Binge EatingNCT05041660
Using Virtual Reality and Sensor Technology to Enhance Outcomes From Treatment for Binge Eating
A study testing Virtual-reality-based training and Computerized training in people with Binge Eating and Inhibition (Psychology), run by Drexel University at 1 site in United States.
Trial summary
This study evaluates whether virtual-reality-based inhibitory control trainings are more effective than computerized trainings in reducing binge eating symptomatology. These trainings are used to improve people's ability to resist their impulses towards highly palatable foods (such as chips or cookies). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Binge Eating, Inhibition (Psychology)
- What is being tested?
- Virtual-reality-based training and Computerized training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2019to 5 Aug 2020
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Speak, write, and understand English
- Age 18-65 years
- Experience objectively or subjectively large binge eating episodes once per week or more for the past three months
- Objectively large binge episodes are defined by the Eating Disorder Examination (EDE; a measure employed in this study) as consisting of at least two full meals of two courses at each (i.e., four courses total) or of at least three main courses
- Participants, also as per the EDE, must also experience a loss of control over their eating for the given episode to qualify as an objective binge
- Subjective binges are those which do not meet the food quantity criteria but during which participants experience a loss of control and feel they have eaten too much
- If applicable, have stable psychiatric medication for the past three months.
Who cannot join
- Acute suicide risk
- Are planning on receiving psychological treatment for binge eating during the course of their participation in the study
- Are planning to participate in a structured weight loss treatment program (e.g., WeightWatchers, behavioral weight loss treatment) during the course of their participation in the study
- Are currently receiving weight loss treatment
- Have a BMI below 17.5
- Co-morbid clinically significant psychological disorder that would require attention beyond the study treatment (i.e., bipolar I disorder, substance dependence, and/or psychotic conditions)
Show all 12Show fewer
- Diagnosis of intellectual disability or autism spectrum disorder
- History of neurological condition or traumatic brain injury
- Current pregnancy or intention to become pregnant during the course of their participation
- History of bariatric surgery
- Are currently using a stimulant medication (e.g., Ritalin, Adderall)
- No internet connection at home
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel Universitty
Philadelphia, Pennsylvania, 19104
About this study
This study evaluates whether virtual-reality-based inhibitory control trainings are more effective than computerized trainings in reducing binge eating symptomatology. These trainings are used to improve people's ability to resist their impulses towards highly palatable foods (such as chips or cookies). These trainings also offer promise as a companion to Cognitive Behavioral Therapy, an often used and relatively effective therapeutic methodology.
Read the detailed description
Low levels of inhibitory control (i.e., the ability to withhold a quick, automatic response) is strongly linked with binge eating pathology. One of the most widely used and effective treatments for binge eating leaves 40-60% of patients partially or fully symptomatic at post-treatment. Researchers have begun to investigate the efficacy of computerized inhibitory control trainings (ICTs), which are tasks in which participants are asked repeatedly withhold a keypress responses to food stimuli. The intention of these trainings is to improve inhibitory control and to, in turn, reduce dysregulated eating behavior.
Results for the efficacy of ICTs are promising, yet mixed. ICTs that are gamified (i.e., turned into a video game) using virtual reality technology have high potential to address the barriers which may be limiting the efficacy of previous ICTs. The current study aims to finalize development and test the feasibility, acceptability and preliminary efficacy of the first-ever virtual reality ICT (VR-ICT) for individuals with binge eating pathology.
Thus, the study's aims are as follows:
Primary aim 1: Enhance features of a previously developed, VR-based ICT for binge eating.
Primary aim 2: Examine the feasibility and acceptability of the VR ICT training program.
Primary aim 3: Examine the efficacy of VR-ICT versus a non-VR ICT and ICT vs. sham training, for reductions in binge eating from pre to post-treatment and at follow-up.
Based on previous research and data from a pilot study, the investigators hypothesize a) that the VR ICT training program will be feasible and acceptable and b) that the VR-ICT and ICT will produce superior reductions in binge eating from pre- to post-treatment and at follow-up, as compared, respectively, with the non-VR ICT and the sham ICT.
- Conditions
- Binge Eating, Inhibition (Psychology)
- Being tested
- Virtual-reality-based training, Inhibitory Control Training, Sham Inhibitory Control Training, Computerized training
- Keywords
- Inhibitory control, Virtual reality, Binge eating, Continuous glucose monitoring
- Medical subject headings
- Bulimia, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual-reality-based trainingOther
Also called VR
Uses virtual reality for the inhibitory control training, rather than a relatively simplistic computerized training.
Inhibitory Control TrainingOther
Also called ICT
Uses an active inhibitory control training which includes a "stop" signal.
Sham Inhibitory Control TrainingOther
Uses an inhibitory control training which does not include a "stop" signal.
Computerized trainingOther
Uses a relatively simplistic computerized training.
| Study group | Role | What they receive |
|---|---|---|
| VR ICT | Experimental | Virtual-reality-based inhibitory control training done daily at home for 6 weeks. Receives: Other: Virtual-reality-based training; Other: Inhibitory Control Training |
| VR Sham ICT | Sham comparator | Virtual-reality-based sham inhibitory control training (i.e., one that does not include a "stop" signal and that thus does not truly train inhibitory control) done daily at home for 6 weeks. Receives: Other: Virtual-reality-based training; Other: Sham Inhibitory Control Training |
| Non-VR ICT | Active comparator | Computerized inhibitory control training done daily at home for 6 weeks. Receives: Other: Inhibitory Control Training; Other: Computerized training |
| Non-VR Sham ICT | Sham comparator | Computerized sham inhibitory control training (i.e., one that does not include a "stop" signal and that thus does not truly train inhibitory control) done daily at home for 6 weeks. Receives: Other: Sham Inhibitory Control Training; Other: Computerized training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol recruitment
This outcome will be assessed according to whether the investigators can recruit at least 40 participants. This forms the first half of the assessment of the protocol's feasibility.
Measured: The investigators will assess adherence at follow-up assessments (18 weeks after baseline assessment)
Protocol retention
This outcome will be assessed according to whether > 75% of participants completed all assessments. This forms the second half of the assessment of the protocol's feasibility.
Measured: The investigators will assess adherence at follow-up assessments (18 weeks after baseline assessment)
Protocol adherence
This outcome will be assessed according to whether participants completed ≥ 75% of all daily training sessions. This forms the first half of the assessment of the protocol's acceptability.
Measured: The investigators will assess adherence at follow-up assessments (18 weeks after baseline assessment).
Protocol satisfaction
This outcome will be assessed according to whether the average participant rating is >= 4 on all questions on the Technology Reactions and Acceptance and Technology Expectancy Questionnaires. This forms the second half of the assessment of the protocol's acceptability.
Measured: The investigators will assess satisfaction at follow-up assessments (18 weeks after baseline assessment).
Impact of VR + ICT vs. VR + Sham on binge eating frequency
This outcome will be assessed according to whether participation in the VR + ICT condition produces a larger change in binge eating episodes than does participation in the VR + Sham condition, as measured using the binge module of the Eating Disorder Examination version 17.
Measured: The investigators will assess efficacy at post-treatment (6 weeks after baseline) and at follow-up (18 weeks after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start14 Oct 2019
- Primary completion5 Aug 2020
- Study completion5 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge EatingStudies 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
- Factorial
- Model description
- The study is a 2x2 factorial design with the factors being VR (VR/non-VR) and ICT (ICT/Sham).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- Drexel Coulter Translational Research Partnership Program
- Responsible party
- Sponsor
- Investigators
- Stephanie Manasse, Ph.D., Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041660
- Sponsor's protocol ID
- 1906007227
- Status last verified
- Sep 2021
- First submitted
- 22 Oct 2019
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Virtual Reality and Sensor Technology to Enhance Outcomes From Treatment for Binge Eating
- ClinicalTrials.gov ID
- NCT05041660
- Acronym / sponsor ID
- 1906007227
- Conditions
- Binge Eating, Inhibition (Psychology)
- Keywords
- Inhibitory control, Virtual reality, Binge eating, Continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- Drexel Coulter Translational Research Partnership Program
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 5 Aug 2020 (actual)
- Study completion
- 5 Aug 2020 (actual)
- First posted
- 13 Sep 2021 (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 evaluates whether virtual-reality-based inhibitory control trainings are more effective than computerized trainings in reducing binge eating symptomatology. These trainings are used to improve people's ability to resist their impulses towards highly palatable foods (such as chips or cookies). These trainings also offer promise as a companion to Cognitive Behavioral Therapy, an often used and relatively effective therapeutic methodology.
Detailed description
Low levels of inhibitory control (i.e., the ability to withhold a quick, automatic response) is strongly linked with binge eating pathology. One of the most widely used and effective treatments for binge eating leaves 40-60% of patients partially or fully symptomatic at post-treatment. Researchers have begun to investigate the efficacy of computerized inhibitory control trainings (ICTs), which are tasks in which participants are asked repeatedly withhold a keypress responses to food stimuli. The intention of these trainings is to improve inhibitory control and to, in turn, reduce dysregulated eating behavior.
Results for the efficacy of ICTs are promising, yet mixed. ICTs that are gamified (i.e., turned into a video game) using virtual reality technology have high potential to address the barriers which may be limiting the efficacy of previous ICTs. The current study aims to finalize development and test the feasibility, acceptability and preliminary efficacy of the first-ever virtual reality ICT (VR-ICT) for individuals with binge eating pathology.
