Skip to content

Exercise and Diet for Pediatric Obesity

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05336006
Enrollment
76
Registered
2022-04-20
Start date
2020-03-10
Completion date
2021-10-30
Last updated
2022-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Pediatric Obesity

Keywords

aerobic training, biochemical, children with obesity, COVID-19, high protein diet

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.

Interventions

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.

OTHERControl group

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

Sponsors

Prince Sattam Bin Abdulaziz University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
5 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Muscle cross sectional area - CSAAt baselineMuscle 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.
AdiponectinAt baselineFasting (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
LeptinAt baselineFasting (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-αAt baselineFasting (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
IL-6At baselineFasting (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

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026