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Clinical Trial NCT06651619 for Dehydration is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Efficacy of Education Versus Education Plus Prescribed Fluid Intake on Hydration Status in High School Athletes
Clinical Trial NCT06651619 is an interventional study for Dehydration that is recruiting. It started on October 1, 2024 with plans to enroll 108 participants. Led by PepsiCo Global R&D, it is expected to complete by June 30, 2025. The latest data from ClinicalTrials.gov was last updated on October 23, 2024.
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.
Official Title
Efficacy of Education Versus Education Plus Prescribed Fluid Intake on Hydration Status in High School Athletes
Conditions
DehydrationOther Study IDs
- PEP-2406
NCT ID Number
Start Date (Actual)
2024-10-01
Last Update Posted
2024-10-23
Completion Date (Estimated)
2025-06-30
Enrollment (Estimated)
108
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
hydration
hypohydration
adolescent
athlete
sports
exercise
behavior
education
high school
hypohydration
adolescent
athlete
sports
exercise
behavior
education
high school
Primary Purpose
Basic Science
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
No InterventionControl 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) . | N/A |
ExperimentalHydration 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). | Hydration Education 30-60 minutes |
ExperimentalHydration 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). | Water Prescribed amount of bottled water the evening prior and 2 hours prior to team practice Hydration Education 30-60 minutes |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
urine specific gravity (USG). | Assessed using hand-held refractometer, units recorded to the nearest 0.001 | Pre-practice x 3 practices in Week 1 and 3 practices in Week 2 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Body weight | Assessed using Tanita portable scale, units recorded to the nearest 0.01 kg | Change from pre-practice to post-practice x 3 practices in Week 1 and 3 practices in Week 2 |
Fluid intake Week 2 (measured for Prescription Group only) | Assessed using beverage weight scale. Units recorded to the nearest 1 ml | Intake from evening before through post-practice x 3 practices in Week 2 |
Thirst questionnaire | 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. | Change from pre-practice to post-practice x 3 practices in Week 1 and 3 practices in Week 2 |
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
13 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Females and males between the ages of 13-19 years old
- Non-smoker
- Currently enrolled in the IMG sports program
- Able to give verbal and written informed consent for participation as well as obtain parental consent if <18 years of age
- Must be fluent in English reading, writing, and speaking
- Parental permission
- Expulsion from school for any reason
- Leaving the IMG sports program
- Pregnant or planning to become pregnant
- Illness or injury that impacts sport participation or fluid balance
- Taking any medication that impacts fluid balance
- Participation in a clinical trial within past 30 days
- Participation in any PepsiCo trial within past 6 months
- 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
PepsiCo Global R&DStudy Central Contact
Contact: Kris Osterberg, PhD, RD, (941) 201 3820, [email protected]
1 Study Locations in 1 Countries
Florida
Gatorade Sports Science Institute (GSSI) at IMG Sports Academy, Bradenton, Florida, 34210, United States
Kris Osterberg, PhD, RD, Contact
Recruiting