Binge-Eating DisorderBEGINNCT04162574

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

An observational study of Binge-Eating Disorder and Bulimia Nervosa, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Binge-Eating Disorder, Bulimia Nervosa
What is being tested?: Recovery Record
How many people: 1,166 participants
Where: 1 siteUnited States
Study dates: 24 Aug 2017to 31 Aug 2021
How long will I take part?: 1 Month
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
No healthy volunteers
Adult

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.

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina
Chapel Hill, Virginia, 27599-7160

Other trials in United States

About this study

Official title: Predicting Binge and Purge Episodes From Passive and Active Apple Watch Data Using a 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.

Read the 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.

Conditions: Binge-Eating Disorder, Bulimia Nervosa
Being tested: Recovery Record
Medical subject headings: Binge-Eating Disorder, Bulimia Nervosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recovery RecordOther
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.

Study groups in NCT04162574
Study group	Role	What they receive
BEGIN Case		Enrolled participants with BN/BED will participate in a 30-day observational study. Receives: Other: Recovery Record

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: all reported disordered eating events during the 30 day observation period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Aug 201731 Aug 2021

First posted14 Nov 2019
Study start24 Aug 2017
Primary completion31 Aug 2021
Study completion31 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 1,166 participants (actual)
Target duration: 1 Month

IDs, dates and publications

ClinicalTrials.gov ID: NCT04162574
Sponsor's protocol ID: 17-0242
Other IDs: R01MH119084
Acronym: BEGIN
Status last verified: Sep 2021
First submitted: 11 Nov 2019
Last updated: 29 Sep 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Anonymized data and scripts will be made available to the general scientific community at the conclusion of the investigation. Specifically, phenotype data will be submitted to the database of Genotypes and Phenotypes (dbGaP) and National Institute of Mental Health Repository \& Genetics Resource (NRGR) and genotype data to dbGaP.

Publications

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.
PubMed 29154574
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.
PubMed 27165092
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.
PubMed 28373853
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.
PubMed 25365535
Flatt RE, Thornton LM, Tregarthen J, Argue S, Bulik CM. How Engagement Changes Over Time in a Digital Eating Disorder App: Observational Study. JMIR Mhealth Uhealth. 2025 Sep 30;13:e68824. doi: 10.2196/68824.
PubMed 41027004
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.
PubMed 37525298
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.
PubMed 37363967
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.
PubMed 37214840
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.
PubMed 35653175
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.
PubMed 32546136

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predicting Binge and Purge Episodes From Passive and Active Apple Watch Data Using a Dynamical Systems Approach
ClinicalTrials.gov ID: NCT04162574
Acronym / sponsor ID: BEGIN / 17-0242
Conditions: Binge-Eating Disorder, Bulimia Nervosa
Study type: Observational
Recruitment status: Completed
Enrolment: 1,166 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: Recovery Record, University of Utah, uBiome, National Institute of Mental Health (NIMH)
Study start: 24 Aug 2017 (actual)
Primary completion: 31 Aug 2021 (actual)
Study completion: 31 Aug 2021 (actual)
First posted: 14 Nov 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Target follow-up: 1 Month
Number of arms: 1

Arm	Type	Receives
BEGIN Case	–	Other: Recovery RecordEnrolled participants with BN/BED will participate in a 30-day observational study.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult
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.

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Recovery RecordObservational 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.	Other	BEGIN Case

Primary outcome

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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
Background: PubMed 29154574Butner 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.
Background: PubMed 27165092Beltz 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.
Background: PubMed 28373853Butner 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.
Background: PubMed 25365535Butner 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.
Derived from this study: PubMed 41027004Flatt RE, Thornton LM, Tregarthen J, Argue S, Bulik CM. How Engagement Changes Over Time in a Digital Eating Disorder App: Observational Study. JMIR Mhealth Uhealth. 2025 Sep 30;13:e68824. doi: 10.2196/68824.
Derived from this study: PubMed 37525298Carrino 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.
Derived from this study: PubMed 37363967Igudesman 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.
Derived from this study: PubMed 37214840Carrino 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.
Derived from this study: PubMed 35653175Kilshaw 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.
Derived from this study: PubMed 32546136Bulik 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.
Individual participant dataSharing planned: Yes. Anonymized data and scripts will be made available to the general scientific community at the conclusion of the investigation. Specifically, phenotype data will be submitted to the database of Genotypes and Phenotypes (dbGaP) and National Institute of Mental Health Repository \& Genetics Resource (NRGR) and genotype data to dbGaP.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cynthia M Bulik principal investigator

UNC at Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Binge-Eating Disorder and Bulimia Nervosa, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04162574, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.