Optimizing Digital Health Technology Interventions to Increase Skill Acquisition and Utilization
Key facts
- Who runs it
- Nemours Children's Clinic
- Where
- Wilmington, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 264 people, planned
- Started
- 6 Jan 2023
- Expected to end
- Jan 2027
- Type of study
- Interventional, 6 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Behavioral Therapy for Eating Disorders
- Skills Monitoring On
- Automated Reminder Messages
- JITAIs
- Record updated
- 11 September 2026
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Are 18 to 65 years old
- Have experienced 12 or more loss of control episodes within the previous 3 months
- Have a BMI above 18.5
- Are located in the US and willing/able to participate in remote treatment and assessments
- Have a smartphone
- Complete the three-day app trial after the baseline assessment (i.e., the participant shows that they can self-monitor their episodes of eating three times a day for three days)
Who cannot take part
- Are already receiving treatment for an eating disorder (e.g., research participants cannot be receiving concurrent eating disorder treatment in the clinical trial and from another provider). Participants willing to pause their existing eating disorder treatment for the duration of the clinical trial are eligible to participate
- Are already receiving pharmacological or behavioral treatment for weight loss
- Are using a substance wherein the substance use is creating significant functional impairment that it is unlikely they can safely and effectively participate in an outpatient treatment study for eating pathology (i.e., the substance use: is interfering with day-to-day responsibilities and/or has gotten them in trouble with the law in the past year and/or has prevented them from attending/completing work and/or school within the past year) and/or if they are experiencing medical symptoms related to their substance use that requires immediate treatment and/or are unwilling or refrain from using the substances when it may interfere with treatment sessions and assessments (i.e., unwilling to not use the substances starting 2 hours prior to assessments and treatment sessions). Substance use is assessed during the phone screen and with the standardized assessment checklist
- Have a mental handicap or are experiencing other severe psychopathology that would limit the research participants' ability to comply with the demands of the current study (e.g., imminent suicide risk, active psychotic disorder). Imminent suicide risk is assessed through the C-SSRS and a full risk assessment (see "Plan for assessing and/or intervening on suicidal ideation" above). Active psychotic disorder is assessed during the phone screen and with the standardized assessment checklist
- If they meet the criteria for PCP clearance (see "Primary care physician clearance" section above) and are not deemed safe for outpatient treatment by a primary care physician
- If they meet the criteria for PCP clearance and are unwilling to receive medical clearance and/or medical monitoring as requested by the study to ensure they are medically safe to participate
- Are unable to fluently speak, write and read English
- Have a BMI below 18.5
- Are pregnant or planning to become pregnant within the next year and a half
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in United States
- Nemours Children's Health, WilmingtonWilmington, United StatesContact: Clinical Research CoordinatorTaking people
About the trial
What the trial wants to find out
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).
The 6 groups in the trial
- Base BT (Skills Monitoring Off + No Micro-Interventions)Existing treatment, for comparison
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.
Treatment: Behavioral Therapy for Eating Disorders
- Base BT + Skills Monitoring On + No Micro-InterventionsTreatment being tested
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.
Treatment: Behavioral Therapy for Eating Disorders and Skills Monitoring On
- Base BT + Skills Monitoring On + Automated Reminder MessagesTreatment being tested
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.
Treatment: Behavioral Therapy for Eating Disorders, Skills Monitoring On, and Automated Reminder Messages
- Base BT + Skills Monitoring On + JITAIsTreatment being tested
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).
Treatment: Behavioral Therapy for Eating Disorders, Skills Monitoring On, and JITAIs
- Base BT + Skills Monitoring Off + Automated Reminder MessagesTreatment being tested
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.
Treatment: Behavioral Therapy for Eating Disorders and Automated Reminder Messages
- Base BT + Skills Monitoring Off + JITAIsTreatment being tested
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).
Treatment: Behavioral Therapy for Eating Disorders and JITAIs
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Optimizing Digital Health Technologies to Improve Therapeutic Skill Use and Acquisition
- Fit questions
- Built from NCT05473013, who can take part
- Record updated
- 11 September 2026