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Exercise and Diet for Pediatric Obesity

Primary Purpose

Pediatric Obesity, COVID-19

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
High-intensity aerobic training with high protein diet
Control group
Sponsored by
Prince Sattam Bin Abdulaziz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pediatric Obesity focused on measuring aerobic training, biochemical, children with obesity, COVID-19, high protein diet

Eligibility Criteria

5 Years - 12 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Positively diagnosed COVID-19 children
  • age group of 5 - 12 years
  • Body mass index (BMI) between 85th to 99th percentiles

Exclusion Criteria:

  • 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,
  • other systemic diseases,
  • contraindications for physical training and family with food restrictions

Sites / Locations

  • Gopal Nambi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

High-intensity aerobic training with high protein diet - Group A

Control group - Group B

Arm Description

High-intensity aerobic training (HAT) was given at 50 to 70 percent of maximum heart rate. Subsequent to stretching, the subjects were asked to do 30 mins of HAT exercises; consisting of 20 mins on the treadmill and 10 mins on a cycle ergometer at 50 to 70 % of MHR, lastly, 10 mins of cool down was performed. Next the participants, in this group A were prescribed with strength training exercises with resistance depending upon each subject's individual muscle assessment. In addition to these physical training exercises, this group also received a high protein diet in the range of 1.1 - 1.3 g/kg protein/ ideal body weight/day (>1 g/kg aBW/d), as prescribed by a qualified nutritionist.

This group is considered a control group and they were allowed to follow their regular physical activities and dietary pattern.

Outcomes

Primary Outcome Measures

Body mass index (BMI)
For children, age adjusted BMI percentile (BMI %) was calculated, which is a reliable and valid measurement to measure the stage of obesity.
Body mass index (BMI)
For children, age adjusted BMI percentile (BMI %) was calculated, which is a reliable and valid measurement to measure the stage of obesity.
Body mass index (BMI)
For children, age adjusted BMI percentile (BMI %) was calculated, which is a reliable and valid measurement to measure the stage of obesity.

Secondary Outcome Measures

Muscle cross sectional area - CSA
Muscle CSA is measured with Magnetic resonance imaging (MRI) scan, it is an expensive measurement. The CSA of three major muscle such as; half way at arm - biceps, thigh - quadriceps and calf muscles were measured and included for analysis.
Muscle cross sectional area - CSA
Muscle CSA is measured with Magnetic resonance imaging (MRI) scan, it is an expensive measurement. The CSA of three major muscle such as; half way at arm - biceps, thigh - quadriceps and calf muscles were measured and included for analysis.
Muscle cross sectional area - CSA
Muscle CSA is measured with Magnetic resonance imaging (MRI) scan, it is an expensive measurement. The CSA of three major muscle such as; half way at arm - biceps, thigh - quadriceps and calf muscles were measured and included for analysis.
Adiponectin
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker Adiponectin levels were measured with ELISA kit
Adiponectin
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker Adiponectin levels were measured with ELISA kit
Adiponectin
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker Adiponectin levels were measured with ELISA kit
Leptin
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker Leptin levels were measured with ELISA kit
Leptin
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker Leptin levels were measured with ELISA kit
Leptin
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker Leptin levels were measured with ELISA kit
TNF-α
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker TNF-α levels were measured with ELISA kit
TNF-α
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker TNF-α levels were measured with ELISA kit
TNF-α
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical markers TNF-α levels were measured with ELISA kit
IL-6
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker IL-6 levels were measured with ELISA kit
IL-6
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker IL-6 levels were measured with ELISA kit
IL-6
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker IL-6 levels were measured with ELISA kit

Full Information

First Posted
April 5, 2022
Last Updated
April 20, 2022
Sponsor
Prince Sattam Bin Abdulaziz University
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1. Study Identification

Unique Protocol Identification Number
NCT05336006
Brief Title
Exercise and Diet for Pediatric Obesity
Official Title
Clinical (BMI & MRI) and Biochemical (Adiponectin, Leptin, TNF-α & IL-6) Effects of High-intensity Aerobic Training With a High Protein Diet in Children With Obesity Following COVID-19 Infection.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
December 25, 2020 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince Sattam Bin Abdulaziz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The coronavirus disease (COVID-19), is a communicable pandemic disease as stated by the world health organization (WHO), which has been affecting the world since December 2019. COVID-19 infected children develop the signs and symptoms of the disease, which can be exaggerated or life-threatening when associated with comorbidities like; obesity, sickle cell anemia, immune disorders, chromosomal abnormalities, chronic respiratory or cardiac problems, and congenital malformations.3 It is observed that children affected with COVID-19 who are physically inactive or in a sedentary lifestyle may induce and develop obesity. It is a major health concern in this pandemic situation, which can be addressed and treated with the use of appropriate physical training and proper dietary habits.
Detailed Description
Children confirmed with COVID-19 infection have some systemic illness, that might lead to children with obesity. They are advised to perform regular physical training and consume a proper diet to prevent and treat negative consequences. Therefore, different obesity management and weight reduction protocols are developed to control and prevent health problems and socio-economic issues associated with obesity. 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, there is a need for an elaborative trial in this field. Hence, the aim of this trial was to investigate and compare the clinical and psychological effects of integrated physical training with a high protein diet versus a low protein diet in community-dwelling COVID-19 infected children with obesity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, COVID-19
Keywords
aerobic training, biochemical, children with obesity, COVID-19, high protein diet

