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一项随机对照试验,旨在测试两种基于技术的糖尿病预防项目在初级保健中的有效性:DiaBEAT-it 研究。

A randomized controlled trial to test the effectiveness of two technology-enhanced diabetes prevention programs in primary care: The DiaBEAT-it study.

机构信息

Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE, United States.

Department of Public Health Sciences, University of Virginia, Charlottesville, VA, United States.

出版信息

Front Public Health. 2023 Feb 24;11:1000162. doi: 10.3389/fpubh.2023.1000162. eCollection 2023.

DOI:10.3389/fpubh.2023.1000162
PMID:36908422
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9998510/
Abstract

OBJECTIVE

To evaluate the effectiveness of two technology-enhanced interventions for diabetes prevention among adults at risk for developing diabetes in a primary care setting.

METHODS

The DiaBEAT-it study employed a hybrid 2-group preference (Choice) and 3-group randomized controlled (RCT) design. This paper presents weight related primary outcomes of the RCT arm. Patients from Southwest Virginia were identified through the Carilion Clinic electronic health records. Eligible participants (18 and older, BMI ≥ 25, no Type 2 Diabetes) were randomized to either Choice ( = 264) or RCT ( = 334). RCT individuals were further randomized to one of three groups: (1) a 2-h small group class to help patients develop a personal action plan to prevent diabetes (SC, = 117); (2) a 2-h small group class plus automated telephone calls using an interactive voice response system (IVR) to help participants initiate weight loss through a healthful diet and regular physical activity (Class/IVR, = 110); or (3) a DVD with same content as the class plus the same IVR calls over a period of 12 months (DVD/IVR, = 107).

RESULTS

Of the 334 participants that were randomized, 232 (69%) had study measured weights at 6 months, 221 (66%) at 12 months, and 208 (62%) at 18 months. Class/IVR participants were less likely to complete weight measures than SC or DVD/IVR. Intention to treat analyses, controlling for gender, race, age and baseline BMI, showed that DVD/IVR and Class/IVR led to reductions in BMI at 6 (DVD/IVR -0.94, < 0.001; Class/IVR -0.70, < 0.01), 12 (DVD/IVR -0.88, < 0.001; Class/IVR-0.82, < 0.001) and 18 (DVD/IVR -0.78, < 0.001; Class/IVR -0.58, < 0.01) months. All three groups showed a significant number of participants losing at least 5% of their body weight at 12 months (DVD/IVR 26.87%; Class/IVR 21.62%; SC 16.85%). When comparing groups, DVD/IVR were significantly more likely to decrease BMI at 6 months ( < 0.05) and maintain the reduction at 18 months ( < 0.05) when compared to SC. There were no differences between the other groups.

CONCLUSIONS

The DiaBEAT-it interventions show promise in responding to the need for scalable, effective methods to manage obesity and prevent diabetes in primary care settings that do not over burden primary care clinics and providers.

REGISTRATION

https://clinicaltrials.gov/ct2/show/NCT02162901, identifier: NCT02162901.

摘要

目的

在初级保健环境中,评估两种增强技术的干预措施在预防有糖尿病风险的成年人糖尿病方面的有效性。

方法

DiaBEAT-it 研究采用了混合 2 组偏好(Choice)和 3 组随机对照(RCT)设计。本文介绍了 RCT 臂的体重相关主要结果。弗吉尼亚州西南部的患者是通过 Carilion 诊所的电子健康记录确定的。符合条件的参与者(18 岁及以上,BMI≥25,无 2 型糖尿病)被随机分配到 Choice(n=264)或 RCT(n=334)。RCT 个体进一步随机分为三组:(1)2 小时的小组课程,帮助患者制定预防糖尿病的个人行动计划(SC,n=117);(2)2 小时的小组课程加上使用交互式语音响应系统(IVR)自动拨打电话,帮助参与者通过健康饮食和定期体育活动开始减肥(Class/IVR,n=110);或(3)12 个月内包含相同课程和相同 IVR 呼叫的 DVD(DVD/IVR,n=107)。

结果

在随机分配的 334 名参与者中,有 232 名(69%)在 6 个月时进行了研究测量体重,221 名(66%)在 12 个月时进行了测量,208 名(62%)在 18 个月时进行了测量。与 SC 或 DVD/IVR 相比,Class/IVR 参与者更不可能完成体重测量。意向治疗分析,控制性别、种族、年龄和基线 BMI,显示 DVD/IVR 和 Class/IVR 在 6 个月时(DVD/IVR-0.94,<0.001;Class/IVR-0.70,<0.01)、12 个月时(DVD/IVR-0.88,<0.001;Class/IVR-0.82,<0.001)和 18 个月时(DVD/IVR-0.78,<0.001;Class/IVR-0.58,<0.01)导致 BMI 降低。所有三组在 12 个月时都有显著比例的参与者体重减轻至少 5%(DVD/IVR 26.87%;Class/IVR 21.62%;SC 16.85%)。当比较组时,与 SC 相比,DVD/IVR 在 6 个月时(<0.05)和在 18 个月时(<0.05)更有可能降低 BMI。其他两组之间没有差异。

结论

DiaBEAT-it 干预措施显示出有希望满足在初级保健环境中管理肥胖和预防糖尿病的需求,这些方法不需要给初级保健诊所和提供者带来过重的负担。

注册

https://clinicaltrials.gov/ct2/show/NCT02162901,标识符:NCT02162901。

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