Exercise and Diet for Pediatric Obesity

Not Applicable

Completed

• Conditions: COVID-19; Pediatric Obesity

• Registration Number: NCT05336006
• Lead Sponsor: Prince Sattam Bin Abdulaziz University

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.

Study Timeline

• Study Start: 2020-03-10
• Primary Completion: 2020-12-25
• Study Completion: 2021-10-30
• Status Verified: 2022-04
• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-20
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body mass index (BMI)	6 months	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

Name	Time	Method
Muscle cross sectional area - CSA	6 months.	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	6 months	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	6 months	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	6 months.	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	6 months.	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

Trial Locations

Locations (1)

Gopal Nambi; 🇸🇦 Al Kharj, Riyadh, Saudi Arabia