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

February 10, 2025 updated by: Case Western Reserve University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
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)
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)
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)
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)
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Baseline/Pre-season (August 2024) and End of Study/End of Competitive Season (~4 months after baseline; December 2024)
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).
up to 4 months after baseline; December 2024
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.
up to 4 months after baseline; December 2024
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.
up to 4 months after baseline; December 2024
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.
Collected weekly during the study, about 4 months from Baseline to End of Study Visits.
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.
Collected weekly during the study, about 4 months from Baseline to End of Study Visits.
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.
Collected weekly during the study, about 4 months from Baseline to End of Study Visits.
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.
Collected weekly during the study, about 4 months from Baseline to End of Study Visits.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Case Western Reserve University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pennington Biomedical Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kristyen Tomcik, PhD, Case Western Reserve University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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