FIT FIRST FOR ALL - The Dose-Response Study

NCT06180772 | Unknown DMC

• 1 other identifier: USouthernDenmark-FIT FIRST
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

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 1:1:1 recruitment of control schools, intervention schools with 3 weekly 40-min FIT FIRST 10 lessons, and intervention schools with 1.5 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 and/or 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.

Conditions

Primary Prevention

Outcome Measures

Primary Outcomes (2)

• Cardiometabolic fitness as assessed by the achieved distance in the Yo-Yo IR1 Children's test

  Cardiometabolic fitness profile will be evaluated by using the Yo-Yo IR1 Children's test measured as the total distance in meters as an indicator for the participants' ability to perform intermittent exercise and their cardiometabolic fitness. The longer the distance, the better the cardiometabolic fitness of the participants.

  Change from baseline to week 20

• Project acceptability as assessed by observations and teachers questionnaires

  Observations will describe the acceptability and specific teacher questionnaires will be applied to evaluate the acceptability of the project.

  Change from baseline to week 20

Secondary Outcomes (9)

• Muscle strength of the lower body as assessed by the standing long jump performance

  Change from baseline to week 20

• Well-being as assessed by the questionnaires KIDSCREEN 27

  Change from baseline to week 20

• Fat percentage based on bioimpedance.

  Change from baseline to week 20

• Postural balance as assessed by the stork balance stand test

  Change from baseline to week 20

• Agility as assessed by the arrowhead agility-test

  Change from baseline to week 20

Study Arms (3)

Control

NO INTERVENTION

Continue normal activities

3/wk

EXPERIMENTAL

Use FIT FIRST 3 times pr. week

Behavioral: FIT FIRST

1.5/wk

EXPERIMENTAL

Use FIT FIRST 1.5 times pr. week

Behavioral: FIT FIRST

Interventions

FIT FIRST BEHAVIORAL

High intensity sports drills and games

1.5/wk; 3/wk

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• part of enrolled classes

You may not qualify if:

• none

Sponsors & Collaborators

• University of Southern Denmark: lead
• Novo Nordisk A/S: collaborator
• National Olympic Committee and Sports Confederation of Denmark: collaborator

Study Sites (1)

University of Southern Denmark

Odense, 5000, Denmark

Location

Study Officials

• Peter Krustrup

  Syddansk Universitet - Sport og Sundhed (IOB)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 22, 2023
• Study Start: December 10, 2022
• Primary Completion: December 24, 2024
• Study Completion: December 24, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)