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临床试验/CTRI/2020/03/024327
CTRI/2020/03/024327已完成1 期

Digital Interventions for Health Promotion and Prevention of T2D and CVD in South Asians.

NIHR GHRU1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年1月4日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
500
试验地点
1
主要终点
To provide a robust evidence base for efficient, effective and scalable m-health interventions to prevent T2D and CVD amongst South Asians

研究概览

简要总结

Study Purpose:

This study aims to prevent type 2 diabetes and cardiovascular diseases through digital mobile apps by encouraging lifestyle changes. As part of the study, we aim to test the effectiveness of various mobile phone applications in the primary prevention of diabetes.

Specific objectives of the study are as follows:

1.Identify and evaluate currently available mobile applications for prevention of T2D and CVD amongst South Asians using the Mobile App Rating Scale (MARS) tool.

2.Develop two applications (apps) locally in association with an app developer.

3.Pilot Test the two newly developed applications and one or two applications from the commercial sector against primary end-points such as app usability, preferences, engagement, along with secondary end points like weight loss and/or inch loss and change in behaviour (step count/calorie intake etc.)

From the pilot study, we hope to develop a novel innovative application that can be tested on a larger scale in a randomised clinical trial mode. We have built this as our future work once we complete the pilot study.  Overall we expect that the digital study will provide a robust evidence base for efficient, effective and scalable m-health interventions to prevent T2D and CVD amongst South Asians

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Participants having a moderate to high IDRS (a score of 30 and above).

排除标准

  • Individuals with known diabetes or any other contra indications that would not permit them to follow lifestyle prescriptions.

结局指标

主要结局

To provide a robust evidence base for efficient, effective and scalable m-health interventions to prevent T2D and CVD amongst South Asians

时间窗: At the end of the study

次要结局

  • To study weight loss and/or inch loss and track behaviour change for a period of 4 months.(At the beginning and end of he study)

研究者

发起方
NIHR GHRU
申办方类型
Government funding agency

研究点 (1)

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