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

Published version
Peer-reviewed

Change log

Authors

Godino, JG 
van Sluijs, EMF 
Marteau, Theresa, M 
Sharp, SJ 

Abstract

Background Information 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 Findings We 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.

Conclusions In 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 Registration The trial is registered with Current Controlled Trials, ISRCTN09650496.

Description

Keywords

physical activity, phenotypes, type 2 diabetes, diabetes mellitus, behavioral and social aspects of health, diet and type 2 diabetes, type 2 diabetes risk, genetics of disease

Journal Title

PLoS Medicine

Conference Name

Journal ISSN

1549-1277
1549-1676

Volume Title

13

Publisher

Public Library of Science (PLoS)
Sponsorship
Medical Research Council (MC_UU_12015/4)
Medical Research Council (MC_UU_12015/7)
NIHR Central Commissioning Facility (NIHRDH-RP-PG-0606-1259)
Medical Research Council (MC_U106179474)
This trial was conducted at the MRC Epidemiology Unit in Cambridge, UK. It was funded by the Medical Research Council (MC_U106179474), the Sixth Framework Programme (LSHM-CT-2006-037197), and the National Institute for Health Research (RP-PG- 0606-1259).