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

PepsiCo

Status: Enrolling

Conditions: Dehydration

Treatments: Other: Hydration Education; Other: Water

Study type: Interventional

Funder types: Industry

Identifiers

NCT06651619

PEP-2406

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 13 to 19 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 3 patient groups

Control

No Intervention group

Description:

No hydration education or fluid prescription. Pre-practice urine specific gravity (USG), pre- and post-practice body mass, thirst scale measures. Fluid intake during practice (whatever the team is drinking) .

Hydration Education between Week 1 and Week 2

Experimental group

Description:

In-depth education session regarding the effects of dehydration, the performance benefits of proper hydration, and how to properly hydrate before, during, and after activity. Pre-practice urine specific gravity (USG), pre- and post-practice body mass, thirst scale measures. Fluid intake during practice (whatever the team is drinking).

Treatment:

Other: Hydration Education

Hydration Education between Week 1 and Week 2 plus Prescribed Hydration Week 2

Experimental group

Description:

In-depth education session regarding the effects of dehydration, the performance benefits of proper hydration, and how to properly hydrate before, during, and after activity. Pre-practice urine specific gravity (USG), pre- and post-practice body mass, thirst scale measures. Provided a standard amount of bottled water to drink the evening prior (1 liter) and in the two hours before practice (20 oz). Fluid intake will be recorded in an intake log. Subjects will be permitted to eat or drink whatever they like in addition to the prescribed fluid. Fluid intake during practice (whatever the team is drinking).

Treatment:

Other: Water

Other: Hydration Education