Меню
Идёт набор NCT06837376

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

Без фазы С лечением Nutritional Deficiency

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Education, Metabolic Testing (Exercise) with shared interpreted results.
Кому может быть актуально
Состояния в реестре: Nutritional Deficiency. Базовые параметры: 13 лет — 19 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Вмешательства

  • Другое Education
    One 45 minute educational session on the role of carbohydrate in exercise
  • Другое Metabolic Testing (Exercise) with shared interpreted results
    One 20-30 minute session. Treadmill, warm-up, then at increasing intensities for 3-minute intervals wearing a mouthpiece for measurement of respiratory gasses (oxygen consumption, carbon dioxide production). Testing starts with a 3-minute warm-up at 3.4 mph, 1% grade, increasing every 3 minutes until a respiratory exchange ratio of 1.0 is reached or volitional exhaustion

Первичные конечные точки

  • Education versus Education plus metabolic testing [Срок оценки: 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.]
Вторичные конечные точки (1)
  • Education alone [Срок оценки: 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.]

Критерии участия

Критерии включения

  • Females aged between the ages of 13-19 years old
  • Non-smoker
  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Gatorade Sports Science Institute at IMG Academy — Bradenton

Идентификаторы

NCT: NCT06837376 · PEP-2408

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