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity aerobic training with high protein diet - Group A
Arm Type
Experimental
Arm Description
High-intensity aerobic training (HAT) was given at 50 to 70 percent of maximum heart rate. Subsequent to stretching, the subjects were asked to do 30 mins of HAT exercises; consisting of 20 mins on the treadmill and 10 mins on a cycle ergometer at 50 to 70 % of MHR, lastly, 10 mins of cool down was performed. Next the participants, in this group A were prescribed with strength training exercises with resistance depending upon each subject's individual muscle assessment. In addition to these physical training exercises, this group also received a high protein diet in the range of 1.1 - 1.3 g/kg protein/ ideal body weight/day (>1 g/kg aBW/d), as prescribed by a qualified nutritionist.
Arm Title
Control group - Group B
Arm Type
Placebo Comparator
Arm Description
This group is considered a control group and they were allowed to follow their regular physical activities and dietary pattern.
Intervention Type
Other
Intervention Name(s)
High-intensity aerobic training with high protein diet
Intervention Description
High-intensity aerobic training (HAT) was given at 50 to 70 percent of maximum heart rate. Subsequent to stretching, the subjects were asked to do 30 mins of HAT exercises; consisting of 20 mins on the treadmill and 10 mins on a cycle ergometer at 50 to 70 % of MHR, lastly, 10 mins of cool down was performed. Next the participants, in this group A were prescribed with strength training exercises with resistance depending upon each subject's individual muscle assessment. In addition to these physical training exercises, this group also received a high protein diet in the range of 1.1 - 1.3 g/kg protein/ ideal body weight/day (>1 g/kg aBW/d), as prescribed by a qualified nutritionist.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
This group is considered a control group and they were allowed to follow their regular physical activities and dietary pattern.
Primary Outcome Measure Information:
Title
Body mass index (BMI)
Description
For children, age adjusted BMI percentile (BMI %) was calculated, which is a reliable and valid measurement to measure the stage of obesity.
Time Frame
At baseline
Title
Body mass index (BMI)
Description
For children, age adjusted BMI percentile (BMI %) was calculated, which is a reliable and valid measurement to measure the stage of obesity.
Time Frame
8 weeks
Title
Body mass index (BMI)
Description
For children, age adjusted BMI percentile (BMI %) was calculated, which is a reliable and valid measurement to measure the stage of obesity.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Muscle cross sectional area - CSA
Description
Muscle CSA is measured with Magnetic resonance imaging (MRI) scan, it is an expensive measurement. The CSA of three major muscle such as; half way at arm - biceps, thigh - quadriceps and calf muscles were measured and included for analysis.
Time Frame
At baseline
Title
Muscle cross sectional area - CSA
Description
Muscle CSA is measured with Magnetic resonance imaging (MRI) scan, it is an expensive measurement. The CSA of three major muscle such as; half way at arm - biceps, thigh - quadriceps and calf muscles were measured and included for analysis.
Time Frame
8 weeks
Title
Muscle cross sectional area - CSA
Description
Muscle CSA is measured with Magnetic resonance imaging (MRI) scan, it is an expensive measurement. The CSA of three major muscle such as; half way at arm - biceps, thigh - quadriceps and calf muscles were measured and included for analysis.
Time Frame
6 months.
Title
Adiponectin
Description
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker Adiponectin levels were measured with ELISA kit
Time Frame
At baseline
Title
Adiponectin
Description
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker Adiponectin levels were measured with ELISA kit
Time Frame
8 weeks
Title
Adiponectin
Description
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker Adiponectin levels were measured with ELISA kit
Time Frame
6 months
Title
Leptin
Description
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker Leptin levels were measured with ELISA kit
Time Frame
At baseline
Title
Leptin
Description
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker Leptin levels were measured with ELISA kit
Time Frame
8 weeks
Title
Leptin
Description
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker Leptin levels were measured with ELISA kit
Time Frame
6 months
Title
TNF-α
Description
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker TNF-α levels were measured with ELISA kit
Time Frame
At baseline
Title
TNF-α
Description
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker TNF-α levels were measured with ELISA kit
Time Frame
8 weeks
Title
TNF-α
Description
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical markers TNF-α levels were measured with ELISA kit
Time Frame
6 months.
Title
IL-6
Description
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker IL-6 levels were measured with ELISA kit
Time Frame
At baseline
Title
IL-6
Description
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker IL-6 levels were measured with ELISA kit
Time Frame
8 weeks
Title
IL-6
Description
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done. Serum and plasma were separated and stored immediately at -800C. Biochemical marker IL-6 levels were measured with ELISA kit
Time Frame
6 months.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Positively diagnosed COVID-19 children age group of 5 - 12 years Body mass index (BMI) between 85th to 99th percentiles Exclusion Criteria: 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, other systemic diseases, contraindications for physical training and family with food restrictions
Facility Information:
Facility Name
Gopal Nambi
City
Al Kharj
State/Province
Riyadh
ZIP/Postal Code
11942
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The master data and other study information can be obtained by contacting the principal investigator.

Learn more about this trial

Exercise and Diet for Pediatric Obesity

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