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Completed

NCT Number: NCT05741879

Gamified Family-based Health Exercise Intervention to Improve Adherence to 24-h Movement Behaviors Recommendations in Children.

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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Key information

Conditions

Physical Inactivity Behavior Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Childhood Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Sedentary Behavior Signs and Symptoms

Age range

4 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Navarrabiomed, Universidad Pública de Navarra

Pamplona, Navarre, 31006, Spain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants without any physical or mental disorders that would prevent them from completing the assessments tests or participating in the exercise intervention program
  • One parent/guardian must answer the questionnaires
  • Informed consent from the participants parent(s)/guardian(s)

Exclusion criteria

  • Participants with psychiatric disorders or chronic illness that limits their participation in physical activities
  • Participants who do not comply with the established procedures
  • Participants who do not understand the Spanish language

Treatment and study plan

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).

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.

Primary outcomes

  1. Changes in 24-h movement behaviors (accelerometers) sedentary time.

    Time frame: Baseline, 12 Week, and 24 Week

    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.

Secondary outcomes

  1. Changes in body composition.

    Time frame: Baseline, 12 Week, and 24 Week

    Body composition measured with bioelectrical impedance (fat mass and body mass).

  2. Changes in muscle composition.

    Time frame: Baseline, 12 Week, and 24 Week

    Muscle composition measured with ultrasound of the thigh/quadriceps/recto femoral.

  3. Changes in health-related physical fitness.

    Time frame: Baseline, 12 Week, and 24 Week

    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.

  4. Changes in Basic Motor Skills.

    Time frame: Baseline, 12 Week, and 24 Week

    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).

  5. Changes in 24-h movement behaviors (self-reported).

    Time frame: Baseline, 12 Week, and 24 Week

    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.

  6. Changes in executive function.

    Time frame: Baseline, 12 Week, and 24 Week

    Measured with "Early Tools" games (Years Toolbox YET-2017).

  7. Changes in Child Self-Regulation & Behavior.

    Time frame: Baseline, 12 Week, and 24 Week

    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).

  8. Changes in quality of life.

    Time frame: Baseline, 12 Week, and 24 Week

    Kiddy-KINDL will be used to assess the health-related quality of life in children.

Sponsors and collaborators

Lead sponsor

Universidad Pública de Navarra

Other

Collaborators

  • Centro Atención Primaria de Iturrama
  • European Regional Development Fund
  • Government of Navarra
  • NavarraBiomed Biomedical Research Center

Registry information

Official study title

Gamified Exercise Intervention to Improve Children's Adherence to 24-hour Movement Recommendations in a Family-Based Health Setting: "3,2,1 Move on Crossover Study".

Acronym: Move On

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2023
Registry last updated
Mar 5, 2025

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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