Overweight ChildrenNCT06009328
Fundamental Movement Skills, Body Mass Index and Quality of Life in Children
An observational study of Overweight Children, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Overweight Children
- What is being tested?
- fundamental movement skills
- How many people
- 216 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 11 Sep 2023
- 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 5 to 7 years
- All sexes
- Child
Study population: normal school aged children from 5-8 years
Who may be able to join
- normal school aged children , aged 5-7 years with different weight categories
Who cannot join
- children with visual or auditory problems or those who experienced surgery in their lower limbs 1 year before study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty Of Physical Therapy
Cairo
Faculty OP Therapy, alaaalnemr28@gmail.com
About this study
Official title: Correlation Between Fundamental Movement Skills, Body Mass Index, and Quality of Life in School Aged Children
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.
Read the 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
- Conditions
- Overweight Children
- Being tested
- fundamental movement skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fundamental movement skillsOther
measured by test of gross motor development
What is being measured
The primary outcome is the main question the study is designed to answer.
test of gross motor development
a valid and reliable test for assessing fundamental movement skills in children aged 3-10 years
Measured: 3 months
body mass index
used to assess anthropometric measurements
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Feb 2023
- Primary completion1 Sep 2023 (estimated)
- Study completion11 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight ChildrenStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Fahmy Hassan Al Nemr, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009328
- Sponsor's protocol ID
- P.T.REC/012/003398
- Status last verified
- Aug 2023
- First submitted
- 19 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Fundamental Movement Skills, Body Mass Index, and Quality of Life in School Aged Children
- ClinicalTrials.gov ID
- NCT06009328
- Acronym / sponsor ID
- P.T.REC/012/003398
- Conditions
- Overweight Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 11 Sep 2023 (estimated)
- First posted
- 24 Aug 2023 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Age groups
- Child
- Study population
- normal school aged children from 5-8 years
Key inclusion criteria (1 listed)
- normal school aged children , aged 5-7 years with different weight categories
Key exclusion criteria (1 listed)
- children with visual or auditory problems or those who experienced surgery in their lower limbs 1 year before study
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 |
|---|---|---|
| fundamental movement skillsmeasured by test of gross motor development | Other | – |
Primary outcome
test of gross motor development
Time frame: 3 months
a valid and reliable test for assessing fundamental movement skills in children aged 3-10 years
body mass index
Time frame: 3 months
used to assess anthropometric measurements
PedsQol scale
Time frame: 3 months
used to assess quality of life in children. generic core scale will be used and total score will be used in analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
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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.
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 Overweight Children, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Aug 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa F AL-Nemr, Phd (01003727467, alaaalnemr28@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
test of gross motor development (time frame: 3 months). The study lists 3 primary outcomes in all. 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 Aug 2023.