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Completed

NCT Number: NCT06377137

High-intensity Small-sided Soccer Games for Cardiometabolic Health in Adolescents With Metabolic Dysfunction

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.

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Key information

Conditions

Obesity, Adolescent Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

11 year–15 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Sport of the University of Porto

Porto, 4200-450, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Small-sided soccer games groups (SSSG)

Behavioral

Physical exercise intervention

Traditional soccer training groups (TSG)

Behavioral

Physical exercise intervention

Primary outcomes

  1. Waist circumference

    Time frame: 16 weeks

    Anthropometric measurement of abdominal obesity; cm

  2. Cardiorespiratory fitness

    Time frame: 16 weeks

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

Secondary outcomes

  1. Variation in fasting blood glucose concentration (mg/dL)

    Time frame: 16 weeks

    Variation in fasting blood glucose concentration after 16 weeks of intervention.

    Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.

  2. Variation in serum insulin concentration (mU/L)

    Time frame: 16 weeks

    Variation in serum insulin concentration after 16 weeks of intervention.

    Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.

  3. Variation in HOMA-IR

    Time frame: 16 weeks

    Variation in HOMA-IR after 16 weeks of intervention.

    Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.

  4. Variation in glycosylated hemoglobin concentration (mg/dL)

    Time frame: 16 weeks

    Variation in Glycosylated hemoglobin concentration after 16 weeks of intervention.

    Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.

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

    Time frame: 16 weeks

    Variation in High-density lipoprotein cholesterol concentration after 16 weeks of intervention.

    Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.

  6. Variation in low-density lipoprotein cholesterol concentration (mg/dL)

    Time frame: 16 weeks

    Variation in low-density lipoprotein cholesterol concentration after 16 weeks of intervention.

    Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.

  7. Variation in total cholesterol concentration (mg/dL)

    Time frame: 16 weeks

    Variation in total cholesterol concentration after 16 weeks of intervention.

    Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.

  8. Variation in blood triglycerides concentration (mg/dL)

    Time frame: 16 weeks

    Variation in blood triglycerides concentration after 16 weeks of intervention.

    Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.

  9. Variation in blood Alanine aminotransferase concentration (U/L)

    Time frame: 16 weeks

    Variation in blood Alanine aminotransferase concentration after 16 weeks of intervention.

    Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.

  10. Variation in blood Aspartate aminotransferase concentration (U/L)

    Time frame: 16 weeks

    Variation in blood Aspartate aminotransferase concentration after 16 weeks of intervention.

    Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.

  11. Variation in blood Gamma glutamyl transferase concentration (U/L)

    Time frame: 16 weeks

    Variation in blood Gamma glutamyl transferase concentration after 16 weeks of intervention.

    Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.

  12. 6-minute walk test

    Time frame: 16 weeks

    Distance covered walking in 6 minutes.

  13. Hand grip strength

    Time frame: 16 weeks

    Hand grip strength test measured with a digital hand dynamometer

  14. Lower limb strength

    Time frame: 16 weeks

    Assessed by Horizontal jump test.

  15. Body composition

    Time frame: 16 weeks

    Assessed by the electrical bioimpedance method

  16. Body mass index

    Time frame: 16 weeks

    Weight and height will be combined to report BMI in kg/m^2

  17. Neck circumference

    Time frame: 16 weeks

    Assessed by anthropometric techniques

  18. Blood Pressure (mmHg)

    Time frame: 16 weeks

    Systolic and diastolic blood pressure measured with digital sphygmomanometer

  19. Physical activity

    Time frame: 16 weeks

    Physical activity will be assessed objectively with a triaxial accelerometer used 24h/d during 7 consecutive days.

  20. Sleep quality

    Time frame: 16 weeks

    Sleep quality will be assessed objectively with a triaxial accelerometer used 24h/d during 7 consecutive days.

  21. Perceived enjoyment of physical activity

    Time frame: 16 weeks

    Assessed by the Physical Activity Enjoyment Scale questionnaire (PACES). Raw scores are transformed into a scale from 16 to 80. Higher scores correspond to higher perceived enjoyment.

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 22, 2024
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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