Digital Intervention for Binge Eating Disorder in Black Women

Overseen By Rachel Goode, PhD,MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Pregnancy, Substance abuse, Anorexia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a digital intervention to help Black women manage binge eating and prevent weight gain. The research focuses on a program called "Centering Appetite," accessible through a smartphone app and online lessons. It targets Black women with obesity who experience at least one binge-eating episode weekly. Participants should live or work near Kannapolis, NC, and regularly use a Bluetooth-enabled smartphone. The goal is to provide culturally relevant support to reduce binge eating and improve health outcomes. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new, culturally tailored health solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this digital intervention is safe for treating binge eating disorder in Black women?

Research shows that treatments for binge eating disorder (BED) are generally easy for people to handle. Studies have found that cognitive behavioral therapies (a type of talk therapy) and some medications can help reduce binge-eating episodes. These methods have worked well in many cases without causing serious side effects.

For the specific treatment in this trial, called "Centering Appetite," detailed studies about its safety are not yet available. However, since it involves participating from home and focuses on boosting confidence in making changes, it is likely low-risk. Most people using similar methods in other trials did not report major health problems.

This trial is not in a phase that usually tests safety in depth, suggesting the treatment is expected to be safe enough for participants. Those considering joining might find it helpful to ask about any specific risks during the consent process. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Centering Appetite" intervention for binge eating disorder in Black women because it offers a digital, accessible, and personalized approach to tackling this condition. Unlike traditional treatments that may involve in-person therapy or medication, this intervention is delivered through a smartphone app, making it more convenient and less stigmatizing. It focuses on building self-efficacy, empowering participants to manage their eating behaviors and prevent weight gain, which is a fresh approach compared to existing options. By providing psychoeducation and support remotely, this method has the potential to reach a wider audience and offer continuous, flexible support.

What evidence suggests that the Centering Appetite intervention could be effective for binge eating in Black women?

Research has shown that treating binge eating disorder (BED) often involves methods like cognitive behavioral therapy and medications, which can help reduce the frequency of binge-eating episodes. For Black women, who face unique cultural and systemic challenges, a personalized approach is important. In this trial, the Centering Appetite program aims to boost confidence in managing eating habits to reduce binge eating and prevent weight gain. Early results suggest that culturally relevant programs can lead to better outcomes for groups that haven't had as much success with standard treatments. While specific data for this program isn't available yet, focusing on building confidence and cultural relevance aligns with effective strategies for reducing binge eating. ^{1 2 4 6 7}

Who Is on the Research Team?

Rachel Goode, PhD,MPH

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for Black women over 18 with obesity (BMI ≥ 30) who binge eat at least once a week and live or work within 30 miles of Kannapolis, NC. They must use a smartphone and complete a questionnaire. It's not for those in other weight programs, using drugs/alcohol heavily, pregnant, treating substance abuse/eating disorders, or with anorexia history.

Inclusion Criteria

BMI ≥ 30 kg/m^2

Have and regularly use a Bluetooth-enabled smartphone

Report at least one binge eating episode weekly

Exclusion Criteria

Are concurrent intravenous drug users

Consume >4 alcoholic beverages/day

Currently pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a digital health appetite awareness and behavioral weight program via a smartphone app and online lessons

6 months

Remote participation via app and online lessons

Follow-up

Participants are monitored for changes in binge eating episodes and weight regain

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Centering Appetite

Trial Overview 'Centering Appetite' is being tested as a culturally-relevant digital treatment to help Black women manage obesity and binge eating. The study aims to address the high rates of obesity by focusing on reducing binge eating behaviors through accessible technology.

How Is the Trial Designed?

Group I: Centering Appetite Intervention, Then Attention- Control Group Experimental Treatment 1 Intervention

Participants randomized to the attention-control group will participate remotely via a smartphone app and online lessons. The intervention will build participants' self-efficacy to reduce binge eating and to assist them in preventing weight gain.

Group II: Attention- Control Group, Then Centering Appetite Intervention Active Control 1 Intervention

Participants randomized to the centering appetite intervention group will receive weekly psychoeducation emails about general wellness topics, discussion of binge eating, diet, and physical activity.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a pilot study involving 155 participants with binge-spectrum eating disorder, offering a choice between two digital interventions did not lead to significantly better treatment outcomes compared to random assignment.

