Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06377137
Other study ID # University of the Porto
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 10, 2023
Est. completion date September 1, 2023

Study information

Verified date April 2024
Source Universidade do Porto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date September 1, 2023
Est. primary completion date April 10, 2023
Accepts healthy volunteers No
Gender Male
Age group 11 Years to 15 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Small-sided soccer games groups (SSSG)
Physical exercise intervention
Traditional soccer training groups (TSG)
Physical exercise intervention

Locations

Country Name City State
Portugal Faculty of Sport of the University of Porto Porto

Sponsors (1)

Lead Sponsor Collaborator
Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Waist circumference Anthropometric measurement of abdominal obesity; cm 16 weeks
Primary Cardiorespiratory fitness 1-mile walk/run test; minutes to run 1 mile 16 weeks
Secondary 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.
16 weeks
Secondary 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.
16 weeks
Secondary 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.
16 weeks
Secondary 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.
16 weeks
Secondary 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.
16 weeks
Secondary 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.
16 weeks
Secondary 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.
16 weeks
Secondary 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.
16 weeks
Secondary 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.
16 weeks
Secondary 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.
16 weeks
Secondary 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.
16 weeks
Secondary 6-minute walk test Distance covered walking in 6 minutes. 16 weeks
Secondary Hand grip strength Hand grip strength test measured with a digital hand dynamometer 16 weeks
Secondary Lower limb strength Assessed by Horizontal jump test. 16 weeks
Secondary Body composition Assessed by the electrical bioimpedance method 16 weeks
Secondary Body mass index Weight and height will be combined to report BMI in kg/m^2 16 weeks
Secondary Neck circumference Assessed by anthropometric techniques 16 weeks
Secondary Blood Pressure (mmHg) Systolic and diastolic blood pressure measured with digital sphygmomanometer 16 weeks
Secondary Physical activity Physical activity will be assessed objectively with a triaxial accelerometer used 24h/d during 7 consecutive days. 16 weeks
Secondary Sleep quality Sleep quality will be assessed objectively with a triaxial accelerometer used 24h/d during 7 consecutive days. 16 weeks
Secondary 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. 16 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04635202 - Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome N/A
Completed NCT05343858 - Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome N/A
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Recruiting NCT05040958 - Carotid Atherosclerotic Plaque Load and Neck Circumference
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Completed NCT03289897 - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan N/A
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Active, not recruiting NCT03613740 - Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion Phase 2
Completed NCT04498455 - Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency Phase 4
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT03697382 - Effect of Daily Steps on Fat Metabolism N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT04509206 - Virtual Teaching Kitchen N/A
Completed NCT05124847 - TREating Pediatric Obesity N/A