Clinical trial NCT05336006: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
COVID-19
Keywords: aerobic training
biochemical
children with obesity
COVID-19
high protein diet
Lead sponsor: Prince Sattam Bin Abdulaziz University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 76
Sex: MALE
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Body mass index (BMI)
timeFrame: At baseline
measure: Body mass index (BMI)
timeFrame: 8 weeks
measure: Body mass index (BMI)
timeFrame: 6 months
Secondary outcomes:
measure: Muscle cross sectional area - CSA
timeFrame: At baseline
measure: Muscle cross sectional area - CSA
timeFrame: 8 weeks
measure: Muscle cross sectional area - CSA
timeFrame: 6 months.
measure: Adiponectin
timeFrame: At baseline
measure: Adiponectin
timeFrame: 8 weeks
measure: Adiponectin
timeFrame: 6 months
measure: Leptin
timeFrame: At baseline
measure: Leptin
timeFrame: 8 weeks
measure: Leptin
timeFrame: 6 months
measure: TNF-α
timeFrame: At baseline
measure: TNF-α
timeFrame: 8 weeks
measure: TNF-α
timeFrame: 6 months.
measure: IL-6
timeFrame: At baseline
measure: IL-6
timeFrame: 8 weeks
measure: IL-6
timeFrame: 6 months.
Other outcomes:
Locations:
city: Al Kharj
country: Saudi Arabia
facility: Gopal Nambi
state: Riyadh
Study officials:
References: