Complementary Feeding Education & Fathers

October 17, 2024 updated by: Oyku Ozboru Askan, Istanbul University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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
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.
Active Comparator: Control Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Karitane Parenting Self Confidence Scale
Time Frame: 6-month and 9-month infant check-ups
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
Time Frame: 6-month and 9-month infant check-ups
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Behavioral Pediatric Feeding Assessment Scale
Time Frame: 6-month and 9-month infant check-ups
The Behavioral Pediatric Feeding Assessment Scale (BPFAS), developed by Crist and colleagues and adapted into Turkish by Önal and colleagues, is a 35-item scale. The scale primarily focuses on the child's feeding behavior, with 25 items specifically addressing the child's feeding status. The Turkish adaptation study concentrated solely on these 25 items. Items on the scale are rated on a 5-point Likert scale. Among the 25 items related to children, 6 are positively worded (items 1, 3, 5, 6, 9, and 16) while 19 are negatively worded. Positively worded items are scored in reverse. The minimum possible score on the BPFAS is 35, and the maximum is 175. Higher scores indicate more severe feeding problems and habits. The scale includes four items related to specific feeding difficulties: 'Food selectivity', 'Early food refusal', 'Early refusal of textured foods', and 'Late food refusal'
6-month and 9-month infant check-ups
The Generalized Anxiety Disorder-7
Time Frame: 6-month and 9-month infant check-ups
The Generalized Anxiety Disorder-7 Item Scale (GAD-7), developed by Spitzer et al. in 2006 and adapted into Turkish by Konkan et al. in 2011, is a 7-item, 4-point Likert scale designed to assess the severity of generalized anxiety disorder (GAD) over the past two weeks. Cut-off scores of 5, 10, and 15 represent mild, moderate, and severe anxiety, respectively. When a total score cutoff of 10 is used, the scale demonstrates a sensitivity of 89% and a specificity of 82% for diagnosing GAD.
6-month and 9-month infant check-ups
The Edinburgh Postnatal Depression Scale
Time Frame: 6-month and 9-month infant check-ups
The Edinburgh Postnatal Depression Scale (EPDS), adapted into Turkish by Engindeniz, is a 10-item self-report questionnaire designed to assess symptoms of postnatal depression. Responses are scored on a 4-point Likert scale ranging from 0 to 3, with a total possible score of 30. Items 1, 2, and 4 are scored in a direct manner (0, 1, 2, 3), while items 3, 5, 6, 7, 8, 9, and 10 are reverse-scored (3, 2, 1, 0). A cutoff score of 13 is commonly used to identify women at risk for postnatal depression. Women scoring 13 or above are considered to be at risk.
6-month and 9-month infant check-ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

October 16, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 17, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IUICH_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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