Healthy Sport Project; Preventing Eating Disorders in Sport (HSP)

April 1, 2024 updated by: Therese Fostervold Mathisen, Ostfold University College

Healthy Sport Project: "Recovery, Body Acceptance and Health in Young Athletes"

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Eating disorders (EDs) are serious illnesses with highest incidence in adolescents. Moreover, athletes have a higher frequency of symptoms of disordered eating (DE) and EDs than non-athletes. There are many reasons to this health issue, but body appearance pressure, competing in body mass sensitive sports, and comments on body appearance are important explanations. Few programs have proved effective in preventing DE and EDs in the general population, or in athletes specifically, and none is permanent operative in sports in Norway. Body Project by prof Eric Stice have proved effective in preventing body dissatisfaction, figure idealization and new onset of EDs in female adolescents above 15 years of age, and with body dissatisfaction, from the general population. A few attempts to adapt this program to female athletes, argue for a comparative positive effect. Three important elements to further address, are: 1) programs need also to be tested in males; 2) programs need to be tested in adolescents of younger age before the typical onset of an ED; and 3) programs need to be possible to administer by non-professionals.

In this study the research group aim to adapt and test the effect of the Body Project, by the pilot study the "Healthy Sport Project", in elite junior athletes attending specialized junior sport high schools (age 14). The final goal for this project group is to create an effective preventive program for body dissatisfaction and DE/EDs in young athletes of both sexes and in mixed sports, and which may be administered by the schoolteachers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Fredrikstad, Norway, 1671
        • Therese Fostervold Mathisen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • pupil at the recruited Sport Jr High School

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
All pupils attending a Elite Sport Jr High School receive intervention
Behavioral: Healthy Sport Project
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.
Other Names:
  • Sports Body Project

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in symptoms of Eating Disorder, Eating Disorder Questionnaire Short-form
Time Frame: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
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
Time Frame: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
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
Time Frame: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
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
Time Frame: After intervention (post, +6 weeks)
Focus group interview following a semistructured manual; asking for experiences with participation in the "Healthy Sport Project"
After intervention (post, +6 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in experiences of Body Appearance Pressure (BAP), questions by research group
Time Frame: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Question on experience of BAP (if it is experienced yes/no)
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
Time Frame: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Question on arenas for experience of BAP (in which contexts; choose between listed arenas)
Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Change in dietary habits, questions by research group
Time Frame: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Questions on meal frequency (numbers); frequency of intake of fruit and vegetables (number of portions); frequency of intake of dairy products (number of portions); frequency of intake of fish (number of portions)
Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Change in dietary habits, questions by research group
Time Frame: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Use of supplements (yes/no)
Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Change in dietary habits, questions by research group
Time Frame: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Use of supplements ( what type of supplements, chose from listed alternatives)
Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Change in nutrition knowledge, questions by research group
Time Frame: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
3 questions asking for examples of foods providing carbohydrates; proteins; fats, respectively.
Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Question on injuries, questions by research group
Time Frame: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
1 Questions asking for any incident of injury (yes/no)
Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Question on injuries, questions by research group
Time Frame: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Where the injury was located (chose from list of anatomical locations)
Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Demographics, questions by research group
Time Frame: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Age (years)
Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Demographics, questions by research group
Time Frame: Before intervention
Sex (male/female)
Before intervention
Demographics, questions by research group
Time Frame: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Sport (any given)
Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Demographics, questions by research group
Time Frame: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Body weight (kg)
Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Demographics, questions by research group
Time Frame: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Height (m)
Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Demographics, questions by research group
Time Frame: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Number of hours in physical activity per week (hours).
Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ostfold University College

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Oslo University Hospital
Norwegian School of Sport Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Therese F Mathisen, PhD, Østfold University College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 277766

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not to be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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