Binge-Eating DisorderNCT05829941
Technology Assisted Treatment for Binge Eating Behavior
A study testing Smartwatch app to deliver binge-eating CBT strategies in people with Binge-Eating Disorder, run by HabitAware Inc..
Trial summary
Binge-eating behavior is a central feature of eating disorders (e.g., binge-eating disorder, bulimia nervosa, anorexia nervosa-binge-eating/purging subtype) and is associated with higher rates of psychopathology, psychosocial impairment, medical comorbidity, and more severe obesity, all of which pose significant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Binge-Eating Disorder
- What is being tested?
- Smartwatch app to deliver binge-eating CBT strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Aug 2025
- 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
- Adults ≥18 years of age
- EDE diagnosis of bulimia nervosa or binge eating disorder, with binge-eating episodes occurring at least 2x/week
Who cannot join
- Pregnancy or lactation
- Acute medical or psychiatric risk
- Psychosis or bipolar disorder (lifetime history)
- Current substance use disorder within the past six months
- BMI less than 18.5 kg/m2
- Acute suicidality requiring hospitalization
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- Food allergies
- Receiving current psychotherapy
- On psychotropic medications that have not been on a stable dose for at least six weeks
Trial locations and contacts
No sites are listed yet.
About this study
Binge-eating behavior is a central feature of eating disorders (e.g., binge-eating disorder, bulimia nervosa, anorexia nervosa-binge-eating/purging subtype) and is associated with higher rates of psychopathology, psychosocial impairment, medical comorbidity, and more severe obesity, all of which pose significant public health problems. Passive detection of binge eating episodes combined with a context-based reminder intervention could assist a patient in resuming healthy eating patterns. This study will test a smartwatch app that identifies binge eating behavior and provides CBT strategies to the patient after the episode.
- Conditions
- Binge-Eating Disorder
- Being tested
- Smartwatch app to deliver binge-eating CBT strategies, Reminder control condition
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartwatch app to deliver binge-eating CBT strategiesBehavioural
Participants will receive a smartwatch with a pre-loaded app that will alert the participant to relevant binge-eating strategies based on their previous detected behavior.
Reminder control conditionBehavioural
Participants will receive a smartwatch that vibrates randomly, and will be instructed the vibration is a cue not to binge eat.
| Study group | Role | What they receive |
|---|---|---|
| HabitAware condition | Experimental | This group will receive the device which messages the participant after a passively detected binge-eating episode with CBT strategies. Receives: Behavioral: Smartwatch app to deliver binge-eating CBT strategies |
| Reminder Condition | Placebo comparator | This group will receive a device that vibrates randomly throughout the day as a reminder not to binge eat. Receives: Behavioral: Reminder control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients in the HabitAware condition that report the treatment is acceptable.
Measured via post-treatment survey
Measured: 8 weeks
Secondary outcomes (1)
Percentage of patients report that the binge episode detection is accurate
Measured via post-treatment survey
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study startDec 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-Eating DisorderStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HabitAware Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829941
- Sponsor's protocol ID
- 132180
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Assisted Treatment for Binge Eating Behavior
- ClinicalTrials.gov ID
- NCT05829941
- Acronym / sponsor ID
- 132180
- Conditions
- Binge-Eating Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- HabitAware Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Study start
- Dec 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 26 Apr 2023 (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.
Binge-eating behavior is a central feature of eating disorders (e.g., binge-eating disorder, bulimia nervosa, anorexia nervosa-binge-eating/purging subtype) and is associated with higher rates of psychopathology, psychosocial impairment, medical comorbidity, and more severe obesity, all of which pose significant public health problems. Passive detection of binge eating episodes combined with a context-based reminder intervention could assist a patient in resuming healthy eating patterns. This study will test a smartwatch app that identifies binge eating behavior and provides CBT strategies to the patient after the episode.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HabitAware condition | Experimental | Behavioral: Smartwatch app to deliver binge-eating CBT strategiesThis group will receive the device which messages the participant after a passively detected binge-eating episode with CBT strategies. |
| Reminder Condition | Placebo comparator | Behavioral: Reminder control conditionThis group will receive a device that vibrates randomly throughout the day as a reminder not to binge eat. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults ≥18 years of age
- EDE diagnosis of bulimia nervosa or binge eating disorder, with binge-eating episodes occurring at least 2x/week
Key exclusion criteria (9 listed)
- Pregnancy or lactation
- Acute medical or psychiatric risk
- Psychosis or bipolar disorder (lifetime history)
- Current substance use disorder within the past six months
- BMI less than 18.5 kg/m2
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 |
|---|---|---|
| Smartwatch app to deliver binge-eating CBT strategiesParticipants will receive a smartwatch with a pre-loaded app that will alert the participant to relevant binge-eating strategies based on their previous detected behavior. | Behavioural | HabitAware condition |
| Reminder control conditionParticipants will receive a smartwatch that vibrates randomly, and will be instructed the vibration is a cue not to binge eat. | Behavioural | Reminder Condition |
Primary outcome
Percentage of patients in the HabitAware condition that report the treatment is acceptable.
Time frame: 8 weeks
Measured via post-treatment survey
1 secondary outcome
Percentage of patients report that the binge episode detection is accurate
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Smartwatch app to deliver binge-eating CBT strategies in people with Binge-Eating Disorder, run by HabitAware Inc..
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 9 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: status not confirmed, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sameer Kumar, BS (2489904720, sameer@habitaware.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients in the HabitAware condition that report the treatment is acceptable. (time frame: 8 weeks). 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 28 Apr 2023.