Nutrition for Health and Performance in Female Collegiate Soccer Players
NCT Number: NCT06581237
Acronym: Eat2Win-CWRU
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: OTHER: Eat2Win App
Sponsor: Case Western Reserve University
Collaborators: Pennington Biomedical Research Center
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-19
Completion Date: 2025-12
Locations: Case Western Reserve University, Cleveland, Ohio, 44106, United States

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.

Primary Outcome Measures: 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), 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: 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)|Contextual Body Image Questionnaire for Athletes (CBIQA), Measures four dimensions of body image (Appearance, Thin-Fat Self-Evaluation, Thin-Fat Others' Evaluation, and Muscularity) in the context of both athletics and daily life. (score), 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), 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)
Other Outcome Measures: 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.