Back to resultsPhysical Training and Diet for Childhood Obesity
Primary Purpose
Obesity, Childhood
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High-intensity aerobic training with high protein diet
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Childhood
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Marwa Eid
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A (high-intensity aerobic training with high protein diet )
Group B(regular physical activities and taken regular diet)
Arm Description
Outcomes
Primary Outcome Measures
Body mass index
For children, age adjusted BMI percentile (BMI %) was calculated
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04789525
Brief Title
Physical Training and Diet for Childhood Obesity
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
December 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (high-intensity aerobic training with high protein diet )
Arm Type
Experimental
Arm Title
Group B(regular physical activities and taken regular diet)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
High-intensity aerobic training with high protein diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body mass index
Description
For children, age adjusted BMI percentile (BMI %) was calculated
Time Frame
6 monthes
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male children.
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Marwa Eid
City
Cairo
ZIP/Postal Code
2011
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Physical Training and Diet for Childhood Obesity
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