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Behavioral Intervention
BEET Program + CBT for Type 2 Diabetes and Eating Disorders
N/A
Waitlist Available
Led By Phoutdavone Phimphasone-Brady, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
T2DM diagnosis
Be older than 18 years old
Must not have
Limited cognitive capacity (e.g., dementia or developmental disorder)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after completion of the 6 cbt sessions and 4-weeks after program completion (time differs by practice, up to 6 months)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test two programs that help people with type 2 diabetes who struggle with disordered eating behaviors. These behaviors, like binge eating or restrictive eating, can make it harder to manage diabetes
Who is the study for?
This trial is for individuals with type 2 diabetes who also struggle with disordered eating behaviors like binge or restrictive eating. It's designed to help them manage these behaviors as part of their diabetes treatment.
What is being tested?
The study is testing two programs: Cognitive Behavioral Therapy Guided Self-Help and The BEET Diabetes Program, to see which might better assist in managing disordered eating in those with type 2 diabetes.
What are the potential side effects?
Since the interventions are behavioral therapy programs, there may not be physical side effects like with medication. Participants could experience emotional discomfort addressing their eating habits.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with type 2 diabetes.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a condition like dementia that affects my thinking.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after completion of the 6 cbt sessions and 4-weeks after program completion (time differs by practice, up to 6 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after completion of the 6 cbt sessions and 4-weeks after program completion (time differs by practice, up to 6 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disordered Eating Behaviors (DEBs) - Change in Participant-Reported Outcomes (PROs)
Secondary study objectives
Anxiety - Change in Participant-Reported Outcome (PROs)
Change in participant's HbA1c
Depression - Change in Participant-Reported Outcome (PROs)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: The BEET Diabetes ProgramExperimental Treatment1 Intervention
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).
Group II: Cognitive behavioral Therapy Guided Self-helpActive Control1 Intervention
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."
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,808 Previous Clinical Trials
2,822,160 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,455 Previous Clinical Trials
4,335,028 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,826 Previous Clinical Trials
8,166,434 Total Patients Enrolled
Phoutdavone Phimphasone-Brady, PhDPrincipal InvestigatorUniversity of Colorado, Denver