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临床试验/NCT03369626
NCT03369626已完成不适用

Effectiveness of a Digital Therapeutic in a Geographically Distributed Population With Type 2 Diabetes

FareWell2 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2017年7月26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
发起方
入组人数
118
试验地点
2
主要终点
Level of engagement with the assigned mobile app

研究概览

简要总结

A clinical study evaluating a three month digitally delivered lifestyle change program in adults with Type 2 Diabetes. The FareWell Program (the "Program") aims to reduce well-established biomarkers of cardiometabolic diseases, weight, and medications. The current study is designed to evaluate to what degree adults with Type 2 Diabetes engaged with the Program can improve glycemic control and/or decrease medication needs.

详细描述

The Program aims to reduce well-established biomarkers of cardiometabolic diseases, weight, and medications. It includes meal planning tools, smart shopping lists, recipes curated by a physician, dietitian and chef educator, daily self-monitoring features with personalized weekly goals, bi-weekly live one-on-one health coaching and support from an online member community, and an educational curriculum. Subjects in the Program may receive support from other members of a Care Team (lifestyle medicine physician, chef educator, registered dietitian and/or psychologist/psychiatrist) as needed. The Care Team does not provide medical advice, nor replace traditional medical care. Instead, the Care Team encourages behavior change by providing support and sharing its expertise.

Study participants will have access to the Program for a twelve week period and will be asked to complete short health surveys at baseline and at the end of the study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • diagnosis of type 2 diabetes

排除标准

  • Inability to understand, consent to, or comply with the study protocol for any reason, including inability to read or comprehend English.
  • Does not have a smartphone (either an iPhone or Android phone)

研究组 & 干预措施

FareWell Program

Other

All participants receive the FareWell Program intervention in this evaluation study

干预措施: FareWell Program (Behavioral)

结局指标

主要结局

Level of engagement with the assigned mobile app

时间窗: 12 weeks

How do participants interact with the digital program (e.g. feature use, coaching calls completed, targets tracked, targets met)

次要结局

  • Change in self-reported Hemoglobin A1c(12 weeks)
  • Change in self-reported diabetes medication type or dose(12 weeks)

研究者

发起方
FareWell
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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