NCT03653754

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
428

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2018

Completed
Last Updated

June 24, 2019

Status Verified

June 1, 2019

Enrollment Period

3 months

First QC Date

July 24, 2018

Last Update Submit

June 20, 2019

Conditions

Keywords

growthBody Composition

Outcome Measures

Primary Outcomes (1)

  • BW

    body weight (kg)

    through study completion, an average of 1.5 month

Secondary Outcomes (3)

  • skeletal muscle mass (kg)

    through study completion, an average of 1.5 month

  • fat mass (kg)

    through study completion, an average of 1.5 month

  • height

    through study completion, an average of 1.5 month

Study Arms (2)

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

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

Interventions

Growth (height and body weight), and body composition were measured. For the body composition, Inbody 770 and Inbody S10 were used.

Also known as: Using Inbody 770, Inbody S10
neurodisabilitiestypically developing

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • Who do not want to participate
  • Who are not possible to do the Inbody examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincent's Hospital, The Catholic University of Korea

Suwon, South Korea

Location

MeSH Terms

Conditions

Developmental Disabilities

Interventions

Body Composition

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Biochemical PhenomenaChemical PhenomenaMetabolismBody ConstitutionPhysiological Phenomena

Study Officials

  • Bo Young Hong, MD, PhD

    St. Vincent's hospital, The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 24, 2018

First Posted

August 31, 2018

Study Start

April 16, 2018

Primary Completion

June 30, 2018

Study Completion

November 29, 2018

Last Updated

June 24, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations