NCT06480682

Brief Summary

The International Olympic Committee recently published its consensus statement on relative energy deficiency syndrome (REDs) in sport which was followed by a similar version for dance by clinicians and researchers in dance. REDs is a complex multisystem syndrome with low energy availability as its foundation. Dancers and gymnasts, particularly in ballet, have long been reported to have body weight issues with an increase prevalence of eating disorders which has been associated with early onset osteoporosis. Combat sports have a similar issue, with athletes needing to "make weight" to compete in their ideal weight category that has lead to similar eating disorder and associated issues to dance. Currently there are no data on REDs prevalence in dance, gymnastics or combat sports and therefore understanding the underlying prevalence of REDs in both these populations will provide important information for both clinicians and coaches to help develop a safe and healthy environment for their dancers and athletes to compete/perform and to be able to retire from sport/dance without an increased risk of osteoporosis. In a few sports and dance genres, some participants might be more prone to a negative health effect referred to as relative energy deficiency syndrome (REDs). This is an energy deficiency relative to the balance between dietary energy intake and energy availability required to support homeostasis, health and activities of daily living, growth and sporting activities that can result in multiple systems being affected including decreases in bone health, energy metabolism, reproductive function, musculoskeletal health, immunity, glycogen synthesis and cardiovascular and haematological health. The purpose of this study is to examine the prevalence of REDs in specific sports (combat sports and gymnastics) and dance genres (ballet and musical theatre). Voluntary participants will be tested three times a year over a 5-year period. This will include an annual dual-energy x-ray absorptiometry and blood tests plus resting energy expenditure and questionnaires three times a year.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
39mo left

Started Sep 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress34%
Sep 2024Jul 2029

First Submitted

Initial submission to the registry

June 10, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 10, 2024

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2029

Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

4.9 years

First QC Date

June 10, 2024

Last Update Submit

June 24, 2024

Conditions

Keywords

JudoBalletGymnasticsMaleFemaleDanceweight category sport

Outcome Measures

Primary Outcomes (1)

  • Relative energy deficiency (REDs)

    Prevalence of REDs in cohorts by diagnosis by elimination by medical team.

    Throughout study; an average of 3 times a year

Secondary Outcomes (4)

  • Bone stress injuries

    Number of participants with bone stress injuries. Throughout study an average of 3 times a year

  • Primary Amenorrhea (females)

    Number of participants with primary and secondary amenorrhea. Throughout study an average of 3 times a year

  • Resting Metabolic rate

    Throughout study; an average of 3 times a year

  • Monitoring of all blood markers for below normal values (red flags)

    Throughout study; an average of 3 times a year

Study Arms (3)

Dance

Age: 16-45yrs old Sex: Female and male Activity: Dance (ballet, contemporary, musical theatre); Level: Full-time training at either a dance company, vocational dance school Status: Engaged in full-time training at start of project without activity limiting injury

Radiation: Dual x-ray scanDiagnostic Test: Blood screenOther: QuestionnairesOther: Anthropometric measurementsProcedure: Resting Metabolic rate

Combat Sports

Age: 16-45yrs old Sex: Female and male Activity: Combat sports (judo, karaté, taekwondo); Level: Full-time training at either a NGB centre Status: Engaged in full-time training at start of project without activity limiting injury

Radiation: Dual x-ray scanDiagnostic Test: Blood screenOther: QuestionnairesOther: Anthropometric measurementsProcedure: Resting Metabolic rateOther: Energy expenditure

Gymnastics

Age: 16-45yrs old Sex: Female and male Activity: Gymnastics (artistic) Level: Full-time training at either a NGB centre or academy Status: Engaged in full-time training at start of project without activity limiting injury

Radiation: Dual x-ray scanDiagnostic Test: Blood screenOther: QuestionnairesOther: Anthropometric measurementsProcedure: Resting Metabolic rateOther: Energy expenditure

Interventions

Annual whole body scan monitoring bone mineral density for whole body, radius, L1-4 and femur and body composition

Combat SportsDanceGymnastics
Blood screenDIAGNOSTIC_TEST

Three times a year blood samples will be taken to measure: full blood count, ferritin, B12, folate, erythrocyte sedimentation rate (ESR), renal function, liver function, thyroid stimulating hormone (TSH), Free thyroxine (T4), luteinizing hormone (LH), oestradiol, testosterone, follicle-stimulating hormone (FSH), coeliac screen, vitamin D (25(OH)D), Leptin and Ghrelin

Combat SportsDanceGymnastics

Informed consent; Low energy availability questionnaires for males and females; General health including menstrual status (females)

Also known as: Low Energy Availability Male Questionnaire, Low Energy Availability Female Questionnaire; Consent; Health
Combat SportsDanceGymnastics

Three times a year participant's measurements will be taken: stature, body mass and body composition (bio-impedence)

Combat SportsDanceGymnastics

Resting metabolic rate will be measured by resting gas analysis. Each participant will lie down for a period of 15 minutes, in the final 5 minutes their expired gases are analysed using a breath-by-breath gas analyser (Cortex).

