Teuscher Dorit, Bukman Andrea J, Meershoek Agnes, Renes Reint Jan, Feskens Edith J M, van Baak Marleen A
Department of Human Biology, Maastricht University Medical Centre+, NUTRIM School for Nutrition, Toxicology and Metabolism, P.O Box 616, 6200, MD, Maastricht, The Netherlands.
Division of Human Nutrition, Wageningen University, P.O Box 8129, 6700, EV, Wageningen, The Netherlands.
BMC Public Health. 2015 Feb 12;15:125. doi: 10.1186/s12889-015-1343-z.
People with low socioeconomic status (SES) and some ethnic minorities are often underrepresented in lifestyle programmes. Therefore, a lifestyle programme was developed especially targeting these groups. Developing this lifestyle programme and designing an intervention study to test the effectiveness of this programme was an informative process in which several obstacles were encountered and choices had to be made. Study protocols, however, rarely describe these obstacles encountered in the protocol design process, and it is not always clear why researchers made certain choices. Therefore, the aim of this article is to describe both the final MetSLIM study protocol and the considerations and choices made in designing this study protocol.
METHODS/DESIGN: The developed MetSLIM study has a quasi-experimental design, targeting 30- to 70-year-old adults with an elevated waist circumference, living in deprived neighbourhoods, of Dutch, Turkish or Moroccan descent. The intervention group participates in a 12-month lifestyle programme consisting of individual dietary advice, four group sessions and weekly sports lessons. The control group receives written information about a healthy lifestyle and one group session provided by a dietician. The study contains an elaborate effect, process and economic evaluation. Outcome measures are, among other things, change in waist circumference and the other components of the metabolic syndrome.
Matching the preferences of the target group, such as their preferred setting, has implications for the entire study protocol. The process evaluation of the MetSLIM study will provide insight into the consequences of the choices made in the MetSLIM study protocol in terms of reach, acceptability and delivery of the programme, and the effect and economic evaluation will provide insight into the (cost)effectiveness of the lifestyle programme in order to reduce waist circumference among individuals with low SES of different ethnic origins.
Netherlands Trial Register NTR3721 (since November 27, 2012).
社会经济地位低下（SES）的人群以及一些少数族裔在生活方式项目中的参与度往往较低。因此，专门针对这些群体开发了一项生活方式项目。开发这个生活方式项目并设计一项干预研究来测试该项目的有效性是一个信息丰富的过程，在此过程中遇到了一些障碍，不得不做出一些选择。然而，研究方案很少描述在方案设计过程中遇到的这些障碍，而且研究人员做出某些选择的原因也并不总是很清楚。因此，本文的目的是描述最终的MetSLIM研究方案以及在设计该研究方案时所做的考虑和选择。
方法/设计：已开展的MetSLIM研究采用准实验设计，目标人群为年龄在30至70岁之间、腰围增大、居住在贫困社区、荷兰裔、土耳其裔或摩洛哥裔的成年人。干预组参加为期12个月的生活方式项目，包括个人饮食建议、四次小组课程和每周的体育课。对照组收到关于健康生活方式的书面信息以及营养师提供的一次小组课程。该研究包含详细的效果、过程和经济评估。除其他外，结果指标包括腰围变化和代谢综合征的其他组成部分。
匹配目标群体的偏好，如他们喜欢的环境，会对整个研究方案产生影响。MetSLIM研究的过程评估将深入了解MetSLIM研究方案中所做选择在项目的覆盖范围、可接受性和实施方面的后果，而效果和经济评估将深入了解该生活方式项目在降低不同族裔低SES个体腰围方面的（成本）效益。
荷兰试验注册库NTR3721（自2012年11月27日起）。
