Binge-Eating Genetics Initiative (BEGIN) - Dynamical Systems Approach

Bulimia Nervosa Clinical Trial

— BEGIN  

Official title:

Predicting Binge and Purge Episodes From Passive and Active Apple Watch Data Using a Dynamical Systems Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04162574
• Other study ID #: 17-0242
• Secondary ID: R01MH119084
• Status: Completed
• Start date: August 24, 2017
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1166
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Feeding and Eating Disorders

Intervention

Other:
• Recovery Record
Observational data will be obtained through participants entering data on disordered eating episodes, mood, and food in Recovery Record, an app to assist people in managing their eating disorder during the 30 days of the trial. In addition, participants wear an Apple Watch from which passive data (e.g., heart rate, activity, and geolocation) are collected.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	Virginia

Sponsors (5)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), Recovery Record, uBiome, University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction models for the occurrence of disordered eating episodes in individuals with BN/BED using passive sensor data	Dynamic systems approach will use passive and active data to illustrate the dynamics that lead up to a binge or purge event. Using passive data up to two hours prior to a binge or purge event as recorded within the Recovery Record app by the participant (but not within an hour of a previous event), changes in heart rate and actigraphy will be modeled as a function of current heart rate and actigraphy. Time leading up to the binge or purge event, type of event (binge or purge), and an interaction with the type of event will be included as moderators of the relationship of heart and steps in predicting their changes. As one approaches a binge or purge, this will capture a reduction in pattern stability as the strength of association between current heart rate and steps and changes in these same variables should become weaker as one approaches the binge or purge event. This analysis will be able to identify how early signs of instability are detectable before binge and purge events.	all reported disordered eating events during the 30 day observation period
Primary	Models of the dynamics in the 2 hours after a disordered eating event occurs	Using dynamical system approaches, changes in heart rate and steps will be modeled as a function of current levels in heart rate and steps. Time since the binge/purge, type of event, and BN/BED diagnosis (along with interactions between them) will be used as moderators of the relationships of heart rate and actigraphy in predicting the changes.	all reported disordered eating events during the 30 day observation period
Primary	Prediction models with contextual factors of disordered eating episodes	Contextual factors such as positive and negative mood, time of day, prior same day binge eating and/or purging, location, and use of coping skills will be used to inform the models from OUTCOME 1 to see how these factors moderate likelihood of disordered eating episodes. Current mood is assessed within Recovery Record. When participants log a meal, or a binge or purge, they are asked "Which feelings are you experiencing?" There are 28 response options. These include, but are not limited to Happy, Anxious, Lonely, Guilt, Angry, Depressed. Participants can select as many as they like. For each feeling they endorse, they can indicate the level to which they are experiencing these feeling on a 5-point Likert scale, ranging from options such as 'A little' to 'Extreme', where higher values indicate greater intensity of the feeling endorsed.	all reported disordered eating events during the 30 day observation period