- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06651619
고등학교 운동선수의 수분 공급 상태에 대한 교육과 교육 및 처방된 수분 섭취의 효율성
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.
연구 개요
상세 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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Florida
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Bradenton, Florida, 미국, 34210
- Gatorade Sports Science Institute (GSSI) at IMG Sports Academy
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: 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) . |
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|
실험적: 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 |
|
실험적: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
urine specific gravity (USG).
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Body weight
기간: 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)
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Kris Osterberg, PhD, RD, PepsiCo R&D Life Sciences, Sports Science
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PEP-2406
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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