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

Background: The incidence and prevalence of chronic diseases have reached epidemic proportions during the last decades and is 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: 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 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, followed by (B) a two-armed randomised controlled pre-test/post-test trial, resulting in three study arms, allocated at a 1:1.8:1.8 ratio. 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 three months (Part B).
Discussion: This research can provide valuable insights in the effectiveness of and possible ways forward in the field of personalised prevention making use of lifestyle interventions enriched with modern genetic advancements.

背景：近数十年来，慢性疾病的发病率与患病率已达流行态势，且暂无缓解趋势。慢性疾病的患病人群也愈发年轻化，因非传染性疾病导致的死亡中，逾40%发生于70岁之前。这一现状推动了以预防性医疗保健为目标的信息服务发展，例如Health Potential®。该咨询服务可针对经过严格筛选的、兼具遗传与生活方式相关致病因素的可预防常见慢性疾病，评估个人疾病风险。评估结果由生活方式咨询师面对面告知，同时引导咨询者迈出行为改变的初始步伐，相关信息可辅助咨询者进行生活方式相关决策。
方法：本研究的主要目标为探究Health Potential®服务对不同细分客群的生活方式行为改变的影响。次要目标包括：(1) 探究Health Potential®服务对行为改变影响因素的作用；(2) 探究额外生活方式咨询对行为改变及其影响因素的作用；(3) 描述Health Potential®服务使用者的特征。本研究包含两种整合性研究设计：(A) 双组非随机对照前测/后测试验，随后进行(B) 双组随机对照前测/后测试验，最终形成3个研究组别，按1:1.8:1.8的比例分配。研究参与者为当地预防诊所的客户，他们可购买包含Health Potential®与常规健康检查的个性化健康检查（PHC；干预组），或仅购买常规健康检查（GHC；对照组）（A部分）。其中购买PHC的参与者将被随机分配，在3个月内接受4次额外的生活方式咨询疗程（B部分）。
讨论：本研究可为结合现代遗传学技术的生活方式干预手段在个性化预防领域的有效性及未来发展方向提供宝贵的参考见解。