- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06598111
Increasing Motivation to Reduce Restriction
Amplifying Consequences to Reduce Dietary Restriction: a Proof-of-Concept Study
The goal of this experiment is to learn how to effectively increase motivation to reduce dietary restriction among young adults engaging in clinically significant restrictive eating. The main questions this study aims to answer are:
- Does imagining a future without restrictive eating increase motivation to reduce restrictive eating?
- Does imagining a future without restrictive eating reduce actual restrictive eating behavior?
- Is it more motivating to think about long-term benefits of reducing dietary restriction, or to focus on short-term consequences of dietary restriction?
Researchers will compare (1) amplifying the possible benefits of reducing restrictive eating, (2) amplifying the negative consequences of restrictive eating, or (3) both is more effective for increasing motivation to reduce dietary restriction over a one-week period.
Participants will:
- Complete daily measures of eating disorder symptoms and motivation for 7 days
- Write a narrative describing a day in the future without restrictive eating and read this narrative aloud daily for 7 days
- Be presented with information regarding the negative consequences of dietary restriction daily for 7 days
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study tests whether amplifying the potential benefits of reducing dietary restriction and/or consequences of maintaining dietary restriction increases motivation to address disordered (i.e., restrictive) eating among college students. This is an online study with a between-groups experimental design which takes place over the course of one week. All study procedures are completed online.
Participants are randomized to one of four conditions: Amplified Benefits & Consequences, Amplified Benefits, Amplified Consequences, or a control condition. Baseline measures are completed on the first day of study enrollment, following randomization to experimental condition. Over the subsequent six days, participants receive daily surveys via email every 24 hours and are given 24 hours to complete each survey. In every condition, participants complete daily self-report measures. Depending on condition, participants also completed the following manipulations:
- Amplified Benefits and Consequences condition: Participants are prompted to write a brief, detailed narrative describing a day in their future if they did not restrict their caloric intake and were not concerned about their body weight or shape. Participants type their responses and provide a recording of themselves reading their narrative aloud. On each subsequent day, participants are provided with their written narrative and asked to create a new recording of themselves reading it aloud. After completing their recording and surveys, participants complete a modified version of the Pros and Cons of Anorexia Scale to amplify the negative consequences of restrictive eating. Next, they read a brief informational blurb about the negative health consequences of restrictive eating.
- Amplified Benefits condition: Participants receive the same narrative prompt and recording instructions as participants in the Amplified Benefits & Consequences condition. They are not asked to complete the modified PCAN or presented with blurbs about the consequences of restrictive eating.
- Amplified Consequences condition: Participants in the Amplified Consequences condition are not prompted to write or record a narrative. After completing daily surveys, they complete the modified PCAN and are presented with blurbs about the consequences of restrictive eating.
- Control condition: Participants write a brief narrative nearly identical Amplified Benefits manipulation; however, their prompt instead asks them to consider a future free of concern about finances. Participants type their narrative and record themselves reading it aloud. Each day, participants create a new recording. Participants in the control condition do not complete the modified PCAN and are not provided with informational blurbs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Florida
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Tallahassee, Florida, United States, 32304
- Florida State University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least 18 years of age
- Undergraduate student
- Fluent in English
- Engaging in dietary restriction
Exclusion Criteria:
- Engaging in binge eating
- Unable to consent
- Not yet an adult
- Currently pregnant
- Prisoner status
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Amplified Benefits and Consequences
On the first day of the study (day 0), participants in the Amplified Benefits & Consequences condition write a brief, detailed narrative describing a day in their future if they did not restrict their caloric intake and were not concerned about their body weight or shape.
Participants type their responses and provide a recording of themselves reading their narrative aloud.
On each subsequent day (day 1 through day 6), participants are provided with their written narrative and asked to create a new recording of themselves reading it aloud.
After completing their recording and surveys, participants complete a modified version of the Pros and Cons of Anorexia Scale.
|
Participants write a brief, detailed narrative describing a day in their future if they did not restrict their caloric intake and were not concerned about their body weight or shape.
Participants complete the Pros and Cons of Anorexia scale to amplify the consequences of restrictive eating.
They are also presented with blurbs about the consequences of restrictive eating.
|
|
Experimental: Amplified Benefits
On the first day of the study (day 0), participants in the Amplified Benefits condition write a brief, detailed narrative describing a day in their future if they did not restrict their caloric intake and were not concerned about their body weight or shape.
Participants type their responses and provide a recording of themselves reading their narrative aloud.
On each subsequent day (day 1 through day 6), participants are provided with their written narrative and asked to create a new recording of themselves reading it aloud.
|
Participants write a brief, detailed narrative describing a day in their future if they did not restrict their caloric intake and were not concerned about their body weight or shape.
|
|
Experimental: Amplified Consequences
On each day of the study, participants in the Amplified Consequences condition complete the modified Pros and Cons of Anorexia scale and are presented with blurbs about the consequences of restrictive eating.
|
Participants complete the Pros and Cons of Anorexia scale to amplify the consequences of restrictive eating.
They are also presented with blurbs about the consequences of restrictive eating.
|
|
Placebo Comparator: Control
Participants in the control condition write a brief narrative considering a future free of concern about finances.
As with the active conditions, participants type their narrative on day 0 and record themselves reading it aloud each day.
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Participants write a brief narrative considering a future free of concern about finances.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in dietary restraint
Time Frame: Baseline (day 0), day 1, day 2, day 3 day 4, day 5, day 6
|
Dietary restraint was measured using two items drawn from the Eating Disorder Examination Questionnaire.
Each item was rated on a 1-6 scale ranging from 1 (Not at all/never) to 6 (Markedly/all the time).
Scores on each item were averaged to create a single dietary restraint score.
Changes in daily scores were used to quantify changes in dietary restraint over time.
|
Baseline (day 0), day 1, day 2, day 3 day 4, day 5, day 6
|
|
Change in motivation
Time Frame: Baseline (day 0), day 1, day 2, day 3 day 4, day 5, day 6
|
Motivation was measured using the Readiness and Motivation Questionnaire, which is a self-report measure assessing motivation to change disordered attitudes and behaviors.
Items reflect four categories: precontemplation, action, internality, and confidence.
Respondents rate each item on a percentage scale ranging from zero to 100.
The RMQ was modified to include only items assessing dietary restriction, with one item assessing each of the aforementioned categories.
Items were anchored to the last 24 hours.
Changes in daily scores were used to quantify changes in motivation over time.
|
Baseline (day 0), day 1, day 2, day 3 day 4, day 5, day 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in body dissatisfaction
Time Frame: Baseline (day 0), day 1, day 2, day 3 day 4, day 5, day 6
|
Body dissatisfaction was measured using two items drawn from the Eating Disorder Examination Questionnaire.
Each item was rated on a 1-6 scale ranging from 1 (Not at all/never) to 6 (Markedly/all the time).
Scores on each item were averaged to create a single body dissatisfaction score.
Changes in daily scores were used to quantify changes in body dissatisfaction over time.
|
Baseline (day 0), day 1, day 2, day 3 day 4, day 5, day 6
|
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Change in shape/weight overvaluation
Time Frame: Baseline (day 0), day 1, day 2, day 3 day 4, day 5, day 6
|
Shape/weight overvaluation was measured using three items drawn from the Eating Disorder Examination Questionnaire.
Each item was rated on a 1-6 scale ranging from 1 (Not at all/never) to 6 (Markedly/all the time).
Scores on each item were averaged to create a single shape/weight overvaluation score.
Changes in daily scores were used to quantify changes in shape/weight overvaluation over time.
|
Baseline (day 0), day 1, day 2, day 3 day 4, day 5, day 6
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00003465
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
product manufactured in and exported from the U.S.
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.
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