NCT07212101

Brief Summary

Sleep is an essential biological function that impacts nearly every aspect of an athlete's physical and mental health. For athletes, the importance of high-quality sleep cannot be overstated, as it plays a critical role in performance, recovery, and overall well-being. Sleep supports muscle recovery by promoting protein synthesis and the release of growth hormones, essential for healing after intense physical exertion. Furthermore, adequate sleep is crucial for maintaining cognitive sharpness, decision-making abilities, and emotional regulation-all of which are necessary for optimal athletic performance. The study will assess both sleep quality and quantity in baseball players at Columbia University. These tools will help quantify key sleep metrics, including sleep duration, latency (the time it takes to fall asleep), and the number of awakenings during the night. Similarly, the study will analyze dietary patterns using the Automated Self-Administered 24-Hour Dietary Assessment (ASA24), tracking nutrient intake, meal timing, and the consumption of ultra-processed foods. These assessments will establish a baseline from which to measure improvement post-intervention. The intervention will focus on improving diet, time in bed, and light exposure to improve sleep, diet, and performance in collegiate baseball athletes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 8, 2025

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

September 23, 2025

Last Update Submit

December 11, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Athletic performance (position-specific for batters and pitchers)

    Batters: Baseball radar gun, outcome is exit velocity (speed at which ball leaves the bat, in miles/h) Pitchers: Baseball radar gun measuring velocity (miles/h)

    pre and post intervention (4-6 weeks)

  • Sleep quality

    Duration (h:min)

    Nightly for 6 weeks

  • Sleep quality

    Sleep stage (%REM, %Deep sleep)

    Nightly for 6 weeks

  • Dietary quality

    3-day food recalls (ASA-24)

    pre and post intervention (4-6 weeks)

Secondary Outcomes (5)

  • Generalized Anxiety Disorder (GAD-7)

    pre and post intervention (4-6 weeks)

  • Patient Health Questionnaire-9

    pre and post intervention (4-6 weeks)

  • Sport Anxiety Scale-2

    pre and post intervention (4-6 weeks)

  • Pitching accuracy

    pre and post intervention (4-6 weeks)

  • Isometric wall push

    pre and post intervention (4-6 weeks)

Study Arms (1)

Sleep & diet intervention

EXPERIMENTAL

Participants will be asked to increase their fruit and vegetable consumption, time in bed, and modify light exposure across the day

Behavioral: Sleep and diet

Interventions

Sleep and dietBEHAVIORAL

Participants will be asked to increase their fruit and vegetable consumption, time in bed, and modify light exposure across the day

Sleep & diet intervention

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Collegiate baseball player at Columbia University

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

SleepDiet

Intervention Hierarchy (Ancestors)

Nervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Marie-Pierre St-Onge

    Columbia University Vagelos College of Physicians & Surgeons

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single group intervention evaluating outcomes pre and post intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutritional Medicine

Study Record Dates

First Submitted

September 23, 2025

First Posted

October 8, 2025

Study Start

September 16, 2025

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations