Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06180772
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-22
First Post:
2022-12-12
Brief Title:
FIT FIRST FOR ALL - The Dose-Response Study
Sponsor:
University of Southern Denmark
Organization:
University of Southern Denmark
Study Overview
Official Title:
FIT FIRST FOR ALL - The Dose-Response Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the present study FIT FIRST 10 will run over 20 weeks with cardiometabolic fitness as the primary outcome and project acceptability as the co-primary outcome In this study the investigators will be testing the dose-response of the FIT FIRST concept by having two experimental groups This will be a cluster RCT with a 111 recruitment of control schools intervention schools with 3 weekly 40-min FIT FIRST 10 lessons and intervention schools with 15 weekly 40-min session There will be recruited a total of 1000 children with 500 8-9-year-olds from 2nd and 3rd grade in each group from a minimum of 40 classes from 16 schools There will be subgroup analyses of children with low socioeconomic status and ethnic minority background Intervention effects will be tested as on health profile cardiometabolic and musculoskeletal fitness motivation for physical activity acceptability of the programme for stakeholders as well as the implementation potential The study will be running in Q1 and Q2 in 2023
It is hypothesized that the FIT FIRST 10 concept will improve the well-being increase sports club participation as well as increase fitness and health levels among 8-9-year-old children with low fitness low socioeconomic andor ethnic minority background However it is also hypothesized that the effects on well-being and fitness levels caused by the intervention may be most significant among ethnic minority children not enrolled in sports clubs
It is hypothesized that the FIT FIRST 10 concept will improve the well-being increase sports club participation as well as increase fitness and health levels among 8-9-year-old children with low fitness low socioeconomic andor ethnic minority background However it is also hypothesized that the effects on well-being and fitness levels caused by the intervention may be most significant among ethnic minority children not enrolled in sports clubs
Detailed Description:
Background Physical activity PA is an important part of a healthy lifestyle for children and youth as it improves physical fitness motor competences and well-being and reduces the risk of developing overweight and lifestyle diseases later in life Current recommendations from the Danish Health Authorities are that young people should participate in at least 60 min of moderate-to-vigorous physical activity MVPA per day of which at least 3 times 30 min per week should involve vigorous physical activity VPA
As childrens total amount of daily PA is a product of their activities in and outside of school it can be of value to look for synergetic effects that can be achieved by having developed abilities and motivation for activities in school that can be used in leisure time sports clubs
Based on the beforementioned knowledge investigators have developed the FIT FIRST programme FIT FIRST was originally an acronym for a 40-week intervention study for 8-9-year-olds Frequent Intense Training through Football Interval Running and Circuit Strength Training This study showed that 3x40 min per week of FIT FIRST ball game and circuit strength training activities was very effective in improving fat percentage blood pressure muscle strength postural balance and bone mineralization In 2018 the FIT FIRST 10 concept was developed for 6-9-year-olds that covered 10 sports using the same principles
In the present study FIT FIRST 10 will run over 20 weeks with cardiometabolic and musculoskeletal fitness as the primary outcomes and project acceptability as co-primary outcomes In this study the investigators will be testing the dose-response of the FIT FIRST 10 concept by having two experimental groups This will be a cluster RCT with a 111 recruitment of control schools intervention schools with 3 weekly 40-min FIT FIRST 10 lessons and intervention schools with 15 weekly 40-min session There will be recruited a total of 2400 children with 800 8-9-year-olds from 2nd and 3rd grade in each group from approximately 60 classes from 24 schools There will be subgroup analyses of children with low socioeconomic status and ethnic minority background
Intervention effects will be tested as in Study I on health profile cardiometabolic and muscular fitness motivation for physical activity acceptability of the programme for stakeholders and implementation potential The study will be running in Q1 and Q2 in 2023
Measures
Fitness levels and health profile
Yo-Yo IR1 Childrens test total distance in meters will be used to evaluate cardiometabolic fitness For muscular fitness the standing long jump test in meters the handgrip strength test in kilograms the arrowhead agility-test in seconds and the stork balance stand test in seconds will be used
To evaluate the effects on health measurements of resting heart rate beats per minute and blood pressure millimeters of mercury will be recorded
Also the participants body composition and height will be measured using Tanita scales and InBody 230 Bioimpedance The measurements of the participants body composition includes measures of their body mass in kilograms skeletal muscle mass in kilograms and fat percentage To investigate the prevalence of overweight and obesity BMI z-scores kgm2 will be calculated by using the participants relative weight adjusted for child age and sex
