Condition category
Mental and Behavioural Disorders
Date applied
22/01/2013
Date assigned
05/02/2013
Last edited
05/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The prevalence of eating disorders (ED) is higher among elite athletes than non-athletes, particularly among athletes competing in weight-sensitive sports, and higher in female than male athletes.
Concerning the physical and psychosocial complications related to eating disorders and the use of extreme weight regulation methods, it is strongly desirable to prevent eating disorders in sport. At present, no studies concerning prevention of eating disorders among elite athletes have been performed and strategies to prevent eating disorders are lacking
Thus the aims of this study are to examine the effect of a one-year multi-component intervention program on the development of ED and symptoms associated with ED among adolescent female and male elite athletes.
The results of this long-term intervention project will reveal important knowledge on how to prevent eating disorders among athletes.

Who can participate?
The sample is the total population of first grade students starting in the fall 2008 at Elite Sport High Schools in Norway. There are sixteen schools containing 711 athletes and 194 coaches attending the project. The Norwegian Elite Sport High Schools are private and public high schools with programs designed for talented athletes.

What does this study involve?
The schools were randomly allocated to the intervention or control group. All athletes from each school were randomized to the same treatment arm (intervention or control).
The project consists of two parts:
1. The survey involved both athletes and coaches, and took place during the fall 2008. In pre- and post tests the surveys included both standardized tests and own developed questions, and a clinical interview with the athletes.
2. The intervention included lectures and exercises in different areas which are considered important in the preventing eating disorders. The intervention started in the spring in 2009 and was completed in May 2010.

What are the possible benefits and risks of participating?
Possible benefits for the athletes attending the intervention are increased knowledge and optimized eating behavior and self-esteem. Reduced risk of developing an ED.
Athletes with an ED regardless of whether they are in the intervention or control will be guided on how they make contact on the system for supervision / treatment.
Possible benefits for the coaches are increased knowledge about nutrition, body composition, weight issues, ED, mental training, self-esteem and self-confidence, as well as how to identify and manage disordered eating and ED problems among athletes.
By taking part of this study there are no risks of physical injury or harm. However, by focusing on topics such as sport nutrition, growth and development, there may be a risk of increasing the prevalence of symptoms associated with ED.

Where is the study run from?
The study took part at the different Elite Sport High Schools during school-hour.

When is the study starting and how long is it expected to run for?
The study started in 2008 when athletes born in 1992 were 1-year students at high school. The study ended when the participants ended high school (June 2011).

Who is funding the study?
Oslo Sport Trauma Research Center. The center has been established through generous grants from the Royal Norwegian Ministry of Culture, the South-Eastern Norway Regional Health Authority, the International Olympic Committee, the Norwegian Olympic Committee & Confederation of Sport, and the Norsk Tipping AS. This project has been supported by a generous grant from Olympiatoppen.

Who is the main contact?
Marianne Martinsen
marianne.martinsen@nih.no

Trial website

http://www.klokavskade.no/en/Project/162---Idrett-helse-og-prestasjon/

Contact information

Type

Scientific

Primary contact

Mrs Marianne Martinsen

ORCID ID

Contact details

Oslo Sport Trauma Research Center
Norwegian School of Sport Sciences
P.O. Box 4014
Ullevaal Stadion
Oslo
0806
Norway
+47 23 26 22 64
marianne.martinsen@nih.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Preventing eating disorders in sports: A cluster randomised controlled trial

Acronym

Study hypothesis

The prevalence of eating disorders is higher among elite athletes than non-athletes, particularly among athletes competing in weight-sensitive sports. Adolescence is a high risk period of developing eating disorders.

The main objective of the study was to examine the effect of a one-year multi-component intervention program on the development of eating disorders and symptoms associated with eating disorders among adolescent female and male elite athletes.

Study hypothesis:
1. The intervention will prevent new cases of eating disorders among female and male athletes attending the intervention.
2. The intervention will reduce the percentage of reported symptoms associated with eating disorders among the athletes attending the intervention compared to the athletes attending the control schools.

Ethics approval

The National Committees for Research Ethics, 17th September 2008 , ref:S-08442d. 1008/10620

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Clinical eating disorders

Intervention

This is a cluster randomised controlled trial, where the 16 Elite Sport High Schools were cluster randomised to intervention (n = 9) and control (n=7).

The intervention was a one-year multi-component intervention program, aiming to prevent the development of eating disorders and symptoms associated with eating disorders (ED).

The intervention program was organized as lectures, teamwork exercises, and practical and theoretical assignments (during the lectures and as homework). The lectures consisted of four 90-minutes sessions conducted at school during school hours by the research group. In addition, our communication with the athletes was based on e-mail, a closed Facebook group and different electronic communication tools used by the school the athletes attended.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Fulfilling the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for Anorexia Nervosa, Bulimia Nervosa or Eating Disorders Not Otherwise Specified.
Eating disorders were determined by using the clinical interview Eating Disorder Examination (EDE). The clinical interview was conducted after questionnaire screening, at pretest and at post test 2 (1-year follow-up).

Secondary outcome measures

Symptoms associated with ED assessed at baseline, after the intervention (posttest 1) and posttest 2 (9-month follow-up) based on the self-reported questionnaire.

Overall trial start date

01/10/2008

Overall trial end date

01/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. 1-year students attending one of the Elite Sport High School in Norway (born in 1992)
2. Coaches working with the 1-year students at one of the Elite Sport High Schools in Norway

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

711 athletes and 194 coaches

Participant exclusion criteria

1. 1-year students not born in 1992
2. Not received written consent to participate from the athletes and or their parents.

Recruitment start date

01/10/2008

Recruitment end date

01/07/2011

Locations

Countries of recruitment

Norway

Trial participating centre

Oslo Sport Trauma Research Center
Oslo
0806
Norway

Sponsor information

Organisation

Oslo Sports Trauma Research Center (Norway)

Sponsor details

Norwegian School of Sport Sciences
P.O. Box 4014
Ullevaal Stadion
Oslo
0806
Norway
+47 23 26 23 67
ostrc@nih.no

Sponsor type

Research organisation

Website

http://www.klokavskade.no/en/

Funders

Funder type

Research organisation

Funder name

Oslo Sport Trauma Research Center (Norway) - The center has been established through generous grants from the Royal Norwegian Ministry of Culture, the South-Eastern Norway Regional Health Authority, the International Olympic Committee, the Norwegian Olympic Committee & Confederation of Sport, and the Norsk Tipping AS. This project has been supported by a generous grant from Olympiatoppen.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes