Exercise and Diet for Pediatric Obesity

NCT05336006 | Completed DMC

• 1 other identifier: RHPT/020/058
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity; COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Body mass index (BMI)

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

  At baseline

• Body mass index (BMI)

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

  8 weeks

• Body mass index (BMI)

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

  6 months

Secondary Outcomes (15)

• Muscle cross sectional area - CSA

  At baseline

• Muscle cross sectional area - CSA

  8 weeks

• Muscle cross sectional area - CSA

  6 months.

• Adiponectin

  At baseline

• Adiponectin

  8 weeks

Study Arms (2)

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

EXPERIMENTAL

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.

Other: High-intensity aerobic training with high protein diet

Control group - Group B

PLACEBO COMPARATOR

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

Other: Control group

Interventions

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.

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

Control group OTHER

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

Control group - Group B

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Positively diagnosed COVID-19 children
• age group of 5 - 12 years
• Body mass index (BMI) between 85th to 99th percentiles

You may not qualify if:

• 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

Sponsors & Collaborators

• Prince Sattam Bin Abdulaziz University: lead

Study Sites (1)

Gopal Nambi

Al Kharj, Riyadh Region, 11942, Saudi Arabia

Location

MeSH Terms

Conditions

Pediatric Obesity; COVID-19

Interventions

Diet, High-Protein; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 20, 2022
• Study Start: March 10, 2020
• Primary Completion: December 25, 2020
• Study Completion: October 30, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

SA (1)