Exercise and Diet for Pediatric Obesity

NCT ID: NCT05336006

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-10
• Study Completion Date: 2021-10-30

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.

Conditions

Pediatric Obesity; COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

High-intensity aerobic training with high protein diet

Intervention Type: 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 - Group B

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

Group Type: PLACEBO_COMPARATOR

Control group

Intervention Type: OTHER

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

Interventions

High-intensity aerobic training with high protein diet

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

Control group

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Prince Sattam Bin Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Gopal Nambi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gopal Nambi

Al Kharj, Riyadh Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

RHPT/020/058

Identifier Type: -

Identifier Source: org_study_id