Fundamental Movement Skills, Body Mass Index and Quality... | NCT06009328

Studies
Fundamental Movement Skills, Body Mass Index and Quality of Life in Children

NCT06009328

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Aug 24, 2023Actual

Enrollment

216Estimated

Phase

Not provided

Conditions

Overweight Children

Interventions

fundamental movement skills

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Actual

Primary Completion Date

Sep 1, 2023Estimated

Completion Date

Sep 11, 2023Estimated

First Submitted Date

Aug 19, 2023

First Submission Date that Met QC Criteria

Aug 19, 2023

First Posted Date

Aug 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2023

Last Update Posted Date

Aug 24, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alaa Fahmy Hassan Al Nemr, lecturer in pediatric department, faculty of physical therapy, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Early childhood obesity is a serious worldwide problem, and fundamental movement skills (FMS) are very important factors in human movement. Thus, several advanced studies have examined the associations between FMS, body mass index (BMI) and quality of life.

The purpose of this study was to investigate the relation between FMS, BMI and quality of life in Egyptian school aged children.

Detailed Description

A total of 216 primary school aged children, aged 5-7 y from both sex participated in this study. FMS were measured using the Test of Gross Motor Development-II (TGMD-II), and BMI was calculated as the weight (kg) divided by the square of the height (m) [weight/ height2] ,and quality of life was measured by PedsQol scale

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

216Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fundamental movement skills	Other	measured by test of gross motor development

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
test of gross motor development	a valid and reliable test for assessing fundamental movement skills in children aged 3-10 years	3 months
body mass index	used to assess anthropometric measurements	3 months
PedsQol scale	used to assess quality of life in children. generic core scale will be used and total score will be used in analysis	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- normal school aged children , aged 5-7 years with different weight categories

Exclusion Criteria:

children with visual or auditory problems or those who experienced surgery in their lower limbs 1 year before study

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

7 Years

Standard Ages

Child

Study Population

normal school aged children from 5-8 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alaa F AL-Nemr, Phd	Contact	01003727467		alaaalnemr28@cu.edu.eg
Alaa f alnemr	Contact	01003727467		alaaalnemr28@cu.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty Of Physical Therapy	Recruiting	Cairo			Egypt