- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07228507
Video Intervention of Relative Energy Deficiency in Sport (Video_REDs)
Video-based Educational Intervention on Healthcare Professionals' Knowledge of Relative Energy Deficiency in Sport
Study Overview
Status
Detailed Description
The objective was to assess the effectiveness of a brief online educational video in improving knowledge, attitudes, and perceived confidence toward the Triad and REDs among Spanish healthcare professionals.
Design: Randomized controlled educational trial. A total of 200 Spanish healthcare professionals (physicians, nurses, and physiotherapists) were randomized 1:1 into an intervention group (VG) and a control group (CG). The VG received access to an 18-minute YouTube-based educational video titled "Triad of the Female Athlete and RED-S". The CG did not have access to the video until the study was completed. Both completed a validated 16-question questionnaire before and after the intervention.
The Primary Outcome Measure was the change in knowledge score about the Female/Male Athlete Triad and REDs. Secondary outcomes included questions from the definition group (questions 1 and 3), low energy availability group (questions 2, 4, 5, 10, 14, 15 and 16), the menstrual health group (questions 6,9,11 and 13) and the bone health group (questions 7,8 and 12)
Descriptive analyses were conducted to determine means, standard deviations, frequencies, and percentages. A two-way repeated-measures ANOVA was performed after verifying the statistical assumptions required for this methodology. Outliers were examined using the first and third quartiles and the interquartile range. Participants with a total score ≤4 were excluded from the analysis to preserve the reliability and validity of the data and to ensure that statistical analyses reflected only responses with adequate informational content consistent with the study conditions. Data normality was assessed through Q-Q plots and the Shapiro-Wilk test. The effects of the group factor (VG vs. CG), the time factor (pre- vs. post-test), and their interaction were analysed, considering a 95% confidence interval (p ≤ 0.05).
Knowledge Questions
- What do you consider to be the three components of the Female Athlete Triad?
- Low energy availability in a person occurs when the energy to maintain the functions required by the human body to preserve health and optimal performance is insufficient.
- What is the main factor that would cause REDs?
- Low energy availability could be associated with a decrease in carbohydrate intake.
- There may be low energy availability without changes in weight or body mass index.
- Menarche in adolescents after the age of 15 is normal if they engage in intense physical activity.
- At what age does peak bone mineral density occur in women?
- Osteopenia in adolescent girls or young adult women can be reversed if, in adulthood, they reduce the intensity or volume of their physical activity.
- In a physically active woman, secondary amenorrhea can be considered normal if she engages in intense sport.
- Menstrual disorders in physically active women are a risk factor for having low bone mineral density.
- Low energy availability can cause secondary amenorrhea in physically active women.
- In physically active women, menstrual cycle alterations or amenorrhea are indicators of intense training.
- In physically active women, stress fractures may occur at a higher rate in women with prolonged amenorrhea than in eumenorrheic women.
- Low energy availability can affect an athlete's recovery.
- Low energy availability can increase performance (strength, speed, power).
- After performing intense exercise, the basis of caloric intake should be...
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Basque Country
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Leioa, Basque Country, Spain, 48940
- Universidad del Pais Vasco
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Registered in a health professional association in Spain (medicine, nursing, or physiotherapy).
- Voluntary participation and completion of the baseline questionnaire.
- Consent to provide an email address for communication and randomization
Exclusion Criteria:
- Not to be registered in a health professional association in Spain (medicine, nursing, or physiotherapy).
- Incomplete questionnaire responses.
- Total score ≤4 in the pre-test, to preserve data reliability and validity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Educational video
Participants attend an educational video and complete the questionnaire pre- and post-intervention.
|
Participants in the intervention arm attended an educational session designed to improve knowledge about the Female Athlete Triad and REDs, focusing on definition, low energy availability, menstrual function, and bone health.
|
|
No Intervention: Control
Participants complete the same questionnaire at baseline and follow-up without receiving the educational video
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in knowledge score (mean proportion of correct answers) from baseline to post-intervention.
Time Frame: Baseline and 4 weeks after intervention
|
Knowledge assessed using a 16-item questionnaire on the Female Athlete Triad and Relative Energy Deficiency in sport.
Each item scored 0-1 and the outcome is a score 0-16 points.
A higher scores means better knowledge.
|
Baseline and 4 weeks after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in definition questions group
Time Frame: Baseline and 4 weeks after intervention
|
Correct answers from the definition questions group.
Each question is scored 0-1 and the outcome is a score 0-2 points.
A higher scores indicate greater knowledge.
|
Baseline and 4 weeks after intervention
|
|
Change in low energy availability questions group
Time Frame: Baseline and 4 weeks after intervention
|
Correct answers from the low energy availability questions group.
Each question is scored 0-1 and the outcome is a score 0-7 points A higher scores indicate greater knowledge.
|
Baseline and 4 weeks after intervention
|
|
Change in menstrual questions group
Time Frame: Baseline and 4 weeks after intervention
|
Correct answers from the menstrual questions group.
Each question is scored 0-1 and the outcome is a score 0-4 points.
A higher scores indicate greater knowledge.
|
Baseline and 4 weeks after intervention
|
|
Change in bone health questions group
Time Frame: Baseline and 4 weeks after intervention
|
Correct answers from the bone questions group.
Each question is scored 0-1 and the outcome is a score 0-3 points.
A higher scores indicate greater knowledge.
|
Baseline and 4 weeks after intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Susana M Gil, MD, PhD, University of the Basque Country (UPV/EHU)
Publications and helpful links
General Publications
- Tam R, Beck KL, Manore MM, Gifford J, Flood VM, O'Connor H. Effectiveness of Education Interventions Designed to Improve Nutrition Knowledge in Athletes: A Systematic Review. Sports Med. 2019 Nov;49(11):1769-1786. doi: 10.1007/s40279-019-01157-y.
- Verhoef SJ, Wielink MC, Achterberg EA, Bongers MY, Goossens SMTA. Knowledge on relative energy deficiency in sport among physiotherapists and physicians. Eur J Sport Sci. 2024 Jan 30;24(1):156-63. doi: 10.1002/ejsc.12026. PMCID: PMC11235195.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M10_2024_104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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