Thomson Hazel, Oliver Nick, Godsland Ian F, Darzi Ara, Srivanichakorn Weerachai, Majeed Azeem, Johnston Desmond G, Nanditha Arun, Snehalatha Chamukuttan, Raghavan Arun, Susairaj Priscilla, Simon Mary, Satheesh Krishnamoorthy, Ramachandran Ambady, Sharp Stephen, Westgate Kate, Brage Søren, Wareham Nick
Diabetes and Endocrinology, Imperial College London St Mary's Hospital Campus, Norfolk Place, London, W2 1PG, UK.
Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, Norfolk Place, London, W2 1PG, UK.
BMC Endocr Disord. 2018 Sep 10;18(1):63. doi: 10.1186/s12902-018-0293-8.
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.
METHODS/DESIGN: 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 , 4 April 2012 (India); NCT01795833 , 21 February 2013 (UK).
2型糖尿病在印度和英国都是严重的临床问题。通过饮食和体育活动调整来采取健康的生活方式有助于预防2型糖尿病。然而，对高危人群实施生活方式调整计划成本高昂，因此需要更便宜的替代方法。在我们的研究中，我们正在使用短信服务（SMS）计划作为一种工具，提供健康的生活方式建议并激发积极性。本研究的目的是评估以这种方式使用短信对英国和印度的糖尿病前期患者（糖化血红蛋白A1c为6.0%至≤6.4%；42 - 47 mmol/mol）的疗效和用户可接受性。
方法/设计：这是一项随机对照试验，对参与者进行为期2年的随访。在经过筛查并接受糖尿病前期的结构化教育计划后，参与者被随机分为对照组或干预组。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、激励和支持信息。对照组仅接受监测。在印度，试验在筛查后包括5次访视（0、6、12、18和24个月）。在英国，筛查后有4次访视（0、6、12和24个月）。在基线和所有随访访视时评估问卷（EQ - 5D、RPAQ、行为改变的跨理论模型以及食物频率（英国）/24小时饮食回忆（印度））和身体活动监测器（Actigraph GT3X + 加速度计）。在所有随访访视中评估短信可接受性问卷。主要结局是根据糖化血红蛋白A1c达到6.5%或以上（印度）以及任何世界卫生组织标准（英国）定义的进展为2型糖尿病。次要结局包括体重、体重指数、腰围、血压、空腹血糖的变化；血脂；糖化血红蛋白A1c≤6.0%的参与者比例；胰岛素抵抗指数（HOMA - IR）；胰岛β细胞功能指数（HOMA - β）；短信的可接受性；饮食参数；身体活动和生活质量。
本研究旨在评估除标准生活方式建议外，量身定制的短信在两个不同国家减少糖尿病前期向2型糖尿病进展方面的疗效。
ClinicalTrials.gov；NCT01570946，2012年4月4日（印度）；NCT01795833，2013年2月21日（英国）。
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