The BEET Diabetes Feasibility Trial

Disordered Eating Behaviors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06247514
• Other study ID #: 23-1891
• Secondary ID: K23DK134758
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 5, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: February 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: May 31, 2026
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Disordered Eating Behaviors

Intervention

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.
• 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."

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diabetes Distress - Change in Participant-Reported Outcome (PROs)	Comparison of change in patient-reported outcome around diabetes distress. Measured by the Diabetes Distress Scale-17 (DDS-17). The DDS-17 measures distress in four domains: emotional burden, interpersonal distress, physician-related distress, and regimen-related distress. The DDS is a 17-item self-report instrument. Each of the 17 items is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem." A score of < 2.0 was defined as little or no distress, 2.0-2.9 as moderate distress, and = 3.0 as high distress.	After completion of the 6 CBT sessions and 4-weeks after program completion (time differs by practice, up to 6 months)
Secondary	Diabetes Self-Efficacy - Change in Participant-Reported Outcome (PROs)	The Diabetes Self-Efficacy Scale (DSES) is a brief assessment measuring confidence in self-management behaviors. DSES is a reliable and valid instrument for assessing self-efficacy related to diabetes self-management. The DSES has eight items answered on an eight-point Likert scale, ranging from 1 (not confident at all) to 10 (totally confident). The total DSES score ranges from 8 to 80, with higher scores indicating higher diabetes self-efficacy.	After completion of the 6 CBT sessions and 4-weeks after program completion (time differs by practice, up to 6 months)
Secondary	Depression - Change in Participant-Reported Outcome (PROs)	Comparison of change in patient-reported outcomes around depression measured by the Personal Health Questionnaire-8 (PHQ-8), an 8-item scale used for diagnostic and severity measures for depressive disorders in large clinical studies. PHQ-8 score = 10 represents clinically significant depression.	After completion of the 6 CBT sessions and 4-weeks after program completion (time differs by practice, up to 6 months)
Secondary	Anxiety - Change in Participant-Reported Outcome (PROs)	Comparison of change in patient-reported outcomes around anxiety measured by the Generalized Anxiety Disorder Scale 7 (GAD-7), a widely used scale with 7 questions to assess symptoms of Generalized Anxiety Disorder. GAD-7 total score for the seven items ranges from 0 to 21, which are 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety.	After completion of the 6 CBT sessions and 4-weeks after program completion (time differs by practice, up to 6 months)
Secondary	Change in participant's HbA1c	Comparison of change in participant's HbA1c levels in either intervention. Measured by Siemens DCA Vantage (Potassium Ferricyanide), it evaluates the average amount of glucose in the blood, measuring the percentage of glycated (glycosylated) hemoglobin. A decreased value indicates improvements in glucose functioning.	Baseline, After completion of the 6 CBT sessions and 4-weeks after program completion (time differs by practice, up to 6 months)