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临床试验/NCT02676648
NCT02676648已完成不适用

Randomized Trial of Web-Delivered Interventions for Blood Sugar Control for Individuals With Type 2 Diabetes

University of Michigan1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2016年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
HbA1c

研究概览

简要总结

The goal of the research is to optimize an online and mobile multicomponent 12-month diet and lifestyle intervention for improving the blood glucose control of individuals with type 2 diabetes.

详细描述

The research will identify the most promising intervention components. The following components will be tested: dietary adherence testing with a breath meter, text messages, and diet-appropriate foods and cookbooks. The primary goal is to optimize the intervention by examining the HbA1c results at 12 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •overweight or obese
  • •English-speaking
  • •diagnosis of type 2 diabetes (HbA1c > 6.5%)
  • •regular access to the internet and text messages

排除标准

  • •taking diabetes medications other than metformin
  • •being pregnant or breastfeeding
  • •currently undergoing cancer treatments
  • •untreated serious mental illness

研究组 & 干预措施

Experimental: Condition 4

Experimental
  1. core program; 2) text messages

干预措施: Text messages (Behavioral)

Experimental: Condition 8

Experimental
  1. core program; 3) text messages; 4) diet-appropriate food and cookbooks

干预措施: Text messages (Behavioral)

Experimental: Condition 1

Experimental
  1. core program; 2) breath meter; 3) text messages; 4) diet-appropriate food and cookbooks

干预措施: Multicomponent online program (Behavioral)

Experimental: Condition 1

Experimental
  1. core program; 2) breath meter; 3) text messages; 4) diet-appropriate food and cookbooks

干预措施: Breath meter (Behavioral)

Experimental: Condition 1

Experimental
  1. core program; 2) breath meter; 3) text messages; 4) diet-appropriate food and cookbooks

干预措施: Text messages (Behavioral)

Experimental: Condition 1

Experimental
  1. core program; 2) breath meter; 3) text messages; 4) diet-appropriate food and cookbooks

干预措施: Diet-appropriate foods and cookbooks (Behavioral)

Experimental: Condition 2

Experimental
  1. core program

干预措施: Multicomponent online program (Behavioral)

Experimental: Condition 3

Experimental
  1. core program; 2) breath meter

干预措施: Multicomponent online program (Behavioral)

Experimental: Condition 3

Experimental
  1. core program; 2) breath meter

干预措施: Breath meter (Behavioral)

Experimental: Condition 4

Experimental
  1. core program; 2) text messages

干预措施: Multicomponent online program (Behavioral)

Experimental: Condition 5

Experimental
  1. core program; 2) diet-appropriate food and cookbooks

干预措施: Multicomponent online program (Behavioral)

Experimental: Condition 5

Experimental
  1. core program; 2) diet-appropriate food and cookbooks

干预措施: Diet-appropriate foods and cookbooks (Behavioral)

Experimental: Condition 6

Experimental
  1. core program; 2) breath meter; 3) text messages

干预措施: Multicomponent online program (Behavioral)

Experimental: Condition 6

Experimental
  1. core program; 2) breath meter; 3) text messages

干预措施: Breath meter (Behavioral)

Experimental: Condition 6

Experimental
  1. core program; 2) breath meter; 3) text messages

干预措施: Text messages (Behavioral)

Experimental: Condition 7

Experimental
  1. core program; 2) breath meter; 3) diet-appropriate food and cookbooks

干预措施: Multicomponent online program (Behavioral)

Experimental: Condition 7

Experimental
  1. core program; 2) breath meter; 3) diet-appropriate food and cookbooks

干预措施: Breath meter (Behavioral)

Experimental: Condition 7

Experimental
  1. core program; 2) breath meter; 3) diet-appropriate food and cookbooks

干预措施: Diet-appropriate foods and cookbooks (Behavioral)

Experimental: Condition 8

Experimental
  1. core program; 3) text messages; 4) diet-appropriate food and cookbooks

干预措施: Multicomponent online program (Behavioral)

Experimental: Condition 8

Experimental
  1. core program; 3) text messages; 4) diet-appropriate food and cookbooks

干预措施: Diet-appropriate foods and cookbooks (Behavioral)

结局指标

主要结局

HbA1c

时间窗: 12 months

Change in HbA1c from baseline to 12 months post baseline

次要结局

  • Body Weight Percent Lost(12 months)

研究者

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

Laura Saslow

Assistant Professor

University of Michigan

研究点 (1)

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