Restrictive EatingNCT06598111
Increasing Motivation to Reduce Restriction
A study testing Amplified Benefits and Amplified Consequences in people with Restrictive Eating, run by Florida State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restrictive Eating
- What is being tested?
- Amplified Benefits and Amplified Consequences
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2023to 5 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Undergraduate student
- Fluent in English
- Engaging in dietary restriction
Who cannot join
- Engaging in binge eating
- Unable to consent
- Not yet an adult
- Currently pregnant
- Prisoner status
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32304
About this study
Official title: 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?
Read more
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
Read the 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.
- Conditions
- Restrictive Eating
- Being tested
- Amplified Benefits, Amplified Consequences, Control
- Keywords
- online, experiment, restrictive eating, motivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amplified BenefitsOther
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.
Amplified ConsequencesOther
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.
ControlOther
Participants write a brief narrative considering a future free of concern about finances.
| Study group | Role | What they receive |
|---|---|---|
| Amplified Benefits and Consequences | Experimental | 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. Receives: Other: Amplified Benefits; Other: Amplified Consequences |
| Amplified Benefits | Experimental | 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. Receives: Other: Amplified Benefits |
| Amplified Consequences | Experimental | 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. Receives: Other: Amplified Consequences |
| Control | Placebo comparator | 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dietary restraint
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.
Measured: Baseline (day 0), day 1, day 2, day 3 day 4, day 5, day 6
Change in motivation
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.
Measured: Baseline (day 0), day 1, day 2, day 3 day 4, day 5, day 6
Secondary outcomes (2)
Change in body dissatisfaction
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.
Measured: Baseline (day 0), day 1, day 2, day 3 day 4, day 5, day 6
Change in shape/weight overvaluation
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.
Measured: Baseline (day 0), day 1, day 2, day 3 day 4, day 5, day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start18 Jan 2023
- Primary completion5 Mar 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restrictive EatingStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Harris, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598111
- Sponsor's protocol ID
- STUDY00003465
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protocol was not designed to allow for IPD sharing.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplifying Consequences to Reduce Dietary Restriction: a Proof-of-Concept Study
- ClinicalTrials.gov ID
- NCT06598111
- Acronym / sponsor ID
- STUDY00003465
- Conditions
- Restrictive Eating
- Keywords
- online, experiment, restrictive eating, motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 19 Sep 2024 (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.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Amplified Benefits and Consequences | Experimental | Other: Amplified Benefits, Other: Amplified ConsequencesOn 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. |
| Amplified Benefits | Experimental | Other: Amplified BenefitsOn 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. |
| Amplified Consequences | Experimental | Other: Amplified ConsequencesOn 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. |
| Control | Placebo comparator | Other: ControlParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Undergraduate student
- Fluent in English
- Engaging in dietary restriction
Key exclusion criteria (5 listed)
- Engaging in binge eating
- Unable to consent
- Not yet an adult
- Currently pregnant
- Prisoner status
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 |
|---|---|---|
| Amplified BenefitsParticipants 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. | Other | Amplified Benefits, Amplified Benefits and Consequences |
| Amplified ConsequencesParticipants 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. | Other | Amplified Benefits and Consequences, Amplified Consequences |
| ControlParticipants write a brief narrative considering a future free of concern about finances. | Other | Control |
Primary outcome
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.
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.
2 secondary outcomes
Change in body dissatisfaction
Time frame: Baseline (day 0), day 1, day 2, day 3 day 4, day 5, day 6
Change in shape/weight overvaluation
Time frame: Baseline (day 0), day 1, day 2, day 3 day 4, day 5, day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. Protocol was not designed to allow for IPD sharing.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amplified Benefits and Amplified Consequences in people with Restrictive Eating, run by Florida State University 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 19 Sep 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dietary restraint (time frame: Baseline (day 0), day 1, day 2, day 3 day 4, day 5, day 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.