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Набор скоро начнётся NCT06810414

Evaluation of an Expectancy Challenge Intervention for Food and Alcohol Disturbance Among College Students

Без фазы С лечением College Drinking Disordered Eating

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: Food and alcohol disturbance expectancy challenge.
Кому может быть актуально
Состояния в реестре: College Drinking, Disordered Eating. Базовые параметры: 18 лет — 25 лет · Все.
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 →
Официальное название

Feasibility, Acceptability, and Preliminary Efficacy of an Expectancy Challenge Intervention for Food and Alcohol Disturbance Among College Students

Обзор

This study aims to create and test an intervention that helps college students re-evaluate their beliefs about food and alcohol disturbance (FAD) and, in turn, reduce how often they engage in it or intend to in the future. The main questions it aims to answer are: 1. Does the intervention help students have less positive beliefs about the effects of FAD and more negative beliefs about its effects? 2. If college students' beliefs about FAD change, does that lead them to engage in it less often or plan to do it less? 3. Will college students who engage in FAD sign up for the study, complete it, and feel that the intervention is helpful and valuable? Participants will take part in one 2-hour in-person laboratory-based study session where they will fill out surveys, learn about FAD, and engage in exercises designed to challenge their existing beliefs about it. They will also complete a follow-up survey online one month after their in-person study visit.

Подробное описание

Food and alcohol disturbance (FAD) is the use of any compensatory behavior (e.g., caloric restriction) within the context of a drinking episode for the purpose of 1) compensating for alcohol-related calories and/or 2) enhancing the effects of alcohol. FAD occurs at alarmingly high rates among undergraduates and is associated with a myriad of deleterious consequences. Expectancy effects (i.e., beliefs regarding the anticipated outcomes of a behavior) have been shown to influence the initiation and maintenance of alcohol and disordered eating behaviors. Prior work suggests that expectancies for these behaviors can be modified via expectancy challenges (i.e., ECs; interventions that aim to undermine expectancies by providing learning opportunities that demonstrate the discrepancy between the actual versus perceived effects of a behavior). An EC has never been applied to FAD. However, given that FAD is comprised of both alcohol and disordered eating behaviors, and preliminary work suggests that FAD expectancies share some similarities with alcohol and restriction expectancies, it is likely that an EC could be similarly applied to FAD. Thus, the purpose of the proposed project is to develop an effective and acceptable EC designed to modify FAD expectancies and reduce FAD among undergraduates, informed by the alcohol EC literature.

Participants will be randomized to a 120-minute in-person non-experiential (i.e., no alcohol administration) EC designed to undermine FAD expectancies (experimental group) or a control group. To make existing expectancies salient, the EC will include audio recordings of reported FAD expectancies from students who engaged in FAD in my preliminary qualitative work (Berry \& Looby, 2024). Participants will then engage in discussions to evaluate whether these effects are pharmacological or perceived. The intervention will also provide psychoeducation on expectancies, FAD, alcohol, and the effects of compensatory behaviors on weight, which will prompt participants to reevaluate their extant expectancies. This will be followed by a reflective writing exercise to allow participants to further elaborate on any changes to their challenged expectancies. FAD expectancies will be assessed at baseline, immediately post-intervention, and one-month follow-up. FAD frequency will be assessed at baseline and follow-up. Additionally, participants in the experimental group will provide feedback on the intervention's acceptability and feasibility post-intervention.

Вмешательства

  • Поведенческое Food and alcohol disturbance expectancy challenge
    The intervention will focus on strengthening negative FAD expectancies and weakening positive FAD expectancies.

Первичные конечные точки

  • Food and Alcohol Disturbance Expectancy Questionnaire [Срок оценки: This measure will be administered to all participants at baseline, immediately post-intervention, and at the study's one-month follow-up]
  • Food and Alcohol Disturbance Intentions Questions [Срок оценки: This measure will be administered to all participants at baseline, immediately post-intervention, and at the study's one-month follow-up]
  • College Eating and Drinking Behaviors Scale [Срок оценки: This measure will be administered at baseline and at the one-month follow-up]
  • Food and Alcohol Disturbance Timeline Followback [Срок оценки: This measure will be administered at baseline and at the one-month follow-up]
Вторичные конечные точки (1)
  • Brief Young Adult Alcohol Consequences Questionnaire [Срок оценки: This measure will be administered at baseline and at the one-month follow-up]

Критерии участия

Критерии включения

  • Must be between the ages of 18 and 25
  • Must report engaging in FAD at least two times over the past month

Критерии исключения

  • They have a current or past history of receiving psychological treatment for their alcohol use and/or eating behaviors
  • They are currently trying to reduce their drinking

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Wyoming — Laramie

Публикации

  • Berry KA, Looby A. "If You Don't Eat, You Can Get Drunk Faster": A Qualitative Investigation of Food and Alcohol Disturbance (FAD) Expectancies. Subst Use Misuse. 2024;59(11):1647-1655. doi: 10.1080/10826084.2024.2369161. Epub 2024 Jun 25. PMID 38918931
  • Berry KA, Choquette EM, Looby A, Rancourt D. Unification of the food and alcohol disturbance literature: A systematic review. Clin Psychol Rev. 2024 Nov;113:102486. doi: 10.1016/j.cpr.2024.102486. Epub 2024 Aug 14. PMID 39168054
  • Shepherd CB, Berry KA, Ye X, Li K. Food and alcohol disturbance among US college students: a mixed methods scoping review. J Am Coll Health. 2023 Aug-Sep;71(6):1715-1731. doi: 10.1080/07448481.2021.1947300. Epub 2021 Jul 22. PMID 34292851

Идентификаторы

NCT: NCT06810414 · IRB-2024-467

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