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临床试验 NCT06651619 针对脱水目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Efficacy of Education Versus Education Plus Prescribed Fluid Intake on Hydration Status in High School Athletes
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临床试验NCT06651619是一项针对脱水的干预性研究试验，目前试验状态为招募中。试验始于2024年10月1日，计划招募108名患者。该研究由PepsiCo Global R&D主导，预计于2025年6月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2024年10月23日。
简要概括
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.
官方标题
Efficacy of Education Versus Education Plus Prescribed Fluid Intake on Hydration Status in High School Athletes
疾病
脱水其他研究标识符
- PEP-2406
NCT编号
实际开始日期
2024-10-01
最近更新发布
2024-10-23
预计完成日期
2025-06-30
计划入组人数
108
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
hydration
hypohydration
adolescent
athlete
sports
exercise
behavior
education
high school
hypohydration
adolescent
athlete
sports
exercise
behavior
education
high school
主要目的
基础研究
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
无干预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) . | 不适用 |
实验性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). | Hydration Education 30-60 minutes |
实验性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). | 水 Prescribed amount of bottled water the evening prior and 2 hours prior to team practice Hydration Education 30-60 minutes |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
资格标准
适龄参与研究
儿童, 成人
最低年龄要求
13 Years
适龄性别
全部
接受健康志愿者
是
- 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&D研究中心联系人
联系人: Kris Osterberg, PhD, RD, (941) 201 3820, [email protected]
1 位于 1 个国家/地区的研究中心
Florida
Gatorade Sports Science Institute (GSSI) at IMG Sports Academy, Bradenton, Florida, 34210, United States
Kris Osterberg, PhD, RD, 联系人
招募中