Nutrition for Health and Performance in Female Collegiate Soccer Players (Eat2Win-CWRU)

The Effects of App-Based Dietary Guidance on Determinants of Underfueling and Performance in Female Collegiate Soccer Players

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Eat2Win App

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eat2Win App; Participants will be provided a sport-specific nutrition program on the Eat2Win app.	Other: Eat2Win App; Voluntary use of the app will occur throughout the sport season.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low Energy Availability in Females Questionnaire (LEAF -Q)	Focuses on physiological symptoms of insufficient energy intake. includes 25 questions arranged in three separate, sequential sections: injuries, gastrointestinal, and reproductive functions. (score; 0-36; total score ≥8 is to be considered at risk)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting Energy Expenditure	Indirect calorimetry-determined resting energy expenditure expressed as kilocalories per day and adjusted for the residual difference between measured and predicted values determined as a function of fat mass, fat-free mass, age and sex according to best practices in the field.	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)
Grip Strength	Grip force in kilograms determined by a handgrip dynamometer, conducted on both arms, according to standard practice procedures.	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)
Body Composition - Fat Mass	Fat mass (kilograms) and as a percent of total body mass.	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)
Body Composition - Fat Free Mass	Fat Free Mass (kilograms) and expressed as a percent of total body mass.	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)
Contextual Body Image Questionnaire for Athletes (CBIQA)	Measures four dimensions of body image (Appearance (3 questions), Body Shape (3 questions), Muscularity (3 questions) and Body Weight and Fat (5 questions)) in the context of both athletics and daily life. (7-point Likert scale for each question; scaled scores for each of the four dimensions are obtained by dividing the sum of each question score within that dimension divided by the number of questions in that dimension; scoring is relative to each question with a score of 4 being neutral)	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)
Eating Disorder Examination Questionnaire (EDE-Q)	Measures eating disorder psychopathology. It provides a measure of the range and severity of eating disorder features. (score; continuous beginning at 0; a higher score means greater risk)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breath Analysis	Untargeted gas chromatography tandem mass spectrometry analysis of breath molecules. (semi-quantitative; parts per million and parts per billion)	Baseline/Pre-season (August 2024) and End of Study/End of Competitive Season (~4 months after baseline; December 2024)
Eat2Win App Use - Usage Time	Usage of the Eat2Win app during the course of the study. Presented as app usage time (hours:minutes).	up to 4 months after baseline; December 2024
Eat2Win App Use - App Clicks	Usage of the Eat2Win app during the course of the study. Presented as clicks (number) within the app for utilizing app functions.	up to 4 months after baseline; December 2024
Eat2Win App Use - App Scoring	Usage of the Eat2Win app during the course of the study. Presented as a numerical score within the app for utilizing app functions.	up to 4 months after baseline; December 2024
Total Energy Nutritional Intake	Total Energy (kcals) quantified by the automated self-administered 24-hour dietary assessment tool.	Collected weekly during the study, about 4 months from Baseline to End of Study Visits.
Protein Nutritional Intake	Protein Nutritional Intake (grams) quantified by the automated self-administered 24-hour dietary assessment tool.	Collected weekly during the study, about 4 months from Baseline to End of Study Visits.
Carbohydrate Nutritional Intake	Carbohydrate Nutritional Intake (grams) quantified by the automated self-administered 24-hour dietary assessment tool.	Collected weekly during the study, about 4 months from Baseline to End of Study Visits.
Fat Nutritional Intake	Fat Nutritional Intake (grams) quantified by the automated self-administered 24-hour dietary assessment tool.	Collected weekly during the study, about 4 months from Baseline to End of Study Visits.

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Kristyen Tomcik, PhD, Case Western Reserve University

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2024
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: health; nutrition; eHealth; performance; dietetics; relative energy deficiency in sport (RED-S)
• Other Study ID Numbers: STUDY20240738

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared upon reasonable request, with appropriate data sharing agreements in place, and according to institutional policy.
• IPD Sharing Time Frame: Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 12 months. Extensions will be considered on a case-by-case basis.
• IPD Sharing Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No