NCT05294237

Brief Summary

The primary aim of this hybrid-effectiveness-implementation cluster randomised study is to investigate if a supported implementation of an injury prevention exercise program (Happy program) involving a train-the-trainer workshop and coach support during the season is superior to an unsupported implementation of the Happy program involving the availability of the program on webpages, in improving adherence (volume, frequency, duration) of the Happy program among coaches for young (11-17 years of age) Danish female and male handball players during one handball season. Secondary aims are to investigate if the supported implementation is superior to the unsupported implementation in improving behavioural outcomes among the coaches and in reducing the risk for new ankle, knee, and shoulder injuries among young (11-17 years of age) Danish female and male handball players during one handball season. Further, the investigators aim to evaluate how and why adherence and behavioural determinants towards use of the Happy program might improve (or not).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
950

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2021

Completed
9 months until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

11 months

First QC Date

June 24, 2021

Last Update Submit

June 20, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Adherence volume at team level

    How much the Happy components have been delivered (adherence volume) will be evaluated as the number of Happy components delivered per week at team level over the full season Reports of Happy program usage will be recorded electronically on a weekly basis by the head coach of each team using a web application. A full warm-up session includes 7 components. A full resistance exercise training includes 4 components. The coaches are encouraged to perform all Happy program components with their players twice a week

    Measured weekly over 7 months

  • Shoulder, knee and ankle injuries using the Oslo Sports Trauma Research Center Health problems Questionnaire (OSTRC-H2)

    The primary injury outcomes will be time to any new handball-related ankle, knee and shoulder injury defined as any tissue damage or other derangement of normal physical function due to participation in handball, resulting from rapid or repetitive transfer of kinetic energy, following a recent consensus statement from the International Olympic Committee Injury status will be monitored weekly during the season using the Oslo Sports Trauma Research Center Overuse Injury Questionnaire distributed electronically to the players via an application. The questionnaire also measures exposure to handball, both training and match, during the last seven days.

    Measured weekly over 7 months

Secondary Outcomes (6)

  • Adherence volume of the Happy warm-up components at team level

    Assessed weekly over 7 months

  • Adherence volume of the Happy resistance training components at team level

    Assessed weekly over 7 months

  • Adherence volume of the Happy resistance training components at player level

    Assessed weekly over 7 months

  • Substantial shoulder, knee and ankle injuries using the Oslo Sports Trauma Research Center Health problems Questionnaire (OSTRC-H2)

    Assessed weekly over 7 months

  • Health Action Process Approach (HAPA) Questionnaire responses

    Will be assessed at baseline, mid-season (3 months after baseline) and at end season (7 months)

  • +1 more secondary outcomes

Other Outcomes (13)

  • Training volume

    Assessed weekly over 7 months

  • Match volume

    Assessed weekly over 7 months

  • Illness outcomes using the Oslo Sports Trauma Research Center Health problems Questionnaire (OSTRC-H2)

    Assessed weekly over 7 months

  • +10 more other outcomes

Study Arms (2)

Supported Implementation (Intervention)

EXPERIMENTAL

The Happy-program will be available online on a webpage and consists of 7 warm-up components and 4 resistance training components that can be completed after handball practice. The warm-up program has three exercise variations for each of the seven components. The coaches may deliver the four resistance training components in the field or in the gym. The resistance training components in the field and the gym targets the same four body areas but differs in that the components in the gym are performed with equipment, while the components in the field can be performed without equipment. Each resistance training component has three levels. Happy ambassadors (Health professionals with a handball player or coach background) will conduct a 3-hour train-the trainer workshop in the beginning of the season and provide coaches with the opportunity for support throughout the season. At mid-season, the ambassadors will re-visit the clubs for 1,5-hour supervision and support.

Behavioral: Happy programBehavioral: Support

Unsupported implementation (control)

ACTIVE COMPARATOR

Access to the Happy program will be available online to the coaches. No additional education or support will be provided.

Behavioral: Happy program

Interventions

Happy programBEHAVIORAL

The Happy program consists of handball specific warm-up components and resistance training components and will be available online.

Supported Implementation (Intervention)Unsupported implementation (control)
SupportBEHAVIORAL

The support consists of a coach workshop at the beginning of the season and the opportunity for additional support for the coaches throughout the season.

Supported Implementation (Intervention)

Eligibility Criteria

Age11 Years - 17 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale, male, non-binary, prefer not to answer, other
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • playing in youth teams from the age groups under (u)13, u15, and u17
  • playing in handball club with at least four teams in the desired age groups

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark

Odense, Southern Denmark, 5230, Denmark

Location

Related Publications (1)

  • Moller M, Nygaard Andersen L, Moller S, Kongsted A, Juhl CB, Roos EM. Health And Performance Promotion in Youth (HAPPY) hybrid effectiveness-implementation cluster randomised trial: comparison of two strategies to implement an injury prevention exercise programme in Danish youth handball. Br J Sports Med. 2024 Oct 22;58(20):1205-1214. doi: 10.1136/bjsports-2023-107880.

MeSH Terms

Conditions

Athletic Injuries

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Merete Møller, PhD

    University of Southern Denmark, Department of Sports Science and Biomechanics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The clubs will be randomly assigned to either the control or intervention group at a 1:1 allocation ratio, using a computer-generated randomisation schedule. The randomisation will be performed by a person not else involved in the trial.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2021

First Posted

March 24, 2022

Study Start

June 21, 2021

Primary Completion

May 15, 2022

Study Completion

June 30, 2023

Last Updated

June 27, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations