- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06810414
Evaluation of an Expectancy Challenge Intervention for Food and Alcohol Disturbance Among College Students (FAD)
Feasibility, Acceptability, and Preliminary Efficacy of an Expectancy Challenge Intervention for Food and Alcohol Disturbance Among College Students
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:
- Does the intervention help students have less positive beliefs about the effects of FAD and more negative beliefs about its effects?
- If college students' beliefs about FAD change, does that lead them to engage in it less often or plan to do it less?
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alison Looby, PhD
- Phone Number: 307-314-2314
- Email: alooby@uwyo.edu
Study Contact Backup
- Name: Katherine A Berry, MS
- Phone Number: 307-314-2669
- Email: kberry11@uwyo.edu
Study Locations
-
-
Wyoming
-
Laramie, Wyoming, United States, 82071
- University of Wyoming
-
Contact:
- Alison Looby, PhD
- Phone Number: 307-314-2314
- Email: alooby@uwyo.edu
-
Contact:
- Katherine A Berry, MS
- Phone Number: 307-314-2669
- Email: kberry11@uwyo.edu
-
Principal Investigator:
- Katherine A Berry, MS
-
Sub-Investigator:
- Alison Looby, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must be between the ages of 18 and 25
- Must report engaging in FAD at least two times over the past month
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: FAD Expectancy Challenge Condition
Participants in the experimental condition will be delivered the FAD expectancy challenge intervention.
|
The intervention will focus on strengthening negative FAD expectancies and weakening positive FAD expectancies.
|
|
No Intervention: Disordered Eating Psychoeducation
Participants in the control condition will receive psychoeducation on disordered eating behaviors, with only a brief mention of FAD, and excluding any discussion of expectancies and consequences.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food and Alcohol Disturbance Expectancy Questionnaire
Time Frame: This measure will be administered to all participants at baseline, immediately post-intervention, and at the study's one-month follow-up
|
The Food and Alcohol Disturbance Expectancy Questionnaire is a 30-item self-report questionnaire that assesses positive and negative expectancies for FAD.
Participants will be asked to indicate the extent to which they believe or expect each FAD-related outcome to occur if they engaged in FAD, using a five-point scale from 0 (Strongly Disagree) to 5 (Strongly Agree).
Scores on each factor will be summed and averaged, with higher scores indicating stronger expectancies.
|
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
Time Frame: This measure will be administered to all participants at baseline, immediately post-intervention, and at the study's one-month follow-up
|
Two questions will be used to assess intentions to engage in FAD for both caloric compensation and alcohol enhancement motives.
Items will be rated on a scale from 0 (Very unlikely) to 10 (Very likely), with higher scores indicating greater intentions to engage in FAD.
|
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
Time Frame: This measure will be administered at baseline and at the one-month follow-up
|
The CEDBS is a 21-item questionnaire that measures the frequency of past-month FAD.
Items are rated on a scale from 1 (Never) to 6 (Always), with higher scores indicating more frequent FAD.
|
This measure will be administered at baseline and at the one-month follow-up
|
|
Food and Alcohol Disturbance Timeline Followback
Time Frame: This measure will be administered at baseline and at the one-month follow-up
|
This measure will assess past-month FAD frequency, including FAD motives and compensatory behaviors.
The number of days that participants reported engaging in FAD will be summed, with higher scores indicating more frequent FAD.
|
This measure will be administered at baseline and at the one-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brief Young Adult Alcohol Consequences Questionnaire
Time Frame: This measure will be administered at baseline and at the one-month follow-up
|
The Brief Young Adult Alcohol Consequences Questionnaire is a 24-item self-reported questionnaire that assesses past-month alcohol-related negative consequences using a dichotomous "Yes" or "No" response item format.
A composite score indicating how many consequences participants experienced will be created by summing the number of alcohol problems reported.
Higher scores will represent greater alcohol consequences.
|
This measure will be administered at baseline and at the one-month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Katherine A Berry, MS, University of Wyoming
- Study Chair: Alison Looby, PhD, University of Wyoming
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-2024-467
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on College Drinking
-
Penn State UniversityNot yet recruiting
-
University of MinnesotaNational Institute on Alcohol Abuse and Alcoholism (NIAAA); University of Michigan and other collaboratorsCompleted
-
State University of New York at BuffaloNot yet recruitingSexual Violence | College Drinking | Behavioral ChangesUnited States
-
Penn State UniversityRecruitingCannabis Use | College Drinking | Underage Drinking | Drinking, Teen | Drinking, College | Teen DrinkingUnited States
-
Brown UniversityCompleted
-
James M. HensonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingCollege Student DrinkingUnited States
-
Abby BraitmanNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Enrolling by invitationCollege Student DrinkingUnited States
-
Lehigh UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Brown UniversityCompletedCollege DrinkingUnited States
-
Abby BraitmanNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Completed
-
Abby BraitmanNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedCollege Student DrinkingUnited States
Clinical Trials on Food and alcohol disturbance expectancy challenge
-
Hôpital Armand TrousseauCompletedReflux, Gastroesophageal | Atopic Dermatitis | Tolerance | Proctocolitis | Food Allergy in InfantsFrance
-
University of PalermoAurelio SeiditaRecruiting
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedAlcohol; Use, ProblemUnited States
-
University of WyomingCompletedPrescription Drug Abuse (Not Dependent)United States
-
University of Illinois at Urbana-ChampaignCarle Foundation HospitalTerminated
-
LactalisNot yet recruiting
-
Hamilton Health Sciences CorporationCanadian Institutes of Health Research (CIHR); AAAAI FoundationRecruiting
-
Medical University of WarsawRecruitingCow Milk Allergy | Food AllergyPoland
-
University of Illinois at Urbana-ChampaignUniversity of Missouri-Columbia; Washington University School of MedicineActive, not recruiting
-
University of Colorado, DenverTerminated