Knowledge of Nutritional Concerns in Physically Active Females

Nutritional Deficiency Clinical Trial

Official title:

Effectiveness of an Educational Intervention Tool Related to Nutritional Concerns in Physically Active Female Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05589077
• Other study ID #: 22-1348
• Status: Completed
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: May 5, 2023

Study information

• Verified date: October 2022
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 5, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Malnutrition
• Nutritional Deficiency

Intervention

Behavioral:
• Education on Female Athlete Nutritional Concerns
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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.