BEET Program + CBT for Type 2 Diabetes and Eating Disorders

Enrolling by invitation at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Pregnancy, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with type 2 diabetes who also experience disordered eating behaviors, such as frequent binge eating or skipping meals. It tests two programs: one combines diabetes management with education on eating behaviors (The BEET Diabetes Program), and the other uses a self-help book for cognitive behavioral therapy (Cognitive Behavioral Therapy Guided Self-Help). The goal is to determine which approach better aids in managing both diabetes and eating issues. This trial may suit those diagnosed with type 2 diabetes who often struggle with eating behaviors affecting their daily life. As an unphased trial, it provides a unique opportunity to explore innovative approaches to managing diabetes and eating behaviors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that cognitive behavioral therapy (CBT), such as that used in the BEET Diabetes Program and CBT Guided Self-Help, is generally safe and well-tolerated. CBT has been widely applied to various conditions, including eating disorders, without major safety concerns.

In studies on CBT for eating disorders, most participants experience few, if any, side effects. The therapy focuses on changing thought patterns and behaviors, which typically doesn't cause physical side effects. Although specific safety data for the BEET Diabetes Program is unavailable, it employs similar CBT principles, emphasizing behavior change and self-monitoring, suggesting it should be equally safe.

Both treatments in the trial teach strategies and self-monitoring to help manage disordered eating and diabetes. Participants often feel more in control of their eating habits and diabetes management with these tools.

Overall, based on past research with similar methods, the treatments in this study are expected to be safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BEET Diabetes Program because it uniquely integrates strategies for managing type 2 diabetes with methods to address disordered eating behaviors. Unlike standard diabetes treatments that primarily focus on medication and lifestyle changes to control blood sugar, this program emphasizes psychoeducation, goal setting, and self-monitoring to tackle both diabetes management and eating habits. Additionally, the BEET Program offers a structured sequence of sessions guided by trained supporters, which helps maintain motivation and promotes sustainable behavioral changes. Meanwhile, the Cognitive Behavioral Therapy Guided Self-help stands out by empowering individuals through a self-help book, "Overcoming Binge Eating" by Christopher G. Fairburn, making it accessible even to those without prior CBT experience. This dual approach could provide a more comprehensive and supportive treatment option for individuals struggling with diabetes and eating disorders.

What evidence suggests that this trial's treatments could be effective for managing disordered eating behaviors in type 2 diabetes?

Research shows that unhealthy eating habits can complicate diabetes management. In this trial, participants will join one of two treatment arms. The BEET Diabetes Program, one treatment under study, addresses these issues and has shown promise in reducing eating disorder symptoms in people with type 2 diabetes. Studies emphasize the importance of focusing on food habits, exercise, and blood sugar control in diabetes care.

The other treatment arm involves Cognitive Behavioral Therapy Guided Self-Help (CBTgsh), which has also effectively reduced binge eating in people with type 2 diabetes. Previous research found that CBT improved eating habits and helped manage diabetes more effectively. Both treatments in this trial aim to tackle unhealthy eating to enhance diabetes management. ^{6 7 8 9 10}

Who Is on the Research Team?

Phoutdavone Phimphasone-Brady, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for individuals with type 2 diabetes who also struggle with disordered eating behaviors like binge or restrictive eating. It's designed to help them manage these behaviors as part of their diabetes treatment.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.

HbA1c ≥ 6.5

Positive disordered eating screen: Scored ≥ 2 on the study pre-screen for Disordered Eating OR ≥2 on the Diabetes Eating Problems Survey-Revised (DEPS-R) question #2 (skipping meals), #8 (binge eating), or #15 (self-induced vomiting)

Exclusion Criteria

Plans to leave the practice in the next year

I have a condition like dementia that affects my thinking.

Pregnancy or planning to become pregnant in the next 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Refinement

Behavioral health providers refine the BEET Diabetes Program for implementation in real-world settings

4 weeks

Treatment

Participants receive either the BEET Diabetes Program or Cognitive Behavioral Therapy Guided Self-help over 6 sessions

6 weeks

6 sessions (3 weekly, 3 biweekly)

Follow-up

Participants are monitored for changes in diabetes distress, self-efficacy, anxiety, HbA1c, disordered eating behaviors, and depression

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy Guided Self-Help
• The BEET Diabetes Program

Trial Overview The study is testing two programs: Cognitive Behavioral Therapy Guided Self-Help and The BEET Diabetes Program, to see which might better assist in managing disordered eating in those with type 2 diabetes.

How Is the Trial Designed?

Group I: The BEET Diabetes Program Experimental Treatment 1 Intervention

The BEET Diabetes program consists of 6 sessions that follow a sequence: the first 3-sessions weekly and the last 3-sessions every other week. These sessions help participants learn strategies and health behavior change through a self-monitoring form. Supporters (in this study, the BHPs) guide individuals through the program, maintain motivation, and facilitate appropriate goal-setting. The BEET Diabetes Program emphasizes treating disorder eating behaviors (DEBs) in the context of diabetes (i.e., psychoeducation on DEBs in diabetes, optimal daily glucose management, benefits of physical activity, and fruit and vegetable intake).

Group II: Cognitive behavioral Therapy Guided Self-help Active Control 1 Intervention

The Cognitive Behavioral Therapy Guided Self-help consists of 6 sessions that follow a sequence: the first 3-sessions weekly and the last 3-sessions every other week. These sessions help participants learn strategies and health behavior change through a self-monitoring form. The CBTgsh program is delivered through the self-help book: "Overcoming Binge Eating" by Christopher G. Fairburn. Guided support sessions can be provided by personnel with no background training or knowledge of CBT or DEBs, as the book acts as the "expert."

