Feeding DisordersNCT05664529
Mother-Child Interactions During Feeding
An observational study of Feeding Disorders and Mother-Child Relations, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The feeding process is based on a mutual relationship and interaction, as it takes place with the active participation of the child and the parent. Feeding problems are among the most common behavioral problems in early childhood. Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Feeding Disorders, Mother-Child Relations, Feeding; Disorder, Nonorganic Origin, in (Very Young) Child
- What is being tested?
- Chatoor Feeding Scale
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: healthy children aged between 6-36 months and their parents
Who may be able to join
- healthy children 6-36 months of age from outpatient pediatric clinics with parents willing to participate into the study
Who cannot join
- Children with chronic diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine
Istanbul
About this study
Official title: Evaluation of Mother-Child Interactions During Feeding in Toddlers
The feeding process is based on a mutual relationship and interaction, as it takes place with the active participation of the child and the parent. Feeding problems are among the most common behavioral problems in early childhood. Inappropriate eating habits can cause growth retardation, unhealthy food preferences, and obesity. Parent-child interaction during feeding is particularly important in developing healthy feeding behavior.
The aim of this study is to evaluate the interaction between mother and child during feeding, by using the Feeding Scale in Turkish children aged 6-36 months.
A cross sectional, observational study will be conducted to explore mother-child relationship during feeding period by using Chatoor Feeding Scale.
Read the detailed description
Healthy feeding practices are particularly important in the early childhood due to rapid growth. Between 25 and 40% of healthy infants, and 80% of infants with a health problem have feeding problems. Almost 50% of mothers complain that at least one of their children eats inadequate amount of food. Feeding problems in early childhood includes prolonged, disruptive and stressful mealtimes, food refusal, lack of appropriate independent feeding, nocturnal eating, distraction to increase intake and prolonged breast or bottle feeding.
Eating behavior is a social process, also have a biological aspect. After excluding organic causes of feeding problems, family's attitude, roles and expectations must be examined. The determination of family responsibilities, feeding habits, life styles, perceptions and concerns can be guidance for understanding of feeding difficulties.
Mothers are primarily responsible for child care and feeding process traditionally. Many factors such as mother's knowledge about feeding, cultural believes, workload, media effect, psychological symptoms, child's temperament, time spent together are important points on feeding process.
Verbal and non-verbal communication methods can be learned by the observation of family members at the mealtime. Eating disorder of the child and depression of the mother can be related to each other. Anxiety level, anger, lack of empathy and also child's irritability and negative mood can disturb interaction during feeding. As a result of unresponsiveness to child's eating skills and signals, food refusal can be seen. Oppressive and restrictive style can trigger different pathological conditions related with feeding process.
Mother-child interactions in the etiology of feeding disorders has been investigated by a series of studies. The initial studies used nonorganic failure to thrive (NOFTT) as a diagnosis for children younger than 3 years of age who were unable to gain weight inadequately due to behavioral problems related to feeding. Some other "behavioral style" studies also suggested to use Mealtime Observation Schedule, DSM-IV (Diagnostic and Statistical Manual) Criteria, Diagnostic Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood-Revised Edition (DC:0-3R) as a diagnostic category of feeding disorder of infancy or early childhood. Feeding Scale developed by Chatoor is a useful tool to evaluate mother-child interactions during feeding.
This study is designed to observe and evaluate the relationship between child and mother during feeding at home in the transition to complementary feeding.
Our primary objective is to examine the mother infant relationship by using the Feeding Scale in infants aged 6 to 36 months. Parents of children aged between 6 and 36 months examined in Marmara University Hospital Pediatrics outpatient clinics will be informed about the study, and informed consent will be obtained on a voluntary basis if they wish to participate. A home video record during a regular mealtime will be requested from mothers. Mother will be instructed to feed the baby as she always does and record the mealtime by video or phone without distracting the baby. If the child still wishes to continue feeding after 20 minutes, the video recording will be allowed to continue until the mother ends the mealtime. However, in the scale evaluation, only the interactions in the first 20 minutes will be scored.
It is aimed to divide the intended audience into age groups according to developmental age groups. Therefore, a total of 120 mother-infant couples (dyads) including 30 children between 6-12 months, 30 children between 12-18 months, 30 children between 18-24 months and 30 children between 24-36 months will be targeted to include in the study.
Secondary objectives are to examine other factors affecting mother-infant relationship during feeding, such as neurodevelopment (assessed by Denver II), maternal anxiety (Generalized Anxiety Disorder-7), maternal depression (Edinburgh postpartum depression scale), postpartum bonding (The Postpartum Bonding Questionnaire) and baby sleep (Brief infant sleep questionnaire).
