SBIR/STTR Research Award
Using Continuous Glucose Monitoring to Detect and Intervene on Maintenance Factors for Transdiagnostic Binge Eating Pathology
Award amount
$883,830Program and phase
SBIR · Phase IAward year
2019Award details
- Awarding agency
- Department of Health and Human Services
- Branch
- National Institutes of Health
- Recipient company
- PromptWorks, LLC
- Proposal award date
- 2019-09-24
- Contract end date
- 2021-08-31
- UEI
- SPM3FKBS8DX4
- Solicitation number
- PA18-579
- Topic code
- 104
Research abstract
PROJECT SUMMARY
Although CBT is an effective treatment for many individuals with transdiagnostic binge eating, recent systematic
reviews and meta-analyses have found that 40-50% of patients with binge eating disorder (BED) and nearly
70% of patients with bulimia nervosa (BN) remain fully or partially symptomatic after a full course of CBT.
Reducing rigid dietary restriction is one of the only mechanisms of action that has been consistently identified in
treatments for binge eating. In particular, adherence to a regular eating schedule (e.g. eating three meals and
one-two snacks per day and not going more than four waking hours without eating) is one of the biggest
predictors of treatment success in both BN and BED. Although one of the primary goals of CBT for binge eating
is the reduction of dietary restriction (with over 50% of session content dedicated to this goal in most treatment
manuals), many patients continue to engage in restrictive eating behaviors during and after treatment,
suggesting that CBT is failing to sufficiently improve this clinical target. This pattern of results suggests a critical
need both to understand why many individuals fail to improve in existing treatments and to develop new
intervention approaches or augmentations that can produce superior treatment outcomes.
The primary goal of this STTR Phase 1 application is to develop and pilot an mHealth intervention system
(SenseSupport) that can be used as an augmentation to traditional CBT for transdiagnostic binge eating that
can better target dietary restriction. Our proposed mHealth intervention system will use continuous glucose
monitoring (CGM) to 1) accurately detect dietary restriction as it occurs, 2) accurately detect known risk-factors
for a reoccurrence of dietary restriction (e.g. binge eating and self-induced vomiting episodes), 3) deliver real-
time push notifications linked to brief CBT-based interventions when dietary restriction, binge eating, or self-
induced vomiting is detected, and 4) share objective data on eating behaviors with a treatment provider to
enhance the therapeutic work occurring during in-person CBT. In months 0-6, we will collect data from 30
individuals with clinically significant binge eating who will wear a Dexcom G6 CGM for four weeks while
electronically tracking all eating behaviors and disordered eating symptoms. While data collection is ongoing,
we will also use months 0-6 to the SenseSupport system. During months 7-24, we will conduct a small (n=30)
clinical trial using an ABAB design (A= SenseSupport On, B=SenseSupport Off) to test the feasibility,
acceptability, and target engagement of the SenseSupport System. Receipt of this award will allow members of
PromptWorks, Drexel University, the University of Pennsylvania, and Dexcom to develop an innovative
intervention system that we believe can reduce dietary restriction and improve treatment outcomes for
individuals with clinically significant binge eating. The proposed system would be the first of its kind for the
treatment of eating pathology with high potential to market to the over 42 million individuals who experience
clinically significant binge eating in the United States as well as to treatment facilities that could use our tool as
a way to augment existing treatment approaches.PROJECT NARRATIVE
Although cognitive behavioral therapy (CBT) can be an effective treatment for transdiagnostic binge eating
pathology, a large percent of individuals do not experience clinically significant improvements in rigid dietary
restriction (a well-established maintenance factor for binge eating) and treatment outcomes suffer as a result.
The primary goal of this STTR Phase 1 application is to develop and pilot an mHealth intervention system
(SenseSupport) that can be used as an augmentation to traditional CBT for transdiagnostic binge eating that
can better target dietary restriction. Our proposed mHealth intervention system will use continuous glucose
monitoring to 1) accurately detect dietary restriction as it occurs, 2) accurately detect known risk-factors for a
reoccurrence of dietary restriction (e.g. binge eating and self-induced vomiting episodes), 3) deliver real-time
push notifications linked to brief CBT-based interventions when dietary restriction, binge eating, or self-induced
vomiting is detected, and 4) share objective data on eating behaviors with a treatment provider to enhance the
therapeutic work occurring during in-person CBT.
Technology keywords
Not reported
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