Avery Leah, Sniehotta Falko F, Denton Sarah J, Steen Nick, McColl Elaine, Taylor Roy, Trenell Michael I
Institute of Cellular Medicine, William Leech Building, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.
Trials. 2014 Feb 3;15:46. doi: 10.1186/1745-6215-15-46.
BACKGROUND: Physical activity (PA) and nutrition are the cornerstones of diabetes management. Several reviews and meta-analyses report that PA independently produces clinically important improvements in glucose control in people with Type 2 diabetes. However, it remains unclear what the optimal strategies are to increase PA behaviour in people with Type 2 diabetes in routine primary care. METHODS: This study will determine whether an evidence-informed multifaceted behaviour change intervention (Movement as Medicine for Type 2 Diabetes) targeting both consultation behaviour of primary healthcare professionals and PA behaviour in adults with Type 2 diabetes is both acceptable and feasible in the primary care setting. An open pilot study conducted in two primary care practices (phase one) will assess acceptability, feasibility and fidelity. Ongoing feedback from participating primary healthcare professionals and patients will provide opportunities for systematic adaptation and refinement of the intervention and study procedures. A two-arm parallel group clustered pilot randomised controlled trial with patients from participating primary care practices in North East England will assess acceptability, feasibility, and fidelity of the intervention (versus usual clinical care) and trial processes over a 12-month period. Consultation behaviour involving fidelity of intervention delivery, diabetes and PA related knowledge, attitudes/beliefs, intentions and self-efficacy for delivering a behaviour change intervention targeting PA behaviour will be assessed in primary healthcare professionals. We will rehearse the collection of outcome data (with the focus on data yield and quality) for a future definitive trial, through outcome assessment at baseline, one, six and twelve months. An embedded qualitative process evaluation and treatment fidelity assessment will explore issues around intervention implementation and assess whether intervention components can be reliably and faithfully delivered in routine primary care. DISCUSSION: Movement as Medicine for Type 2 Diabetes will address an important gap in the evidence-base, that is, the need for interventions to increase free-living PA behaviour in adults with Type 2 diabetes. The multifaceted intervention incorporates an online accredited training programme for primary healthcare professionals and represents, to the best of our knowledge, the first of its kind in the United Kingdom. This study will establish whether the multifaceted behavioural intervention is acceptable and feasible in routine primary care. TRIAL REGISTRATION: Movement as Medicine for Type 2 Diabetes (MaMT2D) was registered with Current Controlled Trials on the 14th January 2012: ISRCTN67997502. The first primary care practice was randomised on the 5th October 2012.
背景:体育活动(PA)和营养是糖尿病管理的基石。多项综述和荟萃分析报告称,体育活动能独立地使2型糖尿病患者的血糖控制取得具有临床意义的改善。然而,在常规初级保健中,尚不清楚增加2型糖尿病患者体育活动行为的最佳策略是什么。 方法:本研究将确定一项针对初级医疗保健专业人员的咨询行为和2型糖尿病成年人的体育活动行为的循证多方面行为改变干预措施(2型糖尿病的运动疗法)在初级保健环境中是否可接受且可行。在两家初级保健机构进行的开放性预试验(第一阶段)将评估其可接受性、可行性和保真度。参与研究的初级医疗保健专业人员和患者持续提供的反馈将为系统调整和完善干预措施及研究程序提供机会。一项双臂平行组整群预试验随机对照试验,将纳入英格兰东北部参与研究的初级保健机构的患者,在12个月的时间内评估干预措施(与常规临床护理相比)的可接受性、可行性和保真度以及试验过程。将在初级医疗保健专业人员中评估涉及干预措施实施保真度、糖尿病和体育活动相关知识、态度/信念、意图以及实施针对体育活动行为的行为改变干预措施的自我效能的咨询行为。我们将通过在基线、1个月、6个月和12个月时进行结局评估,为未来的确定性试验预演结局数据的收集(重点是数据产量和质量)。一项嵌入式定性过程评估和治疗保真度评估将探讨干预措施实施过程中的问题,并评估干预措施的各个组成部分能否在常规初级保健中可靠且如实地实施。 讨论:2型糖尿病的运动疗法将填补证据基础中的一个重要空白,即需要采取干预措施来增加2型糖尿病成年人的日常体育活动行为。这种多方面的干预措施包括为初级医疗保健专业人员提供的在线认证培训项目,据我们所知,这在英国尚属首次。本研究将确定这种多方面的行为干预措施在常规初级保健中是否可接受且可行。 试验注册:2型糖尿病的运动疗法(MaMT2D)于2012年1月14日在“当前受控试验”注册:ISRCTN67997502。第一家初级保健机构于2012年10月5日被随机分组。
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