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

NCT04162574 | Completed DMC

• 2 other identifiers: 17-0242R01MH119084
• Study Type: observational
• Target: 1,166
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge-Eating Disorder; Bulimia Nervosa

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

BEGIN Case

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

Other: Recovery Record

Interventions

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.

BEGIN Case

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Recovery Record: collaborator
• University of Utah: collaborator
• uBiome: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, Virginia, 27599-7160, United States

Location

Related Publications (9)

• 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.

  PMID: 29154574 BACKGROUND

• 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.

  PMID: 27165092 BACKGROUND

• 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.

  PMID: 28373853 BACKGROUND

• 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.

  PMID: 25365535 BACKGROUND

• Carrino EA, Flatt RE, Pawar PS, Sanzari CM, Tregarthen JP, Argue S, Thornton LM, Bulik CM, Watson HJ. Sociodemographic and clinical characteristics of treated and untreated adults with bulimia nervosa or binge-eating disorder recruited for a large-scale research study. J Eat Disord. 2023 Jul 31;11(1):126. doi: 10.1186/s40337-023-00846-4.

  PMID: 37525298 DERIVED

• Igudesman D, Abbaspour A, Reed KK, Flatt RE, Becken B, Thornton LM, Bulik CM, Carroll IM. Laxative Abuse Is Associated With a Depleted Gut Microbial Community Structure Among Women and Men With Binge-Eating Disorder or Bulimia Nervosa: The Binge Eating Genetics Initiative. Psychosom Med. 2023 Oct 1;85(8):727-735. doi: 10.1097/PSY.0000000000001226. Epub 2023 Jun 19.

  PMID: 37363967 DERIVED

• Carrino E, Flatt R, Pawar P, Sanzari C, Tregarthen J, Argue S, Thornton L, Bulik C, Watson H. Sociodemographic and Clinical Characteristics of Treated and Untreated Adults with Bulimia Nervosa and/or Binge-eating Disorder Recruited for a Large-Scale Research Study. Res Sq [Preprint]. 2023 May 10:rs.3.rs-2899349. doi: 10.21203/rs.3.rs-2899349/v1.

  PMID: 37214840 DERIVED

• 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.

  PMID: 35653175 DERIVED

• 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.

  PMID: 32546136 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples are collected from each participant for future studies on the genetics of eating disorders

MeSH Terms

Conditions

Binge-Eating Disorder; Bulimia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Cynthia M Bulik

  UNC at Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 14, 2019
• Study Start: August 24, 2017
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Assessment phenotype data will be submitted within 6 months after the end of the study. Genotype data will be submitted after the first set of analyses with these data are complete. All data will be available as long as the repositories maintain the datasets (indefinitely).
• Access Criteria: The databases are controlled-access meaning that individuals who wish to have access to the data must apply to the respective repository and meet all of their criteria.

Locations

US (1)