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

Primary Purpose

Obesity, Childhood

Status
Recruiting
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
High-Intensity Interval Training
Medium-Intensity Interval Training
Sponsored by
Universidad Surcolombiana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Childhood focused on measuring Obesity, children, High-Intensity Interval Training, Adipokines

Eligibility Criteria

6 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidad SurcolombianaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

HIIG Group

MIIG Group

Control Group

Arm Description

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

: 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.

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.

Outcomes

Primary Outcome Measures

IL-6 salival levels
elisa test for IL-6 in saliva levels = 26.89 ± 9.97 pg/mL
TNF-α salival levels
elisa test for IL-6 in saliva levels= 43,56 ± 6,44 pg/mL
Leptin salival levels
ng / ml
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
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

Secondary Outcome Measures

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.
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
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

Full Information

First Posted
November 30, 2021
Last Updated
March 23, 2022
Sponsor
Universidad Surcolombiana
Collaborators
Maciste Macias, Gilberto Astaiza
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1. Study Identification

Unique Protocol Identification Number
NCT05294601
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Anticipated)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Surcolombiana
Collaborators
Maciste Macias, Gilberto Astaiza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
Keywords
Obesity, children, High-Intensity Interval Training, Adipokines

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three groups with nutritional interventions and recreational games and observation before and after of physiological variables needed in the outcomes.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIIG Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
MIIG Group
Arm Type
Active Comparator
Arm Description
: 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
High-Intensity Interval Training
Other Intervention Name(s)
High Intensity Interval Games
Intervention Description
high intensity exercise with games
Intervention Type
Other
Intervention Name(s)
Medium-Intensity Interval Training
Other Intervention Name(s)
Medium-Intensity Interval Games
Intervention Description
medium intensity exercise with games
Primary Outcome Measure Information:
Title
IL-6 salival levels
Description
elisa test for IL-6 in saliva levels = 26.89 ± 9.97 pg/mL
Time Frame
12 weeks
Title
TNF-α salival levels
Description
elisa test for IL-6 in saliva levels= 43,56 ± 6,44 pg/mL
Time Frame
12 weeks
Title
Leptin salival levels
Description
ng / ml
Time Frame
12 weeks
Title
Adiponectin salival levels
Description
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
Time Frame
12 weeks
Title
Insulin salival levels with elisa test
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Heart rate variability
Description
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.
Time Frame
12 weeks
Title
fat mass percentage
Description
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
Time Frame
12 weeks
Title
Percentage of muscle mass
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Universidad Surcolombiana
Phone
(+57) 300 798 6760
Email
doctoradoencienciasdelasalud@usco.edu.co
First Name & Middle Initial & Last Name or Official Title & Degree
Gilberto Astaiza, MD
Phone
3002129824
Email
comitedeetica@usco.edu.co
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Y Rodriguez-Triviño, Ph.D student
Organizational Affiliation
Universidad Surcolombiana-Universidad del Valle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Surcolombiana
City
Neiva
State/Province
Huila
ZIP/Postal Code
410010
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolás A Núñez Gómez, PhD
Phone
(+57) 300 798 6760
Email
doctoradoencienciasdelasalud@usco.edu.co

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30227396
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.
Results Reference
background
PubMed Identifier
26667697
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.
Results Reference
background
PubMed Identifier
26948135
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.
Results Reference
background
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.
Results Reference
result

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

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