The BEET Diabetes Feasibility Trial

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06247514
Status
Enrolling By Invitation

Conditions

  • Disordered Eating Behaviors

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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."

Study Details

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.

Key Dates

Start date
Dec 6, 2024
Status verified
Apr 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: The BEET Diabetes Program
    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).
  • Active Comparator: Cognitive behavioral Therapy Guided Self-help
    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."

Primary Outcome Measure

Disordered Eating Behaviors (DEBs) - Change in Participant-Reported Outcomes (PROs) [ Time Frame: 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) ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045-
Denver Health and Hospital AuthorityDenverColorado80204-

Find similar trials in Aurora, CO

By research site
University of Colorado Anschutz Medical Campus· Aurora, CODenver Health and Hospital Authority· Denver, CO

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