Obesity, ChildhoodNCT04789525
Physical Training and Diet for Childhood Obesity
A study testing High-intensity aerobic training with high protein diet in people with Obesity, Childhood, run by Cairo University at 1 site in Egypt.
Trial summary
It is observed that children affected with COVID-19 who are physically inactive or in a sedentary lifestyle may induce and develop childhood obesity (CO). the management of this clinical condition has received very little attention, there is no well-defined exercise protocols or dietary prescription for this special… Read more about this study
- Who is it for?
- Ages 5 to 12 years, men only
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- High-intensity aerobic training with high protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2020to 25 Dec 2020
- Phase
- Interventional
- 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 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- A positive diagnosis of COVID-19
- Male children
- 5 - 12 years of age Body mass index (BMI).
- Between 85t h to 99th percentiles were considered for childhood obesity.
Who cannot join
- Subjects with a history of physical training
- Taking medications, recent surgeries.
- Fractures and joint problems in the lower extremity.
- Cardiac and respiratory problems.
- Neurological issues, major psychiatric problems.
- Any other systemic diseases, contraindications for physical training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical (BMI & MRI) and Biochemical (Adiponectin, Leptin, TNF-α & IL-6) Effects of High-intensity Aerobic Training With High Protein Diet in Childhood Obesity Following COVID-19 Infection
It is observed that children affected with COVID-19 who are physically inactive or in a sedentary lifestyle may induce and develop childhood obesity (CO). the management of this clinical condition has received very little attention, there is no well-defined exercise protocols or dietary prescription for this special population; therefore, it needs an elaborative trial in this field, so the aim of his study was to find the clinical and biochemical effects of high-intensity aerobic training with a high protein diet in childhood obesity following COVID-19 infection
- Conditions
- Obesity, Childhood
- Being tested
- High-intensity aerobic training with high protein diet
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity aerobic training with high protein dietOther
High-intensity aerobic training was given with 50 to 70 % of the maximum heart rate. the intervention started with 10 mins of warm-up exercise through stretching of upper and lower limb muscles. Subsequent to stretching, the subjects were asked to do 30 mins of exercises; consisting of 20 mins on the treadmill and 10 mins of cycle ergometer at 50 to 70 % of MHR, then with 10 mins of cool down.
| Study group | Role | What they receive |
|---|---|---|
| Group A (high-intensity aerobic training with high protein diet ) | Experimental | Not described Receives: Other: High-intensity aerobic training with high protein diet |
| Group B(regular physical activities and taken regular diet) | Experimental | Not described Receives: Other: High-intensity aerobic training with high protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
For children, age adjusted BMI percentile (BMI %) was calculated
Measured: 6 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start10 Mar 2020
- Primary completion1 Oct 2020
- Study completion25 Dec 2020
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Eid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789525
- Sponsor's protocol ID
- Obesity
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- 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 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical (BMI & MRI) and Biochemical (Adiponectin, Leptin, TNF-α & IL-6) Effects of High-intensity Aerobic Training With High Protein Diet in Childhood Obesity Following COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04789525
- Acronym / sponsor ID
- Obesity
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 25 Dec 2020 (actual)
- First posted
- 9 Mar 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.
It is observed that children affected with COVID-19 who are physically inactive or in a sedentary lifestyle may induce and develop childhood obesity (CO). the management of this clinical condition has received very little attention, there is no well-defined exercise protocols or dietary prescription for this special population; therefore, it needs an elaborative trial in this field, so the aim of his study was to find the clinical and biochemical effects of high-intensity aerobic training with a high protein diet in childhood obesity following COVID-19 infection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (high-intensity aerobic training with high protein diet ) | Experimental | Other: High-intensity aerobic training with high protein diet |
| Group B(regular physical activities and taken regular diet) | Experimental | Other: High-intensity aerobic training with high protein diet |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- A positive diagnosis of COVID-19
- Male children
- 5 - 12 years of age Body mass index (BMI).
- Between 85t h to 99th percentiles were considered for childhood obesity.
Key exclusion criteria (6 listed)
- Subjects with a history of physical training
- Taking medications, recent surgeries.
- Fractures and joint problems in the lower extremity.
- Cardiac and respiratory problems.
- Neurological issues, major psychiatric problems.
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 |
|---|---|---|
| High-intensity aerobic training with high protein dietHigh-intensity aerobic training was given with 50 to 70 % of the maximum heart rate. the intervention started with 10 mins of warm-up exercise through stretching of upper and lower limb muscles. Subsequent to stretching, the subjects were asked to do 30 mins of exercises; consisting of 20 mins on the treadmill and 10 mins of cycle ergometer at 50 to 70 % of MHR, then with 10 mins of cool down. | Other | Group A (high-intensity aerobic training with high protein diet ), Group B(regular physical activities and taken regular diet) |
Primary outcome
Body mass index
Time frame: 6 monthes
For children, age adjusted BMI percentile (BMI %) was calculated
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 11 Mar 2021.
- 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?
A study testing High-intensity aerobic training with high protein diet in people with Obesity, Childhood, 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 4 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 11 Mar 2021. 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: 6 monthes). 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 11 Mar 2021.