NCT05583162

Brief Summary

The "Healthy Sport Project" is an adapted program from the Body Project by prof Eric Stice, aiming to reduce body dissatisfaction and symptoms of disordered eating and eating disorders in adolescent elite athletes. This trial aim to evaluate the effect of the program using a one-arm pilot study design in 14 years age old athletes at a Norwegian Elite Sport Junior High School.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

April 2, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

October 8, 2022

Last Update Submit

April 1, 2024

Conditions

Keywords

eating disordersdisordered eatingbody dissatisfactionfigure idealisationmental healthpreventionathletesportadolescentelite sport

Outcome Measures

Primary Outcomes (4)

  • Change in symptoms of Eating Disorder, Eating Disorder Questionnaire Short-form

    9 Questions on eating restriction, on worries for body weight and appearance. Rated by number of days the different content has been relevant. By Fairburn and Beglin, 2008

    Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention

  • Change in Body Acceptance, Body Acceptance Scale, version 2

    10 Questions on body acceptance, rated by a 5 point Likert Scale (never - always). By Halliwell et al 2017.

    Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention

  • Change in symptoms of internalization of body figure ideals, SATAQ-4

    10 Questions from subscales of SATAQ-4 (thinness idealisation and muscularity idealization), rated by 5 point Likert Scale. By Schaefer et al 2015

    Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention

  • Experiences from participating in the project

    Focus group interview following a semistructured manual; asking for experiences with participation in the "Healthy Sport Project"

    After intervention (post, +6 weeks)

Secondary Outcomes (6)

  • Change in experiences of Body Appearance Pressure (BAP), questions by research group

    Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention

  • Change in experiences of Body Appearance Pressure (BAP), questions by research group

    Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention

  • Change in dietary habits, questions by research group

    Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention

  • Change in dietary habits, questions by research group

    Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention

  • Change in dietary habits, questions by research group

    Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention

  • +1 more secondary outcomes

Other Outcomes (8)

  • Question on injuries, questions by research group

    Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention

  • Question on injuries, questions by research group

    Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention

  • Demographics, questions by research group

    Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention

  • +5 more other outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

All pupils attending a Elite Sport Jr High School receive intervention

Behavioral: Healthy Sport Project

Interventions

2 interactive information lectures (given per class of 30 pupils), and 4 interactive workshops (given to sex-homogenous groups of 10 pupils). One per week, a total of 6 weeks with intervention.

Also known as: Sports Body Project
Intervention

Eligibility Criteria

Age13 Years - 14 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBased on gender identity
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • pupil at the recruited Sport Jr High School

You may not qualify if:

  • no informed consent from parents
  • not willing to participate
  • a diagnosis of an eating disorder and being under (or waiting for) treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Therese Fostervold Mathisen

Fredrikstad, 1671, Norway

Location

MeSH Terms

Conditions

Feeding and Eating DisordersAthletic InjuriesPsychological Well-Being

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersWounds and InjuriesPersonal SatisfactionBehavior

Study Officials

  • Therese F Mathisen, PhD

    Østfold University College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Masking is not performed in a one-arm study
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: A cohort of athletes receive intervention in this pilot study, and changes from pre to post intervention are evaluated
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 8, 2022

First Posted

October 17, 2022

Study Start

August 10, 2022

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

April 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Not to be shared

Locations