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임상시험 NCT06651619은(는) 탈수에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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카드 뷰

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

모집중
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임상시험 NCT06651619은(는) 탈수에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2024년 10월 1일에 시작되어 108명의 참여자를 모집하고 있습니다. PepsiCo Global R&D이(가) 진행하며, 2025년 6월 30일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 10월 23일에 갱신되었습니다.
간단한 개요
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.

상세한 설명
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.
공식 제목

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

질환/상태
탈수
기타 연구 식별자
  • PEP-2406
NCT 번호
실제 연구 시작일
2024-10-01
최신 업데이트 게시
2024-10-23
예상 연구 완료일
2025-06-30
계획된 등록 인원
108
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
hydration
hypohydration
adolescent
athlete
sports
exercise
behavior
education
high school
주요 목적
기초과학
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (공개라벨)
시험군 / 개입
참가자 그룹/시험군개입/치료
비개입Control
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) .
해당 없음
실험적Hydration 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
실험적Hydration 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).
Prescribed amount of bottled water the evening prior and 2 hours prior to team practice
Hydration Education
30-60 minutes
주요결과변수
결과변수측정값 설명시간 범위
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
이차결과변수
결과변수측정값 설명시간 범위
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
적격성 기준

연령대
어린이, 성인
최소 연령
13 Years
참여 가능한 성별
전체
건강한 참가자 허용
  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

  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
PepsiCo Global R&D logoPepsiCo Global R&D
연구 대표 연락처
연락처: Kris Osterberg, PhD, RD, (941) 201 3820, [email protected]
1 1개국에 임상시험 장소

Florida

Gatorade Sports Science Institute (GSSI) at IMG Sports Academy, Bradenton, Florida, 34210, United States
Kris Osterberg, PhD, RD, 연락처
모집중