- Conditions
- Feeding Disorders, Mother-Child Relations, Feeding; Disorder, Nonorganic Origin, in (Very Young) Child, Postpartum Depression
- Being tested
- Chatoor Feeding Scale
- Keywords
- child, feeding disorders, maternal depression
- Medical subject headings
- Feeding and Eating Disorders, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chatoor Feeding ScaleDiagnostic test
Chatoor Feeding Scale will be used to evaluate mother infant relationship during feeding. Mothers will be asked to record a natural feeding session at home by video. The videos will be sent to the investigators by the parents. The first 20 minutes of the video will be evaluated for scoring.
| Study group | Role | What they receive |
|---|---|---|
| healthy children aged 6-36 months | 120 healthy children with or without any feeding difficulties reported by the mothers will be included. A 20-minute videotaped feeding session will be evaluated by Chatoor Feeding Scale to examine mother-infant relationship during feeding. Receives: Diagnostic Test: Chatoor Feeding Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feeding Scale scores
Chatoor Feeding Scale will be used to evaluate mother-infant relationship during feeding. 20-minute at home videotaped feeding session will be evaluated. The Feeding Scale is composed of 46 items scored on a 4-point Likert scale (from 0 o 3) of how often and how intensely each of the behaviors occurred. The scale is composed of five subscales: Factor I (Dyadic Reciprocity) was a positive behavior while the remaining four factors (Dyadic Conflict, Talk and distraction, Struggle for Control, Maternal Non- Contingency) reflected negative behaviors. Unit scores were summed to produce factor scores and a high score for all factors reflect higher amounts of the behavior.
Measured: baseline
Secondary outcomes (4)
Generalized Anxiety Disorder questionnaire-7 scores of mothers
It is a seven item scale developed to screen for anxiety in general in primary care settings. The questionnaire score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. Cut off score for Turkish validation has been set at 8.
Measured: baseline
Edinburgh postnatal depression scale (EPDS) scores of mothers
Maternal depression will be measured by Edinburgh postnatal depression scale (EPDS). This is a 10-item self-administered scale (scores of 0,1,2 and 3), developed for detection of symptoms of psychosocial distress during pregnancy and in the postnatal period. The tool has been validated to Turkish. A score of >12 's at as the cut off point.
Measured: baseline
The Postpartum Bonding Questionnaire
The scale consists of 25 items, with four factors. The first factor was labelled general emotional factor, the second anger towards and rejection of baby; the third infant-focus anxiety; and the fourth, risk of abuse. The scale was found reliable in Turkish.
Measured: baseline
Parental report of infant sleep patterns using the Brief Infant Sleep Questionnaire
Infant sleep parameters will be measured by Expanded-Brief Infant Sleep Questionnaire (BISQ) : BISQ is a screening questionnaire for sleep in infants and young children. Variables include nocturnal sleep duration, daytime sleep duration, number of night wakenings, duration of night time wakefulness, nocturnal sleep onset time, settling time, method of falling asleep, location of sleep.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 Aug 2022
- Primary completion1 Sep 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Feeding DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Perran Boran, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664529
- Sponsor's protocol ID
- 09.2022.585
- Status last verified
- Aug 2024
- First submitted
- 16 Dec 2022
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Requests for wider sharing of data (for example in response to information on the, Marmara University webpages and in publications about the study and willingness to share), will be addressed on a case-by-case basis. Any data sharing request will be made to investigators through a pre-defined data requisition form. This form will contain information about the applicant, institution, purpose of data request, study objectives, ethical clearance of the study, etc. Once a request has been made the data governance body will discuss if that request was appropriate and meets the criteria set by the participating centres; data will be released following signing of the data sharing agreement. The data will be stored on the Marmara University servers and not be deposited in any 'community' database.
Publications
Chatoor I, Hommel S, Sechi C, Lucarelli L. DEVELOPMENT OF THE PARENT-CHILD PLAY SCALE FOR USE IN CHILDREN WITH FEEDING DISORDERS. Infant Ment Health J. 2018 Mar;39(2):153-169. doi: 10.1002/imhj.21702. Epub 2018 Feb 27.
PubMed 29485687Reisz S, Aviles AI, Messina S, Duschinsky R, Jacobvitz D, Hazen N. Fathers' attachment representations and infant feeding practices. Appetite. 2019 Nov 1;142:104374. doi: 10.1016/j.appet.2019.104374. Epub 2019 Jul 22.
PubMed 31344420Wendt V, Bergmann S, Herfurth-Majstorovic K, Keitel-Korndorfer A, von Klitzing K, Klein AM. Parent-child interaction during feeding or joint eating in parents of different weights. Eat Behav. 2015 Aug;18:131-6. doi: 10.1016/j.eatbeh.2015.04.007. Epub 2015 May 10.
