挪威健康生活研究：一项针对成年人身体活动和饮食进行纵向随访的实用随机对照试验方案
The Norwegian Healthy Life Study: protocol for a pragmatic RCT with longitudinal follow-up on physical activity and diet for adults.
作者信息
Abildsnes Eirik, Meland Eivind, Mildestvedt Thomas, Stea Tonje H, Berntsen Sveinung, Samdal Gro Beate
机构信息
Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
Department of Public Health, Sport and Nutrition, University of Agder, Kristiansand, Norway.
出版信息
BMC Public Health. 2017 Jan 5;17(1):18. doi: 10.1186/s12889-016-3981-1.
BACKGROUND
The Norwegian Directorate of Health recommends that Healthy Life Centres (HLCs) be established in primary health care to support behaviour change and reduce the risk of non-communicable diseases. The aim of the present study protocol is to present the rationale, design and methods of a combined pragmatic randomized controlled trial (RCT) and longitudinal cohort study of the effects of attending HLCs concerning physical activity, sedentary behaviour and diet and to explore how psychological well-being and motivational factors may mediate short- and long-term effects.
METHODS
The present study will combine a 6-month RCT with a longitudinal cohort study (24 months from baseline) conducted at six HLCs from June 2014 to Sept 2017. Participants are randomized to behavioural change interventions or a 6-month waiting list control group.
DISCUSSION
A randomized trial of interventions in HLCs has the potential to influence the development of policy and practice for behaviour change interventions and patient education programmes in Norway. We discuss some of the important preconditions for obtaining valid results from a complex intervention and outline some of the characteristics of ecological approaches in health care research that can enable a pragmatic intervention study.
TRIAL REGISTRATION
The study was retrospectively registered on September 19, 2014 and is available online at ClinicalTrials.gov (ID: NCT02247219 ).
背景
挪威卫生局建议在初级卫生保健机构设立健康生活中心（HLC），以支持行为改变并降低非传染性疾病的风险。本研究方案的目的是介绍一项实用随机对照试验（RCT）与纵向队列研究相结合的研究的基本原理、设计和方法，该研究旨在探讨参加HLC对身体活动、久坐行为和饮食的影响，并探究心理健康和动机因素如何介导短期和长期影响。
方法
本研究将把一项为期6个月的RCT与一项纵向队列研究（从基线起24个月）相结合，研究于2014年6月至2017年9月在六个HLC进行。参与者被随机分配到行为改变干预组或为期6个月的等待名单对照组。
讨论
对HLC干预措施进行随机试验有可能影响挪威行为改变干预措施和患者教育计划的政策制定和实践发展。我们讨论了从复杂干预中获得有效结果的一些重要前提条件，并概述了卫生保健研究中生态方法的一些特征，这些特征有助于开展实用干预研究。
试验注册
该研究于2014年9月19日进行回顾性注册，可在ClinicalTrials.gov网站上在线获取（ID：NCT02247219）。
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