Disordered Eating BehaviorsNCT06247514
The BEET Diabetes Feasibility Trial
A study testing The BEET Diabetes Program and Cognitive Behavioral Therapy Guided Self-Help in people with Disordered Eating Behaviors, run by University of Colorado, Denver at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Disordered Eating Behaviors
- What is being tested?
- The BEET Diabetes Program and Cognitive Behavioral Therapy Guided Self-Help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Dec 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Denver Health and Hospital Authority
Denver, Colorado, 80204
About this study
Official title: The Balanced and Empowered Eating (BEET) in Diabetes Feasibility Trial
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.
Read the 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
- Being tested
- The BEET Diabetes Program, Cognitive Behavioral Therapy Guided Self-Help
- Keywords
- Type 2 diabetes, Disordered Eating Behaviors, Cognitive behavioral therapy, Diabetes distress, Depression, Anxiety, Diabetes self-efficacy
- Medical subject headings
- Disordered Eating Behavior, Diabetes Mellitus, Type 2, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The BEET Diabetes ProgramBehavioural
Also called The Balanced and Empowered Eating (BEET) In 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-HelpBehavioural
Also called Overcoming Binge Eating by Christopher G. Fairburn
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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." Receives: Behavioral: Cognitive Behavioral Therapy Guided Self-Help |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: Baseline, After completion of the 6 CBT sessions and 4-weeks after program completion (time differs by practice, up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start6 Dec 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disordered Eating BehaviorsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Phoutdavone Phimphasone-Brady, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247514
- Sponsor's protocol ID
- 23-1891
- Other IDs
- K23DK134758
- Status last verified
- Apr 2025
- First submitted
- 25 Jan 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Balanced and Empowered Eating (BEET) in Diabetes Feasibility Trial
- ClinicalTrials.gov ID
- NCT06247514
- Acronym / sponsor ID
- 23-1891
- Conditions
- Disordered Eating Behaviors
- Keywords
- Type 2 diabetes, Disordered Eating Behaviors, Cognitive behavioral therapy, Diabetes distress, Depression, Anxiety, Diabetes self-efficacy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| The BEET Diabetes Program | Experimental | Behavioral: The BEET Diabetes ProgramThe 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). |
| Cognitive behavioral Therapy Guided Self-help | Active comparator | Behavioral: Cognitive Behavioral Therapy Guided Self-HelpThe 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." |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The BEET Diabetes ProgramAlso: The Balanced and Empowered Eating (BEET) In Diabetes ProgramThe 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. | Behavioural | The BEET Diabetes Program |
| Cognitive Behavioral Therapy Guided Self-HelpAlso: Overcoming Binge Eating by Christopher G. Fairburn6-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." | Behavioural | Cognitive behavioral Therapy Guided Self-help |
Primary outcome
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)
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.
5 secondary outcomes
Diabetes Distress - Change in Participant-Reported Outcome (PROs)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Baseline, After completion of the 6 CBT sessions and 4-weeks after program completion (time differs by practice, up to 6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Phoutdavone Phimphasone-Brady, PhD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The BEET Diabetes Program and Cognitive Behavioral Therapy Guided Self-Help in people with Disordered Eating Behaviors, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025; AzTrials last refreshed its copy on 27 Oct 2026.