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Open Access Study protocol

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

Job G Godino1, Esther MF van Sluijs1, Theresa M Marteau2, Stephen Sutton3, Stephen J Sharp1 and Simon J Griffin1*

Author Affiliations

1 MRC Epidemiology Unit, Institute of Metabolic Science, Addenbrooke's Hospital, Hills Road, Box 285, CB2 0QQ, Cambridge, UK

2 Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Forvie Site, Robinson Way, CB2 0SR, Cambridge, UK

3 Behavioural Science Group, Institute of Public Health, University of Cambridge, Forvie Site, Robinson Way, CB2 0SR, Cambridge, UK

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BMC Public Health 2012, 12:444  doi:10.1186/1471-2458-12-444

Published: 18 June 2012

Abstract

Background

Type 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.

Methods

In 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.

Discussion

This 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 registration

Current Controlled Trials ISRCTN09650496

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