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OpenTrials
Completed

NCT Number: NCT05336006

Exercise and Diet for Pediatric Obesity

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.

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Key information

Conditions

Pediatric Obesity Body Weight COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

5 year–12 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Gopal Nambi

Al Kharj, Riyadh Region, 11942, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-intensity aerobic training with high protein diet

Other

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.

Control Group

Other

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

Primary outcomes

  1. Body mass index (BMI)

    Time frame: At baseline

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

  2. Body mass index (BMI)

    Time frame: 8 weeks

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

  3. Body mass index (BMI)

    Time frame: 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 outcomes

  1. Muscle cross sectional area - CSA

    Time frame: At baseline

    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.

  2. Muscle cross sectional area - CSA

    Time frame: 8 weeks

    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.

  3. Muscle cross sectional area - CSA

    Time frame: 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.

  4. Adiponectin

    Time frame: At baseline

    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

  5. Adiponectin

    Time frame: 8 weeks

    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

  6. Adiponectin

    Time frame: 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

  7. Leptin

    Time frame: At baseline

    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

  8. Leptin

    Time frame: 8 weeks

    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

  9. Leptin

    Time frame: 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

  10. TNF-α

    Time frame: At baseline

    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

  11. TNF-α

    Time frame: 8 weeks

    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

  12. TNF-α

    Time frame: 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

  13. IL-6

    Time frame: At baseline

    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

  14. IL-6

    Time frame: 8 weeks

    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

  15. IL-6

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Prince Sattam Bin Abdulaziz University

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Apr 20, 2022
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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