NCT06810414

Brief 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. 1.Does the intervention help students have less positive beliefs about the effects of FAD and more negative beliefs about its effects?
  2. 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. 3.Will college students who engage in FAD sign up for the study, complete it, and feel that the intervention is helpful and valuable?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

February 24, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2026

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

1.2 years

First QC Date

January 30, 2025

Last Update Submit

February 26, 2025

Conditions

Keywords

food and alcohol disturbancedrunkorexiacollege drinkingdisordered eatingexpectancy challenge

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    This measure will be administered at baseline and at the one-month follow-up

Secondary Outcomes (1)

  • Brief Young Adult Alcohol Consequences Questionnaire

    This measure will be administered at baseline and at the one-month follow-up

Study Arms (2)

FAD Expectancy Challenge Condition

EXPERIMENTAL

Participants in the experimental condition will be delivered the FAD expectancy challenge intervention.

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.

Interventions

The intervention will focus on strengthening negative FAD expectancies and weakening positive FAD expectancies.

FAD Expectancy Challenge Condition

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wyoming

Laramie, Wyoming, 82071, United States

Location

Related Publications (3)

  • 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: 38918931BACKGROUND
  • 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: 39168054BACKGROUND
  • 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: 34292851BACKGROUND

MeSH Terms

Conditions

Alcohol Drinking in College

Interventions

FoodEthanol

Condition Hierarchy (Ancestors)

Alcohol DrinkingDrinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and BeveragesAlcoholsOrganic Chemicals

Study Officials

  • Katherine A Berry, MS

    University of Wyoming

    PRINCIPAL INVESTIGATOR
  • Alison Looby, PhD

    University of Wyoming

    STUDY CHAIR

Central Study Contacts

Katherine A Berry, MS

CONTACT

Alison Looby, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychology Doctoral Candidate

Study Record Dates

First Submitted

January 30, 2025

First Posted

February 5, 2025

Study Start

February 24, 2025

Primary Completion

May 8, 2026

Study Completion

May 8, 2026

Last Updated

February 27, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations