Bulimia NervosaNCT04126694
Using Continuous Glucose Monitoring to Detect and Intervene on Maintenance Factors for Trans-diagnostic Binge Eating Pathology
A study testing CBT with smartphone application SenseSupport in people with Bulimia Nervosa and Binge Eating, run by Drexel University at 1 site in United States.
Trial summary
The current study will be one of the first to develop and test a passive data collection technique to detect both meal consumption and disordered eating symptoms in patients with clinically significant binge eating and the first just-in-time adaptive interventions (JITAIs) systems using passive sensing technology for… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bulimia Nervosa, Binge Eating
- What is being tested?
- CBT with smartphone application SenseSupport
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2020to 1 Aug 2021
- 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
- Are 18 to 65 years old
- Experience clinically significant binge eating (defined as 12 or more objectively large binge eating episodes in the past 3 months)
- Engage in clinically significant dietary restriction (define as >1 standard deviation above community norms on the Eating Disorder Examination Dietary Restraint Subscale)
- Have a BMI above 18.5
- Are able to give consent
Who cannot join
- Are unable to fluently speak, write and read English
- Are receiving treatment for an eating disorder
- Require immediate treatment for medical complications as a result of eating disorder symptoms
- Have a mental handicap, or are experiencing other severe psychopathology that would limit the participants' ability to comply with the demands of the current study (e.g. severe depression with suicidal intent, active psychotic disorder)
- Have diabetes
- Are pregnant or planning to become pregnant within the next year
Trial locations and contacts
1 site in 1 country.
About this study
The current study will be one of the first to develop and test a passive data collection technique to detect both meal consumption and disordered eating symptoms in patients with clinically significant binge eating and the first just-in-time adaptive interventions (JITAIs) systems using passive sensing technology for eating pathology to be empirically evaluated. A small iterative open clinical trial using an ABAB design (A= SenseSupport Off, B=SenseSupport On) will be conducted to test the feasibility, acceptability, and target engagement of SenseSupport when paired with a 12 week in-person CBT treatment program. The hypothesis that larger decreases in dietary restriction will be observed during SenseSupport On phases compared to SenseSupport Off phases will be tested in this clinical trial.
- Conditions
- Bulimia Nervosa, Binge Eating
- Being tested
- CBT with smartphone application SenseSupport
- Medical subject headings
- Bulimia Nervosa, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT with smartphone application SenseSupportBehavioural
SenseSupport intervention system used as an augment to a 12 week in-person CBT treatment for transdiagnostic binge eating pathology
| Study group | Role | What they receive |
|---|---|---|
| CBT with smartphone application | Experimental | 12 weeks of CBT with SenseSupport smartphone application Receives: Behavioral: CBT with smartphone application SenseSupport |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of weekly episodes of going ≥ 4 waking hours without eating
The number of weekly episodes of going ≥ 4 waking hours without eating captured through CGM and EMA data as well as an EDE-Q assessment before each weekly therapy session. Higher numbers indicate more weekly episodes of dietary restriction. There are no subscale scores or a total score. The number of weekly episodes of going ≥ 4 waking hours without eating will be used to assess the amount of dietary restriction occurring throughout the course of treatment as compared to baseline dietary restriction for the participant.
Measured: 12 weeks
Secondary outcomes (3)
Eating Disorder Examination Questionnaire (EDE-Q)
The Eating Disorder Examination Questionnaire measures eating pathology. The EDE-Q yields four subscale scores: Restraint, Eating Concern, Shape Concern, and Weight Concern. The possible score range for each subscale is 0 to 6. The total score may also be reported (determined by averaging the subscale scores); the score range for the total score is also 0 to 6. For subscale scores and total score, higher scores indicate more severe pathology. The restraint sub-scale of the EDE-Q will be used to assess utilization of skills related to reducing dietary restraint.
Measured: Assessed before each weekly treatment session throughout treatment duration (12 weeks)
Feedback Questionnaire (FQ)
The feedback questionnaire asks qualitative questions about the application. The feedback questionnaire does not report either subscale scores or a total score. The FQ will be used to obtain qualitative acceptability ratings.
Measured: Assessed at weekly treatment sessions throughout treatment duration (12 weeks)
Technology Acceptance Model Scale (TAMS)
The Technology Acceptance Model Scale measures usefulness and ease of use of a technological product. The TAMS yields two subscale scores (usefulness and ease of use). The possible score range for each subscale is 6 to 49. Higher scores indicate greater usefulness and ease of use. The TAMS will be used to assess the perceived usefulness and perceived ease-of-use of the smartphone application to evaluate acceptability.
Measured: Assessed at weekly treatment sessions throughout treatment duration (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start6 Jul 2020
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bulimia NervosaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will receive 12 sessions of in-person CBT delivered over 12 weeks. In weeks 1-2, participants will wear the CGM devices, but will not receive JITAIs and therapists will not have access to the clinician portal. During weeks 3-4, JITAIs will be "turned on" such that patients begin to receive push notifications based on CGM data and therapists will have access to the clinician portal. The A/B periods will be repeated (weeks 5-6 and 9-10, SenseSupport Off; weeks 7-8 and 11-12 SenseSupport On) to ensure that improvements in dietary restriction are due to SenseSupport and not simply to the effect of time in treatment. Similar to the approach used in prior studies, participants will be ran in small waves (n= 3-5 per wave). During each wave, feasibility, acceptability, and target engagement will be assessed, and if acceptable milestones have not been achieved, SenseSupport will be modified before beginning the next wave.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126694
- Sponsor's protocol ID
- 1907007293
- Status last verified
- Sep 2021
- First submitted
- 11 Oct 2019
- Last updated
- 23 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Juarascio AS, Srivastava P, Presseller EK, Lin M, Patarinski AGG, Manasse SM, Forman EM. Using Continuous Glucose Monitoring to Detect and Intervene on Dietary Restriction in Individuals With Binge Eating: The SenseSupport Withdrawal Design Study. JMIR Form Res. 2022 Dec 14;6(12):e38479. doi: 10.2196/38479.
PubMed 36515992
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Continuous Glucose Monitoring to Detect and Intervene on Maintenance Factors for Trans-diagnostic Binge Eating Pathology
- ClinicalTrials.gov ID
- NCT04126694
- Acronym / sponsor ID
- 1907007293
- Conditions
- Bulimia Nervosa, Binge Eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 15 Oct 2019 (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 current study will be one of the first to develop and test a passive data collection technique to detect both meal consumption and disordered eating symptoms in patients with clinically significant binge eating and the first just-in-time adaptive interventions (JITAIs) systems using passive sensing technology for eating pathology to be empirically evaluated. A small iterative open clinical trial using an ABAB design (A= SenseSupport Off, B=SenseSupport On) will be conducted to test the feasibility, acceptability, and target engagement of SenseSupport when paired with a 12 week in-person CBT treatment program. The hypothesis that larger decreases in dietary restriction will be observed during SenseSupport On phases compared to SenseSupport Off phases will be tested in this clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will receive 12 sessions of in-person CBT delivered over 12 weeks. In weeks 1-2, participants will wear the CGM devices, but will not receive JITAIs and therapists will not have access to the clinician portal. During weeks 3-4, JITAIs will be "turned on" such that patients begin to receive push notifications based on CGM data and therapists will have access to the clinician portal. The A/B periods will be repeated (weeks 5-6 and 9-10, SenseSupport Off; weeks 7-8 and 11-12 SenseSupport On) to ensure that improvements in dietary restriction are due to SenseSupport and not simply to the effect of time in treatment. Similar to the approach used in prior studies, participants will be ran in small waves (n= 3-5 per wave). During each wave, feasibility, acceptability, and target engagement will be assessed, and if acceptable milestones have not been achieved, SenseSupport will be modified before beginning the next wave.
| Arm | Type | Receives |
|---|---|---|
| CBT with smartphone application | Experimental | Behavioral: CBT with smartphone application SenseSupport12 weeks of CBT with SenseSupport smartphone application |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are 18 to 65 years old
- Experience clinically significant binge eating (defined as 12 or more objectively large binge eating episodes in the past 3 months)
- Engage in clinically significant dietary restriction (define as >1 standard deviation above community norms on the Eating Disorder Examination Dietary Restraint Subscale)
- Have a BMI above 18.5
- Are able to give consent
Key exclusion criteria (6 listed)
- Are unable to fluently speak, write and read English
- Are receiving treatment for an eating disorder
- Require immediate treatment for medical complications as a result of eating disorder symptoms
- Have a mental handicap, or are experiencing other severe psychopathology that would limit the participants' ability to comply with the demands of the current study (e.g. severe depression with suicidal intent, active psychotic disorder)
- Have diabetes
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 |
|---|---|---|
| CBT with smartphone application SenseSupportSenseSupport intervention system used as an augment to a 12 week in-person CBT treatment for transdiagnostic binge eating pathology | Behavioural | CBT with smartphone application |
Primary outcome
Number of weekly episodes of going ≥ 4 waking hours without eating
Time frame: 12 weeks
The number of weekly episodes of going ≥ 4 waking hours without eating captured through CGM and EMA data as well as an EDE-Q assessment before each weekly therapy session. Higher numbers indicate more weekly episodes of dietary restriction. There are no subscale scores or a total score. The number of weekly episodes of going ≥ 4 waking hours without eating will be used to assess the amount of dietary restriction occurring throughout the course of treatment as compared to baseline dietary restriction for the participant.
3 secondary outcomes
Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: Assessed before each weekly treatment session throughout treatment duration (12 weeks)
Feedback Questionnaire (FQ)
Time frame: Assessed at weekly treatment sessions throughout treatment duration (12 weeks)
Technology Acceptance Model Scale (TAMS)
Time frame: Assessed at weekly treatment sessions throughout treatment duration (12 weeks)
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 23 Sep 2021.
- Derived from this study: PubMed 36515992Juarascio AS, Srivastava P, Presseller EK, Lin M, Patarinski AGG, Manasse SM, Forman EM. Using Continuous Glucose Monitoring to Detect and Intervene on Dietary Restriction in Individuals With Binge Eating: The SenseSupport Withdrawal Design Study. JMIR Form Res. 2022 Dec 14;6(12):e38479. doi: 10.2196/38479.
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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 CBT with smartphone application SenseSupport in people with Bulimia Nervosa and Binge Eating, 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 5 inclusion and 6 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 23 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. 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?
Number of weekly episodes of going ≥ 4 waking hours without eating (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04126694, which also lists 1 linked publication.
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 23 Sep 2021.