Does Type 2 Diabetes Genetic Testing and Counseling Reduce Modifiable Risk Factors? A Randomized Controlled Trial of Veterans

Voils, Corrine I.; Coffman, Cynthia J.; Grubber, Janet M.; Edelman, David; Sadeghpour, Azita; Maciejewski, Matthew L.; Bolton, Jamiyla; Cho, Alex; Ginsburg, Geoffrey S.; Yancy, William S.

doi:10.1007/s11606-015-3315-5

Cited by 36 publications

(62 citation statements)

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“…Of the 18 articles that assessed a nutrition-related outcome, 6 (33%) showed a positive, health-promoting effect of genetic testing on behaviour change at one or more time points (both short term and long term, as further outlined in Tables 1 and 2). While this does not indicate that the majority of studies positively influenced nutrition, multiple studies of good quality have demonstrated that it is possible to facilitate healthier nutritional behaviours through the provision of genetic testing [8, 9, 11, 46, 49, 51]. …”

Section: Resultsmentioning

confidence: 99%

A Systematic Review of Genetic Testing and Lifestyle Behaviour Change: Are We Using High-Quality Genetic Interventions and Considering Behaviour Change Theory?

et al. 2018

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Background: Studying the impact of genetic testing interventions on lifestyle behaviour change has been a priority area of research in recent years. Substantial heterogeneity exists in the results and conclusions of this literature, which has yet to be explained using validated behaviour change theory and an assessment of the quality of genetic interventions. The theory of planned behaviour (TPB) helps to explain key contributors to behaviour change. It has been hypothesized that personalization could be added to this theory to help predict changes in health behaviours. Purpose: This systematic review provides a detailed, comprehensive identification, assessment, and summary of primary research articles pertaining to lifestyle behaviour change (nutrition, physical activity, sleep, and smoking) resulting from genetic testing interventions. The present review further aims to provide in-depth analyses of studies conducted to date within the context of the TPB and the quality of genetic interventions provided to participants while aiming to determine whether or not genetic testing facilitates changes in lifestyle habits. This review is timely in light of a recently published “call-to-action” paper, highlighting the need to incorporate the TPB into personalized healthcare behaviour change research. Methods: Three bibliographic databases, one key website, and article reference lists were searched for relevant primary research articles. The PRISMA Flow Diagram and PRISMA Checklist were used to guide the search strategy and manuscript preparation. Out of 32,783 titles retrieved, 26 studies met the inclusion criteria. Three quality assessments were conducted and included: (1) risk of bias, (2) quality of genetic interventions, and (3) consideration of theoretical underpinnings – primarily the TPB. Results: Risk of bias in studies was overall rated to be “fair.” Consideration of the TPB was “poor,” with no study making reference to this validated theory. While some studies (n = 11; 42%) made reference to other behaviour change theories, these theories were generally mentioned briefly, and were not thoroughly incorporated into the study design or analyses. The genetic interventions provided to participants were overall of “poor” quality. However, a separate analysis of studies using controlled intervention research methods demonstrated the use of higher-quality genetic interventions (overall rated to be “fair”). The provision of actionable recommendations informed by genetic testing was more likely to facilitate behaviour change than the provision of genetic information without actionable lifestyle recommendations. Several studies of good quality demonstrated changes in lifestyle habits arising from the provision of genetic interventions. The most promising lifestyle changes were changes in nutrition. Conclusions: It is possible to facilitate behaviour change using genetic testing as the catalyst. Future research should ensure that high-quality genetic interventions are provided to participants, and should consider validate...

