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

University of North Carolina (UNC)

Status: Completed

Conditions: Binge-Eating Disorder; Bulimia Nervosa

Treatments: Other: Recovery Record

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04162574

17-0242

R01MH119084 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,166 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,166 participants in 1 patient group

BEGIN Case

Description:

Enrolled participants with BN/BED will participate in a 30-day observational study.

Treatment:

Other: Recovery Record