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

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Obesity, Adolescent

• Registration Number: NCT06377137
• Lead Sponsor: Universidade do Porto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-10
• Primary Completion: 2023-04-10
• Study Completion: 2023-09-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-17
• Last Update Submitted: 2024-04-17
• Study First Posted: 2024-04-22
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Waist circumference	16 weeks	Anthropometric measurement of abdominal obesity; cm
Cardiorespiratory fitness	16 weeks	1-mile walk/run test; minutes to run 1 mile

Secondary Outcome Measures

Name	Time	Method
Variation in low-density lipoprotein cholesterol concentration (mg/dL)	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.
Hand grip strength	16 weeks	Hand grip strength test measured with a digital hand dynamometer
Lower limb strength	16 weeks	Assessed by Horizontal jump test.
Blood Pressure (mmHg)	16 weeks	Systolic and diastolic blood pressure measured with digital sphygmomanometer
Variation in HOMA-IR	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.
Variation in blood Alanine aminotransferase concentration (U/L)	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.
Body mass index	16 weeks	Weight and height will be combined to report BMI in kg/m\^2
Variation in high-density lipoprotein cholesterol concentration (mg/dL)	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.
Variation in serum insulin concentration (mU/L)	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.
Variation in blood triglycerides concentration (mg/dL)	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.
Variation in blood Gamma glutamyl transferase concentration (U/L)	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.
Variation in fasting blood glucose concentration (mg/dL)	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.
Variation in glycosylated hemoglobin concentration (mg/dL)	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.
Variation in total cholesterol concentration (mg/dL)	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.
Variation in blood Aspartate aminotransferase concentration (U/L)	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.
Body composition	16 weeks	Assessed by the electrical bioimpedance method
Neck circumference	16 weeks	Assessed by anthropometric techniques
Physical activity	16 weeks	Physical activity will be assessed objectively with a triaxial accelerometer used 24h/d during 7 consecutive days.
Sleep quality	16 weeks	Sleep quality will be assessed objectively with a triaxial accelerometer used 24h/d during 7 consecutive days.
Perceived enjoyment of physical activity	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.
6-minute walk test	16 weeks	Distance covered walking in 6 minutes.

Trial Locations

Locations (1)

Faculty of Sport of the University of Porto; 🇵🇹 Porto, Portugal