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Completed

NCT Number: NCT06581237

Nutrition for Health 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.

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Key information

Conditions

Healthy Feeding and Eating Disorders Mental Disorders Relative Energy Deficiency in Sport

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eat2Win App

Other

Voluntary use of the app will occur throughout the sport season.

Primary outcomes

  1. Low Energy Availability in Females Questionnaire (LEAF -Q)

    Time frame: 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)

    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)

Secondary outcomes

  1. Resting Energy Expenditure

    Time frame: 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)

    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.

  2. Grip Strength

    Time frame: 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 force in kilograms determined by a handgrip dynamometer, conducted on both arms, according to standard practice procedures.

  3. Contextual Body Image Questionnaire for Athletes (CBIQA)

    Time frame: 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)

    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)

  4. Eating Disorder Examination Questionnaire (EDE-Q)

    Time frame: 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)

    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)

  5. Body Composition - Fat Mass

    Time frame: 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)

    Fat mass (kilograms) and as a percent of total body mass.

  6. Body Composition - Fat Free Mass

    Time frame: 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)

    Fat Free Mass (kilograms) and expressed as a percent of total body mass.

Other outcomes

  1. Breath Analysis

    Time frame: Baseline/Pre-season (August 2024) and End of Study/End of Competitive Season (~4 months after baseline; December 2024)

    Untargeted gas chromatography tandem mass spectrometry analysis of breath molecules. (semi-quantitative; parts per million and parts per billion)

  2. Eat2Win App Use - Usage Time

    Time frame: up to 4 months after baseline; December 2024

    Usage of the Eat2Win app during the course of the study. Presented as app usage time (hours:minutes).

  3. Eat2Win App Use - App Clicks

    Time frame: up to 4 months after baseline; December 2024

    Usage of the Eat2Win app during the course of the study. Presented as clicks (number) within the app for utilizing app functions.

  4. Eat2Win App Use - App Scoring

    Time frame: up to 4 months after baseline; December 2024

    Usage of the Eat2Win app during the course of the study. Presented as a numerical score within the app for utilizing app functions.

  5. Total Energy Nutritional Intake

    Time frame: Collected weekly during the study, about 4 months from Baseline to End of Study Visits.

    Total Energy (kcals) quantified by the automated self-administered 24-hour dietary assessment tool.

  6. Protein Nutritional Intake

    Time frame: Collected weekly during the study, about 4 months from Baseline to End of Study Visits.

    Protein Nutritional Intake (grams) quantified by the automated self-administered 24-hour dietary assessment tool.

  7. Carbohydrate Nutritional Intake

    Time frame: Collected weekly during the study, about 4 months from Baseline to End of Study Visits.

    Carbohydrate Nutritional Intake (grams) quantified by the automated self-administered 24-hour dietary assessment tool.

  8. Fat Nutritional Intake

    Time frame: Collected weekly during the study, about 4 months from Baseline to End of Study Visits.

    Fat Nutritional Intake (grams) quantified by the automated self-administered 24-hour dietary assessment tool.

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • Pennington Biomedical Research Center

Registry information

Official study title

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

Acronym: Eat2Win-CWRU

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 3, 2024
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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