PubMed 26051882Cerniglia L, Cimino S, Ballarotto G. Mother-child and father-child interaction with their 24-month-old children during feeding, considering paternal involvement and the child's temperament in a community sample. Infant Ment Health J. 2014 Sep-Oct;35(5):473-81. doi: 10.1002/imhj.21466. Epub 2014 Aug 13.
PubMed 25798497Chatoor I, Sechi C, Vismara L, Lucarelli L. A cross-sectional study of father-daughter/son interactions from 1 Month to 3 years of age with the feeding and play scales: Exploring the psychometric properties. Appetite. 2022 Jan 1;168:105671. doi: 10.1016/j.appet.2021.105671. Epub 2021 Sep 1.
PubMed 34481013
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mother-Child Interactions During Feeding in Toddlers
- ClinicalTrials.gov ID
- NCT05664529
- Acronym / sponsor ID
- 09.2022.585
- Conditions
- Feeding Disorders, Mother-Child Relations, Feeding; Disorder, Nonorganic Origin, in (Very Young) Child, Postpartum Depression
- Keywords
- child, feeding disorders, maternal depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The feeding process is based on a mutual relationship and interaction, as it takes place with the active participation of the child and the parent. Feeding problems are among the most common behavioral problems in early childhood. Inappropriate eating habits can cause growth retardation, unhealthy food preferences, and obesity. Parent-child interaction during feeding is particularly important in developing healthy feeding behavior.
The aim of this study is to evaluate the interaction between mother and child during feeding, by using the Feeding Scale in Turkish children aged 6-36 months.
A cross sectional, observational study will be conducted to explore mother-child relationship during feeding period by using Chatoor Feeding Scale.
Detailed description
Healthy feeding practices are particularly important in the early childhood due to rapid growth. Between 25 and 40% of healthy infants, and 80% of infants with a health problem have feeding problems. Almost 50% of mothers complain that at least one of their children eats inadequate amount of food. Feeding problems in early childhood includes prolonged, disruptive and stressful mealtimes, food refusal, lack of appropriate independent feeding, nocturnal eating, distraction to increase intake and prolonged breast or bottle feeding.
Eating behavior is a social process, also have a biological aspect. After excluding organic causes of feeding problems, family's attitude, roles and expectations must be examined. The determination of family responsibilities, feeding habits, life styles, perceptions and concerns can be guidance for understanding of feeding difficulties.
Mothers are primarily responsible for child care and feeding process traditionally. Many factors such as mother's knowledge about feeding, cultural believes, workload, media effect, psychological symptoms, child's temperament, time spent together are important points on feeding process.
Verbal and non-verbal communication methods can be learned by the observation of family members at the mealtime. Eating disorder of the child and depression of the mother can be related to each other. Anxiety level, anger, lack of empathy and also child's irritability and negative mood can disturb interaction during feeding. As a result of unresponsiveness to child's eating skills and signals, food refusal can be seen. Oppressive and restrictive style can trigger different pathological conditions related with feeding process.
Mother-child interactions in the etiology of feeding disorders has been investigated by a series of studies. The initial studies used nonorganic failure to thrive (NOFTT) as a diagnosis for children younger than 3 years of age who were unable to gain weight inadequately due to behavioral problems related to feeding. Some other "behavioral style" studies also suggested to use Mealtime Observation Schedule, DSM-IV (Diagnostic and Statistical Manual) Criteria, Diagnostic Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood-Revised Edition (DC:0-3R) as a diagnostic category of feeding disorder of infancy or early childhood. Feeding Scale developed by Chatoor is a useful tool to evaluate mother-child interactions during feeding.
This study is designed to observe and evaluate the relationship between child and mother during feeding at home in the transition to complementary feeding.
Our primary objective is to examine the mother infant relationship by using the Feeding Scale in infants aged 6 to 36 months. Parents of children aged between 6 and 36 months examined in Marmara University Hospital Pediatrics outpatient clinics will be informed about the study, and informed consent will be obtained on a voluntary basis if they wish to participate. A home video record during a regular mealtime will be requested from mothers. Mother will be instructed to feed the baby as she always does and record the mealtime by video or phone without distracting the baby. If the child still wishes to continue feeding after 20 minutes, the video recording will be allowed to continue until the mother ends the mealtime. However, in the scale evaluation, only the interactions in the first 20 minutes will be scored.
It is aimed to divide the intended audience into age groups according to developmental age groups. Therefore, a total of 120 mother-infant couples (dyads) including 30 children between 6-12 months, 30 children between 12-18 months, 30 children between 18-24 months and 30 children between 24-36 months will be targeted to include in the study.
Secondary objectives are to examine other factors affecting mother-infant relationship during feeding, such as neurodevelopment (assessed by Denver II), maternal anxiety (Generalized Anxiety Disorder-7), maternal depression (Edinburgh postpartum depression scale), postpartum bonding (The Postpartum Bonding Questionnaire) and baby sleep (Brief infant sleep questionnaire).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy children aged 6-36 months | – | Diagnostic Test: Chatoor Feeding Scale120 healthy children with or without any feeding difficulties reported by the mothers will be included. A 20-minute videotaped feeding session will be evaluated by Chatoor Feeding Scale to examine mother-infant relationship during feeding. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- healthy children aged between 6-36 months and their parents
Key inclusion criteria (1 listed)
- healthy children 6-36 months of age from outpatient pediatric clinics with parents willing to participate into the study
Key exclusion criteria (1 listed)
- Children with chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chatoor Feeding ScaleChatoor Feeding Scale will be used to evaluate mother infant relationship during feeding. Mothers will be asked to record a natural feeding session at home by video. The videos will be sent to the investigators by the parents. The first 20 minutes of the video will be evaluated for scoring. | Diagnostic test | healthy children aged 6-36 months |
Primary outcome
Feeding Scale scores
Time frame: baseline
Chatoor Feeding Scale will be used to evaluate mother-infant relationship during feeding. 20-minute at home videotaped feeding session will be evaluated. The Feeding Scale is composed of 46 items scored on a 4-point Likert scale (from 0 o 3) of how often and how intensely each of the behaviors occurred. The scale is composed of five subscales: Factor I (Dyadic Reciprocity) was a positive behavior while the remaining four factors (Dyadic Conflict, Talk and distraction, Struggle for Control, Maternal Non- Contingency) reflected negative behaviors. Unit scores were summed to produce factor scores and a high score for all factors reflect higher amounts of the behavior.
4 secondary outcomes
Generalized Anxiety Disorder questionnaire-7 scores of mothers
Time frame: baseline
Edinburgh postnatal depression scale (EPDS) scores of mothers
Time frame: baseline
The Postpartum Bonding Questionnaire
Time frame: baseline
Parental report of infant sleep patterns using the Brief Infant Sleep Questionnaire
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 29485687Chatoor I, Hommel S, Sechi C, Lucarelli L. DEVELOPMENT OF THE PARENT-CHILD PLAY SCALE FOR USE IN CHILDREN WITH FEEDING DISORDERS. Infant Ment Health J. 2018 Mar;39(2):153-169. doi: 10.1002/imhj.21702. Epub 2018 Feb 27.
- Background: PubMed 31344420Reisz S, Aviles AI, Messina S, Duschinsky R, Jacobvitz D, Hazen N. Fathers' attachment representations and infant feeding practices. Appetite. 2019 Nov 1;142:104374. doi: 10.1016/j.appet.2019.104374. Epub 2019 Jul 22.
- Background: PubMed 26051882Wendt V, Bergmann S, Herfurth-Majstorovic K, Keitel-Korndorfer A, von Klitzing K, Klein AM. Parent-child interaction during feeding or joint eating in parents of different weights. Eat Behav. 2015 Aug;18:131-6. doi: 10.1016/j.eatbeh.2015.04.007. Epub 2015 May 10.
- Background: PubMed 25798497Cerniglia L, Cimino S, Ballarotto G. Mother-child and father-child interaction with their 24-month-old children during feeding, considering paternal involvement and the child's temperament in a community sample. Infant Ment Health J. 2014 Sep-Oct;35(5):473-81. doi: 10.1002/imhj.21466. Epub 2014 Aug 13.
- Background: PubMed 34481013Chatoor I, Sechi C, Vismara L, Lucarelli L. A cross-sectional study of father-daughter/son interactions from 1 Month to 3 years of age with the feeding and play scales: Exploring the psychometric properties. Appetite. 2022 Jan 1;168:105671. doi: 10.1016/j.appet.2021.105671. Epub 2021 Sep 1.
- Individual participant dataSharing planned: No. Requests for wider sharing of data (for example in response to information on the, Marmara University webpages and in publications about the study and willingness to share), will be addressed on a case-by-case basis. Any data sharing request will be made to investigators through a pre-defined data requisition form. This form will contain information about the applicant, institution, purpose of data request, study objectives, ethical clearance of the study, etc. Once a request has been made the data governance body will discuss if that request was appropriate and meets the criteria set by the participating centres; data will be released following signing of the data sharing agreement. The data will be stored on the Marmara University servers and not be deposited in any 'community' database.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Perran Boran principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Feeding Disorders and Mother-Child Relations, run by Marmara 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feeding Scale scores (time frame: baseline). 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 NCT05664529, which also lists 5 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 20 Aug 2024.