The BEET Diabetes Feasibility Trial

NCT06247514 | Enrolling By Invitation DMC

• 2 other identifiers: 23-1891K23DK134758
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Disordered eating behaviors (DEBs, e.g., binge eating or restrictive eating) can significantly impact type 2 diabetes (T2D) self-management and engagement in treatment for diabetes. Managing DEBs is a treatment component in diabetes self-management; however, it is not often the primary focus, and trained behavioral health providers are inconsistently involved in comprehensive diabetes management. This study plans to pilot two behavior change programs for disordered eating in T2D and gather information on factors that predict successful adoption and implementation in real-world clinical settings.

Conditions

Disordered Eating Behaviors

Keywords

Type 2 diabetes; Disordered Eating Behaviors; Cognitive behavioral therapy; Diabetes distress; Depression; Anxiety; Diabetes self-efficacy

Outcome Measures

Primary Outcomes (1)

• Disordered Eating Behaviors (DEBs) - Change in Participant-Reported Outcomes (PROs)

  Comparison of change in patient-reported outcomes around diabetes eating problems for participants with type 2 diabetes. The Diabetes Eating Problems Survey - Revised (DEPS-R) is a validated self-reported screening tool comprising 16 items that assess diabetes-specific eating issues. Participants will be asked about eating habits, diabetes control, insulin misuse, and other compensatory behaviors. Higher scores indicate greater eating disorder psychopathology. Scores greater than 20 indicate individuals with a level of disordered eating warranting further attention.

  At the end of the 6 CBT sessions (weekly or biweekly) and 4-weeks after program completion (time differs by practice, up to 6 months)

Secondary Outcomes (5)

• Diabetes Distress - Change in Participant-Reported Outcome (PROs)

  After completion of the 6 CBT sessions and 4-weeks after program completion (time differs by practice, up to 6 months)

• Diabetes Self-Efficacy - Change in Participant-Reported Outcome (PROs)

  After completion of the 6 CBT sessions and 4-weeks after program completion (time differs by practice, up to 6 months)

• Depression - Change in Participant-Reported Outcome (PROs)

  After completion of the 6 CBT sessions and 4-weeks after program completion (time differs by practice, up to 6 months)

• Anxiety - Change in Participant-Reported Outcome (PROs)

  After completion of the 6 CBT sessions and 4-weeks after program completion (time differs by practice, up to 6 months)

• Change in participant's HbA1c

  Baseline, After completion of the 6 CBT sessions and 4-weeks after program completion (time differs by practice, up to 6 months)

Study Arms (2)

The BEET Diabetes Program

EXPERIMENTAL

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).

Behavioral: The BEET Diabetes Program

Cognitive behavioral Therapy Guided Self-help

ACTIVE COMPARATOR

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."

Behavioral: Cognitive Behavioral Therapy Guided Self-Help

Interventions

The BEET Diabetes Program BEHAVIORAL

The BEET Diabetes program is an adapted CBT program specifically designed to treat disordered eating and improve diabetes self-management. Participants receive support from BHPs to guide them through the program, maintain motivation, and facilitate appropriate goal setting.

Also known as: The Balanced and Empowered Eating (BEET) In Diabetes Program

The BEET Diabetes Program

Cognitive Behavioral Therapy Guided Self-Help BEHAVIORAL

6-session cognitive behavioral therapy delivered through the self-help book "Overcoming Binge Eating Self-help" by Christopher G. Fairburn. The manual focuses on reducing binge-eating episodes. Guided support sessions can be provided by personnel with no background training or knowledge of CBT or disordered eating behaviors, as the book acts as the "expert."

Also known as: Overcoming Binge Eating by Christopher G. Fairburn

Cognitive behavioral Therapy Guided Self-help

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T2DM diagnosis
• 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)

You may not qualify if:

• Pregnancy or planning to become pregnant in the next 12 months
• Limited cognitive capacity (e.g., dementia or developmental disorder)
• Less than a year of life expectancy
• Plans to leave the practice in the next year

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Disordered Eating Behavior; Diabetes Mellitus, Type 2; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavior; Feeding and Eating Disorders; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms

Study Officials

• Phoutdavone Phimphasone-Brady, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot feasibility trial. BHPs will be randomized and trained to deliver the intervention or the comparator. They will be encouraged to deliver the programs as they typically would in a clinical setting while maintaining fidelity to session content.

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 8, 2024
• Study Start: December 6, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

US (2)