NCT05587270

Brief Summary

Eating disorders (ED) are serious mental illnesses with high mortality rates and significant impact on an individual's quality of life. These disorders are characterized by preoccupation of weight and shape, leading to restrictive eating behavior and compensatory behaviors (purging and excessive/compulsive exercise). Comorbidities with mental health problems are common. Athletes in leanness-focused sports report higher levels of EDs compared to athletes from sports without such focus . Energy Availability (EA) has been suggested the key variable in "Relative Energy Deficiency in Sports" (RED-S) with studies reporting impairment of reproductive function and bone formation. Climbing is a weight sensitive sport where athletes generally, benefit from a lean body shape and low weight, a risk factors for ED. Therefore, climbing athletes can be expected to be at high-risk to develop these conditions. To our knowledge, there are no studies on the prevalence and magnitude of EDs among climbers. Due to the overrepresentation of EDs reported in sports and the poor treatment prognosis, early detection and prevention of ED symptoms are essential. The present study will study the prevalence of ED symptoms, changes over time and trajectories of key variables along with related problem areas such as bone health and mental health problems in order to take steps towards tailored strategies for the prevention of EDs in climbing. The overall purpose of the project is to study prevalence and changes over a two-year period (with a planned follow-up period of up to five years) of eating disordered (ED) symptoms, mental health problems, overuse injuries, bone health as well as indications of relative energy deficiency (RED-S) in elite vs. sub-elite Swedish climbers. Climbers will be compared to a group of normal controls. Further, differences will be studied in groups with high vs. low levels of EDs, comparing occurrence of mental health problems, overuse injuries and bone health. Trajectories of mentioned variables over time will be analyzed.

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
366

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

3.8 years

First QC Date

October 17, 2022

Last Update Submit

November 3, 2022

Conditions

Keywords

DepressionAnxietyStressPainRock climbingEating disordersCohort

Outcome Measures

Primary Outcomes (2)

  • Eating disorders

    Eating Disorders: The Eating Disorders Examination-Questionnaire (EDE-Q 6.0) will be used and consists of four subscales: restraint, eating concern, shape concern and weight concern, addressing core dimensions of eating disorders (Berg et al., 2012). Higher scores on the global scale and subscales denote more problematic eating behaviours and attitudes. A cut-off of 2 on the global scale indicate a sublclinical eating disorder and a score of 4 or higher on the global score is generally used as clinically significant.

    2022-2025

  • Relative energy deficiency

    Basic symptoms indicative of RED-S will be assessed by 17 questions about meal pattern, menstrual function and injuries. These questions were developed and previously used with a Swedish figure skating population, 13 years and older (n=224; Edlund, 2020).

    2022-2025

Secondary Outcomes (6)

  • Sleep quality

    2022-2025

  • Depression, anxiety and stress

    2022-2025

  • Body Image

    2022-2025

  • Compulsive Exercise

    2022-2025

  • Perfectionism

    2022-2025

  • +1 more secondary outcomes

Study Arms (2)

Rock Climbers

The whole eligible population of Swedish climbers on elite- or sub-elite levels of competition will be invited to participate in the study. Participants will be both male and female, 13 years and older. There are approximately 40 climbers eligible at elite level and a minimum of 80 climbers at sub-elite level of competition.

Other: Web based surveysRadiation: DXA

Controls

A non-athlete control group (n matched to the study group) from the general population, will be invited to participate in the study.

Other: Web based surveys

Interventions

A web-based survey will explain the purpose, aims, and ethical rights, as well as how to complete the questionnaire online. Further, information about, and an invitation to participate in the DXA-scan will be included with this information. Upon electronic consent by both parent and athlete (or just athlete if of consenting age (15 y o a)), access to the multi-section questionnaire will be granted. Contact details of the researchers will be available in case of difficulties comprehending the questions. Following completion, the participants' data will be sent to a secure database for analysis. Participants will be ensured of the confidentiality of the study and will be free to withdraw from the study. Parents will also be asked to provide their consent if participants age is under 14.

ControlsRock Climbers
DXARADIATION

All participants will be invited to complete a DXA scan at baseline. DXA is to date the most reliable way of examining the long-term physical consequences of RED-S.

Rock Climbers

Eligibility Criteria

Age13 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll individuals invited to participate in the study will answer the question about sex (female or male). All analysis with regard to sex in the study are based on these categories.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The whole eligible population of Swedish climbers on elite- or sub-elite levels of competition will be invited to participate in the study. Participants will be both male and female, 13 years and older.

You may qualify if:

  • Age over 13
  • Men: completed a boulder route rated harder than 6b or a lead route rated 7a+ within the last three months.
  • Women: completed a boulder route rated harder than 6a or a lead route rated 6c within the last year.

You may not qualify if:

  • \* None
  • \* Previous or current participation on elite level in any sport.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Göteborg University

Gothenburg, Västergötaland, 40530, Sweden

RECRUITING

Related Publications (2)

  • Nigicser I, Identeg F, Sansone M, Hedelin H, Forsberg N, Tranaeus U, Edlund K. Do Swedish rock-climbers exhibit more eating disorder and body dissatisfaction symptoms than non-climbers? A cross-sectional study. BMJ Open. 2024 Oct 16;14(10):e085265. doi: 10.1136/bmjopen-2024-085265.

  • Edlund K, Nigicser I, Sansone M, Identeg F, Hedelin H, Forsberg N, Tranaeus U. Protocol for a 2-year longitudinal study of eating disturbances, mental health problems and overuse injuries in rock climbers (CLIMB). BMJ Open. 2023 Sep 13;13(9):e074631. doi: 10.1136/bmjopen-2023-074631.

MeSH Terms

Conditions

Musculoskeletal PainFeeding and Eating DisordersRelative Energy Deficiency in SportDepressionAnxiety DisordersPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Mikael Sansone, M.D, Ph.D.

    Göteborg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikael Sansone, M.D, Ph.D.

CONTACT

Klara Edlund, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 20, 2022

Study Start

February 15, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 8, 2022

Record last verified: 2022-11

Locations