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NCT Number: NCT06647875

Complementary Feeding Education & Fathers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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'

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Merve Yayla

CONTACT

[email protected]

+902124142000 ext. 30468

Oyku Ozboru Askan, MD, PhD

CONTACT

[email protected]

+90 212 414 2000 ext. 30469

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 18, 2024
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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