Viewing Study NCT06377137



Ignite Creation Date: 2024-05-06 @ 8:25 PM
Last Modification Date: 2024-10-26 @ 3:27 PM
Study NCT ID: NCT06377137
Status: COMPLETED
Last Update Posted: 2024-04-22
First Post: 2024-04-01

Brief Title: High-intensity Small-sided Soccer Games for Cardiometabolic Health in Adolescents With Metabolic Dysfunction
Sponsor: Universidade do Porto
Organization: Universidade do Porto

Study Overview

Official Title: High Intensity Training Based on Small-sided Soccer Games for Health Effects on Cardiometabolic Health Motor Performance and Adherence to 24-hour Movement Guidelines in Adolescents With Overweight and Metabolic Dysfunction
Status: COMPLETED
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Pediatric obesity is considered one of the most important public health problems worldwide due to its high prevalence and associated comorbidities Physical exercise has been shown to have an important role in the treatment of obesity and associated cardiometabolic dysfunction Small-sided soccer games SSSG have been explored as a promising way of increasing physical exercise due to its benefits on cardiometabolic health and high degree of enjoyment which favors long-term adherence

The objective of this research is to determine the effects of a 16-week high-intensity SSSG-based exercise intervention on cardiometabolic risk factors physical fitness adherence to 24-hour movement patterns enjoyment and adherence to the intervention in adolescents with metabolic dysfunction and compare them to the effects of a traditional soccer intervention

The investigators hypothesize that high-intensity SSSG are more effective in improving the obesity-related cardiometabolic risk profile in adolescents with cardiometabolic dysfunction compared to traditional soccer training

A parallel 3-arm randomized controlled trial will be conducted in adolescents with overweight and metabolic dysfunction between 11 and 15 years of age The inclusion criteria are i age between 11-15 years at the time of intervention start ii overweight or obesity BMI 85th percentile iii Abdominal obesity 90th percentile as assessed by waist circumference or a waist-to-height ratio 05 iv willing to participate in the study regardless of possible group allocation v informed consent given by participant and legal representatives Exclusion criteria i health condition not compatible with participation in physical exercise ii history of recent musculoskeletal injury hindering exercise participation iii concurrent participation in a structured weight loss or exercise program

Those eligible to participate in the study will be randomly assigned to one of three groups i SSSG group ii traditional soccer play group TSG or iii non-exercise intervention control group CG Participants in both exercise intervention groups will undergo a 16-week intervention The SSSG group will participate in a high-intensity small-sided soccer games training while the TSG will undergo a technical and tactical skills training program and traditional soccer training The CG participants will continue with regular school physical education classes without any additional intervention Before and after the intervention all participants will be assessed for cardiometabolic and hepatic biochemical markers physical fitness anthropometry and body composition blood pressure objective daily physical activity and sleep quality and perceived enjoyment of participation in SSSG and TSG The primary outcomes of the study will be waist circumference and cardiorespiratory fitness

The study protocol was approved by the Ethics Committee of the Faculty of Sport of the University of Porto and by the Scientific Ethics Committee of the Adventist University of Chile
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None