Relative Energy Deficiency in SportsNCT05390346
Screening Program of Relative Energy Deficiency in Sports in College Athletes
A study testing Nutrition education in people with Relative Energy Deficiency in Sports, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relative Energy Deficiency in Sports
- What is being tested?
- Nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2020to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Relative Energy Deficiency in Sports
- Being tested
- Nutrition education
- Keywords
- Relative Energy Deficiency in Sports, Anorexia, menstrual disorder, sport injury
- Medical subject headings
- Anorexia, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition educationBehavioural
The intervention programs consist of nutrition monitoring and diet intervention.
| Study group | Role | What they receive |
|---|---|---|
| college athletes | Experimental | Screening Program of RED-S in College Athletes and Establish Diagnosis and Intervention Model Receives: Behavioral: Nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 19-21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Aug 2020
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relative Energy Deficiency in SportsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Yin-Chou Lin, MD, Principal investigator, Taoyuan Chang Gung Memorial Hospital, Taoyuan, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390346
- Sponsor's protocol ID
- 201902254A3
- Status last verified
- Feb 2022
- First submitted
- 28 Feb 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Program of Relative Energy Deficiency in Sports in College Athletes and Establish Diagnosis and Intervention Model
- ClinicalTrials.gov ID
- NCT05390346
- Acronym / sponsor ID
- 201902254A3
- Conditions
- Relative Energy Deficiency in Sports
- Keywords
- Relative Energy Deficiency in Sports, Anorexia, menstrual disorder, sport injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| college athletes | Experimental | Behavioral: Nutrition educationScreening Program of RED-S in College Athletes and Establish Diagnosis and Intervention Model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (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
Key exclusion criteria (5 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition educationThe intervention programs consist of nutrition monitoring and diet intervention. | Behavioural | college athletes |
Primary outcome
Evaluate the phenomenon of low Energy Availability (low EA) among college athletes in Taiwan.
Time frame: 0-6 months
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).
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).
Time frame: 7-18 months
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).
Evaluate the improvement of energy availability (EA) after intervention with nutrition education.
Time frame: 19-21 months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yin-Chou Lin, MD principal investigator
Taoyuan Chang Gung Memorial Hospital, Taoyuan, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition education in people with Relative Energy Deficiency in Sports, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the phenomenon of low Energy Availability (low EA) among college athletes in Taiwan. (time frame: 0-6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.