NCT06377137

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 ≥ 0.5; (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

April 1, 2024

Last Update Submit

April 17, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Waist circumference

    Anthropometric measurement of abdominal obesity; cm

    16 weeks

  • Cardiorespiratory fitness

    1-mile walk/run test; minutes to run 1 mile

    16 weeks

Secondary Outcomes (21)

  • Variation in fasting blood glucose concentration (mg/dL)

    16 weeks

  • Variation in serum insulin concentration (mU/L)

    16 weeks

  • Variation in HOMA-IR

    16 weeks

  • Variation in glycosylated hemoglobin concentration (mg/dL)

    16 weeks

  • Variation in high-density lipoprotein cholesterol concentration (mg/dL)

    16 weeks

  • +16 more secondary outcomes

Study Arms (3)

Small-sided soccer games groups (SSSG)

EXPERIMENTAL

SSSG will perform 16 weeks of training, 3 sessions/week, and \~55 minutes/session. Each session will begin with a 15-minute warm-up, 32 minutes of principal activity, and 5 minutes of cool down. The SSSG will consist of a program based on high-intensity SSSG. The training protocol is based on a pilot study conducted to characterize the exertion profile. The SSSG will be performed in a fractional regimen of 8 sets of 4 minutes and 2 minutes rest. The format of the SSGs will be 3v3, although they can be adapted to 2v2 or 4v4 when necessary. In addition, it will take place in a playing area of 9 x 18 meters equivalent to 27 square meters per player. To encourage high intensity, the following will be used (i) man-to-man marking; (ii) to score a goal, the entire team must be in the opponent's half of the field; (iii) balls will be available to reduce stoppages in play; (iv) the coach will motivate the team to maintain high intensity.

Behavioral: Small-sided soccer games groups (SSSG)

Traditional soccer training groups (TSG)

EXPERIMENTAL

SSSG will perform 16 weeks of training, 3 sessions/week, and \~55 minutes/session. Each session will begin with a 15-minute warm-up, 32 minutes of principal activity, and 5 minutes of cool down. The TSG group will base its training on 30 minutes of technical exercises with the ball individually or in pairs (dribbling, shooting and passing), ending with 10 minutes of a match organized according to the original characteristics of an indoor soccer game.

Behavioral: Traditional soccer training groups (TSG)

Control Group (CG)

NO INTERVENTION

CG will perform only regular school physical education classes without any additional intervention

Interventions

Physical exercise intervention

Small-sided soccer games groups (SSSG)

Physical exercise intervention

Traditional soccer training groups (TSG)

Eligibility Criteria

Age11 Years - 15 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age between 11-15 years at the time of intervention start
  • Overweight or obesity (BMI\> 85th percentile)
  • Abdominal obesity ≥90th percentile as assessed by waist circumference or a waist-to- height ratio ≥ 0.5
  • Willing to participate in the study regardless of possible group allocation
  • Informed consent given by participant and legal representatives

You may not qualify if:

  • Health condition not compatible with participation in physical exercise
  • History of recent musculoskeletal injury hindering exercise participation
  • Concurrent participation in a structured weight loss or exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sport of the University of Porto

Porto, 4200-450, Portugal

Location

MeSH Terms

Conditions

Pediatric ObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 1, 2024

First Posted

April 22, 2024

Study Start

March 10, 2023

Primary Completion

April 10, 2023

Study Completion

September 1, 2023

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations