Clinical trial NCT06581237: Nutrition for Health and Performance in Female Collegiate Soccer Players
Official title: The Effects of App-Based Dietary Guidance on Determinants of Underfueling and Performance in Female Collegiate Soccer Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: relative energy deficiency in sport (RED-S)
performance
health
nutrition
dietetics
eHealth
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: Pennington Biomedical Research Center
First posted: 2024-09-03
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to conduct a pilot trial using an app-based approach to improve the health and performance of female collegiate soccer athletes through nutrition education and personalized feedback. The app-based program is designed to promote better performance through education on sport-specific fueling and good nutrition practices.

Detailed description: Objectives: Combat female soccer athletes underfueling during their competitive season.

Study Overview: This project proposes an open label, pilot research endeavor between the Department of Nutrition at Case Western Reserve University (CWRU), Pennington Biomedical Research Center (PBRC) and the NCAA Division III CWRU Women's Soccer Team. The proposed study design will implement a commercially available, dietitian-designed phone app, Eat2Win. Eat2Win provides targeted nutritional education, specifically for soccer athletes, to improve fueling for sport and health. Additionally, Eat2Win's photo-based phone app technology will be used to provide individualized feedback to improve athlete fueling. Anthropometric, aerobic fitness (VO2), resting metabolic rate, physical activity, body composition and health-related questionnaire data will be collected from a subset of athletes at three timepoints: pre-season, in-season, and post-season. Biological measures from fingerstick blood and breath will be collected in a subset of participants at the three timepoints.

General Aims/Hypothesis: Our intervention will strive to improve athlete health and performance through nutrition education and personalized feedback using the Eat2Win app.

Eligibility criteria: Inclusion Criteria:

* Currently active and NCAA-eligible (including academic standing) member of the Case Western Reserve University (CWRU) Women's Soccer Team
* Owns a mobile device compatible with the Eat2Win Dietary App platform
* Signed Informed Consent

Exclusion Criteria:

* Pregnant women or women who are nursing
* Unwilling to provide anthropometric and/or biological (i.e. finger prick blood) samples during collection periods
* History of diagnosed disordered eating

Primary outcomes:
measure: Low Energy Availability in Females Questionnaire (LEAF -Q)
timeFrame: Baseline/Pre-season (August 2024), Mid-season (~2 months after baseline; October 2024), End of Study/End of Competitive Season (~4 months after baseline; December 2024)
Secondary outcomes:
measure: Resting Energy Expenditure
timeFrame: Baseline/Pre-season (August 2024), Mid-season (~2 months after baseline; October 2024), End of Study/End of Competitive Season (~4 months after baseline; December 2024)
measure: Grip Strength
timeFrame: Baseline/Pre-season (August 2024), Mid-season (~2 months after baseline; October 2024), End of Study/End of Competitive Season (~4 months after baseline; December 2024)
measure: Contextual Body Image Questionnaire for Athletes (CBIQA)
timeFrame: Baseline/Pre-season (August 2024), Mid-season (~2 months after baseline; October 2024), End of Study/End of Competitive Season (~4 months after baseline; December 2024)
measure: Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: Baseline/Pre-season (August 2024), Mid-season (~2 months after baseline; October 2024), End of Study/End of Competitive Season (~4 months after baseline; December 2024)
measure: Body Composition - Fat Mass
timeFrame: Baseline/Pre-season (August 2024), Mid-season (~2 months after baseline; October 2024), End of Study/End of Competitive Season (~4 months after baseline; December 2024)
measure: Body Composition - Fat Free Mass
timeFrame: Baseline/Pre-season (August 2024), Mid-season (~2 months after baseline; October 2024), End of Study/End of Competitive Season (~4 months after baseline; December 2024)
Other outcomes:
measure: Breath Analysis
timeFrame: Baseline/Pre-season (August 2024) and End of Study/End of Competitive Season (~4 months after baseline; December 2024)
measure: Eat2Win App Use - Usage Time
timeFrame: up to 4 months after baseline; December 2024
measure: Eat2Win App Use - App Clicks
timeFrame: up to 4 months after baseline; December 2024
measure: Eat2Win App Use - App Scoring
timeFrame: up to 4 months after baseline; December 2024
measure: Total Energy Nutritional Intake
timeFrame: Collected weekly during the study, about 4 months from Baseline to End of Study Visits.
measure: Protein Nutritional Intake
timeFrame: Collected weekly during the study, about 4 months from Baseline to End of Study Visits.
measure: Carbohydrate Nutritional Intake
timeFrame: Collected weekly during the study, about 4 months from Baseline to End of Study Visits.
measure: Fat Nutritional Intake
timeFrame: Collected weekly during the study, about 4 months from Baseline to End of Study Visits.
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Kristyen Tomcik, PhD
role: PRINCIPAL_INVESTIGATOR
References: