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Effect of direct-to-consumer genomewide profiling to assess disease risk.

ABSTRACT: The use of direct-to-consumer genomewide profiling to assess disease risk is controversial, and little is known about the effect of this technology on consumers. We examined the psychological, behavioral, and clinical effects of risk scanning with the Navigenics Health Compass, a commercially available test of uncertain clinical validity and utility.We recruited subjects from health and technology companies who elected to purchase the Health Compass at a discounted rate. Subjects reported any changes in symptoms of anxiety, intake of dietary fat, and exercise behavior at a mean (±SD) of 5.6±2.4 months after testing, as compared with baseline, along with any test-related distress and the use of health-screening tests.From a cohort of 3639 enrolled subjects, 2037 completed follow-up. Primary analyses showed no significant differences between baseline and follow-up in anxiety symptoms (P=0.80), dietary fat intake (P=0.89), or exercise behavior (P=0.61). Secondary analyses revealed that test-related distress was positively correlated with the average estimated lifetime risk among all the assessed conditions (?=0.117, P<0.001). However, 90.3% of subjects who completed follow-up had scores indicating no test-related distress. There was no significant increase in the rate of use of screening tests associated with genomewide profiling, most of which are not considered appropriate for screening asymptomatic persons in any case.In a selected sample of subjects who completed follow-up after undergoing consumer genomewide testing, such testing did not result in any measurable short-term changes in psychological health, diet or exercise behavior, or use of screening tests. Potential effects of this type of genetic testing on the population at large are not known. (Funded by the National Institutes of Health and Scripps Health.).

SUBMITTER: Bloss CS

PROVIDER: S-EPMC3786730 | biostudies-literature | 2011 Feb

REPOSITORIES: biostudies-literature

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Effect of direct-to-consumer genomewide profiling to assess disease risk.

Bloss Cinnamon S CS Schork Nicholas J NJ Topol Eric J EJ

The New England journal of medicine 20110112 6

<h4>Background</h4>The use of direct-to-consumer genomewide profiling to assess disease risk is controversial, and little is known about the effect of this technology on consumers. We examined the psychological, behavioral, and clinical effects of risk scanning with the Navigenics Health Compass, a commercially available test of uncertain clinical validity and utility.<h4>Methods</h4>We recruited subjects from health and technology companies who elected to purchase the Health Compass at a discou ...[more]

PMID: 21226570

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Project description: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.

Dataset Information

Effect of direct-to-consumer genomewide profiling to assess disease risk.

Publications

Effect of direct-to-consumer genomewide profiling to assess disease risk.

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