Well-being body image self-worth and quality of life
KIDSCREEN 27 which is a validated questionnaire measuring physical well-being mental well-being social well-being and school well-being in the school environment will be used Childrens body perception and satisfaction will be measured using the Childrens Body Image Scale a pictorial scale developed for 7-11 year old children Furthermore the short form of the Physical Self-Inventory PSI-S will be used to evaluate overall selfworth ie perceptions of ones physical self and specific sub-components physical appearance strength physical condition and sport competence
Evaluation of physical activity and sport club participation
A questionnaire will provide information in terms of types of activities undertaken outside school
Process evaluation
The RE-AIM framework will be used to ensure a holistic assessment of intervention and implementation outcomes A mixed-method approach including document analysis participant observations objective measurements survey instruments and interviews will be applied The RE-AIM framework has been used extensively to assess school-based PA interventions and to guide process evaluations The RE-AIM have been in several studies The framework constitutes five key elements ie Reach Effectiveness Adoption Implementation and Maintenance
Also the ecological model of implementation by Durlak and Dupree will be used
As childrens total amount of daily PA is a product of their activities in and outside of school it can be of value to look for synergetic effects that can be achieved by having developed abilities and motivation for activities in school that can be used in leisure time sports clubs
Based on the beforementioned knowledge investigators have developed the FIT FIRST programme FIT FIRST was originally an acronym for a 40-week intervention study for 8-9-year-olds Frequent Intense Training through Football Interval Running and Circuit Strength Training This study showed that 3x40 min per week of FIT FIRST ball game and circuit strength training activities was very effective in improving fat percentage blood pressure muscle strength postural balance and bone mineralization In 2018 the FIT FIRST 10 concept was developed for 6-9-year-olds that covered 10 sports using the same principles
In the present study FIT FIRST 10 will run over 20 weeks with cardiometabolic and musculoskeletal fitness as the primary outcomes and project acceptability as co-primary outcomes In this study the investigators will be testing the dose-response of the FIT FIRST 10 concept by having two experimental groups This will be a cluster RCT with a 111 recruitment of control schools intervention schools with 3 weekly 40-min FIT FIRST 10 lessons and intervention schools with 15 weekly 40-min session There will be recruited a total of 2400 children with 800 8-9-year-olds from 2nd and 3rd grade in each group from approximately 60 classes from 24 schools There will be subgroup analyses of children with low socioeconomic status and ethnic minority background
Intervention effects will be tested as in Study I on health profile cardiometabolic and muscular fitness motivation for physical activity acceptability of the programme for stakeholders and implementation potential The study will be running in Q1 and Q2 in 2023
Measures
Fitness levels and health profile
Yo-Yo IR1 Childrens test total distance in meters will be used to evaluate cardiometabolic fitness For muscular fitness the standing long jump test in meters the handgrip strength test in kilograms the arrowhead agility-test in seconds and the stork balance stand test in seconds will be used
To evaluate the effects on health measurements of resting heart rate beats per minute and blood pressure millimeters of mercury will be recorded
Also the participants body composition and height will be measured using Tanita scales and InBody 230 Bioimpedance The measurements of the participants body composition includes measures of their body mass in kilograms skeletal muscle mass in kilograms and fat percentage To investigate the prevalence of overweight and obesity BMI z-scores kgm2 will be calculated by using the participants relative weight adjusted for child age and sex
Well-being body image self-worth and quality of life
KIDSCREEN 27 which is a validated questionnaire measuring physical well-being mental well-being social well-being and school well-being in the school environment will be used Childrens body perception and satisfaction will be measured using the Childrens Body Image Scale a pictorial scale developed for 7-11 year old children Furthermore the short form of the Physical Self-Inventory PSI-S will be used to evaluate overall selfworth ie perceptions of ones physical self and specific sub-components physical appearance strength physical condition and sport competence
Evaluation of physical activity and sport club participation
A questionnaire will provide information in terms of types of activities undertaken outside school
Process evaluation
The RE-AIM framework will be used to ensure a holistic assessment of intervention and implementation outcomes A mixed-method approach including document analysis participant observations objective measurements survey instruments and interviews will be applied The RE-AIM framework has been used extensively to assess school-based PA interventions and to guide process evaluations The RE-AIM have been in several studies The framework constitutes five key elements ie Reach Effectiveness Adoption Implementation and Maintenance
Also the ecological model of implementation by Durlak and Dupree will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None