College DrinkingFADNCT06810414
Evaluation of an Expectancy Challenge Intervention for Food and Alcohol Disturbance Among College Students
A study testing Food and alcohol disturbance expectancy challenge in people with College Drinking and Disordered Eating, run by University of Wyoming at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- College Drinking, Disordered Eating
- What is being tested?
- Food and alcohol disturbance expectancy challenge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2025to 8 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must be between the ages of 18 and 25
- Must report engaging in FAD at least two times over the past month
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Wyoming
Laramie, Wyoming, 82071
Katherine A Berry, MS, 307-314-2669, kberry11@uwyo.edu
Alison Looby, PhD, 307-314-2314, alooby@uwyo.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- College Drinking, Disordered Eating
- Being tested
- Food and alcohol disturbance expectancy challenge
- Keywords
- food and alcohol disturbance, drunkorexia, college drinking, disordered eating, expectancy challenge
- Medical subject headings
- Alcohol Drinking in College
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food and alcohol disturbance expectancy challengeBehavioural
The intervention will focus on strengthening negative FAD expectancies and weakening positive FAD expectancies.
| Study group | Role | What they receive |
|---|---|---|
| FAD Expectancy Challenge Condition | Experimental | Participants in the experimental condition will be delivered the FAD expectancy challenge intervention. Receives: Behavioral: Food and alcohol disturbance expectancy challenge |
| Disordered Eating Psychoeducation | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Food and Alcohol Disturbance Expectancy Questionnaire
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.
Measured: 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
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.
Measured: 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
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.
Measured: This measure will be administered at baseline and at the one-month follow-up
Food and Alcohol Disturbance Timeline Followback
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.
Measured: This measure will be administered at baseline and at the one-month follow-up
Secondary outcomes (1)
Brief Young Adult Alcohol Consequences Questionnaire
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.
Measured: This measure will be administered at baseline and at the one-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start24 Feb 2025 (estimated)
- Primary completion8 May 2026 (estimated)
- Study completion8 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for College DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wyoming
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Berry, University of Wyoming
- Investigators
- Katherine A Berry, MS, Principal investigator, University of WyomingAlison Looby, PhD, Study chair, University of Wyoming
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810414
- Sponsor's protocol ID
- IRB-2024-467
- Acronym
- FAD
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38918931Berry 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.
PubMed 39168054Shepherd 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.
PubMed 34292851
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Preliminary Efficacy of an Expectancy Challenge Intervention for Food and Alcohol Disturbance Among College Students
- ClinicalTrials.gov ID
- NCT06810414
- Acronym / sponsor ID
- FAD / IRB-2024-467
- Conditions
- College Drinking, Disordered Eating
- Keywords
- food and alcohol disturbance, drunkorexia, college drinking, disordered eating, expectancy challenge
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of WyomingUniversity, hospital or other
- Study start
- 24 Feb 2025 (estimated)
- Primary completion
- 8 May 2026 (estimated)
- Study completion
- 8 May 2026 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAD Expectancy Challenge Condition | Experimental | Behavioral: Food and alcohol disturbance expectancy challengeParticipants in the experimental condition will be delivered the FAD expectancy challenge intervention. |
| Disordered Eating Psychoeducation | No intervention | –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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Must be between the ages of 18 and 25
- Must report engaging in FAD at least two times over the past month
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food and alcohol disturbance expectancy challengeThe intervention will focus on strengthening negative FAD expectancies and weakening positive FAD expectancies. | Behavioural | FAD Expectancy Challenge Condition |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Brief Young Adult Alcohol Consequences Questionnaire
Time frame: This measure will be administered at baseline and at the one-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Background: PubMed 38918931Berry 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.
- Background: PubMed 39168054Berry 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.
- Background: PubMed 34292851Shepherd 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine A Berry, MS principal investigator
University of Wyoming
Alison Looby, PhD study chair
University of Wyoming
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food and alcohol disturbance expectancy challenge in people with College Drinking and Disordered Eating, run by University of Wyoming at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine A Berry, MS (307-314-2669, kberry11@uwyo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06810414, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.