Growth and Body Composition in Children

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.

Study Overview

• Status: Completed
• Conditions: Growth; Child Development; Disability, Developmental
• Intervention / Treatment: Diagnostic test: Measurement of growth and body composition

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 428

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon-si, Korea, Republic of
    • St. Vincent's Hospital, The Catholic University of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
typically developing; Intervention: Measurement of growth and body composition. Growth (height, body weight), and body composition was measured at school.	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.; Other Names: Using Inbody 770, Inbody S10
neurodisabilities; Intervention: Measurement of growth and body composition. Growth (height, body weight), and body composition was measured at school.	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.; Other Names: Using Inbody 770, Inbody S10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BW	body weight (kg)	through study completion, an average of 1.5 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
fat mass (kg)	fat mass measured by body composition analyzers (Inbody 770 and Inbody S10)	through study completion, an average of 1.5 month
height	height	through study completion, an average of 1.5 month

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Investigators: Principal Investigator: Bo Young Hong, MD, PhD, St. Vincent's Hospital, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): November 29, 2018

Study Registration Dates

• First Submitted: July 24, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): June 24, 2019
• Last Update Submitted That Met QC Criteria: June 20, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: growth; Body Composition
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Developmental Disabilities
• Other Study ID Numbers: VC17ONSI0200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No