Alghafri Thamra S, Alharthi Saud M, Al-Farsi Yahya M, Craigie Angela M, Mcleod Maureen, Anderson Annie S
Directorate General of Health Services, Ministry of Health, PO Box 2723, , Postal Code 112, Muscat, Oman.
Department of Family Medicine and Public Health, College of Medicine and Health Sciences, Sultan Qaboos University, Muscat, Oman.
BMC Public Health. 2017 Jan 6;17(1):28. doi: 10.1186/s12889-016-3990-0.
Benefits of physical activity in the management of diabetes are well documented. However, evidence on the effectiveness of interventions integrating physical activity in diabetes care is sparse especially in the countries of the Gulf Cooperation Council. The results from this study will increase our understanding of the use of multi-component interventions aimed at increasing physical activity levels in inactive adults with type 2 diabetes in primary health care in Oman.
METHODS/DESIGN: The study is a one year 1:1 cluster randomized controlled trial of the MOVEdiabetes programme (intervention) versus usual care in eight primary health care centres in Oman. The MOVEdiabetes programme utilizes face to face physical activity consultations promoting 150 min of moderate to vigorous physical activity per week (≥600MET-mins/week), pedometers to self-monitor step counts and monthly telephone WhatsApp messages for follow up support. Inactive adults with type 2 diabetes and no contraindication to physical activity will be recruited over a two months period, and followed up for 12 months. To demonstrate a 50% between group difference in physical activity levels (MET-mins/week) over 12 months, (at a power of 80%, and significance level of 5%), 128 participants would be required to complete the study (64 in each arm). Based on a drop-out rate of 20%, 154 participants would require to be recruited (77 in each arm). Assuming a recruitment rate of 70%, 220 potential eligible participants would need to be approached. The primary outcome is change in levels of physical activity measured by the Global Physical Activity Questionnaire. In addition, accelerometers will be used in a sub group to objectively assess physical activity. Secondary outcomes include changes in metabolic and cardiovascular biomarkers, change in self-reported health, social support, self-efficacy for physical activity, and perceived acceptability of the program. All intervention delivery and support costs will be monitored.
This study will contribute to the evidence on the feasibility, cultural acceptability and efficacy of interventional approaches for increasing physical activity in primary care for persons with type 2 diabetes in Oman.
International Standard Randomised Controlled Trials No: ISRCTN14425284 . Registered 12 April 2016.
体育活动对糖尿病管理的益处已有充分记录。然而，关于将体育活动纳入糖尿病护理干预措施有效性的证据却很少，尤其是在海湾合作委员会国家。本研究结果将增进我们对在阿曼初级卫生保健中使用多组分干预措施以提高2型糖尿病非活跃成年人身体活动水平的理解。
方法/设计：本研究是一项为期一年的1:1整群随机对照试验，在阿曼的八个初级卫生保健中心对比“MOVEdiabetes项目”（干预组）与常规护理。“MOVEdiabetes项目”采用面对面的体育活动咨询，促进每周进行150分钟的中等至剧烈体育活动（≥600梅脱-分钟/周），使用计步器自我监测步数，并通过每月的电话WhatsApp消息提供后续支持。在两个月的时间内招募2型糖尿病非活跃成年人且无体育活动禁忌证者，并随访12个月。为了在12个月内显示两组之间体育活动水平（梅脱-分钟/周）有50%的差异（检验效能为80%，显著性水平为5%），需要128名参与者完成研究（每组64名）。基于20%的失访率，需要招募154名参与者（每组77名）。假设招募率为70%，则需要接触220名潜在符合条件的参与者。主要结局是通过全球体育活动问卷测量的体育活动水平变化。此外，将在一个亚组中使用加速度计客观评估体育活动。次要结局包括代谢和心血管生物标志物的变化、自我报告的健康状况变化、社会支持、体育活动自我效能以及对该项目的感知可接受性。将监测所有干预实施和支持成本。
本研究将为关于在阿曼对2型糖尿病患者进行初级护理时增加体育活动的干预方法的可行性、文化可接受性和有效性提供证据。
国际标准随机对照试验编号：ISRCTN14425284。于2016年4月12日注册。
