GrowthNCT03653754
Growth and Body Composition in Children
An observational study of Growth and Child Development, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
This study is planned to measure and compare body composition indexes and growth between typically developing children and those with disabilities in South Korea for understanding the nutritional and growth status. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth, Child Development, Disability, Developmental
- What is being tested?
- Measurement of growth and body composition
- How many people
- 428 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Apr 2018to 29 Nov 2018
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 1. Typically developing children who are in the 5th and 6th grades of elementary schools 2. Children with neurodevelopmental disabilities in a special school
Who may be able to join
- Those who agreed to participate both parents and a child
- Typically developing children: among the 5th and 6th grade of two elementary schools.
- Children with neurodevelopmental disabilities: among the students in a special school.
Who cannot join
- Who do not want to participate
- Who are not possible to do the Inbody examination
Trial locations and contacts
1 site in 1 country.
South Korea1 site
St. Vincent's Hospital, The Catholic University of Korea
Suwon
About this study
Official title: Growth and Body Composition in Children With Disabilities and Typically Developing Children
This study is planned to measure and compare body composition indexes and growth between typically developing children and those with disabilities in South Korea for understanding the nutritional and growth status.
Read the detailed description
- Inclusion criteria for typically developing children
- typically developing children in 5th and 6th grades of elementary schools
- children whose parents checked the agreement form distributed by schools
- Inclusion criteria for children with disabilities
- children and adolescent who are in special schools
- children whose parents checked the agreement form distributed by schools
- children who were able to cooperate during the body composition analysis
- Exclusion criteria for both groups
- those whom do not have written informed consent
- who are not able to stay calmly during the body composition analysis
- All measurements done at two elementary schools on the day of the annual physical examination
- Measurement of height and body weight for growth
- Measurement of body composition index: Inbody 770 and Inbody S10, body composition analyzers
- Conditions
- Growth, Child Development, Disability, Developmental
- Being tested
- Measurement of growth and body composition
- Keywords
- growth, Body Composition
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of growth and body compositionDiagnostic test
Also called Using Inbody 770, Inbody S10
Growth (height and body weight), and body composition were measured. For the body composition, Inbody 770 and Inbody S10 were used.
| Study group | Role | What they receive |
|---|---|---|
| typically developing | Intervention: Measurement of growth and body composition. Growth (height, body weight), and body composition was measured at school. Receives: Diagnostic Test: Measurement of growth and body composition | |
| neurodisabilities | Intervention: Measurement of growth and body composition. Growth (height, body weight), and body composition was measured at school. Receives: Diagnostic Test: Measurement of growth and body composition |
What is being measured
The primary outcome is the main question the study is designed to answer.
BW
body weight (kg)
Measured: through study completion, an average of 1.5 month
Secondary outcomes (3)
skeletal muscle mass (kg)
skeletal muscle mass measured by body composition analyzers (Inbody 770 and Inbody S10)
Measured: through study completion, an average of 1.5 month
fat mass (kg)
fat mass measured by body composition analyzers (Inbody 770 and Inbody S10)
Measured: through study completion, an average of 1.5 month
height
height
Measured: through study completion, an average of 1.5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start16 Apr 2018
- Primary completion30 Jun 2018
- Study completion29 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GrowthStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Young Hong, The Catholic University of Korea
- Investigators
- Bo Young Hong, MD, PhD, Principal investigator, St. Vincent's hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653754
- Sponsor's protocol ID
- VC17ONSI0200
- Status last verified
- Jun 2019
- First submitted
- 24 Jul 2018
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Body Composition in Children With Disabilities and Typically Developing Children
- ClinicalTrials.gov ID
- NCT03653754
- Acronym / sponsor ID
- VC17ONSI0200
- Conditions
- Growth, Child Development, Disability, Developmental
- Keywords
- growth, Body Composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 31 Aug 2018 (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.
This study is planned to measure and compare body composition indexes and growth between typically developing children and those with disabilities in South Korea for understanding the nutritional and growth status.
Detailed description
- Inclusion criteria for typically developing children
- typically developing children in 5th and 6th grades of elementary schools
- children whose parents checked the agreement form distributed by schools
- Inclusion criteria for children with disabilities
- children and adolescent who are in special schools
- children whose parents checked the agreement form distributed by schools
- children who were able to cooperate during the body composition analysis
- Exclusion criteria for both groups
- those whom do not have written informed consent
- who are not able to stay calmly during the body composition analysis
- All measurements done at two elementary schools on the day of the annual physical examination
- Measurement of height and body weight for growth
- Measurement of body composition index: Inbody 770 and Inbody S10, body composition analyzers
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| typically developing | – | Diagnostic Test: Measurement of growth and body compositionIntervention: Measurement of growth and body composition. Growth (height, body weight), and body composition was measured at school. |
| neurodisabilities | – | Diagnostic Test: Measurement of growth and body compositionIntervention: Measurement of growth and body composition. Growth (height, body weight), and body composition was measured at school. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 1. Typically developing children who are in the 5th and 6th grades of elementary schools 2. Children with neurodevelopmental disabilities in a special school
Key inclusion criteria (3 listed)
- Those who agreed to participate both parents and a child
- Typically developing children: among the 5th and 6th grade of two elementary schools.
- Children with neurodevelopmental disabilities: among the students in a special school.
Key exclusion criteria (2 listed)
- Who do not want to participate
- Who are not possible to do the Inbody examination
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 |
|---|---|---|
| Measurement of growth and body compositionAlso: Using Inbody 770, Inbody S10Growth (height and body weight), and body composition were measured. For the body composition, Inbody 770 and Inbody S10 were used. | Diagnostic test | neurodisabilities, typically developing |
Primary outcome
BW
Time frame: through study completion, an average of 1.5 month
body weight (kg)
3 secondary outcomes
skeletal muscle mass (kg)
Time frame: through study completion, an average of 1.5 month
fat mass (kg)
Time frame: through study completion, an average of 1.5 month
height
Time frame: through study completion, an average of 1.5 month
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 24 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Bo Young Hong, MD, PhD principal investigator
St. Vincent's hospital, The Catholic University of Korea
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 Growth and Child Development, run by The Catholic University of Korea at 1 site in South Korea.
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 2 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 24 Jun 2019. 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 South Korea. 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?
BW (time frame: through study completion, an average of 1.5 month). 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 24 Jun 2019; AzTrials last refreshed its copy on 30 Oct 2026.