Preventing Athlete Under-fueling Through Nutrition. (PERFORM)

Prevention and Education for RED-S Through Fueling Outcomes and Research in Metabolic Health

The goal is to improve nutrition screening and support for Division III athletes.

The study will use standard, low-risk nutrition screening methods, such as measuring height, weight, grip strength, and body composition, as well as having athletes complete questionnaires. Dietitians trained in sports nutrition will provide nutrition advice based on these screenings.

Data will be collected at three points during the season: before the season starts, mid-season, and after the season ends. This study builds on earlier research conducted at Case Western Reserve University that showed nutrition support can improve athletes' health and performance.

Study Overview

• Status: Recruiting
• Conditions: Athlete; Relative Energy Deficiency in Sport; Low Energy Availability
• Intervention / Treatment: Behavioral: Low Energy Availability Screening and Nutrition Support

Detailed Description

OBJECTIVES: Combat student athletes' under fueling before, during and after the competitive season and assess financial feasibility for scaling to the university level.

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 Athletic Department. The proposed study design will implement improved nutrition screening and support, applying standard-of-practice processes that are used at the highest level of collegiate sport (Division I) modified for the Division III athlete. This study will utilize minimal-risk/standard-of-care nutrition screening procedures along with standard-of-care nutrition advice from dietitians trained in sports nutrition. All athletes will be screened with minimal risk items such as anthropometrics, questionnaires, grip strength and body composition testing. While additional voluntary metrics will be provided in a subset of individuals based on team and individual availability and include aerobic fitness (VO2), resting metabolic rate, physical activity, body composition and sports performance. Data will be collected at three timepoints: pre-season, mid-season, and post-season. Notably, this work expands upon the investigators' prior pilot study that showed nutrition support improved athlete health and performance metrics. This study has streamlined the protocol and transition to standard-of-care nutrition support to improve scalability and reduce risk to participants.

GENERAL AIMS/HYPOTHESIS: This research program will evidence the importance of nutrition to improve athlete health and performance in Division III athletes. The investigators hypothesize that nutrition screening and support will improve athlete health and performance metrics. As a feasibility study, the primary aim is to assess the feasibility of scaling this nutrition support to a larger student athlete population than the first pilot trial (estimated 100-200 athletes compared to the original 27 from the pilot study). The investigators will assess feasibility from both logistic and financial perspectives. Secondary aims include athlete health and wellness metrics, such as body composition, strength, and health and wellness questionnaires, involving body image, injuries, energy levels and other important mental and physical factors.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristyen Tomcik, PhD; Phone Number: 216.368.0708; Email: kat20@case.edu

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Case Western Reserve University
      • Contact: Kristyen Tomcik, PhD; Phone Number: 216-368-0708; Email: kristyen.tomcik@case.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age range: from 18 years of age and up
2. Currently active and NCAA-eligible (including academic standing) member of any Case Western Reserve University (CWRU) Athletic Team
3. Signed Informed Consent

Exclusion Criteria:

1. Under 18 years of age
2. Pregnant women or women who are nursing
3. Unwilling to provide anthropometrics, questionnaires or other collection needs
4. History of a diagnosed disordered eating

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Athletes	Behavioral: Low Energy Availability Screening and Nutrition Support; Athletes will receive screening for low energy availability, strength and body composition assessments and receive nutrition support from a sports dietitian over the competitive season.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip Strength	Grip force in kilograms determined by a handgrip dynamometer, conducted on both arms, according to standard practice procedures.	Baseline/Pre-season (August 2025), Mid-season (~2 months after baseline; October 2025), End of Study/End of Competitive Season (~4 months after baseline; December 2025)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low Energy Availability in Females Questionnaire (LEAF -Q)	Female participants only. 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 2025), Mid-season (~2 months after baseline; October 2025), End of Study/End of Competitive Season (~4 months after baseline; December 2025)
Low Energy Availability in Males Questionnaire (LEAM -Q)	The low energy availability in males questionnaire (LEAM -Q), focuses on physiological symptoms of relative energy deficiency. Categories include dizziness, gastrointestinal function, thermoregulation at rest, health problems, and recovery. The questionnaire also focuses on physiological symptoms of relative energy deficiency. A higher total score indicates a greater risk of low energy availability. Precise scoring cutoffs are not yet defined.	Baseline/Pre-season (August 2025), Mid-season (~2 months after baseline; October 2025), End of Study/End of Competitive Season (~4 months after baseline; December 2025)
Body Composition - Fat Mass	Fat mass (kilograms) and as a percent of total body mass.	Baseline/Pre-season (August 2025), Mid-season (~2 months after baseline; October 2025), End of Study/End of Competitive Season (~4 months after baseline; December 2025)
Body Composition - Fat Free Mass	Fat Free Mass (kilograms) and expressed as a percent of total body mass.	Baseline/Pre-season (August 2025), Mid-season (~2 months after baseline; October 2025), End of Study/End of Competitive Season (~4 months after baseline; December 2025)
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)	Baseline/Pre-season (August 2025), Mid-season (~2 months after baseline; October 2025), End of Study/End of Competitive Season (~4 months after baseline; December 2025)
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)	Baseline/Pre-season (August 2025), Mid-season (~2 months after baseline; October 2025), End of Study/End of Competitive Season (~4 months after baseline; December 2025)
Muscle Dysmorphic Disorder Inventory (MDDI)	The MDDI consists of 13 items addressing drive for size, appearance intolerance, and functional impairment, and serves as a screening tool for muscularity concerns and muscle dysmorphia. Based on a 5-point likert scale. A higher score indicates greater risk for Muscle Dysmorphic Disorder.	Baseline/Pre-season (August 2025), Mid-season (~2 months after baseline; October 2025), End of Study/End of Competitive Season (~4 months after baseline; December 2025)

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Kristyen Tomcik, PhD, Case Western Reserve University

Publications and helpful links

General Publications

• Thomas DT, Erdman KA, Burke LM. Position of the Academy of Nutrition and Dietetics, Dietitians of Canada, and the American College of Sports Medicine: Nutrition and Athletic Performance. J Acad Nutr Diet. 2016 Mar;116(3):501-528. doi: 10.1016/j.jand.2015.12.006.
• Mountjoy M, Sundgot-Borgen J, Burke L, Carter S, Constantini N, Lebrun C, Meyer N, Sherman R, Steffen K, Budgett R, Ljungqvist A. The IOC consensus statement: beyond the Female Athlete Triad--Relative Energy Deficiency in Sport (RED-S). Br J Sports Med. 2014 Apr;48(7):491-7. doi: 10.1136/bjsports-2014-093502.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 18, 2025
• First Submitted That Met QC Criteria: August 18, 2025
• First Posted (Actual): August 22, 2025

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: sport; fat mass; lean body mass; collegiate
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Relative Energy Deficiency in Sport; Therapeutics; Nutrition Therapy
• Other Study ID Numbers: STUDY20250865

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