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临床试验/NCT06837376
NCT06837376已完成不适用

Effects of Metabolic Testing Data and Education on Attitudes and Beliefs Related to Carbohydrate Intake in Adolescent Female Athletes

PepsiCo Global R&D3 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年2月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
3
主要终点
Education versus Education plus metabolic testing

研究概览

简要总结

Many studies have consistently shown that females across sports under consume carbohydrate. Registered dietitians working with athletes have also reported female athletes chronically under consume carbohydrate. The primary objective of this study is to compare the effectiveness of education versus education plus interpreted individual metabolic (exercise) testing results to change attitudes and beliefs of female athletes regarding carbohydrate intake. The secondary objective is to assess the effectiveness of the education alone on attitudes and beliefs towards consuming carbohydrate in female athletes.

The study hypothesis is that education alone will not significantly impact attitudes and beliefs, and that metabolic testing and the interpretation of the individual results will alter attitudes and beliefs toward carbohydrate intake.

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
Female
接受健康志愿者

入选标准

  • Females aged between the ages of 13-19 years old
  • Currently enrolled in an IMG Academy sport
  • Willing to fast overnight (10 hours) prior to testing (for metabolic testing group).
  • Understand the protocol and be 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.
  • You are not employed by, or have a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If you are unsure if a company would be considered a competitor to Gatorade, let the study investigator know the name of the other company and the nature of your relationship to that company before you sign the informed consent
  • If subject has asthma, they may still participate in but will be required to bring their prescribed inhaler if placed in the metabolic testing group

排除标准

  • Expulsion from school for any reason
  • Leaving the IMG sports team
  • Pregnant or planning to become pregnant
  • Participated in any other clinical trial in the past 30 day
  • Participated in any PepsiCo trial in the past 6 months
  • Physical injury that would prevent participation in exercise group

研究组 & 干预措施

Education plus metabolic testing

Other

Classroom session with slides and videos. Exercise with shared exercise data.

干预措施: Education (Other)

Education plus metabolic testing

Other

Classroom session with slides and videos. Exercise with shared exercise data.

干预措施: Metabolic Testing (Exercise) with shared interpreted results (Other)

Education only

Other

Classroom session with slides and videos.

干预措施: Education (Other)

结局指标

主要结局

Education versus Education plus metabolic testing

时间窗: Change in Nutrition Attitudes Questionnaire score from Baseline visit to same questionnaire re-taken 2 weeks later. For each questionnaire, a higher score will be correlated to more positive sentiments around carbohydrate intake.

To compare the effectiveness of education alone versus education plus interpreted individual metabolic testing results to change attitudes and beliefs of female athletes regarding carbohydrate intake.

次要结局

  • Education alone(Change in Nutrition Attitudes Questionnaire score from Baseline visit to same questionnaire re-taken 2 weeks later. A higher score will be correlated to more positive sentiments around carbohydrate intake.)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (3)

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