Lifestyle Advice Combined with Personalized Estimates of Genetic or Phenotypic Risk of Type 2 Diabetes, and Objectively Measured Physical Activity: A Randomized Controlled Trial

Abstract

BackgroundInformation about genetic and phenotypic risk of type 2 diabetes is now widely available and is being incorporated into disease prevention programs. Whether such information motivates behavior change or has adverse effects is uncertain. We examined the effect of communicating an estimate of genetic or phenotypic risk of type 2 diabetes in a parallel group, open, randomized controlled trial.Methods and FindingsWe recruited 569 healthy middle-aged adults from the Fenland Study, an ongoing population-based, observational study in the east of England (Cambridgeshire, UK). We used a computer-generated random list to assign participants in blocks of six to receive either standard lifestyle advice alone (control group, n = 190) or in combination with a genetic (n = 189) or a phenotypic (n = 190) risk estimate for type 2 diabetes (intervention groups). After 8 wk, we measured the primary outcome, objectively measured physical activity (kJ/kg/day), and also measured several secondary outcomes (including self-reported diet, self-reported weight, worry, anxiety, and perceived risk). The study was powered to detect a between-group difference of 4.1 kJ/kg/d at follow-up. 557 (98%) participants completed the trial. There were no significant intervention effects on physical activity (difference in adjusted mean change from baseline: genetic risk group versus control group 0.85 kJ/kg/d (95% CI −2.07 to 3.77, p = 0.57); phenotypic risk group versus control group 1.32 (95% CI −1.61 to 4.25, p = 0.38); and genetic risk group versus phenotypic risk group −0.47 (95% CI −3.40 to 2.46, p = 0.75). No significant differences in self-reported diet, self-reported weight, worry, and anxiety were observed between trial groups. Estimates of perceived risk were significantly more accurate among those who received risk information than among those who did not. Key limitations include the recruitment of a sample that may not be representative of the UK population, use of self-reported secondary outcome measures, and a short follow-up period.ConclusionsIn this study, we did not observe short-term changes in behavior associated with the communication of an estimate of genetic or phenotypic risk of type 2 diabetes. We also did not observe changes in worry or anxiety in the study population. Additional research is needed to investigate the conditions under which risk information might enhance preventive strategies. (Current Controlled Trials ISRCTN09650496; Date applied: April 4, 2011; Date assigned: June 10, 2011).Trial RegistrationThe trial is registered with Current Controlled Trials, ISRCTN09650496.

Can Precision Medicine Reduce the Burden of Diabetes?

“…17 If risk information led to healthier lifestyles, it could significantly reduce the number of people with T2DM. However, the use of genetic risk assessment to reduce T2DM risk has been tested in three randomized controlled trials, [21][22][23] with negative results in all studies. Providing genetic risk information was no more effective than conventional risk counseling in changing patient behavior 22,23 and did not increase self-reported motivation or adherence to a prevention program.…”

“…However, the use of genetic risk assessment to reduce T2DM risk has been tested in three randomized controlled trials, [21][22][23] with negative results in all studies. Providing genetic risk information was no more effective than conventional risk counseling in changing patient behavior 22,23 and did not increase self-reported motivation or adherence to a prevention program. 21 One study also assessed the effect of a non-genetic measure of risk for T2DM (based on body mass index [BMI], age, and sex); provision of this risk information similarly had no effect on behavioral outcomes.…”

“I don’t believe it.” Acceptance and skepticism of genetic health information among African-American and White smokers

“…Informing individuals that they have a high-risk variant can increase their lung cancer risk perceptions (Lipkus, Schwartz-Bloom, Kelley, & Pan, 2015; Sanderson et al, 2014; Shepperd et al, 2013), worry (Shepperd et al, 2013), and 30-day cessation (Lipkus et al, 2015). However, systematic reviews, a meta-analysis, and a randomized controlled trial have each questioned the efficacy of using personalized genetic testing to motivate smoking cessation and other health behavior changes (Godino et al, 2016; Hollands et al, 2016; Marteau et al, 2010). …”

Evidence-based medicine and big genomic data

“…Table 2 summarizes RCTs that have assessed newer multigenic predictive score information [i.e. scores made of multiple (≥19) common genetic variants] for improving outcomes in various diseases (35–38). The results are rather disappointing.…”