Thus, the study's aims are as follows:
Primary aim 1: Enhance features of a previously developed, VR-based ICT for binge eating.
Primary aim 2: Examine the feasibility and acceptability of the VR ICT training program.
Primary aim 3: Examine the efficacy of VR-ICT versus a non-VR ICT and ICT vs. sham training, for reductions in binge eating from pre to post-treatment and at follow-up.
Based on previous research and data from a pilot study, the investigators hypothesize a) that the VR ICT training program will be feasible and acceptable and b) that the VR-ICT and ICT will produce superior reductions in binge eating from pre- to post-treatment and at follow-up, as compared, respectively, with the non-VR ICT and the sham ICT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- The study is a 2x2 factorial design with the factors being VR (VR/non-VR) and ICT (ICT/Sham).
| Arm | Type | Receives |
|---|---|---|
| VR ICT | Experimental | Other: Virtual-reality-based training, Other: Inhibitory Control TrainingVirtual-reality-based inhibitory control training done daily at home for 6 weeks. |
| VR Sham ICT | Sham comparator | Other: Virtual-reality-based training, Other: Sham Inhibitory Control TrainingVirtual-reality-based sham inhibitory control training (i.e., one that does not include a "stop" signal and that thus does not truly train inhibitory control) done daily at home for 6 weeks. |
| Non-VR ICT | Active comparator | Other: Inhibitory Control Training, Other: Computerized trainingComputerized inhibitory control training done daily at home for 6 weeks. |
| Non-VR Sham ICT | Sham comparator | Other: Sham Inhibitory Control Training, Other: Computerized trainingComputerized sham inhibitory control training (i.e., one that does not include a "stop" signal and that thus does not truly train inhibitory control) done daily at home for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Speak, write, and understand English
- Age 18-65 years
- Experience objectively or subjectively large binge eating episodes once per week or more for the past three months
- If applicable, have stable psychiatric medication for the past three months.
Key exclusion criteria (12 listed)
- Acute suicide risk
- Are planning on receiving psychological treatment for binge eating during the course of their participation in the study
- Are planning to participate in a structured weight loss treatment program (e.g., WeightWatchers, behavioral weight loss treatment) during the course of their participation in the study
- Are currently receiving weight loss treatment
- Have a BMI below 17.5
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 |
|---|---|---|
| Virtual-reality-based trainingAlso: VRUses virtual reality for the inhibitory control training, rather than a relatively simplistic computerized training. | Other | VR ICT, VR Sham ICT |
| Inhibitory Control TrainingAlso: ICTUses an active inhibitory control training which includes a "stop" signal. | Other | Non-VR ICT, VR ICT |
| Sham Inhibitory Control TrainingUses an inhibitory control training which does not include a "stop" signal. | Other | Non-VR Sham ICT, VR Sham ICT |
| Computerized trainingUses a relatively simplistic computerized training. | Other | Non-VR ICT, Non-VR Sham ICT |
Primary outcome
Protocol recruitment
Time frame: The investigators will assess adherence at follow-up assessments (18 weeks after baseline assessment)
This outcome will be assessed according to whether the investigators can recruit at least 40 participants. This forms the first half of the assessment of the protocol's feasibility.
Protocol retention
Time frame: The investigators will assess adherence at follow-up assessments (18 weeks after baseline assessment)
This outcome will be assessed according to whether > 75% of participants completed all assessments. This forms the second half of the assessment of the protocol's feasibility.
Protocol adherence
Time frame: The investigators will assess adherence at follow-up assessments (18 weeks after baseline assessment).
This outcome will be assessed according to whether participants completed ≥ 75% of all daily training sessions. This forms the first half of the assessment of the protocol's acceptability.
Protocol satisfaction
Time frame: The investigators will assess satisfaction at follow-up assessments (18 weeks after baseline assessment).
This outcome will be assessed according to whether the average participant rating is >= 4 on all questions on the Technology Reactions and Acceptance and Technology Expectancy Questionnaires. This forms the second half of the assessment of the protocol's acceptability.
Impact of VR + ICT vs. VR + Sham on binge eating frequency
Time frame: The investigators will assess efficacy at post-treatment (6 weeks after baseline) and at follow-up (18 weeks after baseline).
This outcome will be assessed according to whether participation in the VR + ICT condition produces a larger change in binge eating episodes than does participation in the VR + Sham condition, as measured using the binge module of the Eating Disorder Examination version 17.
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 13 Sep 2021.
- 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. This study is not recruiting at the moment.
Stephanie Manasse, Ph.D. principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual-reality-based training and Computerized training in people with Binge Eating and Inhibition (Psychology), run by Drexel 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 7 inclusion and 12 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 13 Sep 2021. 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?
Protocol recruitment (time frame: The investigators will assess adherence at follow-up assessments (18 weeks after baseline assessment)). The study lists 5 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 13 Sep 2021.