Screening Program of Relative Energy Deficiency in Sports in College Athletes

Screening Program of Relative Energy Deficiency in Sports in College Athletes and Establish Diagnosis and Intervention Model

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Relative Energy Deficiency in Sports
• Intervention / Treatment: Behavioral: Nutrition education

Detailed Description

This project is divided into 3 steps for a period of two years. The first step (0-6 months) is expected to recruit a total of 100 college athletes from Taekwondo, judo, rhythmic gymnastics, and long-distance runners for Relative Energy Deficiency in Sports (RED-S) screening. The second step (7-18 months) is targeted at athletes who have been screened for potential RED-S risk (the number is tentatively 30) in the first step.

The diagnostic tools refer to the clinical assessment of Relative Energy Deficiency in Sport Clinical Assessment Tool (RED-S CAT). The third stage (19-21 months) is intervention programs targeted at the athletes who are diagnosed with RED-S (the number is tentatively 20) at 2nd step. The intervention programs consist of nutrition monitoring and diet intervention. The investigators hope that through this study will know the prevalence of 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Taoyuan Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (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

Exclusion Criteria:

• (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: college athletes; Screening Program of RED-S in College Athletes and Establish Diagnosis and Intervention Model	Behavioral: Nutrition education; The intervention programs consist of nutrition monitoring and diet intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Principal Investigator: Yin-Chou Lin, MD, Taoyuan Chang Gung Memorial Hospital, Taoyuan, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Anorexia; sport injury; Relative Energy Deficiency in Sports; menstrual disorder
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Relative Energy Deficiency in Sport
• Other Study ID Numbers: 201902254A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No