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

Trial Summary

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 data supports the effectiveness of the treatment Centering Appetite for binge eating disorder in Black women?

A study on appetite awareness training combined with lifestyle modification showed that Black women at risk for binge eating disorder experienced reduced binge eating and body dissatisfaction after participating in the program, with these improvements maintained at a follow-up. ^{1 2 3 4 5}

Is the digital intervention for binge eating disorder in Black women safe?

The study on appetite awareness and lifestyle modification for Black women at risk for binge eating disorder found that participants reported satisfaction with the program, and there were no safety concerns mentioned. This suggests that the intervention is generally safe for participants. ^{3 6 7 8 9}

How is the treatment 'Centering Appetite' different from other treatments for binge eating disorder?

The 'Centering Appetite' treatment is unique because it is a digital intervention specifically designed for Black women, potentially offering a more culturally tailored approach compared to other treatments. It may incorporate elements of the addictive appetite model, which is a novel approach in addressing binge eating behaviors. ^{4 10 11 12 13}

What is the purpose of this trial?

More than 30% of Black women with obesity binge eat. Binge eating may increase the risk for the development of metabolic syndrome and binge-eating-disorder (BED), which is associated with severe obesity. Though several effective treatments for binge eating exist, Black women have not fared well. Not only has their inclusion in treatment trials been limited, but when participating, they are more likely to drop out, and/or lose less weight, compared to their White counterparts. Furthermore, treatment for binge eating is often not available in primary care and community-based settings places where Black women are more likely to receive treatment for their eating and weight-related concerns. Currently, there is scant intervention research to treat binge eating in Black women. With the highest rates of obesity (57%) nationally, Black women are in need of culturally-relevant treatments for binge eating and weight gain prevention. Given the established relationship between frequent binge eating and subsequent weight gain, addressing binge eating among Black women with obesity is imperative.

Research Team

Rachel Goode, PhD,MPH

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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

I am receiving treatment for eating difficulties.

Currently pregnant

In substance abuse treatment

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Examining race as a predictor and moderator of treatment outcomes for binge-eating disorder: Analysis of aggregated randomized controlled trials. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Creating an appetite awareness and lifestyle modification intervention for Black women at risk for binge eating disorder: A pilot open trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial comparing smartphone assisted versus traditional guided self-help for adults with binge eating. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A pilot study of interpersonal psychotherapy for preventing excess weight gain in adolescent girls at-risk for obesity. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Ethnic and racial comparisons of weight-loss treatment utilization history and outcomes in patients with obesity and binge-eating disorder. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Emerging Treatments in Eating Disorders. [2018]

9. New Zealand 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. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

A pilot multiple-baseline study of a mobile cognitive behavioral therapy for the treatment of eating disorders in university students. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Usability Evaluation of a Cognitive-Behavioral App-Based Intervention for Binge Eating and Related Psychopathology: A Qualitative Study. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a digital tele-guided intervention targeting components of the addictive appetite model for bulimia nervosa and binge-eating disorder in Korea. [2022]

13. England 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. [2023]