Behavioral Intervention for Binge Eating

Overseen By Andrea K Graham, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Pregnancy, No clinical services, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to conduct a micro-randomized trial to learn which evidence-based targets within a mobile intervention for binge eating and weight-related behaviors are most impactful for which people and in what sequence.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does require that you are not currently receiving clinical services for weight management or binge eating.

What data supports the effectiveness of the FoodSteps behavioral intervention for binge eating?

Research shows that cognitive-behavioral therapy (CBT), a component of many behavioral interventions, is effective for treating binge-eating disorder. Additionally, behavioral weight loss therapy, which is similar to some aspects of FoodSteps, has been shown to produce good outcomes for binge eating and modest weight loss. ^{1 2 3 4 5}

Is the FoodSteps behavioral intervention safe for humans?

The available research does not provide specific safety data for the FoodSteps behavioral intervention or its variants. However, behavioral interventions for binge eating, like cognitive-behavioral therapy (CBT) and dialectical behavior therapy (DBT), are generally considered safe for humans. ^{1 6 7 8 9}

How is the FoodSteps behavioral intervention for binge eating different from other treatments?

The FoodSteps behavioral intervention is unique because it likely incorporates mobile technology to assist with treatment, similar to other smartphone-assisted interventions, which can increase accessibility and adherence compared to traditional methods. This approach may offer a novel way to deliver cognitive-behavioral therapy (CBT) elements and support for individuals with binge eating disorder. ^{1 2 4 10 11}

Eligibility Criteria

This trial is for individuals struggling with obesity, bulimia, binge eating disorder, or frequent binge eating episodes. Specific eligibility criteria are not provided.

Inclusion Criteria

Not pregnant

Recurrent binge eating (≥12 episodes in the past 3 months)

Interested in losing weight and reducing binge eating

Exclusion Criteria

Diagnosis for which the study/intervention is not clinically indicated

I am not currently getting help for weight management or binge eating.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a micro-randomized trial with mobile interventions targeting binge eating and weight-related behaviors

8 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for changes in binge eating and weight-related behaviors

4 weeks

Treatment Details

Interventions

• FoodSteps behavioral intervention

Trial Overview The study tests the FoodSteps behavioral intervention through a micro-randomized trial to determine which parts of the mobile app are most effective for different people and in what order.

Participant Groups

Group I: Limit unhealthy dieting behaviors - Recommended Experimental Treatment 1 Intervention

Individuals will be recommended to limit unhealthy dieting behaviors that week.

Group II: Limit unhealthy dieting behaviors - Assigned Experimental Treatment 1 Intervention

Individuals will be assigned to limit unhealthy dieting behaviors that week.

Group III: Increase physical activity - Recommended Experimental Treatment 1 Intervention

Individuals will be recommended to increase physical activity that week.

Group IV: Increase physical activity - Assigned Experimental Treatment 1 Intervention

Individuals will be assigned to increase physical activity that week.

Group V: Increase healthy eating behaviors - Recommended Experimental Treatment 1 Intervention

Individuals will be recommend to increase healthy eating behaviors that week.

Group VI: Increase healthy eating behaviors - Assigned Experimental Treatment 1 Intervention

Individuals will be assigned to increase healthy eating behaviors that week.

Group VII: Improve self-image - Recommended Experimental Treatment 1 Intervention

Individuals will be recommended to improve self-image that week.

Group VIII: Improve self-image - Assigned Experimental Treatment 1 Intervention

Individuals will be assigned to improve self-image that week.

Group IX: Improve mood - Recommended Experimental Treatment 1 Intervention

Individuals will be recommended to improve mood that week.

Group X: Improve mood - Assigned Experimental Treatment 1 Intervention

Individuals will be assigned to improve mood that week.

FoodSteps behavioral intervention is already approved in United States for the following indications:

Approved in United States as FoodSteps for:

• Binge eating disorder
• Weight-related behaviors

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

Cognitive-behavioral therapy (CBT) is effective in reducing binge eating episodes in patients with bulimia nervosa, showing a significant improvement compared to waiting list controls (relative risk of 0.64).

However, CBT does not demonstrate superior efficacy over other psychotherapies or in its self-help form, indicating that while it is beneficial, there is a need for more diverse and larger trials to fully understand its effectiveness across different eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychotherapy for bulimia nervosa and binging. Hay, PJ., Bacaltchuk, J.[2018]

Cognitive-behavioral therapy and interpersonal psychotherapy are the most effective psychological treatments for binge-eating disorder (BED), but they do not lead to weight loss, while behavioral weight loss therapy can improve BED symptoms and result in modest short-term weight loss.

Key predictors of successful treatment outcomes for BED include the overvaluation of body shape and weight, as well as a rapid response to treatment, highlighting the importance of tailored interventions and clinician training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological and Behavioral Treatments for Binge-Eating Disorder. Grilo, CM.[2022]

Cognitive Behavioral Therapy (CBT), whether individual or group-based, effectively reduces binge eating episodes and improves abstinence rates for up to 4 months, although it does not result in weight loss.

