Recruiting

Digital Health Technology

Sponsor:

Nemours Children's Clinic

Code:

NCT05473013

Conditions

Bulimia Nervosa

Bulimia

Binge Eating

Binge-Eating Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Behavioral Therapy for Eating Disorders

Skills Monitoring On

Automated Reminder Messages

JITAIs

Study Details

Brief summary:

The purpose of this study is to identify the independent and combined effects of two types of self-monitoring and two types of micro-interventions when combined with standard cognitive behavioral treatment for bulimia nervosa (BN) and binge eating disorder (BED). The primary aims of this study are (1) to evaluate the optimal complexity of Self-Monitoring and Micro-Interventions on eating pathology (at post-treatment and at 6 and 12-month follow-ups and (2) to test the hypotheses that the optimal complexity level of each component is moderated by baseline deficits in self-regulation. The secondary aim will be to test target engagement for each level of complexity for each component, i.e., to test whether higher complexity of each technological components is associated with better rates of therapeutic skill use and acquisition and that improvements in skill use and acquisition are associated with improvements in outcomes. A final exploratory aim will be to quantify the component interaction effects, which may be partially additive (because components overlap and/or there is diminishing return), fully additive, or synergistic (in that component complexities may partially depend on each other).

Conditions

Bulimia Nervosa

Bulimia

Binge Eating

Binge-Eating Disorder

Study ID

NCT05473013

Start date

Jan 6, 2023

Status verified date

Jul, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Have experienced 12 or more loss of control episodes within the previous 3 months
2. Have a BMI at or above 18.5
3. Are located in the US and willing/able to participate in treatment and assessments
4. Are able to give consent

Exclusion Criteria:

1. Are unable to fluently speak, write and read English
2. Have a BMI below 18.5
3. Are already receiving treatment for an eating disorder
4. Require immediate treatment for medical complications as a result of eating disorder symptoms
5. Have a mental handicap, or are experiencing other severe psychopathology that would limit the participants' ability to comply with the demands of the current study (e.g. severe depression with suicidal intent, active psychotic disorder, severe substance use)
6. Are pregnant or are planning to become pregnant

Study Design

Enrollment

264 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Base BT (Skills Monitoring Off + No Micro-Interventions)

16 weekly sessions of standard behavioral therapy for eating disorders aimed at changing behaviors that maintain binge eating (e.g. rigid dietary restriction outside of binge episodes, irregular or chaotic eating patterns). This will include traditional self-monitoring of participants' eating patterns, binging, and (if applicable) compensatory behaviors via a smartphone application.

experimental: Base BT + Skills Monitoring On + No Micro-Interventions

16 weekly sessions of standard behavioral therapy for eating disorders aimed at changing behaviors that maintain binge eating (e.g. rigid dietary restriction outside of binge episodes, irregular or chaotic eating patterns). This will include a more complex self-monitoring than the self-monitoring protocol with traditional behavioral treatment. Via a smartphone application, participants will be asked to self-monitor skill usage of the skills provided during treatment sessions on top of monitoring their eating patterns, binging, and (if applicable) compensatory behaviors.

experimental: Base BT + Skills Monitoring On + Automated Reminder Messages

16 weekly sessions of standard behavioral therapy for eating disorders aimed at changing behaviors that maintain binge eating (e.g. rigid dietary restriction outside of binge episodes, irregular or chaotic eating patterns).This will include a more complex self-monitoring than the self-monitoring protocol with traditional behavioral treatment. Via a smartphone application, participants will be asked to self-monitor skill usage of the skills provided during treatment sessions on top of monitoring their eating patterns, binging, and (if applicable) compensatory behaviors. It will also include participants receiving two randomly time automated push notifications from the application each week to remind them about skills they have learned in session to encourage skill use.

experimental: Base BT + Skills Monitoring On + JITAIs

16 weekly sessions of standard behavioral therapy for eating disorders aimed at changing behaviors that maintain binge eating (e.g. rigid dietary restriction outside of binge episodes, irregular or chaotic eating patterns). This will include a more complex self-monitoring than the self-monitoring protocol with traditional behavioral treatment. Via a smartphone application, participants will be asked to self-monitor skill usage of the skills provided during treatment sessions on top of monitoring their eating patterns, binging, and (if applicable) compensatory behaviors. It will also include participants receiving push notifications each week to remind them about skills they have learned in session to encourage skill use during app-identified moments of need (i.e., JITAIs, just-in-time adaptive interventions).

experimental: Base BT + Skills Monitoring Off + Automated Reminder Messages

16 weekly sessions of standard behavioral therapy for eating disorders aimed at changing behaviors that maintain binge eating (e.g. rigid dietary restriction outside of binge episodes, irregular or chaotic eating patterns). This will include traditional self-monitoring of participants' eating patterns, binging, and (if applicable) compensatory behaviors via a smartphone application. It will also include participants receiving two randomly time automated push notifications from the application each week to remind them about skills they have learned in session to encourage skill use.

experimental: Base BT + Skills Monitoring Off + JITAIs

16 weekly sessions of standard behavioral therapy for eating disorders aimed at changing behaviors that maintain binge eating (e.g. rigid dietary restriction outside of binge episodes, irregular or chaotic eating patterns). This will include traditional self-monitoring of participants' eating patterns, binging, and (if applicable) compensatory behaviors via a smartphone application. It will also include participants receiving push notifications each week to remind them about skills they have learned in session to encourage skill use during app-identified moments of need (i.e., JITAIs, just-in-time adaptive interventions).

Interventions

Behavioral Therapy for Eating Disorders

Standard behavioral therapy for eating disorders aimed at changing behaviors that maintain binge eating (e.g. rigid dietary restriction outside of binge episodes, irregular or chaotic eating patterns).

Skills Monitoring On

Integrates behavioral treatment for eating disorders with a more complex self-monitoring than the self-monitoring protocol with traditional behavioral treatment. Via a smartphone application, participants will be asked to self-monitor skill usage of the skills provided during treatment sessions on top of monitoring their eating patterns, binging, and (if applicable) compensatory behaviors.

Automated Reminder Messages

Integrates behavioral treatment for eating disorders with two randomly time automated push notifications from a smartphone application each week to remind participants about skills they have learned in session to encourage skill use.

JITAIs

Integrates behavioral treatment for eating disorders with push notifications each week from a smartphone application to remind participants about skills they have learned in session to encourage skill use during app-identified moments of need (i.e., JITAIs, just-in-time adaptive interventions).

Primary outcome measure

  • Binge eating frequency assessed by the Eating Disorder Examination [ Time Frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment ]
  • Global Eating Pathology [ Time Frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment ]
  • Remission Status [ Time Frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment ]
  • BMI [ Time Frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and at a 6 month and a 12-month post-treatment follow-up assessment ]

Central Contacts and Locations

Central contacts

Adrienne Juarascio, Ph.D.

4438018093asj32@drexe.edu

Locations

Drexel University, Stratton Hall

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

More Information

Sponsor

Nemours Children's Clinic

Last update posted

Aug 19, 2026

Last verified

Jul, 2026

Keywords

  • Eating disorders
  • Bulimia Nervosa
  • Bulimia
  • Binge Eating
  • Binge Eating Disorder
  • Cognitive Behavioral Treatment for Eating Disorders
  • Digital health technologies (DHTs)
  • Micro-Interventions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Nemours Children's Clinic on 2026-08-19.