Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247514
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-08
First Post:
2024-01-25
Brief Title:
The BEET Diabetes Feasibility Trial
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
The Balanced and Empowered Eating BEET in Diabetes Feasibility Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Disordered eating behaviors DEBs eg 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 ie 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 eg 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
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 ie 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23DK134758 | NIH | None | httpsreporternihgovquickSearchK23DK134758 |