Effect of High Intensity Children's Games Compared With Medium Intensityregulation, Obesity Biomarkers and Body Composition in Boys and Girls

NCT05294601 | Unknown DMC

• 1 other identifier: 3685
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of high intensity children's games compared with those of medium intensity on cardiac autonomic regulation, obesity biomarkers and body composition in Boys and Girls from 6 to 9 years old with Obesity or Overweight

Conditions

Obesity, Childhood

Keywords

Obesity; children; High-Intensity Interval Training; Adipokines

Outcome Measures

Primary Outcomes (5)

• IL-6 salival levels

  elisa test for IL-6 in saliva levels = 26.89 ± 9.97 pg/mL

  12 weeks

• TNF-α salival levels

  elisa test for IL-6 in saliva levels= 43,56 ± 6,44 pg/mL

  12 weeks

• Leptin salival levels

  ng / ml

  12 weeks

• Adiponectin salival levels

  elisa test for Adiponectin (also known as Acrp30) is a hormone synthesized by white adipose tissue that mcg/ml participates in the metabolism of glucose and fatty acids. Salivary concentrations of 3.22-28.71 ng/ml

  12 weeks

• Insulin salival levels with elisa test

  Hypoglycemic protein hormone that is secreted in the beta cells of the islets of Langerhans, the established reference ranges for adults are between 2.6 and 24.9μU/ml for insulin for adults, in children it is more variable and depends on age 0.20μU/ml and a maximum of 26.5μU/ml

  12 weeks

Secondary Outcomes (3)

• Heart rate variability

  12 weeks

• fat mass percentage

  12 weeks

• Percentage of muscle mass

  12 weeks

Study Arms (3)

HIIG Group

ACTIVE COMPARATOR

General nutritional recommendations will be suggested in an initial consultation with weekly telephone follow-up. The high intensity children's games program for 12 weeks, . In this group the activities will include 3 weekly sessions. . The games last 6 minutes with a 2 minute break, four games per session; which is the one established for children of these ages according to the cited authors. The session is divided into 5 minutes of warm-up, 36 minutes of intervention and 8 minutes of cool-down. The intensity varies between 85-95% of HR max. According to the equation of Tanka et., Al. HR max = 208-0.7 x age

Other: High-Intensity Interval Training

MIIG Group

ACTIVE COMPARATOR

: The interventions will be carried out by a graduate in physical education, recreation and / or sports and the main researcher. General nutritional recommendations will be suggested in an initial consultation with weekly telephone follow-up. The medium intensity physical activity program for 12 weeks (28). Medium intensity activities are very similar to those taught in physical education class. In this group the activities will include 3 weekly sessions, with six episodes of 10 min at 65% to 85% of maximum heart rate (HRmax) separated by 5 min of recovery.

Other: Medium-Intensity Interval Training

Control Group

NO INTERVENTION

In this group, measurements will be made before, during and after the study. Neither medium nor high intensity interventions will be carried out in order to generate comparisons, control biases and confounding and interaction variables. However, the interventions that have been most beneficial in the intervention groups. It could be implemented in this study once the analysis between groups has been completed, according to the recommendations and follow-up by the ethics committee.

Interventions

High-Intensity Interval Training OTHER

high intensity exercise with games

Also known as: High Intensity Interval Games

HIIG Group

Medium-Intensity Interval Training OTHER

medium intensity exercise with games

Also known as: Medium-Intensity Interval Games

MIIG Group

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children from 6 to 9 years old with the consent of their parents or guardians and who agree to participate
• Clinically healthy verified by medical examination according to the Clinical Guide for cardiovascular evaluation prior to sports practice in pediatrics .
• Children with weight above the 85th percentile in relation to their growth and development scale for Colombia and as suggested by the study by Cole et., al
• Children who are included in the general social security system

You may not qualify if:

• Children with musculoskeletal diseases that limit or contraindicate physical activity.
• Children with chronic diseases (chronic asthma, kidney disease, diabetes), or who have received medications that alter body composition or in-sulin secretion such as glucocorticoids.
• Children who on medical examination have shown any history or evidence of heart disease
• Hypertension (defined as blood pressure above the 95th percentile for systolic or diastolic values)
• Diagnosed attention deficit hypersensitivity disorder
• Children who at the clinical discretion cannot participate or who have presented any symptoms (dyspnea, chest pain, palpitations, among others) during the physical fitness test.

Sponsors & Collaborators

• Universidad Surcolombiana: lead
• Maciste Macias: collaborator
• Gilberto Astaiza: collaborator

Study Sites (1)

Universidad Surcolombiana

Neiva, Huila Department, 410010, Colombia

RECRUITING

Related Publications (5)

• van Biljon A, McKune AJ, DuBose KD, Kolanisi U, Semple SJ. Short-Term High-Intensity Interval Training Is Superior to Moderate-Intensity Continuous Training in Improving Cardiac Autonomic Function in Children. Cardiology. 2018;141(1):1-8. doi: 10.1159/000492457. Epub 2018 Sep 18.

  PMID: 30227396 BACKGROUND

• Aguilar Cordero MJ, Ortegon Pinero A, Baena Garcia L, Noack Segovia JP, Levet Hernandez MC, Sanchez Lopez AM. [REBOUND EFFECT OF INTERVENTION PROGRAMS TO REDUCE OVERWEIGHT AND OBESITY IN CHILDREN AND ADOLESCENTS; SYSTEMATIC REVIEW]. Nutr Hosp. 2015 Dec 1;32(6):2508-17. doi: 10.3305/nh.2015.32.6.10071. Spanish.

  PMID: 26667697 BACKGROUND

• Garcia-Hermoso A, Cerrillo-Urbina AJ, Herrera-Valenzuela T, Cristi-Montero C, Saavedra JM, Martinez-Vizcaino V. Is high-intensity interval training more effective on improving cardiometabolic risk and aerobic capacity than other forms of exercise in overweight and obese youth? A meta-analysis. Obes Rev. 2016 Jun;17(6):531-40. doi: 10.1111/obr.12395. Epub 2016 Mar 7.

  PMID: 26948135 BACKGROUND

• Amigo, T. R. R., & Labisa-Palmeira, A. (2020). Moderators of the effect of high-intensity and moderate-intensity games in school children on cardiorespiratory fitness and body composition. Motricidade, 16(2), 156-169.

  RESULT

• Rodriguez-Trivino CY, Quintana S, Osorio-Velez CE, Garcia-Florez M. Effect of high-intensity childhood games on heart rate variability, saliva leptin concentrations, and body composition in children. Braz J Med Biol Res. 2025 Jun 16;58:e14479. doi: 10.1590/1414-431X2025e14479. eCollection 2025.

  PMID: 40531756 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Claudia Y Rodriguez-Triviño, Ph.D student

  Universidad Surcolombiana-Universidad del Valle

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Universidad Surcolombiana

CONTACT

(+57) 300 798 6760; doctoradoencienciasdelasalud@usco.edu.co

Gilberto Astaiza, MD

CONTACT

3002129824; comitedeetica@usco.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three groups with nutritional interventions and recreational games and observation before and after of physiological variables needed in the outcomes.

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: March 24, 2022
• Study Start: April 25, 2022
• Primary Completion: December 30, 2022
• Study Completion: July 30, 2023
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)