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临床试验/NCT06651619
NCT06651619招募中不适用

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

PepsiCo Global R&D2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
108
试验地点
2
主要终点
urine specific gravity (USG).

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Females and males between the ages of 13-19 years old
  • 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

排除标准

  • 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

结局指标

主要结局

urine specific gravity (USG).

时间窗: 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

次要结局

  • Body weight(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)(Intake from evening before through post-practice x 3 practices in Week 2)
  • Thirst questionnaire(Change from pre-practice to post-practice x 3 practices in Week 1 and 3 practices in Week 2)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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