Adolescent OverweightNCT06458634
Weight Variation on Cop
An observational study of Adolescent Overweight, run by Amira Hussin Hussin Mohammed at 1 site in Egypt.
Trial summary
This study will be conducted to investigate the impact of variant weights in adolescents during unperturbed standing conditions. Read more about this study
- Who is it for?
- Ages 16 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Overweight
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 30 Apr 2024
- 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 16 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: They will be assigned into four group of equal numbers according to (BMI) body mass index for age percentile obese group (n=50), overweight group (n=50), underweight group (n=50) and normal group weight (n=50).
Who may be able to join
- Their age will be ranging from 16 to 18 years.
- The sample will be selected according to (BMI-for Age percentile) growth charts according to CDC (Centers for Disease Control and Prevention) (appendix-1) (NCHS, 2014)
- All participant will be free from any musculoskeletal deformities.
- All participant are free of peripheral neuropathic diseases.
- They have no visual or auditory or vestibular disorders.
- They will able to understand, follow and execute instructions included in the testing analysis procedures.
Who cannot join
- All adolescent associated with any musculoskeletal deformities.
- All adolescent associated with any foot deformity.
- All adolescent had a previous foot orthopedic procedure.
- All adolescent has visual or auditory or vestibular disorder.
- All adolescent has peripheral neuropathy.
- Adolescent with morbid obesity BMI >99th for age percentile (Barlow, 2007).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Weight Variation on Cop Displacement During Unperturbed Standing Conditions in Adolescents
This study will be conducted to investigate the impact of variant weights in adolescents during unperturbed standing conditions.
Read the detailed description
200 adolescents from both sexes will be assigned to this study. They will be selected randomly from a secondary school student and first level university students. They will be assigned into four group of equal numbers according to (BMI) body mass index for age percentile obese group (n=50), overweight group (n=50), underweight group (n=50) and normal group weight (n=50).The FREEMED platform and FREESTEP software were used to assess the following parameters for each subject:
- Sway length (mm).
- The Maximum (peak) Oscillation of COP.
- The minimum Oscillation of COP.
- Conditions
- Adolescent Overweight
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Underweight group | This group will be underweight group according to BMI- for age percentile growth chart ranged from BMI-for-age < 5th percentiles. | |
| Normal weight group | This group will be with normal weight according to BMI- for age percentile growth chart which ranged from BMI-for-age 5th to 85th percentiles | |
| Overweight group | This group will be an overweight group according to BMI- for age percentile growth chart which ranged from BMI-for-age 85th to 95th percentiles | |
| Obese group | This group will be obese group according to BMI- for age percentile growth chart which ranged from BMI-for-age > 95th percentiles and <99th percentile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sway length (mm)
The force platform was positioned in the middle of the test-taking silent room. In the static standing trial, each participant had the freedom to converse with their partner at any moment, provided that companion was either sitting or stood in front of them at a distance of roughly two meters. The AP and ML direction COP will be investigated using the data collected during the trial's eighty seconds. Depending on which of the six test trials was being given, the participant was advised to stand quietly and unperturbed throughout the test procedure, with their eyes either open or closed.
Measured: through study completion, an average of 6 months
The Maximum (peak) Oscillation of COP
The force platform was positioned in the middle of the test-taking silent room. In the static standing trial, each participant had the freedom to converse with their partner at any moment, provided that companion was either sitting or stood in front of them at a distance of roughly two meters. The AP and ML direction COP will be investigated using the data collected during the trial's eighty seconds. Depending on which of the six test trials was being given, the participant was advised to stand quietly and unperturbed throughout the test procedure, with their eyes either open or closed.
Measured: through study completion, an average of 6 months
The minimum Oscillation of COP
The force platform was positioned in the middle of the test-taking silent room. In the static standing trial, each participant had the freedom to converse with their partner at any moment, provided that companion was either sitting or stood in front of them at a distance of roughly two meters. The AP and ML direction COP will be investigated using the data collected during the trial's eighty seconds. Depending on which of the six test trials was being given, the participant was advised to stand quietly and unperturbed throughout the test procedure, with their eyes either open or closed.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Nov 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent OverweightStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amira Hussin Hussin Mohammed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amira Hussin Hussin Mohammed, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458634
- Sponsor's protocol ID
- weight variation in COP
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Weight Variation on Cop Displacement During Unperturbed Standing Conditions in Adolescents
- ClinicalTrials.gov ID
- NCT06458634
- Acronym / sponsor ID
- weight variation in COP
- Conditions
- Adolescent Overweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Amira Hussin Hussin MohammedUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 13 Jun 2024 (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.
