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临床试验/NCT02162901
NCT02162901已完成不适用

The Reach and Effectiveness of Technology-enhanced Diabetes Prevention Programs

Virginia Polytechnic Institute and State University2 个研究点 分布在 1 个国家目标入组 597 人开始时间: 2014年3月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
597
试验地点
2
主要终点
Body weight

研究概览

简要总结

The aim of this project is to evaluate the reach, effectiveness, and costs of two patient-centered, theory-based, technology-enhanced diabetes prevention programs to initiate and sustain weight loss among pre-diabetic adults (i.e. impaired fasting glucose or impaired glucose tolerance) within a health care setting. The overall aim is consistent with the NIDDK's Behavioral/Prevention Research Program's focus on individual, family, and community-based strategies for prevention of diabetes and its complications. While evidence of lifestyle interventions that increase physical activity and improve eating habits to achieve modest weight loss in delaying and preventing the onset of type 2 diabetes continues to mount, the translation of these interventions into effective programs to health care settings with modest resources remains a challenge. The proposed research project will conduct a pragmatic clinical trial that employs a hybrid Preference/Randomized Controlled Trial (RCT) designed to compare two technology-enhanced diabetes prevention programs in achieving objectively verified weight loss relative to a standard care control at comparatively lower costs. Adult patients (18 years of age and older) at risk for developing diabetes will be randomized to either the Choice group or the Randomization group. Those patients randomized to the Choice group (n=240) will have the opportunity to choose one of two programs to participate in: 1. A 2-hour Small-Group (SG) session, with automated interactive voice response (IVR) systems targeting personal action planning to support lifestyle change and weight loss over a period of 12 months; or 2. A DVD-based intervention with the same IVR follow-up. Those patients assigned to the RCT group (n=360) will be randomized to one of three groups: 1. SG/IVR; 2. DVD/IVR; or 3. Enhanced standard-care (SC). SC includes the referral to a currently offered pre-diabetes class. Primary outcome measures include weight loss, cost, and reach of each program. Secondary outcome measures include physical activity behavior; eating behavior; and process evaluation. It is hypothesized that both the SG/IVR and the DVD/IVR interventions will produce significantly greater amounts of weight loss at 6, 12, and 18 months following program initiation than SC but will not differ from one another. The investigators also hypothesize that the DVD/IVR will have broader reach and may be more cost-effective than SG/IVR or SC.

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
None

入排标准

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

入选标准

  • age = or > 18 years
  • BMI = or > 25

排除标准

  • Patient's medical record contains ICD-9 codes for a diagnosis of any type of diabetes, congestive heart failure or coronary artery disease
  • Pregnant or becomes pregnant during trial
  • Contraindication to physical activity or weight loss
  • No access to phone
  • Does not speak or read English
  • Patient has indicated "Do Not Contact" in Carilion patient record

结局指标

主要结局

Body weight

时间窗: 12 months

Weight as measured by clinical scale at baseline, and 12 months.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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