Clinical trial NCT04162574: Binge-Eating Genetics Initiative (BEGIN) - Dynamical Systems Approach
Official title: Predicting Binge and Purge Episodes From Passive and Active Apple Watch Data Using a Dynamical Systems Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Binge-Eating Disorder
Bulimia Nervosa
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Recovery Record
name: University of Utah
name: uBiome
name: National Institute of Mental Health (NIMH)
First posted: 2019-11-14
Enrollment: 1166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals between the ages of 18 and 45, who have an iPhone 5 or later, and who are currently experiencing episodes of binge eating can join the study.

Brief summary: The Binge Eating Genetics Initiative (BEGIN) is an observational study where individuals with binge-eating disorder (BED) or bulimia nervosa (BN) complete assessments about eating disorder history, current disordered eating behavior, and mood. Participants also provide active data on binge eating, purging, nutrition, and cognitions using Recovery Record on the Apple Watch. Passive sensor data are collected via native applications over a 30-day period in 1000 individuals with BED or BN. Investigators will combine longitudinal passive (Apple Watch) and active (Recovery Record) data to predict when patients are at high risk of binge eating or purging. Results will enable the deployment of real-time, in-the-moment, personalized signaling of impending binge or purge episodes that will interrupt automatic behaviors and empower patients to exert control over binge eating and purging by engaging in therapeutic alternatives.

Detailed description: The parent study, BEGIN, has full ethical approval. From within Recovery Record, individuals are directed to a link to the BEGIN study. From outside Recovery Record, interested individuals complete a brief screen. If they are potentially eligible, they are directed to Recovery Record. Informed consent for phenotyping is obtained digitally via the Recovery Record app. After consent, interested participants complete a validated eating disorders diagnostic questionnaire based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria adapted from the Structured Clinical Interview for DSM-5 (ED100K). This questionnaire was developed for use in large genetic studies as a means to recruit large samples efficiently with high diagnostic accuracy. Those who screen case positive are offered the opportunity to participate in the full study (with a second informed consent also delivered from within Recovery Record). Eligible participants are mailed a package containing a description of the study, saliva collection kit, stool collection kit, and an Apple Watch. Participants complete the Eating Disorder Examination Questionnaire (EDE-Q), Generalized Anxiety Disorder 7-item scale (GAD-7), and Patient Health Questionnaire-9 (PHQ-9) at enrollment, midpoint, and endpoint. Participants are asked to log mood and food in the Recovery Record app on their Apple Watch for 30 days, the duration of the study. During those 30-days, participants are also asked to submit their saliva and stool samples. Saliva kits are returned directly to Rutgers University Cell and DNA Repository (RUCDR).

The questionnaire, active, and passive data will all be used to characterize patterns of when and where individuals are more/less likely to binge and/or purge in their daily lives. The investigators will identify low-risk and high-risk passive data patterns that will facilitate the prediction of transitions to high risk states signaling impending binge or purge episodes.

Eligibility criteria: Inclusion Criteria:

* Resident of US;
* a current BN or BED diagnosis (confirmed via questionnaire in screening instrument);
* age 18-45 years, inclusive;
* reads, speaks English;
* existing iPhone user with iPhone 5 or later;
* provides informed consent;
* ambulatory

Exclusion Criteria:

* Current use of hormone therapy;
* bariatric surgery, including the following: Roux-en-Y, gastric bypass, laparoscopic adjustable gastric banding, sleeve gastrectomy, duodenal switch with biliopancreatic diversion;
* currently pregnant or breastfeeding;
* thoughts of suicide with a plan in the 2 weeks prior to study enrollment;
* hospitalization due to ED in the 2 weeks prior to study enrollment;
* antibiotic use in the past 30 days (renders temporary ineligibility, but can be - eligible to participate again 30 days after the last dose);
* probiotic use in the past 30 days

Primary outcomes:
measure: Prediction models for the occurrence of disordered eating episodes in individuals with BN/BED using passive sensor data
timeFrame: all reported disordered eating events during the 30 day observation period
measure: Models of the dynamics in the 2 hours after a disordered eating event occurs
timeFrame: all reported disordered eating events during the 30 day observation period
measure: Prediction models with contextual factors of disordered eating episodes
timeFrame: all reported disordered eating events during the 30 day observation period
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: Virginia
Study officials:
affiliation: UNC at Chapel Hill
name: Cynthia M Bulik
role: PRINCIPAL_INVESTIGATOR
References:
citation: Butner JE, Deits-Lebehn C, Crenshaw AO, Wiltshire TJ, Perry NS, Kent de Grey RG, Hogan JN, Smith TW, Baucom KJW, Baucom BRW. A multivariate dynamic systems model for psychotherapy with more than one client. J Couns Psychol. 2017 Nov;64(6):616-625. doi: 10.1037/cou0000238.
citation: Beltz AM, Wright AG, Sprague BN, Molenaar PC. Bridging the Nomothetic and Idiographic Approaches to the Analysis of Clinical Data. Assessment. 2016 Aug;23(4):447-458. doi: 10.1177/1073191116648209.
citation: Butner JE, Wiltshire TJ, Munion AK. Modeling Multi-Agent Self-Organization through the Lens of Higher Order Attractor Dynamics. Front Psychol. 2017 Mar 20;8:380. doi: 10.3389/fpsyg.2017.00380. eCollection 2017.
citation: Butner JE, Gagnon KT, Geuss MN, Lessard DA, Story TN. Utilizing topology to generate and test theories of change. Psychol Methods. 2015 Mar;20(1):1-25. doi: 10.1037/a0037802. Epub 2014 Nov 3.
citation: Kilshaw RE, Adamo C, Butner JE, Deboeck PR, Shi Q, Bulik CM, Flatt RE, Thornton LM, Argue S, Tregarthen J, Baucom BRW. Passive Sensor Data for Characterizing States of Increased Risk for Eating Disorder Behaviors in the Digital Phenotyping Arm of the Binge Eating Genetics Initiative: Protocol for an Observational Study. JMIR Res Protoc. 2022 Jun 2;11(6):e38294. doi: 10.2196/38294.
citation: Bulik CM, Butner JE, Tregarthen J, Thornton LM, Flatt RE, Smith T, Carroll IM, Baucom BRW, Deboeck PR. The Binge Eating Genetics Initiative (BEGIN): study protocol. BMC Psychiatry. 2020 Jun 16;20(1):307. doi: 10.1186/s12888-020-02698-7.