Physical Training and Diet for Childhood Obesity

March 9, 2021 updated by: Marwa Eid, Cairo University

Clinical (BMI & MRI) and Biochemical (Adiponectin, Leptin, TNF-α & IL-6) Effects of High-intensity Aerobic Training With High Protein Diet in Childhood Obesity Following COVID-19 Infection

It is observed that children affected with COVID-19 who are physically inactive or in a sedentary lifestyle may induce and develop childhood obesity (CO). 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, it needs an elaborative trial in this field, so the aim of his study was to find the clinical and biochemical effects of high-intensity aerobic training with a high protein diet in childhood obesity following COVID-19 infection

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 2011
        • Marwa Eid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • A positive diagnosis of COVID-19
  • Male children
  • 5 - 12 years of age Body mass index (BMI).
  • Between 85t h to 99th percentiles were considered for childhood obesity.

Exclusion Criteria:

  • Subjects with a 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.
  • Any other systemic diseases, contraindications for physical training.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (high-intensity aerobic training with high protein diet )
Other: High-intensity aerobic training with high protein diet
High-intensity aerobic training was given with 50 to 70 % of the maximum heart rate. the intervention started with 10 mins of warm-up exercise through stretching of upper and lower limb muscles. Subsequent to stretching, the subjects were asked to do 30 mins of exercises; consisting of 20 mins on the treadmill and 10 mins of cycle ergometer at 50 to 70 % of MHR, then with 10 mins of cool down.
Experimental: Group B(regular physical activities and taken regular diet)
Other: High-intensity aerobic training with high protein diet
High-intensity aerobic training was given with 50 to 70 % of the maximum heart rate. the intervention started with 10 mins of warm-up exercise through stretching of upper and lower limb muscles. Subsequent to stretching, the subjects were asked to do 30 mins of exercises; consisting of 20 mins on the treadmill and 10 mins of cycle ergometer at 50 to 70 % of MHR, then with 10 mins of cool down.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index
Time Frame: 6 monthes
For children, age adjusted BMI percentile (BMI %) was calculated
6 monthes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2020

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

December 25, 2020

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Obesity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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