Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.
BMC Fam Pract. 2012 May 29;13:46. doi: 10.1186/1471-2296-13-46.
The prevention of type 2 diabetes is a recognised health care priority globally. Within the United Kingdom, there is a lack of research investigating optimal methods of translating diabetes prevention programmes, based on the promotion of a healthy lifestyle, into routine primary care. This study aims to establish the behavioural and clinical effectiveness of a structured educational programme designed to target perceptions and knowledge of diabetes risk and promote a healthily lifestyle, particularly increased walking activity, in a multi-ethnic population at a high risk of developing type 2 diabetes.
Cluster randomised controlled trial undertaken at the level of primary care practices. Follow-up will be conducted at 12, 24 and 36 months. The primary outcome is change in objectively measured ambulatory activity. Secondary outcomes include progression to type 2 diabetes, biochemical variables (including fasting glucose, 2-h glucose, HbA1c and lipids), anthropometric variables, quality of life and depression.
10 primary care practices will be recruited to the study (5 intervention, 5 control). Within each practice, individuals at high risk of impaired glucose regulation will be identified using an automated version of the Leicester Risk Assessment tool. Individuals scoring within the 90th percentile in each practice will be invited to take part in the study. Practices will be assigned to either the control group (advice leaflet) or the intervention group, in which participants will be invited to attend a 3 hour structured educational programme designed to promote physical activity and a healthy lifestyle. Participants in the intervention practices will also be invited to attend annual group-based maintenance workshops and will receive telephone contact halfway between annual sessions. The study will run from 2010-2014.
This study will provide new evidence surrounding the long-term effectiveness of a diabetes prevention programme run within routine primary care in the United Kingdom.
ClinicalTrials.Gov identifier: NCT00941954.
预防 2 型糖尿病是全球公认的医疗保健重点。在英国，缺乏研究调查基于促进健康生活方式的最佳方法将糖尿病预防计划转化为常规初级保健。本研究旨在建立一种结构化教育计划的行为和临床效果，该计划旨在针对糖尿病风险的认知和知识，并促进多民族高风险人群的健康生活方式，特别是增加步行活动。
在初级保健实践层面进行的集群随机对照试验。随访将在 12、24 和 36 个月进行。主要结果是客观测量的步行活动的变化。次要结果包括进展为 2 型糖尿病、生化变量（包括空腹血糖、2 小时血糖、HbA1c 和脂质）、人体测量变量、生活质量和抑郁。
将招募 10 个初级保健实践参与研究（5 个干预，5 个对照）。在每个实践中，使用莱斯特风险评估工具的自动化版本识别高血糖调节受损风险的个体。在每个实践中得分在第 90 百分位的个体将被邀请参加研究。实践将被分配到对照组（建议传单）或干预组，参与者将被邀请参加旨在促进体育活动和健康生活方式的 3 小时结构化教育计划。干预实践的参与者还将被邀请参加年度基于小组的维护研讨会，并将在年度会议之间收到电话联系。该研究将于 2010-2014 年进行。
本研究将提供有关在英国常规初级保健中运行的糖尿病预防计划的长期有效性的新证据。
ClinicalTrials.Gov 标识符：NCT00941954。
