Feeding DisordersNCT04130880
Turkish Montreal Children's Hospital Feeding Scale
An observational study of Feeding Disorders, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to test the reliability and validity of the Turkish Montreal Children's Hospital Feeding Scale. Read more about this study
- Who is it for?
- Ages 18 months to 6 years
- Conditions the study is for
- Feeding Disorders
- What is being tested?
- Turkish Montreal Children's Hospital Feeding Scale
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Oct 2019to 15 Dec 2019
- 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 18 months to 6 years
- All sexes
- Child
Study population: Children with cerebral palsy and Children with typical development
Who may be able to join
- Children with cerebral palsy
- Children with typical development
- Aged between 18 months- 6 years
Who cannot join
- Who aged under the age of 18 months and above the age of 6 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability and Validity of the Turkish Montreal Children's Hospital Feeding Scale
The purpose of this study is to test the reliability and validity of the Turkish Montreal Children's Hospital Feeding Scale.
Read the detailed description
The purpose of this study is to test the reliability and validity of the Turkish Montreal Children's Hospital Feeding Scale. The internal consistency, test-retest reliability, and criterion validity of Turkish Montreal Children's Hospital Feeding Scale will be investigated. The internal consistency will be assessed using Cronbach's alpha. Intraclass correlation coefficient (ICC) value with 95 % confidence intervals will be calculated for test-retest reliability. The criterion validity of the scale will be determined by assessing the correlation between the Turkish Montreal Children's Hospital Feeding Scale and Behavioral Pediatrics Feeding Assessment Scale.
- Conditions
- Feeding Disorders
- Being tested
- Turkish Montreal Children's Hospital Feeding Scale
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish Montreal Children's Hospital Feeding ScaleDiagnostic test
The Turkish version of the Montreal Children's Hospital Feeding Scale, and the Behavioral Pediatrics Feeding Assessment Scale will be completed.
| Study group | Role | What they receive |
|---|---|---|
| Children with cerebral palsy | Children with CP who aged between 18 months and 6 years will be evaluated. Receives: Diagnostic Test: Turkish Montreal Children's Hospital Feeding Scale | |
| Children with typical development | Children with typical development who aged between 18 months and 6 years will be evaluated. Receives: Diagnostic Test: Turkish Montreal Children's Hospital Feeding Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Children's Hospital Feeding Scale
The Montreal Children's Hospital Feeding Scale is used to evaluate feeding disorders. It has 14 items which are scored on a 7 point Likert scale. Seven items are scored from the negative to positive direction, and the other seven from the positive to negative direction. The primary feeder marks each item according to frequency or difficulty level of a particular behaviour or the level of parental concern. The total feeding problem score is obtained by adding the scores for each item after reversing the scores of seven items from negative to positive.
Measured: 2 months
Secondary outcomes (1)
Behavioral Pediatrics Feeding Assessment Scale
The Behavioral Pediatrics Feeding Assessment Scale is a widely used parent-report measure of mealtime and feeding behavior. It has 35 items.Greater overall scores indicate higher levels of problematic mealtime and feeding behavior.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start29 Oct 2019
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding DisordersStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgü İNAL, Hacettepe University
- Investigators
- ÖZGÜ İNAL, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130880
- Sponsor's protocol ID
- Turkish Montreal
- Status last verified
- Feb 2020
- First submitted
- 16 Oct 2019
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Montreal Children's Hospital Feeding Scale
- ClinicalTrials.gov ID
- NCT04130880
- Acronym / sponsor ID
- Turkish Montreal
- Conditions
- Feeding Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 18 Oct 2019 (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 purpose of this study is to test the reliability and validity of the Turkish Montreal Children's Hospital Feeding Scale.
Detailed description
The purpose of this study is to test the reliability and validity of the Turkish Montreal Children's Hospital Feeding Scale. The internal consistency, test-retest reliability, and criterion validity of Turkish Montreal Children's Hospital Feeding Scale will be investigated. The internal consistency will be assessed using Cronbach's alpha. Intraclass correlation coefficient (ICC) value with 95 % confidence intervals will be calculated for test-retest reliability. The criterion validity of the scale will be determined by assessing the correlation between the Turkish Montreal Children's Hospital Feeding Scale and Behavioral Pediatrics Feeding Assessment Scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with cerebral palsy | – | Diagnostic Test: Turkish Montreal Children's Hospital Feeding ScaleChildren with CP who aged between 18 months and 6 years will be evaluated. |
| Children with typical development | – | Diagnostic Test: Turkish Montreal Children's Hospital Feeding ScaleChildren with typical development who aged between 18 months and 6 years will be evaluated. |
Who may qualify
- Ages
- 18 months to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- Children with cerebral palsy and Children with typical development
Key inclusion criteria (3 listed)
- Children with cerebral palsy
- Children with typical development
- Aged between 18 months- 6 years
Key exclusion criteria (1 listed)
- Who aged under the age of 18 months and above the age of 6 years.
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 |
|---|---|---|
| Turkish Montreal Children's Hospital Feeding ScaleThe Turkish version of the Montreal Children's Hospital Feeding Scale, and the Behavioral Pediatrics Feeding Assessment Scale will be completed. | Diagnostic test | Children with cerebral palsy, Children with typical development |
Primary outcome
Montreal Children's Hospital Feeding Scale
Time frame: 2 months
The Montreal Children's Hospital Feeding Scale is used to evaluate feeding disorders. It has 14 items which are scored on a 7 point Likert scale. Seven items are scored from the negative to positive direction, and the other seven from the positive to negative direction. The primary feeder marks each item according to frequency or difficulty level of a particular behaviour or the level of parental concern. The total feeding problem score is obtained by adding the scores for each item after reversing the scores of seven items from negative to positive.
1 secondary outcome
Behavioral Pediatrics Feeding Assessment Scale
Time frame: 2 months
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 16 Mar 2020.
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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.
ÖZGÜ İNAL principal investigator
Trakya 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, run by Hacettepe 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 3 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 16 Mar 2020. 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?
Montreal Children's Hospital Feeding Scale (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2020.