Effect of communicating genetic and phenotypic risk for type 2 diabetes in combination with lifestyle advice on objectively measured physical activity: protocol of a randomised controlled trial

BMC Public Health

Study Protocol

Theresa M Marteau¹  Stephen Sutton²  Simon J Griffin³  Job G Godino³  Stephen J Sharp³  Esther MF van Sluijs³ 

[1] Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Forvie Site, Robinson Way, CB2 0SR, Cambridge, UK;Behavioural Science Group, Institute of Public Health, University of Cambridge, Forvie Site, Robinson Way, CB2 0SR, Cambridge, UK;MRC Epidemiology Unit, Institute of Metabolic Science, Addenbrooke's Hospital, Box 285, Hills Road, CB2 0QQ, Cambridge, UK;

关键词: Genetic;    Phenotypic;    Risk;    Communication;    Type 2 diabetes;    Physical activity;    Behaviour;    Randomised controlled trial;    Protocol;   

DOI  :  10.1186/1471-2458-12-444

 received in 2012-05-29, accepted in 2012-05-30,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundType 2 diabetes (T2D) is associated with increased risk of morbidity and premature mortality. Among those at high risk, incidence can be halved through healthy changes in behaviour. Information about genetic and phenotypic risk of T2D is now widely available. Whether such information motivates behaviour change is unknown. We aim to assess the effects of communicating genetic and phenotypic risk of T2D on risk-reducing health behaviours, anxiety, and other cognitive and emotional theory-based antecedents of behaviour change.MethodsIn a parallel group, open randomised controlled trial, approximately 580 adults born between 1950 and 1975 will be recruited from the on-going population-based, observational Fenland Study (Cambridgeshire, UK). Eligible participants will have undergone clinical, anthropometric, and psychosocial measurements, been genotyped for 23 single-nucleotide polymorphisms associated with T2D, and worn a combined heart rate monitor and accelerometer (Actiheart®) continuously for six days and nights to assess physical activity. Participants are randomised to receive either standard lifestyle advice alone (control group), or in combination with a genetic or a phenotypic risk estimate for T2D (intervention groups). The primary outcome is objectively measured physical activity. Secondary outcomes include self-reported diet, self-reported weight, intention to be physically active and to engage in a healthy diet, anxiety, diabetes-related worry, self-rated health, and other cognitive and emotional outcomes. Follow-up occurs eight weeks post-intervention. Values at follow-up, adjusted for baseline, will be compared between randomised groups.DiscussionThis study will provide much needed evidence on the effects of providing information about the genetic and phenotypic risk of T2D. Importantly, it will be among the first to examine the impact of genetic risk information using a randomised controlled trial design, a population-based sample, and an objectively measured behavioural outcome. Results of this trial, along with recent evidence syntheses of similar studies, should inform policy concerning the availability and use of genetic risk information.Trial registrationCurrent Controlled Trials ISRCTN09650496

【 授权许可】

Unknown   
© Godino et al.; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.