将糖尿病预防计划引入老年人群 (BRIDGE)
Over 24 million Americans are over 65 years and have prediabetes. Prediabetes can be addressed using a public health approach: among the 20% of participants in the Diabetes Prevention Program (DPP) who were ages 60 and over, the diet and physical activity intervention conferred a 71% risk reduction of diabetes after an average follow-up of 3 years. The population of older adults is projected to more than double from 52.5 million in 2019 to ~100 million by 2060, and if projections hold, about half (48.3%) will have prediabetes. The proposed hybrid effectiveness implementation type 1 design will compare a DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) to an in person DPP tailored for older adults (DPP arm) using a randomized, controlled trial design (n=230). The preliminary data suggests DPP-TOAT is a feasible and acceptable way to deliver the DPP to older adults, and this will be the first study to compare the effectiveness and implementation of two strategies (telehealth versus in-person) to deliver a tailored DPP for the unique needs of the growing population of older adults.
研究概览
地位
条件
详细说明
Eligible patients will be recruited through electronic health records (Epic and MyChart) and randomized to the 12-month DPP-TOAT or the in-person DPP program. Primary effectiveness outcome will be 6-month weight loss and implementation outcome will be attendance. A pragmatic approach will be used in order to inform future studies conducted in community-based and rural settings. Findings will inform best practices in the delivery of an evidence-based intervention that could reach the 30+ million adults aged 65 and over with prediabetes.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
New York
-
New York、New York、美国、10016
- NYU Langone Health
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Men and women aged 65 years and older
- Diagnosis of pre-diabetes (A1c between 5.7-6.4%, fasting glucose between 100-125 mg/dL, or oral glucose tolerance test between 140-199 mg/dL within past 12 months)
- BMI of greater than or equal to 30
- English-speaking
- Under the care of a Primary care provider (PCP) in the NYU Langone Health system
- Able to travel to NYU Langone for in-person evaluations
- Access to a telephone
- Informed consent
Exclusion Criteria:
- Prevalent diabetes or end-stage renal disease
- Prior participation in the Diabetes Prevention Program
- A documented current history of active psychosis or other cognitive issues via International Classification of Diseases (ICD) -10 codes
- Taking FDA-approved weight loss medications
- PCP stating that patient should not participate
- Inability to communicate due to severe, uncorrectable hearing loss or speech disorder
- Severe visual impairment that precludes completion of assessments and/or intervention
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：In-person Diabetes Prevention Program (DPP)
Participants randomized to the in-person DPP intervention for 12 months |
Diabetes Prevention Program (DPP) is composed of 16 60-minute weekly sessions followed by six 60-minute monthly support sessions over 12 months in person approved by the Centers for Disease Control and Prevention (CDC) |
|
有源比较器：DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm)
Participants randomized to the DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) intervention for 12 months. |
Diabetes Prevention Program (DPP) Tailored for Older Adults and delivered via Telehealth (DPP-TOAT) will be composed of 16 60-minute weekly sessions followed by six 60-minute monthly support sessions |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in weight in participants in DPP-TOAT is similar to those in In-Person DPP
大体时间：Baseline visit, 6 months visit, 12 month visit
|
In-person outcome assessment visits at the New York University Langone research clinic to measure weight at baseline, 6, and 12 months among all randomized participants |
Baseline visit, 6 months visit, 12 month visit
|
|
Changes in HbA1c in participants in DPP-TOAT is similar to those in In-Person DPP
大体时间：Baseline visit, 6 months visit, 12 month visit
|
In-person outcome assessment visits at New York University Langone research clinic to measure glycemia at baseline, 6, and 12 months among all randomized participants |
Baseline visit, 6 months visit, 12 month visit
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adherence to the DPP-TOAT is greater than the in-person DPP
大体时间：Baseline visit, 6 months visit, 12 month visit
|
This will be measured by the number of group sessions completed by each participant. |
Baseline visit, 6 months visit, 12 month visit
|
合作者和调查者
调查人员
- 首席研究员：Jeannette M Beasley, PhD, RDN、NYU Langone Health
- 首席研究员：Joshua Chodosh, MD, MHS、NYU Langone Health
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 21-01039
- 1R01DK127916-01A1 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Data collected from this study include anthropometric and blood draw data that will be uploaded to the participants' electronic medical record and questionnaire data that will only be used for study-related purposes.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.