- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06651619
Effekten av utdanning versus utdanning pluss foreskrevet væskeinntak på hydreringsstatus hos idrettsutøvere på videregående skole
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Florida
-
Bradenton, Florida, Forente stater, 34210
- Gatorade Sports Science Institute (GSSI) at IMG Sports Academy
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: 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) . |
|
|
Eksperimentell: 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). |
30-60 minutes |
|
Eksperimentell: 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). |
30-60 minutes Prescribed amount of bottled water the evening prior and 2 hours prior to team practice |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
urine specific gravity (USG).
Tidsramme: 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 |
Pre-practice x 3 practices in Week 1 and 3 practices in Week 2
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Body weight
Tidsramme: 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 |
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)
Tidsramme: 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 |
Intake from evening before through post-practice x 3 practices in Week 2
|
|
Thirst questionnaire
Tidsramme: 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. |
Change from pre-practice to post-practice x 3 practices in Week 1 and 3 practices in Week 2
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Kris Osterberg, PhD, RD, PepsiCo R&D Life Sciences, Sports Science
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PEP-2406
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