直接面向消费者的疾病风险评估后行为改变的阶段：两项综合对照实用试验的研究方案

Stages of behavioural change after direct-to-consumer disease risk profiling: study protocol of two integrated controlled pragmatic trials.

作者信息

Stewart Kelly F J, Wesselius Anke, Schols Annemie M W J, Zeegers Maurice P

机构信息

Department of Complex Genetics, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands.

Department of Respiratory Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands.

出版信息

Trials. 2018 Apr 19;19(1):240. doi: 10.1186/s13063-018-2630-7.

DOI:10.1186/s13063-018-2630-7

PMID:29673375

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5907695/

Abstract

BACKGROUND

The incidence and prevalence of chronic diseases have reached epidemic proportions during the last decades and are not expected to diminish. Chronic diseases increasingly affect younger individuals too, with over 40% of all deaths due to non-communicable diseases occurring before the age of 70. This has led to the development of information services aimed at preventive health care, such as Health Potential®. This counselling service estimates a personal disease risk of a carefully selected list of preventable common chronic diseases that have both a genetic and a lifestyle component of development. The results are delivered face-to-face by a lifestyle counsellor, simultaneously stimulating initial steps towards behaviour change. This information can assist in lifestyle decision-making.

METHODS/DESIGN: The primary aim is to study the effect of the Health Potential® service on change in lifestyle behaviour in distinguishable customer populations. The secondary aims are (1) to study the effect of the Health Potential® service on determinants of behaviour change, (2) to study the effect of additional lifestyle counselling on behaviour change and determinants thereof, and (3) to describe the characteristics of the Health Potential® customer. The study consists of two integrated designs: (A) a two-armed non-randomised controlled pre-test/post-test trial (1.5:1 ratio), followed by (B) a two-armed randomised controlled pre-test/post-test trial (1:1 ratio), resulting in three study arms. Participants are clients of local prevention clinics, purchasing a personalised health check (PHC; intervention condition), consisting of Health Potential® and a general health check, or the general health check alone (GHC; control condition) (part A). PHC participants will be randomised to receive four additional lifestyle counselling sessions over a period of 3 months (part B).

DISCUSSION

This research can provide valuable insights into the effectiveness of and possible ways forward in the field of personalised prevention making use of lifestyle interventions enriched with modern genetic advancements.

TRIAL REGISTRATION

Nederlands Trial Register, NTR6289 and NTR6288 . Registered on 24 February 2017.

摘要

背景

在过去几十年中，慢性病的发病率和患病率已达到流行程度，且预计不会下降。慢性病对年轻人的影响也日益增加，所有非传染性疾病导致的死亡中，超过40%发生在70岁之前。这促使了旨在预防保健的信息服务的发展，如Health Potential®。这种咨询服务会针对精心挑选的一系列可预防的常见慢性病评估个人患病风险，这些疾病的发展既有遗传因素，也有生活方式因素。结果由生活方式顾问面对面提供，同时激发朝着行为改变迈出的初步步伐。这些信息有助于生活方式的决策。

方法/设计：主要目的是研究Health Potential®服务对不同客户群体生活方式行为变化的影响。次要目的包括：（1）研究Health Potential®服务对行为改变决定因素的影响；（2）研究额外的生活方式咨询对行为改变及其决定因素的影响；（3）描述Health Potential®客户的特征。该研究由两个综合设计组成：（A）一项双臂非随机对照的前测/后测试验（比例为1.5:1），随后是（B）一项双臂随机对照的前测/后测试验（比例为1:1），从而形成三个研究组。参与者是当地预防诊所的客户，他们购买个性化健康检查（PHC；干预组），包括Health Potential®和常规健康检查，或者仅购买常规健康检查（GHC；对照组）（A部分）。PHC参与者将被随机分配在3个月内接受另外四次生活方式咨询（B部分）。