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

• Published in: Current controlled trials in cardiovascular medicine 2018-04, Vol.19 (1), p.240-240, Article 240
• Main Authors: Stewart, Kelly F J, Wesselius, Anke, Schols, Annemie M W J, Zeegers, Maurice P
• Format: Article
• Language: English
• Subjects: Analysis; Choice Behavior; Chronic Disease - epidemiology; Chronic Disease - prevention & control; Chronic diseases; Chronic illnesses; Communicable diseases; Counseling; Counseling - methods; Decision making; Direct-to-consumer genetics; Direct-To-Consumer Screening and Testing; Disease prevention; Epidemiology; Equivalence Trials as Topic; Genetic epidemiology; Genetic Predisposition to Disease; Genetic Testing; Health aspects; Health Behavior; Health Knowledge, Attitudes, Practice; Health promotion; Health Status; Humans; Life Style; Lifestyle epidemiology; Lifestyles; Netherlands - epidemiology; Patient Education as Topic - methods; Patient Participation; Personalised medicine; Personalised prevention; Phenotype; Pragmatic Clinical Trials as Topic; Precision medicine; Prevention; Protective Factors; Risk Factors; Risk Reduction Behavior; Study Protocol; Time Factors; Trials
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-018-2630-7

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