NCT05589077

Brief Summary

Purpose: The purpose of this study is to determine whether implementation of an educational tool for nutritional concerns in 18-25-year-old females who participate in sport increases their understanding of various nutritional concerns. By studying an educational tool geared towards nutritional concerns of the female athlete, clinicians can use the information to improve clinical practice and patient outcomes. Procedure: Participants will be asked to complete a previously validated survey assessing knowledge of nutritional concerns of female athletes: the Female Athlete Triad, Relative Energy Deficiency in Sport, and eating disorders. The survey will be completed immediately pre- and post-receipt of the educational intervention. The intervention includes education on the previously mentioned nutritional concerns.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 17, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 9, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2023

Completed
Last Updated

May 11, 2023

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

October 17, 2022

Last Update Submit

May 9, 2023

Conditions

Keywords

Female AthleteSport NutritionPatient Education

Outcome Measures

Primary Outcomes (3)

  • Change in Knowledge Score

    Participants will be asked 37 questions in the survey assessing their knowledge on nutritional concerns. Each correctly answered question is worth 1 point and each incorrectly answered question is worth -1 point. The highest possible score a participant can receive is 37. The lowest possible score a participant can receive is -37. Higher scores indicate higher levels of knowledge.

    ~10 min for pre-test followed by ~10 min intervention followed by ~10 min post-test.

  • Change in Confidence Score

    Corresponding to each Knowledge question was a Likert scale for confidence (i.e. "How confident are you in this response?"). Response options on the Confidence options ranged from 0 to 5, with 0 indicating "No confidence" and 5 indicating "Completely sure". The total Confidence score is the sum of all confidence responses from each of the scored knowledge questions. The total number of Confidence points ranged from 0-148. A higher confidence score indicates greater confidence from the participant in their knowledge answers. Higher scores indicate higher levels of confidence.

    ~10 min for pre-test followed by ~10 min intervention followed by ~10 min post-test.

  • Change in Impact Score

    The score quantifies the correctness of an answer combined with the level of confidence. Each question has a score range between -1 and 1. The correctness of the answer and level of confidence in the answer produces the Impact score. One point is given for the correct answer and high confidence and one point is subtracted for the incorrect answer and high confidence. The score of the questions is reduced when the respondent has lower confidence in their answer. The scale of confidence corresponds to the following points for impact scoring: Confidence 4 = 1 point, Confidence 3 = 0.75 points, Confidence 2 = 0.5 points, Confidence 1 = 0.25 points, Confidence 0 = 0 points. The total Impact score is the sum of each question's score. Higher scores indicate both high levels of knowledge and confidence simultaneously.

    ~10 min for pre-test followed by ~10 min intervention followed by ~10 min post-test.

Study Arms (1)

Knowledge Assessment and Educational Intervention

EXPERIMENTAL

All participants will be asked to complete the pre-intervention survey assessing knowledge and confidence of female athlete nutritional concerns. Then participants will engage in an educational intervention on these same topics. Following the intervention, participants will repeat the same survey.

Behavioral: Education on Female Athlete Nutritional Concerns

Interventions

Visual and audio information presented within the Qualtrics system will cover topics on the Female Athlete Triad, Relative Energy Deficiency in Sport, and eating disorders.

Knowledge Assessment and Educational Intervention

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Ages 18-25
  • Participate in organized sport

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • Lodge MT, Ackerman KE, Garay J. Knowledge of Triad and RED-S in Female Cross-Country Athletes and Support Staff. J Athl Train. 2021 Jul 30. doi: 10.4085/1062-6050-0175.21. Online ahead of print.

    PMID: 34329432BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Lauren Woelffer

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All participants will complete the same survey and engage in the same intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 21, 2022

Study Start

January 9, 2023

Primary Completion

April 28, 2023

Study Completion

May 5, 2023

Last Updated

May 11, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 9 months and ending 36 months following article publication.
Access Criteria
Data will be made available from the PI upon request.

Locations