The review of 26 studies indicates that while medications can be beneficial for treating Binge Eating Disorder (BED), the overall strength of evidence for treatment efficacy varies, with strong evidence for treatment-related harms and weak evidence for factors influencing treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Binge eating disorder treatment: a systematic review of randomized controlled trials. Brownley, KA., Berkman, ND., Sedway, JA., et al.[2018]

In a study involving 191 patients with binge-eating disorder and obesity, both standard behavioral weight loss (BWL) and adaptive stepped-care treatments showed significant improvements in binge eating and weight loss, with no major differences in remission rates (74.4% for BWL vs. 66.5% for stepped care).

Within the adaptive stepped-care approach, weight-loss medication significantly improved outcomes compared to placebo, particularly for nonresponders who switched to cognitive-behavioral therapy, indicating that combining medication with therapy can enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial testing the effectiveness of adaptive "SMART" stepped-care treatment for adults with binge-eating disorder comorbid with obesity. Grilo, CM., White, MA., Masheb, RM., et al.[2021]

In a study of 90 adults with binge-eating disorder (BED) and obesity, baseline depression scores did not predict or influence the effectiveness of cognitive-behavioral therapy (CBT) or behavioral weight-loss (BWL) treatments over 18 months.

Changes in depression scores during treatment were also not significantly linked to improvements in binge-eating frequency or eating-disorder symptoms, suggesting that patients with high depression can still benefit from existing BED treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining depression scores as predictors and moderators of treatment outcomes in patients with binge-eating disorder. Grilo, CM., Gueorguieva, R., Pittman, B.[2021]

The Emotional Overeating Intervention is a 10-week group therapy program based on Dialectical Behavior Therapy (DBT) specifically designed for adolescents with binge-eating disorder (BED) and related behaviors, aiming to address emotional dysregulation.

This intervention emphasizes the need for culturally and developmentally appropriate adaptations of DBT, providing a framework for future research and clinical implementation in treating adolescents with BED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description of an intervention to treat binge-eating behaviors among adolescents: Applying the Template for Intervention Descriptions and Replication. Pluhar, EI., Kamody, RC., Sanchez, J., et al.[2019]

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]

A targeted internet and app-based intervention focusing solely on cognitive-behavioral techniques to modify dietary restraint significantly reduced binge-eating episodes in 403 participants, most of whom reported binge eating weekly.

The intervention not only decreased binge-eating frequency but also improved various secondary outcomes related to eating concerns and psychological distress, with effects sustained at an 8-week follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting dietary restraint to reduce binge eating: a randomised controlled trial of a blended internet- and smartphone app-based intervention. Linardon, J., Messer, M., Shatte, A., et al.[2023]

A novel acceptance-based behavioral treatment (ABBT) was developed to help individuals with binge eating disorder (BED) reduce binge eating symptoms while also aiming for weight loss, addressing a gap in current treatments like cognitive behavioral therapy (CBT).

Initial testing of ABBT in a clinical case series of four individuals showed promising acceptability, suggesting it may be a viable option for improving both binge eating symptoms and weight loss outcomes, although further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an Acceptance-Based Behavioral Weight Loss Treatment for Individuals With Binge Eating Pathology: A Preliminary Proof of Concept Study and Clinical Case Series. Evans, BC., Murray, HB., Muratore, AF., et al.[2020]

The sequential binge (SB) intervention, used alongside cognitive behavioral therapy (CBT), led to a significant 44% reduction in planned food intake among 15 patients with binge eating disorder who previously did not respond to CBT.

After 16 weeks of SB, 47% of patients achieved binge abstinence for four consecutive weeks, indicating that SB may effectively reduce binge eating frequency and improve control over eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Sequential Binge, a New Therapeutic Approach for Binge Eating: A Pilot Study. Neveu, R., Neveu, D., Barbalat, G., et al.[2018]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Psychotherapy for bulimia nervosa and binging. [2018]

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

Psychological and Behavioral Treatments for Binge-Eating Disorder. [2022]

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

Binge eating disorder treatment: a systematic review of randomized controlled trials. [2018]

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

Randomized controlled trial testing the effectiveness of adaptive "SMART" stepped-care treatment for adults with binge-eating disorder comorbid with obesity. [2021]

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

Examining depression scores as predictors and moderators of treatment outcomes in patients with binge-eating disorder. [2021]

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

Description of an intervention to treat binge-eating behaviors among adolescents: Applying the Template for Intervention Descriptions and Replication. [2019]

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. England pubmed.ncbi.nlm.nih.gov

Targeting dietary restraint to reduce binge eating: a randomised controlled trial of a blended internet- and smartphone app-based intervention. [2023]

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

Developing an Acceptance-Based Behavioral Weight Loss Treatment for Individuals With Binge Eating Pathology: A Preliminary Proof of Concept Study and Clinical Case Series. [2020]

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

The Sequential Binge, a New Therapeutic Approach for Binge Eating: A Pilot Study. [2018]

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

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