Clinical trial NCT05589077: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Deficiency
Keywords: Female Athlete
Sport Nutrition
Patient Education
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will complete the same survey and engage in the same intervention.
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Change in Knowledge Score
timeFrame: ~10 min for pre-test followed by ~10 min intervention followed by ~10 min post-test.
measure: Change in Confidence Score
timeFrame: ~10 min for pre-test followed by ~10 min intervention followed by ~10 min post-test.
measure: Change in Impact Score
timeFrame: ~10 min for pre-test followed by ~10 min intervention followed by ~10 min post-test.
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Lauren Woelffer
role: PRINCIPAL_INVESTIGATOR
References:
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.