Obesity, AdolescentNCT06377137
High-intensity Small-sided Soccer Games for Cardiometabolic Health in Adolescents With Metabolic Dysfunction
A study testing Small-sided soccer games groups (SSSG) and Traditional soccer training groups (TSG) in people with Obesity, Adolescent and Metabolic Syndrome, run by Universidade do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 15 years, men only
- Conditions the study is for
- Obesity, Adolescent, Metabolic Syndrome
- What is being tested?
- Small-sided soccer games groups (SSSG) and Traditional soccer training groups (TSG)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 sitePortugal
- Study dates
- 10 Mar 2023to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 15 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Obesity, Adolescent, Metabolic Syndrome
- Being tested
- Small-sided soccer games groups (SSSG), Traditional soccer training groups (TSG)
- Medical subject headings
- Pediatric Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small-sided soccer games groups (SSSG)Behavioural
Physical exercise intervention
Traditional soccer training groups (TSG)Behavioural
Physical exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Traditional soccer training groups (TSG) |
| Control Group (CG) | No intervention | CG will perform only regular school physical education classes without any additional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference
Anthropometric measurement of abdominal obesity; cm
Measured: 16 weeks
Cardiorespiratory fitness
1-mile walk/run test; minutes to run 1 mile
Measured: 16 weeks
Secondary outcomes (21)
Variation in fasting blood glucose concentration (mg/dL)
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.
Measured: 16 weeks
Variation in serum insulin concentration (mU/L)
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.
Measured: 16 weeks
Variation in HOMA-IR
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.
Measured: 16 weeks
Variation in glycosylated hemoglobin concentration (mg/dL)
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.
Measured: 16 weeks
Variation in high-density lipoprotein cholesterol concentration (mg/dL)
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.
Measured: 16 weeks
Variation in low-density lipoprotein cholesterol concentration (mg/dL)
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.
Measured: 16 weeks
Variation in total cholesterol concentration (mg/dL)
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.
Measured: 16 weeks
Variation in blood triglycerides concentration (mg/dL)
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.
Measured: 16 weeks
Variation in blood Alanine aminotransferase concentration (U/L)
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.
Measured: 16 weeks
Variation in blood Aspartate aminotransferase concentration (U/L)
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.
Measured: 16 weeks
Variation in blood Gamma glutamyl transferase concentration (U/L)
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.
Measured: 16 weeks
6-minute walk test
Distance covered walking in 6 minutes.
Measured: 16 weeks
Hand grip strength
Hand grip strength test measured with a digital hand dynamometer
Measured: 16 weeks
Lower limb strength
Assessed by Horizontal jump test.
Measured: 16 weeks
Body composition
Assessed by the electrical bioimpedance method
Measured: 16 weeks
Body mass index
Weight and height will be combined to report BMI in kg/m^2
Measured: 16 weeks
Neck circumference
Assessed by anthropometric techniques
Measured: 16 weeks
Blood Pressure (mmHg)
Systolic and diastolic blood pressure measured with digital sphygmomanometer
Measured: 16 weeks
Physical activity
Physical activity will be assessed objectively with a triaxial accelerometer used 24h/d during 7 consecutive days.
Measured: 16 weeks
Sleep quality
Sleep quality will be assessed objectively with a triaxial accelerometer used 24h/d during 7 consecutive days.
Measured: 16 weeks
Perceived enjoyment of physical activity
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start10 Mar 2023
- Primary completion10 Apr 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, AdolescentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hélder Fonseca, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377137
- Sponsor's protocol ID
- University of the Porto
- Status last verified
- Apr 2024
- First submitted
- 1 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gomez-Alvarez N, Hermosilla-Palma F, Reyes-Amigo T, Diaz-Alvarado M, Luarte-Rocha C, Espinoza-Puelles JP, Zapata-Lamana R, Cristi-Montero C, Oliveira J, Fonseca H. Effectiveness of High-Intensity Small-Sided Soccer Games Versus Traditional Soccer Training on Cardiovascular and Metabolic Health Outcomes in Adolescents With Increased Metabolic Risk: A Randomized Controlled Trial. Transl Sports Med. 2026 May 13;2026:1078783. doi: 10.1155/tsm2/1078783. eCollection 2026.
PubMed 42137406
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06377137
- Acronym / sponsor ID
- University of the Porto
- Conditions
- Obesity, Adolescent, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Small-sided soccer games groups (SSSG) | Experimental | Behavioral: Small-sided soccer games groups (SSSG)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. |
| Traditional soccer training groups (TSG) | Experimental | Behavioral: Traditional soccer training groups (TSG)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. |
| Control Group (CG) | No intervention | –CG will perform only regular school physical education classes without any additional intervention |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small-sided soccer games groups (SSSG)Physical exercise intervention | Behavioural | Small-sided soccer games groups (SSSG) |
| Traditional soccer training groups (TSG)Physical exercise intervention | Behavioural | Traditional soccer training groups (TSG) |
Primary outcome
Waist circumference
Time frame: 16 weeks
Anthropometric measurement of abdominal obesity; cm
Cardiorespiratory fitness
Time frame: 16 weeks
1-mile walk/run test; minutes to run 1 mile
21 secondary outcomes
Variation in fasting blood glucose concentration (mg/dL)
Time frame: 16 weeks
Variation in serum insulin concentration (mU/L)
Time frame: 16 weeks
Variation in HOMA-IR
Time frame: 16 weeks
Variation in glycosylated hemoglobin concentration (mg/dL)
Time frame: 16 weeks
Variation in high-density lipoprotein cholesterol concentration (mg/dL)
Time frame: 16 weeks
Variation in low-density lipoprotein cholesterol concentration (mg/dL)
Time frame: 16 weeks
Variation in total cholesterol concentration (mg/dL)
Time frame: 16 weeks
Variation in blood triglycerides concentration (mg/dL)
Time frame: 16 weeks
Variation in blood Alanine aminotransferase concentration (U/L)
Time frame: 16 weeks
Variation in blood Aspartate aminotransferase concentration (U/L)
Time frame: 16 weeks
Variation in blood Gamma glutamyl transferase concentration (U/L)
Time frame: 16 weeks
6-minute walk test
Time frame: 16 weeks
Hand grip strength
Time frame: 16 weeks
Lower limb strength
Time frame: 16 weeks
Body composition
Time frame: 16 weeks
Body mass index
Time frame: 16 weeks
Neck circumference
Time frame: 16 weeks
Blood Pressure (mmHg)
Time frame: 16 weeks
Physical activity
Time frame: 16 weeks
Sleep quality
Time frame: 16 weeks
Perceived enjoyment of physical activity
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Derived from this study: PubMed 42137406Gomez-Alvarez N, Hermosilla-Palma F, Reyes-Amigo T, Diaz-Alvarado M, Luarte-Rocha C, Espinoza-Puelles JP, Zapata-Lamana R, Cristi-Montero C, Oliveira J, Fonseca H. Effectiveness of High-Intensity Small-Sided Soccer Games Versus Traditional Soccer Training on Cardiovascular and Metabolic Health Outcomes in Adolescents With Increased Metabolic Risk: A Randomized Controlled Trial. Transl Sports Med. 2026 May 13;2026:1078783. doi: 10.1155/tsm2/1078783. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small-sided soccer games groups (SSSG) and Traditional soccer training groups (TSG) in people with Obesity, Adolescent and Metabolic Syndrome, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist circumference (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06377137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.