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| Name | Class |
|---|---|
| European Regional Development Fund | OTHER |
| Gobierno de Navarra Departamento de Salud | UNKNOWN |
| NavarraBiomed Biomedical Research Center | OTHER |
| Centro Atención Primaria de Iturrama |
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Physical inactivity is the fourth most important risk factor for mortality worldwide and it contributes to weight gain and obesity. On the contrary, it is established that regular physical activity is a prevention and managerial factor of these non-communicable diseases. Therefore, the goal of this study is to design and evaluate the effectiveness of a 12-week physical exercise and lifestyle improvement training program carried out in a family environment, through a web platform, and with "online" supervision. This platform will improve the physical conditioning and adherence to PE in a "family environment", and to promote good development of the child through physical activities and exercises that can be done as a family at home and/or outside.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gamified online exercise in a family environment | Experimental | Strength training Resistance training Flexibility training Basic motor skills training Executive function training |
|
| Standard care Non-supervised daily routines/activities | Active Comparator | Non-supervised daily routines/activities |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamified exercise training | Behavioral | Participants will complete a 2-days-a-week online training routine with their families: Each session will include a Warm-Up/Activation phase (3 minutes: light intensity continuous training), a Training phase (10-26 minutes: 6-12 repetitions, 20-40" of work, 10-20" recovery), and a Cool Down phase (3 minutes: static and dynamic exercises). The exercises will be different each week and will increase in length and intensity accordingly. The sessions will be supervised by the participants parent(s) and/or guardian(s). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in 24-h movement behaviors (accelerometers) sedentary time. | During their visit to Navarrabiomed, participants will receive a (GENEActiv, Activinsights, Kimbolton, UK) accelerometer that will objectively measure their 24-hour movement behaviors (physical activity, sedentary behaviors, and sleep). The participants will wear the accelerometer for seven consecutive days. Additionally, this accelerometer data will be supplemented with a diary to validate sleep time and (non)wear time. | Baseline, 12 Week, and 24 Week |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body composition. | Body composition measured with bioelectrical impedance (fat mass and body mass). | Baseline, 12 Week, and 24 Week |
| Changes in muscle composition. | Muscle composition measured with ultrasound of the thigh/quadriceps/recto femoral. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alicia Mª Alonso MartÃnez, Ph.D | Universidad Pública de Navarra | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Navarrabiomed, Universidad Pública de Navarra | Pamplona | Navarre | 31006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38816854 | Derived | Legarra-Gorgonon G, Garcia-Alonso Y, Ramirez-Velez R, Alonso-Martinez L, Izquierdo M, Alonso-Martinez AM. Assessing basic motor competences, physical fitness, and executive function in 4-5-year-old children: a longitudinal study in a primary care setting. Ital J Pediatr. 2024 May 31;50(1):108. doi: 10.1186/s13052-024-01674-1. | |
| 37580788 |
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| UNKNOWN |
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|
| Standard Care | Behavioral | This group will be allocated to standard care and therefore no gamified online exercise training will be provided. They will continue to perform their daily routine/activities including their basic motor skills classes at school and their extracurricular sports and/or cultural activities. |
|
| Baseline, 12 Week, and 24 Week |
| Changes in health-related physical fitness. | Health-related physical fitness measured, among other tests from the PREFIT battery, with the 20-meter shuttle run test, the handgrip test and the 4x10 speed agility test. | Baseline, 12 Week, and 24 Week |
| Changes in Basic Motor Skills. | Measured with the MOBAK-KG Battery with tests such as the long jump or balance over an inverted beam. MOBAK-KG sum score ranging from 0 (lowest basic motor competencies) to 16 points (highest basic motor competencies). | Baseline, 12 Week, and 24 Week |
| Changes in 24-h movement behaviors (self-reported). | Self-report of physical activity levels and sedentary behaviors in youth will assessed by the Youth Activity Profile - Spain. In this questionnaire, a rating scale is used with a score from 1 to 5 in which, in the first two sections, "1" indicates low intensity and frequency of physical activity and "5" indicates high intensity and frequency of physical activity; while, in the third section, "1" indicates a low amount of sedentary behaviors and "5" an excess of them. | Baseline, 12 Week, and 24 Week |
| Changes in executive function. | Measured with "Early Tools" games (Years Toolbox YET-2017). | Baseline, 12 Week, and 24 Week |
| Changes in Child Self-Regulation & Behavior. | Measured with CSBQ (Child Self-Regulation & Behavior Questionnaire). Parents will be asked to think about their child's behavior during the past 6 months, and to choose whether each statement was: Not true (1), Somewhat true (2), Certainly true (3), or Can't say (4). | Baseline, 12 Week, and 24 Week |
| Changes in quality of life. | Kiddy-KINDL will be used to assess the health-related quality of life in children. | Baseline, 12 Week, and 24 Week |
| Alonso-Martinez AM, Legarra-Gorgonon G, Garcia-Alonso Y, Ramirez-Velez R, Alonso-Martinez L, Erice-Echegaray B, Izquierdo M. Gamified family-based health exercise intervention to improve adherence to 24-h movement behaviors recommendations in children: "3, 2, 1 Move on Study". Trials. 2023 Aug 14;24(1):531. doi: 10.1186/s13063-023-07494-8. |
| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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