Movement as Medicine for Type 2 Diabetes: protocol for an open pilot study and external pilot clustered randomised controlled trial to assess acceptability, feasibility and fidelity of a multifaceted behavioural intervention targeting physical activity in primary care.
Movement as Medicine for Type 2 Diabetes: protocol for an open pilot study and external pilot clustered randomised controlled trial to assess acceptability, feasibility and fidelity of a multifaceted behavioural intervention targeting physical activity in primary care.
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DOI：
10.1186/1745-6215-15-46
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发表时间：
2014-02-03
期刊：
影响因子：
2.5
通讯作者：
Trenell MI
中科院分区：
文献类型：
--
作者：
Avery L;Sniehotta FF;Denton SJ;Steen N;McColl E;Taylor R;Trenell MI
体力活动 (PA) 和营养是糖尿病管理的基石。多项综述和荟萃分析表明，PA 独立地对 2 型糖尿病患者的血糖控制产生了临床上重要的改善。然而，目前尚不清楚在常规初级保健中增加 2 型糖尿病患者 PA 行为的最佳策略是什么。本研究将确定针对初级保健专业人员的咨询行为和成人 2 型糖尿病患者的 PA 行为的循证多方面行为改变干预措施（2 型糖尿病药物运动）在初级保健环境中是否可接受且可行。在两个初级保健实践中进行的开放试点研究（第一阶段）将评估可接受性、可行性和保真度。参与的初级卫生保健专业人员和患者的持续反馈将为干预和研究程序的系统调整和完善提供机会。对来自英格兰东北部参与初级保健实践的患者进行的一项双组平行分组试点随机对照试验将在 12 个月的时间内评估干预措施（与常规临床护理相比）和试验过程的可接受性、可行性和保真度。将在初级卫生保健专业人员中评估咨询行为，涉及干预实施的忠诚度、糖尿病和 PA 相关知识、态度/信念、意图和自我效能，以提供针对 PA 行为的行为改变干预措施。我们将通过基线、1、6 和 12 个月的结果评估，为未来的最终试验排练结果数据的收集（重点是数据产量和质量）。嵌入式定性过程评估和治疗保真度评估将探索干预措施实施的问题，并评估干预措施是否可以在常规初级保健中可靠和忠实地提供。运动作为治疗 2 型糖尿病的药物将解决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 型糖尿病成人的自由生活 PA 行为。这项多方面的干预措施包括针对初级保健专业人员的在线认可培训计划，据我们所知，这在英国尚属首次。本研究将确定多方面的行为干预在常规初级保健中是否可接受且可行。运动治疗 2 型糖尿病 (MaMT2D) 于 2012 年 1 月 14 日在当前对照试验中注册：ISRCTN67997502。第一次初级保健实践于 2012 年 10 月 5 日随机分配。
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. 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. 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. 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.
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DOI：
10.1016/0749-5978(91)90020-t
发表时间：
1991-12-01
影响因子：
4.6
作者：
AJZEN, I
通讯作者：
AJZEN, I
影响因子：
3.5
作者：
Bradley, C;Todd, C;Plowright, R
通讯作者：
Plowright, R
DOI：
10.1186/1748-5908-7-77
发表时间：
2012-08-28
期刊：
Implementation science : IS
影响因子：
--
作者：
Boscart VM;Fernie GR;Lee JH;Jaglal SB
通讯作者：
Jaglal SB
影响因子：
3.7
作者：
Dombrowski SU;Sniehotta FF;Mackintosh J;White M;Rodgers H;Thomson RG;Murtagh MJ;Ford GA;Eccles MP;Araujo-Soares V
通讯作者：
Araujo-Soares V
系统评价与饮食和体育锻炼干预效果提高有关的干预组件评论。
影响因子：
4.5
作者：
Greaves CJ;Sheppard KE;Abraham C;Hardeman W;Roden M;Evans PH;Schwarz P;IMAGE Study Group
通讯作者：
IMAGE Study Group