Binge-Eating Genetics Initiative (BEGIN) - Dynamical Systems Approach
Condition: Binge-Eating Disorder; Bulimia Nervosa
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa
Study type: Observational [Patient Registry]

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.
    

Intervention name(s): Recovery Record
Intervention type(s): Other
Intervention description(s): 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.
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.
      
Biospecimen description: 
      Saliva samples are collected from each participant for future studies on the genetics of
      eating disorders