Obesity, ChildhoodNCT05900843
Weight Abnormalities With Diet and Exercise Frequency in Egyptian Children With Cerebral Palsy
An observational study of Obesity, Childhood and Cerebral Palsy, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The goal of this study was to find prevalence and correlations of different weight abnormalities and risk of abdominal obesity in a random sample of Egyptian children suffering from cerebral palsy. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Obesity, Childhood, Cerebral Palsy, Weight, Body
- How many people
- 259 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2022to 30 Jan 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children diagnosed as Cerebral Palsy between the age of 2 to 18 years
Who may be able to join
- all children diagnosed as Cerebral Palsy between the age of 2 to 18 years old from both sexes in the participating clinics
Who cannot join
- Children suffering from developmental motor delays due to any other diagnosis
- Children who refused to engage in measurement procedures (weight, height, waist circumference and hip circumference)
- Children suffered from fixed deformity that didn't allow to get accurate measurements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Correlations of Weight Abnormalities With Diet and Exercise Frequency in Egyptian Children With Cerebral Palsy
The goal of this study was to find prevalence and correlations of different weight abnormalities and risk of abdominal obesity in a random sample of Egyptian children suffering from cerebral palsy. This cross- sectional study hypothesize the prevalence of weight abnormalities and risk of abdominal obesity in addition to positive correlations between weight abnormalities and number of exercise hours and frequency of meals in a random sample of Egyptian children suffering from cerebral palsy
RESEARCH QUESTION:
- What is the prevalence of weight abnormalities and and risk of abdominal obesity in Egyptian children with cerebral palsy?
- Does the weight abnormalities correlates with number of exercise hours or frequency of meals in children with cerebral palsy?
Read the detailed description
This cross- sectional study will be conducted to identify the prevalence of weight abnormalities and risk of abdominal obesity in a random sample of Egyptian children suffering from cerebral palsy. It included all cerebral palsy cases at six private pediatric rehabilitation clinics in four different governorates (Cairo, Alexandria, Sharkia and Beni-Suef). Data will be collected from patients, records of the referrals to pediatric physical therapy rehabilitation clinics and measurements of weight, height, waist circumference and hip circumference performed by the therapist.
These six settings were selected because;1) They represent different geographical and socioeconomic levels in Egypt, 2) All of them offer pediatric physical therapy rehabilitation sessions at approximately the same range of price ,3) At that time general hospitals were still strictly committed to corona virus control measures, so no data could be available from general hospitals.
The following information will be extracted from the patient records: Sex, Age, Diagnosis, subtype of Cerebral Palsy, level of function and degree of spasticity., associated impairments, dietary intake (number of meals or quality of meals) and number of exercise hours per week. A questionnaire will be designed to get the care givers' report about presence of associated impairments, number of meals per day and number of exercising hours per week, type of associated impairments, quality of meals and type of exercises. All care givers of children diagnosed by cerebral palsy will be interviewed by the therapist to help them fill in the questionnaire and to obtain a consent of their participation. BMI; kg/m2 will be calculated by measuring height and weight. WHR will be calculated by measuring waist circumference and hip circumference. BMI and WHR percentiles will be reported according to sex-specific age group standards for growth set by the WHO growth charts.
- Conditions
- Obesity, Childhood, Cerebral Palsy, Weight, Body, Abdominal Obesity
- Keywords
- weight abnormalities, abdominal obesity, cerebral palsy
- Medical subject headings
- Pediatric Obesity, Cerebral Palsy, Body Weight, Obesity, Abdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
weight and height are measured and compared to charts
Measured: 2 months
Secondary outcomes (2)
Exercising habits
number of exercise hours per week
Measured: 2 months
Dietary habits
Number of meals per day
Measured: 2 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 2023
- Study start15 Nov 2022
- Primary completion15 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tayseer Saber Abdeldayem, Beni-Suef University
- Investigators
- Sabah M Elkady, PhD, Study chair, Cairo UniversityMai A Ahmed, PhD, Study chair, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900843
- Sponsor's protocol ID
- P.T.REC/012/004234
- Status last verified
- Nov 2024
- First submitted
- 3 Feb 2023
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Correlations of Weight Abnormalities With Diet and Exercise Frequency in Egyptian Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05900843
- Acronym / sponsor ID
- P.T.REC/012/004234
- Conditions
- Obesity, Childhood, Cerebral Palsy, Weight, Body, Abdominal Obesity
- Keywords
- weight abnormalities, abdominal obesity, cerebral palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 13 Jun 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.
The goal of this study was to find prevalence and correlations of different weight abnormalities and risk of abdominal obesity in a random sample of Egyptian children suffering from cerebral palsy. This cross- sectional study hypothesize the prevalence of weight abnormalities and risk of abdominal obesity in addition to positive correlations between weight abnormalities and number of exercise hours and frequency of meals in a random sample of Egyptian children suffering from cerebral palsy
RESEARCH QUESTION:
- What is the prevalence of weight abnormalities and and risk of abdominal obesity in Egyptian children with cerebral palsy?
- Does the weight abnormalities correlates with number of exercise hours or frequency of meals in children with cerebral palsy?
Detailed description
This cross- sectional study will be conducted to identify the prevalence of weight abnormalities and risk of abdominal obesity in a random sample of Egyptian children suffering from cerebral palsy. It included all cerebral palsy cases at six private pediatric rehabilitation clinics in four different governorates (Cairo, Alexandria, Sharkia and Beni-Suef). Data will be collected from patients, records of the referrals to pediatric physical therapy rehabilitation clinics and measurements of weight, height, waist circumference and hip circumference performed by the therapist.
These six settings were selected because;1) They represent different geographical and socioeconomic levels in Egypt, 2) All of them offer pediatric physical therapy rehabilitation sessions at approximately the same range of price ,3) At that time general hospitals were still strictly committed to corona virus control measures, so no data could be available from general hospitals.
The following information will be extracted from the patient records: Sex, Age, Diagnosis, subtype of Cerebral Palsy, level of function and degree of spasticity., associated impairments, dietary intake (number of meals or quality of meals) and number of exercise hours per week. A questionnaire will be designed to get the care givers' report about presence of associated impairments, number of meals per day and number of exercising hours per week, type of associated impairments, quality of meals and type of exercises. All care givers of children diagnosed by cerebral palsy will be interviewed by the therapist to help them fill in the questionnaire and to obtain a consent of their participation. BMI; kg/m2 will be calculated by measuring height and weight. WHR will be calculated by measuring waist circumference and hip circumference. BMI and WHR percentiles will be reported according to sex-specific age group standards for growth set by the WHO growth charts.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children diagnosed as Cerebral Palsy between the age of 2 to 18 years
Key inclusion criteria (1 listed)
- all children diagnosed as Cerebral Palsy between the age of 2 to 18 years old from both sexes in the participating clinics
Key exclusion criteria (3 listed)
- Children suffering from developmental motor delays due to any other diagnosis
- Children who refused to engage in measurement procedures (weight, height, waist circumference and hip circumference)
- Children suffered from fixed deformity that didn't allow to get accurate measurements
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
Body Mass Index
Time frame: 2 months
weight and height are measured and compared to charts
2 secondary outcomes
Exercising habits
Time frame: 2 months
Dietary habits
Time frame: 2 months
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 12 Nov 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.
Sabah M Elkady, PhD study chair
Cairo University
Mai A Ahmed, PhD study chair
Beni-Suef University
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, Childhood and Cerebral Palsy, run by Beni-Suef 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 3 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 12 Nov 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?
Body Mass Index (time frame: 2 months). 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 12 Nov 2024.