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

Date Published: November 29, 2016

Publisher: Public Library of Science

Author(s): Job G. Godino, Esther M. F. van Sluijs, Theresa M. Marteau, Stephen Sutton, Stephen J. Sharp, Simon J. Griffin, Kazem Rahimi

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.

Partial Text: The prevalence of type 2 diabetes is increasing worldwide, and primary prevention of the disease is a global priority [1]. Evidence from randomized controlled trials shows that positive changes in health behavior can significantly reduce the incidence of type 2 diabetes among those considered high-risk [2,3]. However, translating these findings into preventive strategies has proven difficult, as it requires motivation of individuals to adopt and maintain changes in physical activity and diet [4].

Details regarding the trial methods have been reported previously [20]. We obtained ethical approval from the Cambridgeshire 1 Research Ethics Committee (No. 10/H0304/78). Each participant provided written informed consent. The trial is registered with Current Controlled Trials (ISRCTN09650496; Date applied: April 4, 2011; Date assigned: June 10, 2011).

In a sample of healthy, middle-aged men and women who were given information about type 2 diabetes and standard lifestyle advice, there was no effect of communicating a genetic or phenotypic estimate of the risk of developing type 2 diabetes on objectively measured physical activity. We did not observe significant intervention effects on self-reported diet and weight, self-rated health, behavioral intentions, anxiety, or worry. This is an important observation, given the expectations that such communications might facilitate behavior change and the concerns about the potential adverse psychological consequences of predictive genetic testing. We also did not observe significant intervention effects on a range of other cognitive and emotional theory-based antecedents to behavior change. We examined several potential moderators, and only sex was found to interact with the intervention effect on physical activity, raising the possibility that genetic risk information may be more influential among women than among men. More research is needed to explore whether women and men respond differently to genetic risk information.



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