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Nutrition, HealthyNCT06647875

Complementary Feeding Education & Fathers

A study testing Complementary Feeding Education in people with Nutrition, Healthy and Father-Child Relations, run by Istanbul University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Nutrition, Healthy, Father-Child Relations
What is being tested?
Complementary Feeding Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2023to 1 Jul 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Oyku Ozboru Askan, MD, PhD contact

+90 212 414 2000 ext. 30469

oyku.ozboruaskan@istanbul.edu.tr

Merve Yayla contact

+902124142000 ext. 30468

merveyayla@ogr.iu.edu.tr

Turkey (Türkiye)1 site, 1 recruiting

  • Istanbul University

    Istanbul

    Oyku Ozboru Askan, +90 212 414 2000 ext. 31547, oyku.ozboruaskan@istanbul.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Complementary Feeding Education
Keywords
complementary feeding, father-child relationship

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Complementary Feeding EducationBehavioural

    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.

Study groups in NCT06647875
Study groupRoleWhat they receive
Intervention GroupExperimentalDuring 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.
Receives: Behavioral: Complementary Feeding Education
Control GroupActive comparatorDuring 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.
Receives: Behavioral: Complementary Feeding Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6-month and 9-month infant check-ups

  2. 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.

    Measured: 6-month and 9-month infant check-ups

Secondary outcomes (3)

  1. The Behavioral Pediatric Feeding Assessment Scale

    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'

    Measured: 6-month and 9-month infant check-ups

  2. The Generalized Anxiety Disorder-7

    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.

    Measured: 6-month and 9-month infant check-ups

  3. The Edinburgh Postnatal Depression Scale

    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.

    Measured: 6-month and 9-month infant check-ups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2024
  2. Study start1 Dec 2023
  3. Primary completion1 May 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Participant
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06647875
Sponsor's protocol ID
IUICH_01
Status last verified
Oct 2024
First submitted
16 Oct 2024
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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/

    PubMed 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.

    PubMed 16215132

  • 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.

    PubMed 3651732

  • 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.

    PubMed 18297638

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Complementary Feeding Education in people with Nutrition, Healthy and Father-Child Relations, run by Istanbul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Oyku Ozboru Askan, MD, PhD (+90 212 414 2000 ext. 30469, oyku.ozboruaskan@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Karitane Parenting Self Confidence Scale (time frame: 6-month and 9-month infant check-ups). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06647875, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.

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