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FIT FIRST FOR ALL - The Dose-Response Study

NCT06180772 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2400

Last updated 2023-12-22

No results posted yet for this study

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

Interventions

BEHAVIORAL

FIT FIRST

High intensity sports drills and games

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • National Olympic Committee and Sports Confederation of Denmark

    collaborator UNKNOWN

  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Peter Krustrup · Syddansk Universitet - Sport og Sundhed (IOB)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-10
Primary Completion
2024-12-24
Completion
2024-12-24

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06180772 on ClinicalTrials.gov