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

NCT ID: NCT06651619

Last Updated: 2024-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Dehydration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control

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) .

Group Type NO_INTERVENTION

No interventions assigned to this group

Hydration Education between Week 1 and Week 2

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).

Group Type EXPERIMENTAL

Hydration Education

Intervention Type OTHER

30-60 minutes

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

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).

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Prescribed amount of bottled water the evening prior and 2 hours prior to team practice

Hydration Education

Intervention Type OTHER

30-60 minutes

Interventions

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Water

Prescribed amount of bottled water the evening prior and 2 hours prior to team practice

Intervention Type OTHER

Hydration Education

30-60 minutes

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PepsiCo Global R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kris Osterberg, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

PepsiCo R&D Life Sciences, Sports Science

Locations

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Gatorade Sports Science Institute (GSSI) at IMG Sports Academy

Bradenton, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kris Osterberg, PhD, RD

Role: CONTACT

(941) 201 3820

Facility Contacts

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Kris Osterberg, PhD, RD

Role: primary

Other Identifiers

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PEP-2406

Identifier Type: -

Identifier Source: org_study_id

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