This study will be conducted to investigate the impact of variant weights in adolescents during unperturbed standing conditions.
Detailed description
200 adolescents from both sexes will be assigned to this study. They will be selected randomly from a secondary school student and first level university students. They will be assigned into four group of equal numbers according to (BMI) body mass index for age percentile obese group (n=50), overweight group (n=50), underweight group (n=50) and normal group weight (n=50).The FREEMED platform and FREESTEP software were used to assess the following parameters for each subject:
- Sway length (mm).
- The Maximum (peak) Oscillation of COP.
- The minimum Oscillation of COP.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Underweight group | – | –This group will be underweight group according to BMI- for age percentile growth chart ranged from BMI-for-age < 5th percentiles. |
| Normal weight group | – | –This group will be with normal weight according to BMI- for age percentile growth chart which ranged from BMI-for-age 5th to 85th percentiles |
| Overweight group | – | –This group will be an overweight group according to BMI- for age percentile growth chart which ranged from BMI-for-age 85th to 95th percentiles |
| Obese group | – | –This group will be obese group according to BMI- for age percentile growth chart which ranged from BMI-for-age > 95th percentiles and <99th percentile |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- They will be assigned into four group of equal numbers according to (BMI) body mass index for age percentile obese group (n=50), overweight group (n=50), underweight group (n=50) and normal group weight (n=50).
Key inclusion criteria (6 listed)
- Their age will be ranging from 16 to 18 years.
- The sample will be selected according to (BMI-for Age percentile) growth charts according to CDC (Centers for Disease Control and Prevention) (appendix-1) (NCHS, 2014)
- All participant will be free from any musculoskeletal deformities.
- All participant are free of peripheral neuropathic diseases.
- They have no visual or auditory or vestibular disorders.
Key exclusion criteria (6 listed)
- All adolescent associated with any musculoskeletal deformities.
- All adolescent associated with any foot deformity.
- All adolescent had a previous foot orthopedic procedure.
- All adolescent has visual or auditory or vestibular disorder.
- All adolescent has peripheral neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sway length (mm)
Time frame: through study completion, an average of 6 months
The force platform was positioned in the middle of the test-taking silent room. In the static standing trial, each participant had the freedom to converse with their partner at any moment, provided that companion was either sitting or stood in front of them at a distance of roughly two meters. The AP and ML direction COP will be investigated using the data collected during the trial's eighty seconds. Depending on which of the six test trials was being given, the participant was advised to stand quietly and unperturbed throughout the test procedure, with their eyes either open or closed.
The Maximum (peak) Oscillation of COP
Time frame: through study completion, an average of 6 months
The force platform was positioned in the middle of the test-taking silent room. In the static standing trial, each participant had the freedom to converse with their partner at any moment, provided that companion was either sitting or stood in front of them at a distance of roughly two meters. The AP and ML direction COP will be investigated using the data collected during the trial's eighty seconds. Depending on which of the six test trials was being given, the participant was advised to stand quietly and unperturbed throughout the test procedure, with their eyes either open or closed.
The minimum Oscillation of COP
Time frame: through study completion, an average of 6 months
The force platform was positioned in the middle of the test-taking silent room. In the static standing trial, each participant had the freedom to converse with their partner at any moment, provided that companion was either sitting or stood in front of them at a distance of roughly two meters. The AP and ML direction COP will be investigated using the data collected during the trial's eighty seconds. Depending on which of the six test trials was being given, the participant was advised to stand quietly and unperturbed throughout the test procedure, with their eyes either open or closed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Adolescent Overweight, run by Amira Hussin Hussin Mohammed 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 13 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sway length (mm) (time frame: through study completion, an average of 6 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 13 Jun 2024.