Combat SportsDanceGymnastics

Energy expenditure was estimated using accelerometery (Genieactive) and activity logs in the participants' normal environment, assessed during 3 weekdays of scheduled dance training and 2 weekend days without scheduled dance training. Focus is on daily energy expenditure

Combat SportsGymnastics

Eligibility Criteria

Age16 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Dancers: ballet, contemporary dance and musical theatre Combat sports: judo, karate, taekwondo Gymnastics: artistic

You may qualify if:

  • Full-time training at either a NGB centre, dance company, vocational dance school or academy
  • Engaged in full-time training at start of project

You may not qualify if:

  • Not engaged in full-time training
  • Injury preventing engagement in training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wolverhampton

Walsall, West Midlands, WS1 3BD, United Kingdom

Location

Related Publications (6)

  • Koltun KJ, Strock NCA, Southmayd EA, Oneglia AP, Williams NI, De Souza MJ. Comparison of Female Athlete Triad Coalition and RED-S risk assessment tools. J Sports Sci. 2019 Nov;37(21):2433-2442. doi: 10.1080/02640414.2019.1640551. Epub 2019 Jul 11.

    PMID: 31296115BACKGROUND
  • Sim A, Burns SF. Review: questionnaires as measures for low energy availability (LEA) and relative energy deficiency in sport (RED-S) in athletes. J Eat Disord. 2021 Mar 31;9(1):41. doi: 10.1186/s40337-021-00396-7.

    PMID: 33789771BACKGROUND
  • Allen N, Kelly S, Lanfear M, Reynolds A, Clarke R, Mountjoy ML, Wyon M, Wolman R. Relative energy deficiency in dance (RED-D): a consensus method approach to REDs in dance. BMJ Open Sport Exerc Med. 2024 Mar 7;10(1):e001858. doi: 10.1136/bmjsem-2023-001858. eCollection 2024.

  • Mountjoy M, Ackerman KE, Bailey DM, Burke LM, Constantini N, Hackney AC, Heikura IA, Melin A, Pensgaard AM, Stellingwerff T, Sundgot-Borgen JK, Torstveit MK, Jacobsen AU, Verhagen E, Budgett R, Engebretsen L, Erdener U. 2023 International Olympic Committee's (IOC) consensus statement on Relative Energy Deficiency in Sport (REDs). Br J Sports Med. 2023 Sep;57(17):1073-1097. doi: 10.1136/bjsports-2023-106994.

  • Civil R, Lamb A, Loosmore D, Ross L, Livingstone K, Strachan F, Dick JR, Stevenson EJ, Brown MA, Witard OC. Assessment of Dietary Intake, Energy Status, and Factors Associated With RED-S in Vocational Female Ballet Students. Front Nutr. 2019 Jan 9;5:136. doi: 10.3389/fnut.2018.00136. eCollection 2018.

  • Staal S, Sjodin A, Fahrenholtz I, Bonnesen K, Melin AK. Low RMRratio as a Surrogate Marker for Energy Deficiency, the Choice of Predictive Equation Vital for Correctly Identifying Male and Female Ballet Dancers at Risk. Int J Sport Nutr Exerc Metab. 2018 Jul 1;28(4):412-418. doi: 10.1123/ijsnem.2017-0327. Epub 2018 Jun 22.

MeSH Terms

Conditions

Relative Energy Deficiency in SportFractures, Stress

Interventions

Absorptiometry, PhotonSurveys and QuestionnairesConsent FormsHealthBasal MetabolismEnergy Metabolism

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthInformed ConsentJurisprudenceSocial Control, FormalHealth Care Economics and OrganizationsRecordsOrganization and AdministrationHealth Services AdministrationPopulation CharacteristicsMetabolism

Study Officials

  • Roger Wolman, PhD

    Honorary Professor

    STUDY CHAIR

Central Study Contacts

Matthew A Wyon, PhD

CONTACT

Ross Cloak, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Exercise Physiology

Study Record Dates

First Submitted

June 10, 2024

First Posted

June 28, 2024

Study Start

September 10, 2024

Primary Completion (Estimated)

July 30, 2029

Study Completion (Estimated)

July 30, 2029

Last Updated

June 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

All anonymised data will be shared via figshare

Shared Documents
STUDY PROTOCOL
Time Frame
Protocol and statistical analysis plan will be available pre data collection Data will be available at point of publication
Access Criteria
All data will be made available in line with Open Science protocols
More information

Available IPD Datasets

Individual Participant Data Set (RED-D)Access
Study Protocol (RED-D)Access

Locations