FIT FIRST for the Bones

NCT07659587 | Enrolling By Invitation DMC

• 1 other identifier: S-20250081
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to conduct a cluster RCT intervention study with adolescents in Denmark and investigate whether the FIT FIRST concept can improve young people's bone health. We hypothesize that students from the schools randomized to the intervention arm will show greater improvements in bone health than students randomized to the control arm. The experiment will be of societal relevance in relation to evidence for the effects of implementing high-intensity physical activity in school.

Conditions

Healthy

Keywords

FIT FIRST; Bone Health

Outcome Measures

Primary Outcomes (1)

• whole-body bone mineral density

  A full-body DXA scan is performed to determine bone mineralization

  From enrollment to the end of treatment at 18 weeks

Secondary Outcomes (1)

• procollagen type I N-terminal propeptide (PINP)

  From enrollment to the end of treatment at 18 weeks

Other Outcomes (3)

• Osteocalcin

  From enrollment to the end of treatment at 18 weeks

• β-C-terminal telopeptide of type I collagen (CTX-I)

  From enrollment to the end of treatment at 18 weeks

• Leg BMD

  From enrollment to the end of treatment at 18 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

3x40 min High Intense training pr week for 18 weeks

Behavioral: FIT FIRST

Control

NO INTERVENTION

Normal behavior

Interventions

FIT FIRST BEHAVIORAL

Frequent Intense Training (3x40 min pr. week for 18 weeks

Intervention

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Part of participating classes

You may not qualify if:

• None

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

University of Southern Denmark

Odense, Funen, 5230, Denmark

Location

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: June 15, 2026
• First Posted: June 22, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)