NCT05390346

Brief Summary

The investigators hope that through this study will know the prevalence of Relative Energy Deficiency in Sports (RED-S) and its impact on sports injuries, performance and illness among college athletes in Taiwan. And also to find an appropriate diagnosis and intervention model to take care of athletes' health and improve sports performance Taiwan's athletes in the future.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

May 25, 2022

Status Verified

February 1, 2022

Enrollment Period

1.9 years

First QC Date

February 28, 2022

Last Update Submit

May 20, 2022

Conditions

Keywords

Relative Energy Deficiency in SportsAnorexiamenstrual disordersport injury

Outcome Measures

Primary Outcomes (3)

  • Evaluate the phenomenon of low Energy Availability (low EA) among college athletes in Taiwan.

    Stage I in this study will recruit college athletes (n=100) to evaluation the subjects' energy availability (EA), calculated as energy intake (EI) minus exercise energy expenditure (EEE), normalized to fat free mass (FFM) per day (unit: kcal/kg·FFM/day). Participants' Energy Availability (EA) value lower than 30 kcal/kg·FFM/day as the status with low Energy Availability (low EA).

    0-6 months

  • Stratification the risk category of RED-S of the college athletes by using the Relative Energy Deficiency in Sport Clinical Assessment Tool (RED-S CAT).

    Stage II in this study will recruit the low Energy Availability (low EA) college athletes in Stage I (n=60), evaluate their risk category of RED-S by using Relative Energy Deficiency in Sport Clinical Assessment Tool (RED-S CAT).

    7-18 months

  • Evaluate the improvement of energy availability (EA) after intervention with nutrition education.

    Stage III in this study will recruit the low Energy Availability (low EA) college athletes in Stage II (n=40) with high or moderate risk. Evaluate the improvement of energy availability (EA) after intervention with nutrition education. Energy availability (EA), calculated as energy intake (EI) minus exercise energy expenditure (EEE), normalized to fat free mass (FFM) per day (unit: kcal/kg·FFM/day).

    19-21 months

Study Arms (1)

college athletes

EXPERIMENTAL

Screening Program of RED-S in College Athletes and Establish Diagnosis and Intervention Model

Behavioral: Nutrition education

Interventions

The intervention programs consist of nutrition monitoring and diet intervention.

college athletes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) agree to participant this study and sign the Informed Consent Form
  • (2) college athletes in National Taiwan Sport University
  • (3) over the age of 18

You may not qualify if:

  • (1) disagree to participant or unwilling to cooperate with the screening, intervention and tracking of this study
  • (2) diabetes
  • (3) thyroid disease
  • (4) hereditary anemia
  • (5) pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taoyuan Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

AnorexiaMenstruation Disturbances

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Yin-Chou Lin, MD

    Taoyuan Chang Gung Memorial Hospital, Taoyuan, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2022

First Posted

May 25, 2022

Study Start

August 1, 2020

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

May 25, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations