Stephen Sutton

Publications of Stephen Sutton

• An explanatory randomised controlled trial of a nurse-led, consultation-based intervention to support patients with adherence to taking glucose lowering medication for type 2 diabetes.

  Authors: Andrew Farmer, Wendy Hardeman, Dyfrig Hughes, A Toby Prevost, Youngsuk Kim, Anthea Craven, Jason Oke, Sue Boase, Mary Selwood, Ian Kellar, Jonathan Graffy, Simon Griffin, Stephen Sutton, Ann Louise Kinmonth

  BMC family practice. 04/2012; 13(1):30.

  ABSTRACT: BACKGROUND: Failure to take medication reduces the effectiveness of treatment leading to increased morbidity and mortality. We evaluated the efficacy of a consultation-based intervention toABSTRACT: BACKGROUND: Failure to take medication reduces the effectiveness of treatment leading to increased morbidity and mortality. We evaluated the efficacy of a consultation-based intervention to support objectively-assessed adherence to oral glucose lowering medication (OGLM) compared to usual care among people with type 2 diabetes. METHODS: This was a parallel group randomised trial in adult patients with type 2 diabetes and HbA1c[greater than or equal to]7.5% (58 mmol/mol), prescribed at least one OGLM. Participants were allocated to a clinic nurse delivered, innovative consultation-based intervention to strengthen patient motivation to take OGLM regularly and support medicine taking through action-plans, or to usual care. The primary outcome was the percentage of days on which the prescribed dose of medication was taken, measured objectively over 12 weeks with an electronic medicationmonitoring device (TrackCap, Aardex, Switzerland). The primary analysis was intention-totreat. RESULTS: 211 patients were randomised between July 1, 2006 and November 30, 2008 in 13 British general practices (primary care clinics). Primary outcome data were available for 194 participants (91.9%). Mean (sd) percentage of adherent days was 77.4% (26.3) in the intervention group and 69.0% (30.8) in standard care (mean difference between groups 8.4%, 95% confidence interval 0.2% to 16.7%, p = 0.044). There was no significant adverse impact on functional status or treatment satisfaction. CONCLUSIONS: This well-specified, theory based intervention delivered in a single session of 30 min in primary care increased objectively measured medication adherence, with no adverse effect on treatment satisfaction. These findings justify a definitive trial of this approach to improving medication adherence over a longer period of time, with clinical and cost-effectiveness outcomes to inform clinical practice. Trial registration Current Controlled Trials ISRCTN30522359.

• Randomized Controlled Trial Evaluation of a Tailored Leaflet and SMS Text Message Self-help Intervention for Pregnant Smokers (MiQuit).

  Authors: Felix Naughton, A Toby Prevost, Hazel Gilbert, Stephen Sutton

  Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco. 02/2012;

  INTRODUCTION: Study aims were to assess the feasibility and acceptability of a tailored self-help smoking cessation intervention for pregnant smokers (MiQuit). Secondary aims were to assess whetherINTRODUCTION: Study aims were to assess the feasibility and acceptability of a tailored self-help smoking cessation intervention for pregnant smokers (MiQuit). Secondary aims were to assess whether MiQuit affected cognitive determinants of quitting and to provide a range of potential effect sizes of the intervention effect on smoking abstinence. METHODS: A randomized controlled trial was undertaken in which pregnant smokers were allocated to either receive MiQuit, a tailored self-help leaflet followed by an 11-week program of tailored text messages, or to a control group, receiving a nontailored self-help leaflet. Participants were 207 pregnant smokers identified by community midwives across 7 NHS Trusts (United Kingdom). At 3-month follow-up, intervention acceptability, cognitive determinants of quitting, and smoking outcomes (self-reported and cotinine-validated 7-day point prevalence abstinence) were assessed. RESULTS: Feasibility: 94% (95% CI 89%-99%) of MiQuit participants reported receiving both intervention components. Acceptability: 9% (95% CI 4%-15%) of MiQuit participants opted to discontinue the text messages. Mechanism: compared with controls, MiQuit participants were more likely to set a quit date (p = .049) and reported higher levels of self-efficacy (p = .024), harm beliefs (p = .052), and determination to quit (p = .019). Potential efficacy: self-reported abstinence-MiQuit 22.9%, control 19.6%; odds ratio (OR) = 1.22, 95% CI 0.62-2.41; cotinine-validated abstinence-MiQuit 12.5%, control 7.8%; OR = 1.68, 95% CI 0.66-4.31.Conclusions:Delivering tailored smoking cessation support to pregnant smokers via leaflet and text message is feasible and acceptable. The positive effects of MiQuit on cognitive determinants and the likelihood of setting a quit date are encouraging. A larger efficacy trial is warranted.

• Predictors of suboptimal glycaemic control in type 2 diabetes patients: The role of medication adherence and body mass index in the relationship between glycaemia and age.

  Authors: Alexander Nagrebetsky, Simon Griffin, Ann Louise Kinmonth, Stephen Sutton, Anthea Craven, Andrew Farmer

  Diabetes research and clinical practice. 01/2012;

  AIMS: To analyse predictors of glycaemic control including medication adherence and body mass index (BMI) in UK general practice patients with sub-optimally controlled type 2 diabetes. METHODS:AIMS: To analyse predictors of glycaemic control including medication adherence and body mass index (BMI) in UK general practice patients with sub-optimally controlled type 2 diabetes. METHODS: Baseline demographic, health- and treatment-related measures were evaluated as predictors of one year glycaemic control defined separately as HbA(1c)≤7.5% and a continuous measure of HbA(1c) concentration, using multivariate regression models. Significant predictors were adjusted for objectively assessed medication adherence and BMI. RESULTS: One-year HbA(1c) concentration was associated with baseline HbA(1c) (p<0.001), BMI (p=0.02), and inversely associated with age (p=0.007) and objectively assessed adherence. Adherent patients had one-year (adjusted) HbA(1c) concentration 0.65% (95% CI -1.04, -0.25; p=0.001) lower than nonadherent. Odds ratios (95% CI) of HbA(1c)≤7.5% for 10-year higher age were 1.63 (1.08, 2.45); for adherent compared to non-adherent patients 1.89 (0.84, 4.25); for patients receiving >5 compared to ≤5 medications 0.32 (0.13, 0.76); and for each 1% increment in baseline HbA(1c) 0.48 (0.31, 0.73). CONCLUSIONS: The lower HbA(1c) achieved from greater adherence to glucose lowering treatment is comparable to that achieved with additional medication. Relationships between older age and better glycaemic control are not explained by better adherence, but may partly relate to lower BMI.

• Effectiveness of physical activity promotion based in primary care: systematic review and meta-analysis of randomised controlled trials.

  Authors: Gillian Orrow, Ann-Louise Kinmonth, Simon Sanderson, Stephen Sutton

  BMJ (Clinical research ed.). 01/2012; 344:e1389.

  To determine whether trials of physical activity promotion based in primary care show sustained effects on physical activity or fitness in sedentary adults, and whether exercise referralTo determine whether trials of physical activity promotion based in primary care show sustained effects on physical activity or fitness in sedentary adults, and whether exercise referral interventions are more effective than other interventions. Systematic review and meta-analysis of randomised controlled trials. Medline, CINAHL, PsycINFO, EMBASE, SPORTDiscus, Centre for Reviews and Dissemination, the Cochrane Library, and article reference lists. Review of randomised controlled trials of physical activity promotion in sedentary adults recruited in primary care, with minimum follow-up of 12 months, reporting physical activity or fitness (or both) as outcomes, and using intention to treat analyses. Two reviewers independently assessed studies for inclusion, appraised risk of bias, and extracted data. Pooled effect sizes were calculated using a random effects model. We included 15 trials (n=8745). Most interventions took place in primary care, included health professionals in delivery, and involved advice or counselling given face to face or by phone (or both) on multiple occasions. Only three trials investigated exercise referral. In 13 trials presenting self reported physical activity, we saw small to medium positive intervention effects at 12 months (odds ratio 1.42, 95% confidence interval 1.17 to 1.73; standardised mean difference 0.25, 0.11 to 0.38). The number needed to treat with an intervention for one additional sedentary adult to meet internationally recommended levels of activity at 12 months was 12 (7 to 33). In four trials reporting cardiorespiratory fitness, a medium positive effect at 12 months was non-significant (standardised mean difference 0.51, -0.18 to 1.20). Three trials of exercise referral found small non-significant effects on self reported physical activity at 12 months (odds ratio 1.38; 0.98 to 1.95; standardised mean difference 0.20, -0.21 to 0.61). Promotion of physical activity to sedentary adults recruited in primary care significantly increases physical activity levels at 12 months, as measured by self report. We found insufficient evidence to recommend exercise referral schemes over advice or counselling interventions. Primary care commissioners should consider these findings while awaiting further trial evaluation of exercise referral schemes and other primary care interventions, with longer follow-up and use of objective measures of outcome.

• Effect on adherence to nicotine replacement therapy of informing smokers their dose is determined by their genotype: a randomised controlled trial.

  Authors: Theresa M Marteau, Paul Aveyard, Marcus R Munafò, A Toby Prevost, Gareth J Hollands, David Armstrong, Stephen Sutton, Chloe Hill, Elaine Johnstone, Ann Louise Kinmonth

  PloS one. 01/2012; 7(4):e35249.

  The behavioural impact of pharmacogenomics is untested. We tested two hypotheses concerning the behavioural impact of informing smokers their oral dose of NRT is tailored to analysis of DNA. WeThe behavioural impact of pharmacogenomics is untested. We tested two hypotheses concerning the behavioural impact of informing smokers their oral dose of NRT is tailored to analysis of DNA. We conducted an RCT with smokers in smoking cessation clinics (N = 633). In combination with NRT patch, participants were informed that their doses of oral NRT were based either on their mu-opioid receptor (OPRM1) genotype, or their nicotine dependence questionnaire score (phenotype). The proportion of prescribed NRT consumed in the first 28 days following quitting was not significantly different between groups: (68.5% of prescribed NRT consumed in genotype vs 63.6%, phenotype group, difference  =  5.0%, 95% CI -0.9,10.8, p  =  0.098). Motivation to make another quit attempt among those (n  =  331) not abstinent at six months was not significantly different between groups (p  =  0.23). Abstinence at 28 days was not different between groups (p = 0.67); at six months was greater in genotype than phenotype group (13.7% vs 7.9%, difference  =  5.8%, 95% CI 1.0,10.7, p  =  0.018). Informing smokers their oral dose of NRT was tailored to genotype not phenotype had a small, statistically non-significant effect on 28-day adherence to NRT. Among those still smoking at six months, there was no evidence that saying NRT was tailored to genotype adversely affected motivation to make another quit attempt. Higher abstinence rate at six months in the genotype arm requires investigation. Controlled-Trials.com ISRCTN14352545.

• Factors predicting recruitment to a UK wide primary care smoking cessation study (the ESCAPE trial).

  Authors: Hazel Gilbert, Baptiste Leurent, Stephen Sutton, Richard Morris, Camille Alexis-Garsee, Irwin Nazareth

  Family practice. 05/2011; 29(1):110-7.

  Recruiting smokers to smoking cessation trials is challenging and participation rates are often low. Consequently, the interventions evaluated may fail to reach a broad spectrum of the targetRecruiting smokers to smoking cessation trials is challenging and participation rates are often low. Consequently, the interventions evaluated may fail to reach a broad spectrum of the target population, thus compromising the generalizability of the findings. Brief interventions, using proactive recruitment, are likely to attract a broader and more representative proportion of the population. We explored the factors that influenced recruitment into a trial evaluating computer-tailored feedback reports that aimed to help smokers to quit [the ESCAPE (Effectiveness of computer-tailored Smoking Cessation Advice in Primary Care) study] in order to investigate the possibilities for increasing recruitment into smoking cessation trials. Current cigarette smokers, identified from GP records, were invited to participate in the study. The main outcome measure was the recruitment rate, i.e. the proportion of participants who responded and were randomized to one of the intervention groups. Predictor variables included geographical region, level of deprivation, practice characteristics and the number and timing of mailings of questionnaires. The recruitment rate varied by practice (2.5-19.8%) and differed significantly between regions (from 16.3% in Scotland to 8.4% in London, P < 0.001). Recruitment decreased significantly by 1.1% between the lowest and highest quintiles of deprivation (P = 0.012), measured by Index of Multiple Deprivation scores, and decreased by 1.33% for every extra 10% smokers identified within a practice population (P = 0.010). Sending reminders increased recruitment by 7.5% (P < 0.001). Multivariable analysis showed region and length of time between mailings were the main predictors of recruitment. Proactive recruitment methods can increase participation in smoking cessation trials and weighting the target sample in favour of more deprived areas will recruit a more representative sample. The number and timing of mailings to potential participants can also increase recruitment.

