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Preventing Athlete Under-fueling Through Nutrition. (PERFORM)

Case Western Reserve University logo

Case Western Reserve University

Status

Enrolling

Conditions

Athlete
Low Energy Availability
Relative Energy Deficiency in Sport

Treatments

Behavioral: Low Energy Availability Screening and Nutrition Support

Study type

Interventional

Funder types

Other

Identifiers

NCT07136038
STUDY20250865

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

300 participants in 1 patient group

Athletes
Experimental group
Treatment:
Behavioral: Low Energy Availability Screening and Nutrition Support

Trial contacts and locations

1

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Central trial contact

Kristyen Tomcik, PhD

Data sourced from clinicaltrials.gov

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