Efficacy of Education Versus Education Plus Prescribed Fluid Intake on Hydration Status in High School Athletes

Not Applicable

Recruiting

• Conditions: Dehydration

• Registration Number: NCT06651619
• Lead Sponsor: PepsiCo Global R&D

Brief Summary

Sports science testing by investigators at Gatorade Sports Science Institute has revealed that many athletes arrive at practice with a high urine specific gravity indicating they are hypohydrated. Though the data showed that most athletes don't lose more than 2% of their body weight in sweat during a training session, it is not known what the cumulative effects of living and training in a hot environment are over the course of a week. Previous research has indicated that prescribing fluid intake is more effective than education in improving drinking behavior during exercise. No studies to date have compared the impact of fluid intake prescription versus education in adolescent boys and girls playing outdoor and indoor sports.

Comparing sexes and training environment may provide more clarity around potential barriers and challenges to proper hydration for each environment.

Detailed Description

This study will implement a parallel design with 4 sports team groups: 1) Indoor girls, 2) Indoor boys, 3) Outdoor girls, and 4) Outdoor boys. Each group of 36 per groups will be randomized into 1 of 3 conditions: 1) control (no intervention), 2) hydration education intervention, 3) prescribed hydration and education intervention. Athletes will be observed for three practices per week for 2 weeks. Practices are separated by at least 48 hours.

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-01
• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2024-10-18
• Last Update Submitted: 2024-10-21
• Study First Posted: 2024-10-22
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Females and males between the ages of 13-19 years old
2. Non-smoker
3. Currently enrolled in the IMG sports program
4. Able to give verbal and written informed consent for participation as well as obtain parental consent if <18 years of age
5. Must be fluent in English reading, writing, and speaking
6. Parental permission

Exclusion Criteria

1. Expulsion from school for any reason
2. Leaving the IMG sports program
3. Pregnant or planning to become pregnant
4. Illness or injury that impacts sport participation or fluid balance
5. Taking any medication that impacts fluid balance
6. Participation in a clinical trial within past 30 days
7. Participation in any PepsiCo trial within past 6 months
8. Any condition the study investigator believes would interfere with eligibility following the study protocol, effect the study results, or put the subject at undue risk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
urine specific gravity (USG).	Pre-practice x 3 practices in Week 1 and 3 practices in Week 2	Assessed using hand-held refractometer, units recorded to the nearest 0.001

Secondary Outcome Measures

Name	Time	Method
Body weight	Change from pre-practice to post-practice x 3 practices in Week 1 and 3 practices in Week 2	Assessed using Tanita portable scale, units recorded to the nearest 0.01 kg
Fluid intake Week 2 (measured for Prescription Group only)	Intake from evening before through post-practice x 3 practices in Week 2	Assessed using beverage weight scale. Units recorded to the nearest 1 ml
Thirst questionnaire	Change from pre-practice to post-practice x 3 practices in Week 1 and 3 practices in Week 2	6 items (thirst, pleasure to drink now, mouth feel, taste, stomach fullness, stomach sickness) each anchored from not at all to very, each on a 100 mm scale.

Trial Locations

Locations (1)

Gatorade Sports Science Institute (GSSI) at IMG Sports Academy; 🇺🇸 Bradenton, Florida, United States