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Section: Resultsmentioning

confidence: 99%

A Systematic Review of Genetic Testing and Lifestyle Behaviour Change: Are We Using High-Quality Genetic Interventions and Considering Behaviour Change Theory?

et al. 2018

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“…However, the volunteers tended to overestimate their risk at baseline and may therefore have been somewhat reassured by the information that they received, albeit not to the extent that they adopted unhealthy behaviors [46]. Nevertheless, we cannot exclude the possibility that provision of risk estimates that exceed participants’ perceived risk might influence behavior, although previous trials have not reported effects among high-risk subgroups [18,19]. Furthermore, it is possible that information concerning the genetic risk of diseases other than diabetes, such as various cancers or chronic neurodegenerative diseases, might elicit a greater response, although this has not been the finding of published trials [47].…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, interpretation has been limited by risk of bias and additional differences between study groups than merely the provision of DNA-based disease risk information. Two recent trials report no behavioral impact of information about the genetic risk of type 2 diabetes [18,19]. However, neither included precise measures of behavior.…”

Section: Introductionmentioning

confidence: 99%

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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

et al. 2016

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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.

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“…4 In this well-designed randomized controlled trial conducted in a primary care setting, investigators analyzed three single nucleotide polymorphisms (SNPs) associated with diabetes risk to calculate the genetic risk for the intervention group and categorized their genetic risk as low, moderate, or high. They found that weight, insulin resistance, physical activity and perceived lifetime risk of diabetes did not differ between groups at 3 or 6 months.…”

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confidence: 99%

Personalizing Diabetes Prevention: Is it Time to Focus on the Intervention?

Kanaya

2015

J GEN INTERN MED

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T here are approximately 86 million adults with prediabetes in the United States, 1 and an estimated 70 % of these individuals will develop type 2 diabetes during their lifetime. Several clinical trials have shown a remarkable reduction of diabetes incidence with intensive lifestyle interventions, 2 but these behavioral changes are difficult to sustain. Less intensive trials testing the real-world effectiveness of behavioral interventions in various settings have found about half the effect on weight loss as the intensive trials. 3 As we enter this age of personalized medicine, could knowing one's genetic risk motivate patients to make and sustain effective behavioral changes?In this issue of JGIM, Voils and colleagues tested whether the addition of genetic risk results to standard diabetes risk estimates with brief lifestyle counseling would be more effective than standard diabetes risk estimates with lifestyle counseling alone for weight loss and behavioral outcomes among veterans. 4 In this well-designed randomized controlled trial conducted in a primary care setting, investigators analyzed three single nucleotide polymorphisms (SNPs) associated with diabetes risk to calculate the genetic risk for the intervention group and categorized their genetic risk as low, moderate, or high. They found that weight, insulin resistance, physical activity and perceived lifetime risk of diabetes did not differ between groups at 3 or 6 months. Daily caloric intake and fat intake were lower in the genetic-risk-informed group at 3 months, but there was no difference at 6 months. This result did not vary among those with high, moderate or low genetic risk in the intervention arm.A prior trial performed in another primary care setting found similarly unimpressive effects of providing genetic risk information from 36 diabetes risk SNPs to participants enrolled in a diabetes prevention program on short-term outcomes of motivation, program attendance or weight loss. 5 Other trials testing the effect of communication of genetic risk of disease on risk-reducing behaviors, such as smoking cessation or physical activity, have also been mostly negative. 6 Why was this the case for the present study? One explanation may be that the trial was underpowered to detect clinically significant effects. The sample size for this study was determined based on the weight loss difference observed between groups from an intensive diabetes prevention trial that required 300 people to be randomized per group. It is possible that a more modest weight loss outcome based on a less intensive intervention such as the proposed method would have required a larger sample size. While 601 participants were randomized, only 534 (89 %) attended the risk counseling session and only 84 % completed the primary endpoint evaluation at 3 months, which further diminished the study's power. Yet the real question is whether the knowledge of high (or moderate/high) genetic risk will motivate individuals to adopt healthier behaviors. The power to detect an interaction by gen...

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Does Type 2 Diabetes Genetic Testing and Counseling Reduce Modifiable Risk Factors? A Randomized Controlled Trial of Veterans

Cited by 36 publications

References 36 publications

A Systematic Review of Genetic Testing and Lifestyle Behaviour Change: Are We Using High-Quality Genetic Interventions and Considering Behaviour Change Theory?

A Systematic Review of Genetic Testing and Lifestyle Behaviour Change: Are We Using High-Quality Genetic Interventions and Considering Behaviour Change Theory?

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

Personalizing Diabetes Prevention: Is it Time to Focus on the Intervention?

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