Obesity, AdolescentNCT05095883
Correlation Between Body Weight and Foot Progression Angle in Adolescents
An observational study of Obesity, Adolescent and Adolescent Development, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
Obesity is associated with functional decline , altered spatiotemporal gait parameters (e.g. lower gait speed, shorter strides, and increased step width), and a significantly higher metabolic cost of walking compared to people with normal body weight. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Adolescent, Adolescent Development
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Oct 2021to 31 Jul 2022
- How long will I take part?
- 6 Months
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Two hundred healthy non-athletic children from both sexes will participate in this study.
Who may be able to join
- All children have normal stature for age percentile according to CDC chart.
- The sample will include both sex and will be divided in to 4 groups according to the CDC (Centers for Disease Control and Prevention) growth charts.
- All children are normal \&perform all activities of daily living
- They were able to understand and follow verbal commands and instructions included in the testing procedures.
Who cannot join
- All of them could be part of recreational activities in their public schools but no competitive sports. Children who participated in any regular sport activities involving the lower extremities will be excluded.
- None of them had any surgical intervention in the lower extremities.
- None of them had any history of musculoskeletal deformities or neuromuscular disorders.
- They had neither visual, auditory defect.
Trial locations and contacts
1 site in 1 country.
About this study
Obesity is associated with functional decline , altered spatiotemporal gait parameters (e.g. lower gait speed, shorter strides, and increased step width), and a significantly higher metabolic cost of walking compared to people with normal body weight. Obesity also negatively affects balance control.This study will investigate foot progression angle in adolescents related to their weight and category classification based on the CDC (Centers for Disease Control and Prevention) growth charts.
- Conditions
- Obesity, Adolescent, Adolescent Development
- 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 |
|---|---|---|
| healthy | Children in this group will be healthy category according to CDC chart which ranged from BMI-for-age 5th to 85th percentiles | |
| overweight | Children in this group will be overweight category according to CDC chart which ranged from BMI-for-age 85th to 95th percentiles | |
| obese | Children in this group will be obese category according to CDC chart which ranged from BMI-for-age > 95th percentiles | |
| underweight | Children in this group will be underweight category according to CDC chart ranged from BMI-for-age < 5th percentiles |
What is being measured
The primary outcome is the main question the study is designed to answer.
foot progression angle for healthy group
participants in healthy group will be assessed for foot progression angle (FPA). The FPA is defined as the angle made by the long axis of the foot from the heel to 2nd metatarsal and the line of progression of gait
Measured: assessed immediately after the procedure
foot progression angle for overweight group
participants in overweight group will be assessed for foot progression angle (FPA). The FPA is defined as the angle made by the long axis of the foot from the heel to 2nd metatarsal and the line of progression of gait.
Measured: assessed immediately after the procedure
foot progression angle for obese group
participants in obese group will be assessed for foot progression angle (FPA). The FPA is defined as the angle made by the long axis of the foot from the heel to 2nd metatarsal and the line of progression of gait.
Measured: assessed immediately after the procedure
foot progression angle for underweight group
participants in underweight group will be assessed for foot progression angle (FPA). The FPA is defined as the angle made by the long axis of the foot from the heel to 2nd metatarsal and the line of progression of gait.
Measured: assessed immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start29 Oct 2021
- Primary completion27 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AdolescentStudies 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
- Cross-sectional
- Enrolment
- 200 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Hussin Hussin Mohammed, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095883
- Sponsor's protocol ID
- adolecents foot angles
- Status last verified
- Jan 2024
- First submitted
- 17 Sep 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Body Weight and Foot Progression Angle in Adolescents
- ClinicalTrials.gov ID
- NCT05095883
- Acronym / sponsor ID
- adolecents foot angles
- Conditions
- Obesity, Adolescent, Adolescent Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 27 Oct 2021 (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.
Obesity is associated with functional decline , altered spatiotemporal gait parameters (e.g. lower gait speed, shorter strides, and increased step width), and a significantly higher metabolic cost of walking compared to people with normal body weight. Obesity also negatively affects balance control.This study will investigate foot progression angle in adolescents related to their weight and category classification based on the CDC (Centers for Disease Control and Prevention) growth charts.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy | – | –Children in this group will be healthy category according to CDC chart which ranged from BMI-for-age 5th to 85th percentiles |
| overweight | – | –Children in this group will be overweight category according to CDC chart which ranged from BMI-for-age 85th to 95th percentiles |
| obese | – | –Children in this group will be obese category according to CDC chart which ranged from BMI-for-age > 95th percentiles |
| underweight | – | –Children in this group will be underweight category according to CDC chart ranged from BMI-for-age < 5th percentiles |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Two hundred healthy non-athletic children from both sexes will participate in this study.
Key inclusion criteria (4 listed)
- All children have normal stature for age percentile according to CDC chart.
- The sample will include both sex and will be divided in to 4 groups according to the CDC (Centers for Disease Control and Prevention) growth charts.
- All children are normal \&perform all activities of daily living
- They were able to understand and follow verbal commands and instructions included in the testing procedures.
Key exclusion criteria (4 listed)
- All of them could be part of recreational activities in their public schools but no competitive sports. Children who participated in any regular sport activities involving the lower extremities will be excluded.
- None of them had any surgical intervention in the lower extremities.
- None of them had any history of musculoskeletal deformities or neuromuscular disorders.
- They had neither visual, auditory defect.
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
foot progression angle for healthy group
Time frame: assessed immediately after the procedure
participants in healthy group will be assessed for foot progression angle (FPA). The FPA is defined as the angle made by the long axis of the foot from the heel to 2nd metatarsal and the line of progression of gait
foot progression angle for overweight group
Time frame: assessed immediately after the procedure
participants in overweight group will be assessed for foot progression angle (FPA). The FPA is defined as the angle made by the long axis of the foot from the heel to 2nd metatarsal and the line of progression of gait.
foot progression angle for obese group
Time frame: assessed immediately after the procedure
participants in obese group will be assessed for foot progression angle (FPA). The FPA is defined as the angle made by the long axis of the foot from the heel to 2nd metatarsal and the line of progression of gait.
foot progression angle for underweight group
Time frame: assessed immediately after the procedure
participants in underweight group will be assessed for foot progression angle (FPA). The FPA is defined as the angle made by the long axis of the foot from the heel to 2nd metatarsal and the line of progression of gait.
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 23 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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 Obesity, Adolescent and Adolescent Development, run by Delta University for Science and Technology 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 4 inclusion and 4 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 23 Jan 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?
foot progression angle for healthy group (time frame: assessed immediately after the procedure). The study lists 4 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 23 Jan 2024.