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

NCT05741879 | Completed DMC

• 1 other identifier: PI_2021/111
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Physical Inactivity; Obesity, Childhood; Sedentary Behavior

Keywords

Lack of physical fitness; Low levels of Basic Motor Skills

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Changes in body composition.

  Baseline, 12 Week, and 24 Week

• Changes in muscle composition.

  Baseline, 12 Week, and 24 Week

• Changes in health-related physical fitness.

  Baseline, 12 Week, and 24 Week

• Changes in Basic Motor Skills.

  Baseline, 12 Week, and 24 Week

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

  Baseline, 12 Week, and 24 Week

Study Arms (2)

Gamified online exercise in a family environment

EXPERIMENTAL

Strength training Resistance training Flexibility training Basic motor skills training Executive function training

Behavioral: Gamified exercise training

Standard care Non-supervised daily routines/activities

ACTIVE COMPARATOR

Non-supervised daily routines/activities

Behavioral: Standard Care

Interventions

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).

Gamified online exercise in a family environment

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.

Standard care Non-supervised daily routines/activities

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Pública de Navarra: lead
• European Regional Development Fund: collaborator
• Gobierno de Navarra Departamento de Salud: collaborator
• NavarraBiomed Biomedical Research Center: collaborator
• Centro Atención Primaria de Iturrama: collaborator

Study Sites (1)

Navarrabiomed, Universidad Pública de Navarra

Pamplona, Navarre, 31006, Spain

Location

Related Publications (2)

• 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.

  PMID: 38816854 DERIVED

• 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.

  PMID: 37580788 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Pediatric Obesity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Alicia Mª Alonso Martínez, Ph.D

  Universidad Pública de Navarra

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 23, 2023
• Study Start: November 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 5, 2025

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)