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

Primary Purpose

Physical Inactivity, Obesity, Childhood, Sedentary Behavior

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Gamified exercise training
Standard Care
Sponsored by
Universidad Pública de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Physical Inactivity focused on measuring Lack of physical fitness, Low levels of Basic Motor Skills

Eligibility Criteria

4 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Navarrabiomed, Universidad Pública de Navarra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gamified online exercise in a family environment

Standard care Non-supervised daily routines/activities

Arm Description

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

Non-supervised daily routines/activities

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in body composition.
Body composition measured with bioelectrical impedance (fat mass and body mass).
Changes in muscle composition.
Muscle composition measured with ultrasound of the thigh/quadriceps/recto femoral.
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.
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).
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.
Changes in executive function.
Measured with "Early Tools" games (Years Toolbox YET-2017).
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).
Changes in quality of life.
Kiddy-KINDL will be used to assess the health-related quality of life in children.

Full Information

First Posted
February 3, 2023
Last Updated
February 14, 2023
Sponsor
Universidad Pública de Navarra
Collaborators
European Regional Development Fund, Gobierno de Navarra Departamento de Salud, NAVARRABIOMED, Centro Atención Primaria de Iturrama
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1. Study Identification

Unique Protocol Identification Number
NCT05741879
Brief Title
Gamified Family-based Health Exercise Intervention to Improve Adherence to 24-h Movement Behaviors Recommendations in Children.
Acronym
Move On
Official 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".
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Pública de Navarra
Collaborators
European Regional Development Fund, Gobierno de Navarra Departamento de Salud, NAVARRABIOMED, Centro Atención Primaria de Iturrama

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Inactivity, Obesity, Childhood, Sedentary Behavior
Keywords
Lack of physical fitness, Low levels of Basic Motor Skills

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gamified online exercise in a family environment
Arm Type
Experimental
Arm Description
Strength training Resistance training Flexibility training Basic motor skills training Executive function training
Arm Title
Standard care Non-supervised daily routines/activities
Arm Type
Active Comparator
Arm Description
Non-supervised daily routines/activities
Intervention Type
Behavioral
Intervention Name(s)
Gamified exercise training
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
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 Outcome Measure Information:
Title
Changes in 24-h movement behaviors (accelerometers) sedentary time.
Description
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.
Time Frame
Baseline, 12 Week, and 24 Week
Secondary Outcome Measure Information:
Title
Changes in body composition.
Description
Body composition measured with bioelectrical impedance (fat mass and body mass).
Time Frame
Baseline, 12 Week, and 24 Week
Title
Changes in muscle composition.
Description
Muscle composition measured with ultrasound of the thigh/quadriceps/recto femoral.
Time Frame
Baseline, 12 Week, and 24 Week
Title
Changes in health-related physical fitness.
Description
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.
Time Frame
Baseline, 12 Week, and 24 Week
Title
Changes in Basic Motor Skills.
Description
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).
Time Frame
Baseline, 12 Week, and 24 Week
Title
Changes in 24-h movement behaviors (self-reported).
Description
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.
Time Frame
Baseline, 12 Week, and 24 Week
Title
Changes in executive function.
Description
Measured with "Early Tools" games (Years Toolbox YET-2017).
Time Frame
Baseline, 12 Week, and 24 Week
Title
Changes in Child Self-Regulation & Behavior.
Description
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).
Time Frame
Baseline, 12 Week, and 24 Week
Title
Changes in quality of life.
Description
Kiddy-KINDL will be used to assess the health-related quality of life in children.
Time Frame
Baseline, 12 Week, and 24 Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia Mª Alonso Martínez, Ph.D
Organizational Affiliation
Universidad Pública de Navarra
Official's Role
Study Chair
Facility Information:
Facility Name
Navarrabiomed, Universidad Pública de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31006
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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