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A 10-session version of cognitive behavior therapy for eating disorders (CBT-T) was effective for nonunderweight cases, showing positive outcomes comparable to longer forms of CBT, despite being delivered by clinical assistants rather than specialists.

The therapy was well-received, with good retention rates and positive changes in symptoms, suggesting that CBT-T could improve access to treatment for eating disorders in various healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 10-session cognitive-behavioral therapy (CBT-T) for eating disorders: Outcomes from a case series of nonunderweight adult patients. Waller, G., Tatham, M., Turner, H., et al.[2019]

In a study of 100 women with type 1 diabetes who were assessed for eating disorders, most showed improvement in their symptoms after treatment at a specialized day hospital, but only 18.8% achieved a good immediate treatment outcome.

The treatment outcomes for women with type 1 diabetes were significantly poorer compared to those without diabetes, highlighting the need for further research to understand and improve treatment strategies for this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eating disorders in individuals with type 1 diabetes: case series and day hospital treatment outcome. Colton, PA., Olmsted, MP., Wong, H., et al.[2022]

Cognitive behavioral therapy for eating disorders (CBT-ED) is shown to be more effective than other treatments for bulimia nervosa (BN) and binge eating disorder (BED), while interpersonal psychotherapy is equally effective for BED.

Current evidence does not support the effectiveness of CBT-ED for adult anorexia nervosa (AN) and is lacking for adolescents, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for the Eating Disorders. Agras, WS., Bohon, C.[2022]

A study involving 29 women with type 1 diabetes and eating disorders showed that multidisciplinary residential treatment significantly reduced blood glucose levels and improved symptoms of eating disorders and psychological concerns.

Longer durations of treatment were linked to greater improvements in psychological symptoms, suggesting that extended care may enhance overall treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary residential treatment of type 1 diabetes mellitus and co-occurring eating disorders. Dickens, YL., Haynos, AF., Nunnemaker, S., et al.[2021]

A new cognitive behavioral therapy-based intervention toolkit was developed collaboratively by 15 individuals with type 1 diabetes and disordered eating, along with 25 healthcare professionals, ensuring it meets the specific needs of patients.

The intervention, which focuses on improving diabetes self-care, will be delivered over 12 sessions by a trained diabetes specialist nurse and is set to be tested in a feasibility randomized controlled trial, highlighting its potential for tailored treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a novel intervention for type 1 diabetes and disordered eating using a participatory action design process: Safe management of people with Type 1 diabetes and EAting Disorders studY (STEADY). Zaremba, N., Robert, G., Allan, J., et al.[2022]

This study developed a cognitive behavioural therapy model that outlines how disordered eating can develop and persist in individuals with type 1 diabetes, based on interviews with 23 women, including those with and without disordered eating.

Key resilience factors identified include 'good enough' psychological adaptation, integrating diabetes into one's identity, and practicing self-care, which can help protect against the development of disordered eating in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cognitive behavioural model of the bidirectional relationship between disordered eating and diabetes self care in people with type 1 diabetes mellitus. Harrison, A., Zaremba, N., Brown, J., et al.[2022]

Citations

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Providing Online guided Self-help for the management of ... The study shows preliminary evidence for online GSH tailored to the needs of individuals with T2D as a feasible and acceptable approach to improving binge ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9830250/

The Role of Disordered Eating in Type 2 Diabetes A 2002 study assessed a group-based CBT intervention for binge eating among women with type 2 diabetes, and found CBT to be an effective intervention for binge ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2770048

Effectiveness of a Digital Cognitive Behavior Therapy ... This cluster randomized clinical trial examines whether a coached, digital, cognitive behavior therapy intervention improves outcomes for ...

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/15598276211002459

The Role of Disordered Eating in Type 2 Diabetes: A Pilot ... The current study sought to assess the efficacy and acceptability of a pilot lifestyle intervention for women with type 2 diabetes and disordered eating.

5. nature.com nature.com/articles/s41598-023-40141-5

Cognitive behavioral therapy for lifestyle changes in ... The most recent study published in this field shows beneficial results of CBT intervention in patients with type 2 diabetes, as patients in the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12465268/

Prevalence and associated factors of eating disorders in ... People with type 2 diabetes (T2DM) have a higher risk of eating disorders, specifically binge eating disorders (BED) and night eating syndrome ( ...

7. professional.diabetes.org professional.diabetes.org/sites/default/files/media/ada_mental_health_workbook_chapter_8.pdf

Eating Problems The most common disordered eating behaviors are binge eating and insulin restriction/omission, but prevalence is not well established. • Eating problems in ...

8. diabetesjournals.org diabetesjournals.org/spectrum/article/37/4/342/154393/Disordered-Eating-Behaviors-and-Eating-Disorders

Disordered Eating Behaviors and Eating Disorders in Youth ... This systematic review aimed to examine disordered eating behaviors (DEBs) in youth with type 2 diabetes.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06325670?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(binge%20eating%20disorder))&rank=7

Type 2 Diabetes and Binge Eating Disorder (BED) The goal of this research project is to improve the treatment of individuals living with both type 2 diabetes (T2D) and Binge Eating Disorder (BED).

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12413400/

The Intersection of Diabetes and Eating Disorders: Prevention ... This article explores the etiology of eating disorders, their manifestations in individuals with diabetes mellitus, and offers clinical insights ...