Clinical trial NCT05294601: Effect of High Intensity Children's Games Compared With Medium Intensityregulation, Obesity Biomarkers and Body Composition in Boys and Girls
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity, Childhood
Keywords: Obesity
children
High-Intensity Interval Training
Adipokines
Lead sponsor: Universidad Surcolombiana
Sponsor class: OTHER
Collaborators: name: Maciste Macias
name: Gilberto Astaiza
First posted: 2022-03-24
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups with nutritional interventions and recreational games and observation before and after of physiological variables needed in the outcomes.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: IL-6 salival levels
timeFrame: 12 weeks
measure: TNF-α salival levels
timeFrame: 12 weeks
measure: Leptin salival levels
timeFrame: 12 weeks
measure: Adiponectin salival levels
timeFrame: 12 weeks
measure: Insulin salival levels with elisa test
timeFrame: 12 weeks
Secondary outcomes:
measure: Heart rate variability
timeFrame: 12 weeks
measure: fat mass percentage
timeFrame: 12 weeks
measure: Percentage of muscle mass
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Neiva
country: Colombia
facility: Universidad Surcolombiana
state: Huila
Study officials:
affiliation: Universidad Surcolombiana-Universidad del Valle
name: Claudia Y Rodriguez-Triviño, Ph.D student
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
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.