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Completed

NCT Number: NCT04162574

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

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina

Chapel Hill, Virginia, 27599-7160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recovery Record

Other

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.

Primary outcomes

  1. Prediction models for the occurrence of disordered eating episodes in individuals with BN/BED using passive sensor data

    Time frame: all reported disordered eating events during the 30 day observation period

    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.

  2. Models of the dynamics in the 2 hours after a disordered eating event occurs

    Time frame: all reported disordered eating events during the 30 day observation period

    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.

  3. Prediction models with contextual factors of disordered eating episodes

    Time frame: all reported disordered eating events during the 30 day observation period

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Recovery Record
  • University of Utah
  • uBiome

Registry information

Official study title

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

Acronym: BEGIN

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Nov 14, 2019
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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