Nutrition for Health and Performance in Female Collegiate Soccer Players

NCT06581237 | Completed

• 1 other identifier: STUDY20240738
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

relative energy deficiency in sport (RED-S); performance; health; nutrition; dietetics; eHealth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Resting Energy Expenditure

  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

  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)

  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)

  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

  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 Outcomes (8)

• Breath Analysis

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

• Eat2Win App Use - Usage Time

  up to 4 months after baseline; December 2024

• Eat2Win App Use - App Clicks

  up to 4 months after baseline; December 2024

Study Arms (1)

Eat2Win App

EXPERIMENTAL

Participants will be provided a sport-specific nutrition program on the Eat2Win app.

Other: Eat2Win App

Interventions

Eat2Win App OTHER

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

Eat2Win App

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead
• Pennington Biomedical Research Center: collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Relative Energy Deficiency in Sport

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Kristyen Tomcik, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: September 3, 2024
• Study Start: August 19, 2024
• Primary Completion: December 20, 2024
• Study Completion: January 31, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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).

Locations

US (1)