Eating DisordersHSPNCT05583162
Healthy Sport Project; Preventing Eating Disorders in Sport
A study testing Healthy Sport Project in people with Eating Disorders and Body Dissatisfaction, run by Ostfold University College at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders, Body Dissatisfaction, Disordered Eating
- What is being tested?
- Healthy Sport Project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteNorway
- Study dates
- 10 Aug 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- pupil at the recruited Sport Jr High School
Who cannot join
- no informed consent from parents
- not willing to participate
- a diagnosis of an eating disorder and being under (or waiting for) treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Eating Disorders, Body Dissatisfaction, Disordered Eating, Adolescent - Emotional Problem, Athletic Injuries
- Being tested
- Healthy Sport Project
- Keywords
- eating disorders, disordered eating, body dissatisfaction, figure idealisation, mental health, prevention, athlete, sport, adolescent, elite sport
- Medical subject headings
- Feeding and Eating Disorders, Athletic Injuries, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Sport ProjectBehavioural
Also called Sports Body 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All pupils attending a Elite Sport Jr High School receive intervention Receives: Behavioral: Healthy Sport Project |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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"
Measured: After intervention (post, +6 weeks)
Secondary outcomes (6)
Change in experiences of Body Appearance Pressure (BAP), questions by research group
Question on experience of BAP (if it is experienced yes/no)
Measured: 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
Question on arenas for experience of BAP (in which contexts; choose between listed arenas)
Measured: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Change in dietary habits, questions by research group
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)
Measured: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Change in dietary habits, questions by research group
Use of supplements (yes/no)
Measured: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Change in dietary habits, questions by research group
Use of supplements ( what type of supplements, chose from listed alternatives)
Measured: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Change in nutrition knowledge, questions by research group
3 questions asking for examples of foods providing carbohydrates; proteins; fats, respectively.
Measured: Before intervention, After intervention (post, +6 weeks), 6 months after end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start10 Aug 2022
- Primary completion31 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A cohort of athletes receive intervention in this pilot study, and changes from pre to post intervention are evaluated
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold University College
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, Oslo University Hospital
- Responsible party
- Principal investigator, Therese Fostervold Mathisen, Ostfold University College
- Investigators
- Therese F Mathisen, PhD, Principal investigator, Østfold University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583162
- Sponsor's protocol ID
- 277766
- Acronym
- HSP
- Status last verified
- Apr 2024
- First submitted
- 8 Oct 2022
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not to be shared
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Sport Project: "Recovery, Body Acceptance and Health in Young Athletes"
- ClinicalTrials.gov ID
- NCT05583162
- Acronym / sponsor ID
- HSP / 277766
- Conditions
- Eating Disorders, Body Dissatisfaction, Disordered Eating, Adolescent - Emotional Problem, Athletic Injuries
- Keywords
- eating disorders, disordered eating, body dissatisfaction, figure idealisation, mental health, prevention, athlete, sport
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Ostfold University CollegeUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, Oslo University Hospital
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A cohort of athletes receive intervention in this pilot study, and changes from pre to post intervention are evaluated
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Healthy Sport ProjectAll pupils attending a Elite Sport Jr High School receive intervention |
Who may qualify
- Ages
- 13 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- pupil at the recruited Sport Jr High School
Key exclusion criteria (3 listed)
- no informed consent from parents
- not willing to participate
- a diagnosis of an eating disorder and being under (or waiting for) treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Sport ProjectAlso: Sports Body Project2 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. | Behavioural | Intervention |
Primary outcome
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
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.
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
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"
6 secondary outcomes
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
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
Change in dietary habits, questions by research group
Time frame: 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
Change in dietary habits, questions by research group
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No. Not to be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Therese F Mathisen, PhD principal investigator
Østfold University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Sport Project in people with Eating Disorders and Body Dissatisfaction, run by Ostfold University College at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.