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

Obesity, Childhood Clinical Trial

Official title:

Efecto de Los Juegos Infantiles de Alta Intensidad Comparado Con Los de Mediana Intensidad Sobre la regulación autonómica Cardiaca, Biomarcadores de Obesidad y composición Corporal en Niños y Niñas de 6 a 9 años Con Obesidad o Sobrepeso

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05294601
• Other study ID #: 3685
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: March 2022
• Source: Universidad Surcolombiana
• Contact: Universidad Surcolombiana
• Phone: (+57) 300 798 6760
• Email: doctoradoencienciasdelasalud[@]usco.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Childhood obesity presents as a multifactorial disease with serious health consequences . In the department of Huila, the situation with respect to cardiovascular diseases (CVD) and childhood obesity is similar to the whole country and is a public health problem, recognized by the territorial entities. Autonomic dysfunction associated with obesity has been documented in adults and has been related to eventual CVD. The evidence for autonomic dysfunction in children remains contradictory, as well as whether this eventual dysfunction can be reversed with training. High intensity interval training (HIIT) is considered efficient because it achieves similar benefits to moderate or low intensity aerobic exercise, but in less time in the adult population ; In children and adolescents, HIIT training strategies have been tested with excellent results, related to both body weight and cardiorespiratory fitness, and could improve autonomic control. In the case of children, HIIT must be transformed to adapt them to the corresponding age. Children's recreational games have a similar pattern to HIIT; with intervals of high intensity alternated by short periods of rest; However, high-intensity games take into account children's motor development and aim to achieve some benefits of HIIT without necessarily meeting its goals in terms of cardiovascular demand. The objective of this study is to evaluate the effect of high intensity children's games (HIIG) compared to medium intensity games (MIIG) on cardiac autonomic regulation and body composition in Boys and Girls from 6 to 9 years old with Obesity or Overweight from the city of Neiva-Huila.

In this research, an experimental type design, a randomized controlled clinical trial, will be applied. Reference population: Children between 6 and 9 years old with overweight and obesity, enrolled in educational institutions in Neiva. To determine the experimental sample, the inclusion and exclusion criteria will be applied. The participants will subsequently be randomly divided into two intervention groups and a control group. The sample for this study will be 35 children in the control group and 35 children in the HIIG group and 35 MIIG children, randomly chosen from among the boys and girls who have authorization from their tutors and who agree to participate voluntarily who have complied with the above criteria. The project will be developed in different four research phases: Phase I (Sensitization to parents and children), Phase II (Medical Assessment, Course navette test, Measurement of heart rate variability, Initial measurement of anthropometric parameters, body composition , salivary biomarkers for obesity), Phase III (high intensity children's games program will be for 12 weeks for the HIIG group and moderate intensity children's games program for the MIIG group according to Biljon et., al and Phase IV (Again, measurement of phase II variables.) It is hoped to determine if training through games changes cardiac autonomic control; inflammatory markers; as well as improve anthropometric variables and positively impact family lifestyles participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Other:
• High-Intensity Interval Training
high intensity exercise with games
• Medium-Intensity Interval Training
medium intensity exercise with games

Locations

Country	Name	City	State
Colombia	Universidad Surcolombiana	Neiva	Huila

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Surcolombiana	Gilberto Astaiza, Maciste Macias

Country where clinical trial is conducted

Colombia, 

References & Publications (4)

Aguilar Cordero MJ, Ortegón Piñero A, Baena García L, Noack Segovia JP, Levet Hernández MC, Sánchez López 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. Review. Spanish. — View Citation

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.

García-Hermoso A, Cerrillo-Urbina AJ, Herrera-Valenzuela T, Cristi-Montero C, Saavedra JM, Martínez-Vizcaíno 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IL-6 salival levels	elisa test for IL-6 in saliva levels = 26.89 ± 9.97 pg/mL	12 weeks
Primary	TNF-a salival levels	elisa test for IL-6 in saliva levels= 43,56 ± 6,44 pg/mL	12 weeks
Primary	Leptin salival levels	ng / ml	12 weeks
Primary	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
Primary	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	Heart rate variability	To assess the group-time effect of high-intensity games compared to medium-intensity games on heart rate variability in boys and girls aged 6 to 9 years with obesity or overweight.	12 weeks
Secondary	fat mass percentage	Body composition: fat mass and muscle mass of boys and girls will be calculated based on the formulas of Slaughter et al. . and bioimpedance technique	12 weeks
Secondary	Percentage of muscle mass	Body composition: fat mass and muscle mass of boys and girls will be calculated based on the formulas of Slaughter et al. . and bioimpedance technique	12 weeks