Both groups showed improvements in binge eating behaviors and related concerns, suggesting that the effectiveness of digital interventions may not be influenced by client preferences when the programs are based on similar cognitive-behavioral principles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Participant's Choice of Different Digital Interventions on Outcomes for Binge-Spectrum Eating Disorders: A Pilot Doubly Randomized Preference Trial. Linardon, J., Shatte, A., Messer, M., et al.[2023]

The study involving 66 participants with binge-eating disorder or bulimia nervosa found that the Noom Monitor app combined with guided self-help treatments (CBT-GSH) significantly reduced objective bulimic episodes compared to traditional CBT-GSH alone.

Participants using the Noom app showed better adherence to meal and snack guidelines, which helped mediate the treatment's effectiveness, although both treatments had similar remission rates at the 6-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial comparing smartphone assisted versus traditional guided self-help for adults with binge eating. Hildebrandt, T., Michaelides, A., Mackinnon, D., et al.[2023]

The ASTrA digital self-help application, designed for individuals with various eating disorders, demonstrated excellent psychometric properties, including high validity and reliability, based on evaluations from 15 patients and 13 clinicians.

Both patients and clinicians found the application acceptable and feasible for clinical use, indicating strong potential for practical implementation in promoting motivation for change in eating disorder treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a transdiagnostic digital interactive application for eating disorders: psychometric properties, satisfaction, and perceptions on implementation in clinical practice. Booij, L., Israël, M., Ferrari, M., et al.[2023]

A qualitative usability evaluation of a new app for binge eating, involving 14 participants with binge eating symptoms, showed that the app had good usability and was well-received for its flexible content and interactivity.

Participants appreciated the app's easy-to-understand information and progress tracking, but raised concerns about its visual design and the absence of professional feedback, highlighting areas for improvement in future app development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability Evaluation of a Cognitive-Behavioral App-Based Intervention for Binge Eating and Related Psychopathology: A Qualitative Study. Linardon, J., King, T., Shatte, A., et al.[2022]

In a pilot study involving 22 adults with binge-eating disorder (BED), the combination of naltrexone and bupropion (NB) was well-tolerated, showing significant reductions in binge-eating frequency, eating-disorder psychopathology, depression, and weight during treatment, although these effects were not significantly different from placebo.

Notably, 45.5% of patients on NB achieved a 3% weight loss compared to none on placebo, indicating a potential benefit of NB for weight management in BED, but further research with a larger sample size is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. Grilo, CM., Lydecker, JA., Morgan, PT., et al.[2022]

Lisdexamfetamine significantly reduces binge eating days and improves related clinical outcomes in adults with moderate-to-severe binge eating disorder, based on a meta-analysis of three randomized controlled trials.

However, patients taking lisdexamfetamine experienced higher rates of discontinuation due to adverse events compared to those on placebo, indicating a need for careful monitoring of safety and tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lisdexamfetamine in the treatment of moderate-to-severe binge eating disorder in adults: systematic review and exploratory meta-analysis of publicly available placebo-controlled, randomized clinical trials. Fornaro, M., Solmi, M., Perna, G., et al.[2023]

Citations

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Enhanced Family-Based Treatment for an Adolescent With ... ... effectiveness of FBT for adolescents with binge-eating disorder (BED) has not been evaluated. This clinical case paper presents the case of BED in an ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4768866/

Binge eating disorder: Evidence-based treatments - PMC We report on three approaches to the treatment of BED: medication only, behavioral intervention only, and medication plus behavioral intervention.

3. nationaleatingdisorders.org nationaleatingdisorders.org/

NEDA | Eating Disorders Support, Awareness & Recovery Access support, explore resources, join community events, and take a free eating disorders screening—start your recovery journey with NEDA!

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9793802/

Binge eating disorder - PMC - PubMed Central Binge eating disorder (BED) is characterized by regular binge-eating episodes during which individuals ingest comparably large amounts of food and experience ...

5. acpjournals.org acpjournals.org/doi/10.7326/M15-2455

Binge-Eating Disorder in Adults: A Systematic Review and ... Therapist-led cognitive behavioral therapy, lisdexamfetamine, and second-generation antidepressants (SGAs) decreased binge-eating frequency and increased ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK551700/

Binge Eating Disorder - StatPearls - NCBI Bookshelf Binge eating disorder is a psychological condition characterized by episodes of uncontrolled consumption of large amounts of food in a short period, typically ...

7. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-023-00804-0

Outcomes for binge eating disorder in a remote weight ... This case report presents outcomes of an intentionally remote weight-inclusive partial hospitalization and intensive outpatient program based on Health at ...