Growth and Body Composition in Children

Child Development Clinical Trial

Official title:

Growth and Body Composition in Children With Disabilities and Typically Developing Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653754
• Other study ID #: VC17ONSI0200
• Status: Completed
• Start date: April 16, 2018
• Est. completion date: November 29, 2018

Study information

• Verified date: June 2019
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Description:

• Inclusion criteria for typically developing children

1. typically developing children in 5th and 6th grades of elementary schools

2. children whose parents checked the agreement form distributed by schools

• Inclusion criteria for children with disabilities

1. children and adolescent who are in special schools

2. children whose parents checked the agreement form distributed by schools

3. children who were able to cooperate during the body composition analysis

• Exclusion criteria for both groups

1. those whom do not have written informed consent

2. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: November 29, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Who do not want to participate

• Who are not possible to do the Inbody examination

Related Conditions & MeSH terms

• Child Development
• Developmental Disabilities
• Disability, Developmental
• Growth

Intervention

Diagnostic Test:
• Measurement of growth and body composition
Growth (height and body weight), and body composition were measured. For the body composition, Inbody 770 and Inbody S10 were used.

Locations

Country	Name	City	State
Korea, Republic of	St. Vincent's Hospital, The Catholic University of Korea	Suwon-si

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BW	body weight (kg)	through study completion, an average of 1.5 month
Secondary	skeletal muscle mass (kg)	skeletal muscle mass measured by body composition analyzers (Inbody 770 and Inbody S10)	through study completion, an average of 1.5 month
Secondary	fat mass (kg)	fat mass measured by body composition analyzers (Inbody 770 and Inbody S10)	through study completion, an average of 1.5 month
Secondary	height	height	through study completion, an average of 1.5 month