search
Back to results

Knowledge of Nutritional Concerns in Physically Active Females

Primary Purpose

Nutritional Deficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education on Female Athlete Nutritional Concerns
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nutritional Deficiency focused on measuring Female Athlete, Sport Nutrition, Patient Education

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Must meet all inclusion criteria (no previous or current health concerns will exclude a participant from the study)

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Knowledge Assessment and Educational Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 17, 2022
Last Updated
May 9, 2023
Sponsor
University of North Carolina, Chapel Hill
search

1. Study Identification

Unique Protocol Identification Number
NCT05589077
Brief Title
Knowledge of Nutritional Concerns in Physically Active Females
Official Title
Effectiveness of an Educational Intervention Tool Related to Nutritional Concerns in Physically Active Female Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
April 28, 2023 (Actual)
Study Completion Date
May 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
The current study is a quasi-experimental study consisting of one virtual session on Qualtrics. Eligible participants (as determined via a screening questionnaire) will use a link to access the questionnaire online. The questionnaire will collect information on participant's demographic background. Then, participants compete a 37-item survey on nutritional concerns and rate their confidence in each answer. Participants were given a score of 1 if the answer was correct, and a score of -1 if the answer was incorrect. 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 range of total scores for Knowledge ranged from -37 to +37 with +37 indicating greatest amount of knowledge. The total Confidence score was 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 indicated greater confidence from the participant in their knowledge answers. Impact scores were also calculated to measure the total composite score of Knowledge plus Confidence to identify an increased understanding of all scores. Impact scores will be calculated using the same procedure as Lodge et al. (2020): "The total points of impact score from the questionnaire range between +37 and -37. A percentage of impact can be calculated using the limits -37 to +37 of the impact score (range of 74 points). A score of 0 will have a percentage of 50%, a score of -37 will have a percentage of 0%, and a score of +37 will have a percentage of 100%. Each question has a score range between +1 and -1. 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. For example, if the answer is correct with the lowest confidence (1), it is scored as 0.25. If the answer is incorrect with the lowest confidence (1), it is scored as -0.25. If the answer selected if "I don't know", or a confidence of zero (0) is selected, it is scored as zero. For questions of "choose all that apply" nature, each possible sub-answer is considered individually".1 Then, participants will engage in a 10-minute educational intervention. The intervention will cover all the information regarding nutritional concerns that were tested in the survey. Participants will repeat the same survey to test their knowledge and confidence in nutritional concerns. Lastly, participants will answer 10 follow-up questions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Deficiency
Keywords
Female Athlete, Sport Nutrition, Patient Education

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will complete the same survey and engage in the same intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Knowledge Assessment and Educational Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education on Female Athlete Nutritional Concerns
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Knowledge Score
Description
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.
Time Frame
~10 min for pre-test followed by ~10 min intervention followed by ~10 min post-test.
Title
Change in Confidence Score
Description
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.
Time Frame
~10 min for pre-test followed by ~10 min intervention followed by ~10 min post-test.
Title
Change in Impact Score
Description
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.
Time Frame
~10 min for pre-test followed by ~10 min intervention followed by ~10 min post-test.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female Ages 18-25 Participate in organized sport Exclusion Criteria: Must meet all inclusion criteria (no previous or current health concerns will exclude a participant from the study)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Woelffer
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication.
IPD Sharing Access Criteria
Data will be made available from the PI upon request.
Citations:
PubMed Identifier
34329432
Citation
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.
Results Reference
background

Learn more about this trial

Knowledge of Nutritional Concerns in Physically Active Females

We'll reach out to this number within 24 hrs