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临床试验/NCT04869917
NCT04869917进行中(未招募)不适用

Behavioral Nudges for Diabetes Prevention (BEGIN) Trial in Primary Care

Northwestern University2 个研究点 分布在 1 个国家目标入组 960 人开始时间: 2022年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
960
试验地点
2
主要终点
Weight

研究概览

简要总结

A large body of research has demonstrated that intensive lifestyle interventions and metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet neither treatment is routinely used in practice. The Behavioral Nudges for Diabetes Prevention (BEGIN) Trial will test two low-touch interventions designed to motivate adoption of these treatments to prevent diabetes. Given that 38% of U.S. adults have prediabetes, the proposed study has potential for large public health impact by testing pragmatic, scalable, and sustainable approaches based in primary care to promote evidence-based treatment for this common condition.

详细描述

Large randomized trials have found that intensive lifestyle interventions (ILI) and metformin are safe and effective treatment options for promoting modest weight loss and preventing type 2 diabetes (T2D) among adults with prediabetes. However, these treatments are rarely used in practice, and little existing research has focused on patient-centered approaches for promoting their use. One potential approach, behavioral nudges, involves manipulating health messages and treatment options to make behavior change more likely and easier to enact. While a large body of evidence suggests that behavioral nudges are effective, they have not been definitively studied for T2D prevention. The study team will address this critical knowledge gap by conducting the Behavioral Nudges for Diabetes Prevention (BEGIN) Trial. The proposed study will take place in primary care clinics, whose unprecedented reach and regular interaction with prediabetic adults make this an ideal setting for translational T2D prevention research. This definitive study will test two low-touch interventions: 1) prediabetes decision aid intervention consisting of a prediabetes decision aid designed to nudge uptake of evidence-based treatments and delivered by health educators; and 2) text messaging intervention consisting of text messages that deliver similar information and use the same behavioral nudges. The proposed R18 study will accomplish the following specific aims to determine the most effective low-touch intervention that promotes maximal treatment adoption and weight loss.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients (aged 18-80 years)
  • with prediabetes
  • overweight/obesity (BMI ≥25kg/m2)
  • patients who speak English or Spanish

排除标准

  • type 2 diabetes
  • serum creatinine >1.4mg/dL in women and >1.5mg/dL in men
  • current use of oral corticosteroids
  • current pregnancy
  • uncontrolled hypertension (≥180/100mmHg)
  • history of metformin use
  • no office visits during the last 12 months

结局指标

主要结局

Weight

时间窗: 12 months

Mean differences in weight (lbs) between treatment arms will be evaluated using mixed models adjusted for clinic site, time between visits, sex, age, race/ethnicity, and baseline cardiometabolic markers

次要结局

  • Participant initiation of treatment to intensive lifestyle (ILI) or Metformin(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew J O'Brien

Associate Professor

Northwestern University

研究点 (2)

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