- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05589077
Knowledge of Nutritional Concerns in Physically Active Females
Effectiveness of an Educational Intervention Tool Related to Nutritional Concerns in Physically Active Female Young Adults
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Knowledge Assessment and Educational Intervention
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Knowledge Score
Time Frame: ~10 min for pre-test followed by ~10 min intervention followed by ~10 min post-test.
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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.
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~10 min for pre-test followed by ~10 min intervention followed by ~10 min post-test.
|
|
Change in Confidence Score
Time Frame: ~10 min for pre-test followed by ~10 min intervention followed by ~10 min post-test.
|
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
Time Frame: ~10 min for pre-test followed by ~10 min intervention followed by ~10 min post-test.
|
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.
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~10 min for pre-test followed by ~10 min intervention followed by ~10 min post-test.
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Collaborators and Investigators
Investigators
- Principal Investigator: Lauren Woelffer, University of North Carolina, Chapel Hill
Publications and helpful links
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 (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-1348
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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