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

March 23, 2022 updated by: claudia rodriguez, Universidad Surcolombiana

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

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 Contact

Study Contact Backup

Study Locations

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

4 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HIIG Group
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
high intensity exercise with games
Other Names:
  • High Intensity Interval Games
Active Comparator: MIIG Group
: 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
medium intensity exercise with games
Other Names:
  • Medium-Intensity Interval Games
No Intervention: Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-6 salival levels
Time Frame: 12 weeks
elisa test for IL-6 in saliva levels = 26.89 ± 9.97 pg/mL
12 weeks
TNF-α salival levels
Time Frame: 12 weeks
elisa test for IL-6 in saliva levels= 43,56 ± 6,44 pg/mL
12 weeks
Leptin salival levels
Time Frame: 12 weeks
ng / ml
12 weeks
Adiponectin salival levels
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability
Time Frame: 12 weeks
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
fat mass percentage
Time Frame: 12 weeks
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
Percentage of muscle mass
Time Frame: 12 weeks
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

Collaborators and Investigators

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

Sponsor

Universidad Surcolombiana

Collaborators

Maciste Macias
Gilberto Astaiza

Investigators

  • Principal Investigator: Claudia Y Rodriguez-Triviño, Ph.D student, Universidad Surcolombiana-Universidad del Valle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

April 25, 2022

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

July 30, 2023

Study Registration Dates

First Submitted

November 30, 2021

First Submitted That Met QC Criteria

March 23, 2022

First Posted (Actual)

March 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3685

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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