Protocol for a clinical trial of text messaging in addition to standard care versus standard care alone in prevention of type 2 diabetes through lifestyle modification in India and the UK.
Protocol for a clinical trial of text messaging in addition to standard care versus standard care alone in prevention of type 2 diabetes through lifestyle modification in India and the UK.
复制标题
DOI：
10.1186/s12902-018-0293-8
复制
发表时间：
2018-09-10
影响因子：
2.7
通讯作者：
Wareham N
中科院分区：
文献类型：
--
作者：
Thomson H;Oliver N;Godsland IF;Darzi A;Srivanichakorn W;Majeed A;Johnston DG;Nanditha A;Snehalatha C;Raghavan A;Susairaj P;Simon M;Satheesh K;Ramachandran A;Sharp S;Westgate K;Brage S;Wareham N
2型糖尿病在印度和英国都是一个严重的临床问题。通过饮食和体育活动的调整采取健康的生活方式可以帮助预防2型糖尿病。然而，对高危群体实施改变生活方式方案的费用很高，需要替代的较便宜的方法。我们在研究中使用短信服务（SMS）程序作为提供健康生活方式建议和激励的工具。该研究的目的是评估英国和印度糖尿病前期（HbA 1c 6.0%至≤6.4%; 42-47 mmol/mol）患者以这种方式使用短信的有效性和用户可接受性。这是一项随机对照试验，参与者随访2年。在接受筛查和结构化的糖尿病前期教育计划后，参与者被随机分配到对照组或干预组。在干预组中，每周发送2-3次短信，内容包括关于饮食、体育活动、生活方式和吸烟的教育、激励和支持内容。对照组仅接受监测。在印度，试验包括筛选后的5次访视（0、6、12、18和24个月）。在英国，筛选后有4次访视（0、6、12和24个月）。在基线和所有随访访视时评估量表（EQ-5D、RPAQ、行为变化跨理论模型和食物频率（英国）/24小时饮食回忆（印度））和体力活动监测器（Actigraph GT 3X+加速度计）。在所有随访访视中评价SMS可接受性问卷。主要结局是进展为2型糖尿病，定义为HbA 1c ≥ 6.5%（印度）和任何WHO标准（英国）。次要结局是体重、体重指数、腰围、血压、空腹血糖、血脂、达到HbA 1c ≤6.0%的受试者比例、HOMA-IR、HOMA-β、SMS可接受性、饮食参数、体力活动和生活质量的变化。该研究旨在评估定制短信除了标准生活方式建议之外，在两个不同国家减少从糖尿病前期到2型糖尿病的进展的功效。ClinicalTrials.gov; NCT 01570946，2012年4月4日（印度）; NCT 01795833，2013年2月21日（英国）。
Type 2 diabetes is a serious clinical problem in both India and the UK. Adoption of a healthy lifestyle through dietary and physical activity modification can help prevent type 2 diabetes. However, implementing lifestyle modification programmes to high risk groups is expensive and alternative cheaper methods are needed. We are using a short messaging service (SMS) programme in our study as a tool to provide healthy lifestyle advice and an aid to motivation. The aim of the study is to assess the efficacy and user acceptability of text messaging employed in this way for people with pre-diabetes (HbA1c 6.0% to ≤6.4%; 42–47 mmol/mol) in the UK and India. This is a randomised, controlled trial with participants followed up for 2 years. After being screened and receiving a structured education programme for prediabetes, participants are randomised to a control or intervention group. In the intervention group, text messages are delivered 2–3 times weekly and contain educational, motivational and supportive content on diet, physical activity, lifestyle and smoking. The control group undergoes monitoring only. In India, the trial involves 5 visits after screening (0, 6, 12, 18 and 24 months). In the UK there are 4 visits after screening (0, 6, 12 and 24 months). Questionnaires (EQ-5D, RPAQ, Transtheoretical Model of Behavioural Change, and food frequency (UK)/24 h dietary recall (India)) and physical activity monitors (Actigraph GT3X+ accelerometers) are assessed at baseline and all follow-up visits. The SMS acceptability questionnaires are evaluated in all follow-up visits. The primary outcome is progression to type 2 diabetes as defined by an HbA1c of 6.5% or over(India) and by any WHO criterion(UK). Secondary outcomes are the changes in body weight, body mass index, waist circumference, blood pressure, fasting plasma glucose; lipids; proportion of participants achieving HbA1c ≤6.0%; HOMA-IR; HOMA-β; acceptability of SMS; dietary parameters; physical activity and quality of life. The study is designed to assess the efficacy of tailored text messaging in addition to standard lifestyle advice to reduce the progression from prediabetes to type 2 diabetes in the two different countries. ClinicalTrials.gov; NCT01570946, 4th April 2012 (India); NCT01795833, 21st February 2013 (UK).
登录
查看更多内容
影响因子：
158.5
作者：
Knowler, WC;Barrett-Connor, E;Nathan, DM
通讯作者：
Nathan, DM
影响因子：
16.2
作者：
Pan, XR;Li, GW;Howard, BV
通讯作者：
Howard, BV
影响因子：
3.3
作者：
Freedson, Patty S.;Lyden, Kate;Staudenmayer, John
通讯作者：
Staudenmayer, John
影响因子：
2.9
作者：
Mulligan, Angela A.;Luben, Robert N.;Khaw, Kay-Tee
通讯作者：
Khaw, Kay-Tee
影响因子：
3.6
作者：
BINGHAM, SA;GILL, C;DAY, NE
通讯作者：
DAY, NE