HealthyEat2Win-CWRUNCT06581237
Nutrition for Health and Performance in Female Collegiate Soccer Players
A study testing Eat2Win App in people with Healthy, run by Case Western Reserve University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Eat2Win App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Eat2Win App
- Keywords
- relative energy deficiency in sport (RED-S), performance, health, nutrition, dietetics, eHealth
- Medical subject headings
- Relative Energy Deficiency in Sport
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eat2Win AppOther
Voluntary use of the app will occur throughout the sport season.
| Study group | Role | What they receive |
|---|---|---|
| Eat2Win App | Experimental | Participants will be provided a sport-specific nutrition program on the Eat2Win app. Receives: Other: Eat2Win App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 (6)
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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start19 Aug 2024
- Primary completion20 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Responsible party
- Sponsor
- Investigators
- Kristyen Tomcik, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581237
- Sponsor's protocol ID
- STUDY20240738
- Acronym
- Eat2Win-CWRU
- Status last verified
- Feb 2025
- First submitted
- 7 Aug 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request, with appropriate data sharing agreements in place, and according to institutional policy.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of App-Based Dietary Guidance on Determinants of Underfueling and Performance in Female Collegiate Soccer Players
- ClinicalTrials.gov ID
- NCT06581237
- Acronym / sponsor ID
- Eat2Win-CWRU / STUDY20240738
- Conditions
- Healthy
- Keywords
- relative energy deficiency in sport (RED-S), performance, health, nutrition, dietetics, eHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eat2Win App | Experimental | Other: Eat2Win AppParticipants will be provided a sport-specific nutrition program on the Eat2Win app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eat2Win AppVoluntary use of the app will occur throughout the sport season. | Other | Eat2Win App |
Primary outcome
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)
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request, with appropriate data sharing agreements in place, and according to institutional policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristyen Tomcik, PhD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eat2Win App in people with Healthy, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.