NCT06247514

The BEET Diabetes Feasibility Trial

The Balanced and Empowered Eating (BEET) in Diabetes Feasibility Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study aims are: Aim 1: The investigators will engage behavioral health providers (BHPs) to refine the Balanced and Empowered Eating in Diabetes (or the BEET Diabetes Program) for implementation in real-world settings. The rationale for engaging and collaborating with BHPs and practice stakeholders early in the research protocol is based on data that few evidence-based psychological programs have been successfully translated into clinical settings. Once the six BHPs are recruited, they will be randomized to receive training and deliver either the intervention (i.e., the BEET Diabetes Program) or the comparator, Cognitive Behavior Therapy (CBT). Then, the investigators will collaborate with the BHPs to refine the behavior change programs for implementation in their clinical settings. Aim 2: The investigators will determine the reach and feasibility of the BEET Diabetes Program in real-world settings. After the intervention refinement period, BHPs will implement and deliver either the intervention or the comparator. To evaluate the adoption, implementation, and potential for maintenance of the BEET Diabetes Program in clinical settings, guided by the RE-AIM framework, the study staff will collect data from clinical leaders, providers and staff, and BHPs via REDCap surveys, observation of sessions delivered by BHPs (live or audio recorded sessions) following a detailed checklist, and data extraction on referral rates and provider adoption from the electronic medical record (e.g., gathering data on the number of referrals or orders submitted by providers in their clinic). The investigators will also conduct semi-structured, 60-minute interviews via Zoom to determine perceived program value and potential for maintenance and long-term use of the programs. Aim 3: The investigators will estimate the effectiveness of the BEET Diabetes Program on patient-reported and clinical outcomes. This is a Phase IIb pilot study to examine research protocol feasibility, intervention acceptability, patient reach, and engagement and estimate intervention effectiveness to finalize the processes and procedures. Patients will be screened and recruited for the study by their BHP in this aim.

Conditions

• Disordered Eating Behaviors

Interventions

Type	Name	Description
BEHAVIORAL	The BEET Diabetes Program	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.
BEHAVIORAL	Cognitive Behavioral Therapy Guided Self-Help	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."

Timeline

• Start date: 2024-12-06
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2024-02-08
• Last updated: 2025-04-11

Locations

2 sites across 1 country: United States