Berendsen Brenda A J, Kremers Stef P J, Savelberg Hans H C M, Schaper Nicolaas C, Hendriks Marike R C
Human Movement Science, NUTRIM, School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, PO Box 616, 6200 MD, Maastricht, The Netherlands.
Health Promotion, NUTRIM, School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.
BMC Fam Pract. 2015 Mar 17;16:37. doi: 10.1186/s12875-015-0254-5.
The impact of physical inactivity and unhealthy diet on health is increasingly profound. Lifestyle interventions targeting both behaviors simultaneously might decrease the prevalence of overweight and comorbidities. The Dutch 'BeweegKuur' is a combined lifestyle intervention (CLI) in primary care, to improve physical activity and dietary behavior in overweight people. In a cluster randomized controlled trial, the (cost-) effectiveness of an intensively guided program has been compared to a less intensively guided program. This process evaluation aimed to assess protocol adherence and potential differences between clusters. In addition, sustainability (i.e. continuation of the CLI in practice after study termination) was evaluated.
Existing frameworks were combined to design the process evaluation for our intervention and setting specifically. We assessed reach, fidelity, dose delivered and received, context and implementation strategy. Both qualitative and quantitative data were used for a comprehensive evaluation. Data were collected in semi-structured interviews with health care providers (HCPs, n = 25), drop-out registration by HCPs, regular questionnaires among participants (n = 411) and logbooks kept by researchers during the trial.
Protocol adherence by professionals and participants varied between the programs and clusters. In both programs the number of meetings with all HCPs was lower than planned in the protocol. Participants of the supervised program attended, compared to participants of the start-up program, more meetings with physiotherapists, but fewer with lifestyle advisors and dieticians. The 'BeweegKuur' was not sustained, but intervention aspects, networks and experiences were still utilized after finalization of the project. Whether clusters continued to offer a CLI seemed dependent on funding opportunities and collaborations.
Protocol adherence in a CLI was problematic in both HCPs and participants. Mainly the amount of dietary guidance was lower than planned, and decreased with increasing guidance by PT. Thus, feasibility of changing physical activity and dietary habits simultaneously by one intervention in one year was not as high as expected. Also the sustainability of CLI was poor. When a CLI program is started, re-invention should be allowed and maximum effort should be taken to guarantee long term continuation, by planning both implementation and sustainability carefully.
Current Controlled Trials ISRCTN46574304 . Registered 23 December 2010.
缺乏体育活动和不健康饮食对健康的影响日益深远。同时针对这两种行为的生活方式干预可能会降低超重和合并症的患病率。荷兰的“运动疗法”是初级保健中的一种综合生活方式干预措施，旨在改善超重人群的体育活动和饮食行为。在一项整群随机对照试验中，比较了强化指导项目与非强化指导项目的（成本）效益。本过程评估旨在评估方案依从性以及各群组之间的潜在差异。此外，还评估了可持续性（即研究结束后该综合生活方式干预在实际中的延续情况）。
结合现有框架，专门针对我们的干预措施和环境设计过程评估。我们评估了覆盖面、保真度、提供和接受的剂量、背景和实施策略。定性和定量数据均用于全面评估。数据通过对医疗保健提供者（HCPs，n = 25）进行半结构化访谈、HCPs记录的退出登记、参与者定期问卷调查（n = 411）以及研究人员在试验期间保存的日志收集。
专业人员和参与者的方案依从性在不同项目和群组之间存在差异。在两个项目中，与所有HCPs的会议次数均低于方案计划。与启动项目的参与者相比，监督项目的参与者与物理治疗师的会议次数更多，但与生活方式顾问和营养师的会议次数更少。“运动疗法”未能持续，但在项目结束后，干预方面、网络和经验仍被利用。各群组是否继续提供综合生活方式干预似乎取决于资金机会和合作情况。
在综合生活方式干预中，HCPs和参与者的方案依从性都存在问题。主要是饮食指导量低于计划，并且随着物理治疗师指导的增加而减少。因此，通过一项干预在一年内同时改变体育活动和饮食习惯的可行性不如预期。综合生活方式干预的可持续性也很差。当启动一个综合生活方式干预项目时，应允许重新创新，并通过仔细规划实施和可持续性，尽最大努力确保长期延续。
当前受控试验ISRCTN46574304。2010年12月23日注册。
