The Balanced and Empowered Eating (BEET) in Diabetes Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Disordered Eating Behaviors (DEBs) - Change in Participant-Reported Outcomes (PROs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Disordered Eating Behaviors (DEBs) - Change in Participant-Reported Outcomes (PROs)
时间窗: 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.
次要结局
- Diabetes Distress - Change in Participant-Reported Outcome (PROs)(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)(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)(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)(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(Baseline, After completion of the 6 CBT sessions and 4-weeks after program completion (time differs by practice, up to 6 months))