Clinical trial NCT06247514: The BEET Diabetes Feasibility Trial
Official title: The Balanced and Empowered Eating (BEET) in Diabetes Feasibility Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Disordered Eating Behaviors
Keywords: Type 2 diabetes
Disordered Eating Behaviors
Cognitive behavioral therapy
Diabetes distress
Depression
Anxiety
Diabetes self-efficacy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-02-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disordered Eating Behaviors (DEBs) - Change in Participant-Reported Outcomes (PROs)
timeFrame: 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:
measure: Diabetes Distress - Change in Participant-Reported Outcome (PROs)
timeFrame: After completion of the 6 CBT sessions and 4-weeks after program completion (time differs by practice, up to 6 months)
measure: Diabetes Self-Efficacy - Change in Participant-Reported Outcome (PROs)
timeFrame: After completion of the 6 CBT sessions and 4-weeks after program completion (time differs by practice, up to 6 months)
measure: Depression - Change in Participant-Reported Outcome (PROs)
timeFrame: After completion of the 6 CBT sessions and 4-weeks after program completion (time differs by practice, up to 6 months)
measure: Anxiety - Change in Participant-Reported Outcome (PROs)
timeFrame: After completion of the 6 CBT sessions and 4-weeks after program completion (time differs by practice, up to 6 months)
measure: Change in participant's HbA1c
timeFrame: Baseline, After completion of the 6 CBT sessions and 4-weeks after program completion (time differs by practice, up to 6 months)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Phoutdavone Phimphasone-Brady, PhD
role: PRINCIPAL_INVESTIGATOR
References: