.

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (11)

• 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 BACKGROUND

• 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).

  BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• Güleç D. Examination of the Validity and Reliability of the Father-Infant Attachment Scale in Turkish Society. MS Thesis. Ege University, 2010.

  BACKGROUND

• 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)

  BACKGROUND

• 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 BACKGROUND

• Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

  PMID: 3651732 BACKGROUND

• Crncec R, Barnett B, Matthey S. Development of an instrument to assess perceived self-efficacy in the parents of infants. Res Nurs Health. 2008 Oct;31(5):442-53. doi: 10.1002/nur.20271.

  PMID: 18297638 BACKGROUND

• 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

  BACKGROUND

Related Links

• Konkan R, Senormanci O, Guclu O, Aydin E, Sungur MZ, Generalized Anxiety Disorder-7 (GAD-7) Test: Turkish Adaptation, Validity and Reliability
• Güleç D. Examination of the Validity and Reliability of the Father-Infant Attachment Scale
• Yilmaz B, Oskay Ü. Karitane Parenting Confidence Scale: Turkish Validity and Reliability Study
• Onal S, Calık Var E, Uçar A. Adaptation Study of the Behavioral Pediatric Feeding Assessment Scale (BPFAS) into Turkish

Central Study Contacts

Oyku Ozboru Askan, MD, PhD

CONTACT

+90 212 414 2000; oyku.ozboruaskan@istanbul.edu.tr

Merve Yayla

CONTACT

+902124142000; merveyayla@ogr.iu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants do not know which group they are in
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: December 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)