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O estudo clínico NCT06651619 para Desidratação está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Efficacy of Education Versus Education Plus Prescribed Fluid Intake on Hydration Status in High School Athletes
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06651619 é um ensaio intervencionista para Desidratação. Seu status atual é: recrutando. O estudo começou em 1 de outubro de 2024 e pretende incluir 108 participantes. Coordenado por PepsiCo Global R&D e deve ser concluído em 30 de junho de 2025. Essas informações foram atualizadas no ClinicalTrials.gov em 23 de outubro de 2024.
Resumo
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.
Descrição detalhada
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.
Título oficial
Efficacy of Education Versus Education Plus Prescribed Fluid Intake on Hydration Status in High School Athletes
Condições
DesidrataçãoOutros IDs do estudo
- PEP-2406
Número NCT
Data de início (real)
2024-10-01
Última atualização postada
2024-10-23
Data de conclusão (estimada)
2025-06-30
Inscrição (estimada)
108
Tipo de estudo
Intervencionista
FASE
N/A
Status
Recrutando
Palavras-chave
hydration
hypohydration
adolescent
athlete
sports
exercise
behavior
education
high school
hypohydration
adolescent
athlete
sports
exercise
behavior
education
high school
Propósito principal
Ciência básica
Alocação do design
Randomizado
Modelo de intervenção
Atribuição paralela
Cegamento (Mascaramento)
Nenhum (Estudo aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Nenhuma intervençãoControl 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). | Água Prescribed amount of bottled water the evening prior and 2 hours prior to team practice Hydration Education 30-60 minutes |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Critérios de elegibilidade
Idades elegíveis
Criança, Adulto
Idade mínima
13 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
- 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&DContato central do estudo
Contato: Kris Osterberg, PhD, RD, (941) 201 3820, [email protected]
1 Locais do estudo em 1 países
Florida
Gatorade Sports Science Institute (GSSI) at IMG Sports Academy, Bradenton, Florida, 34210, United States
Kris Osterberg, PhD, RD, Contato
Recrutando