• Protocol for the ADDITION-Plus study: a randomised controlled trial of an individually-tailored behaviour change intervention among people with recently diagnosed type 2 diabetes under intensive UK general practice care.

  Authors: Simon J Griffin, Rebecca K Simmons, Kate M Williams, A Toby Prevost, Wendy Hardeman, Julie Grant, Fiona Whittle, Sue Boase, Imogen Hobbis, Soren Brage, Kate Westgate, Tom Fanshawe, Stephen Sutton, Nicholas J Wareham, Ann Louise Kinmonth

  BMC public health. 04/2011; 11:211.

  The increasing prevalence of type 2 diabetes poses both clinical and public health challenges. Cost-effective approaches to prevent progression of the disease in primary care are needed. EvidenceThe increasing prevalence of type 2 diabetes poses both clinical and public health challenges. Cost-effective approaches to prevent progression of the disease in primary care are needed. Evidence suggests that intensive multifactorial interventions including medication and behaviour change can significantly reduce cardiovascular morbidity and mortality among patients with established type 2 diabetes, and that patient education in self-management can improve short-term outcomes. However, existing studies cannot isolate the effects of behavioural interventions promoting self-care from other aspects of intensive primary care management. The ADDITION-Plus trial was designed to address these issues among recently diagnosed patients in primary care over one year. ADDITION-Plus is an explanatory randomised controlled trial of a facilitator-led, theory-based behaviour change intervention tailored to individuals with recently diagnosed type 2 diabetes. 34 practices in the East Anglia region participated. 478 patients with diabetes were individually randomised to receive (i) intensive treatment alone (n = 239), or (ii) intensive treatment plus the facilitator-led individual behaviour change intervention (n = 239). Facilitators taught patients key skills to facilitate change and maintenance of key behaviours (physical activity, dietary change, medication adherence and smoking), including goal setting, action planning, self-monitoring and building habits. The intervention was delivered over one year at the participant's surgery and included a one-hour introductory meeting followed by six 30-minute meetings and four brief telephone calls. Primary endpoints are physical activity energy expenditure (assessed by individually calibrated heart rate monitoring and movement sensing), change in objectively measured dietary intake (plasma vitamin C), medication adherence (plasma drug levels), and smoking status (plasma cotinine levels) at one year. We will undertake an intention-to-treat analysis of the effect of the intervention on these measures, an assessment of cost-effectiveness, and analyse predictors of behaviour change in the cohort. The ADDITION-Plus trial will establish the medium-term effectiveness and cost-effectiveness of adding an externally facilitated intervention tailored to support change in multiple behaviours among intensively-treated individuals with recently diagnosed type 2 diabetes in primary care. Results will inform policy recommendations concerning the management of patients early in the course of diabetes. Findings will also improve understanding of the factors influencing change in multiple behaviours, and their association with health outcomes.

• Impact on decisions to start or continue medicines of providing information to patients about possible benefits and/or harms: a systematic review and meta-analysis.

  Authors: Rachel A Crockett, Stephen Sutton, Fiona M Walter, Megan Clinch, Theresa M Marteau, John Benson

  Medical decision making : an international journal of the Society for Medical Decision Making. 03/2011; 31(5):767-77.

  The impact of providing information about medicines to patients on decisions about starting or continuing them is unknown. To estimate the impact on decisions to start or continue medicines, ofThe impact of providing information about medicines to patients on decisions about starting or continuing them is unknown. To estimate the impact on decisions to start or continue medicines, of providing information to patients about possible benefits and/or harms. Electronic searches from 1980 to October 2010; reference and citation searches of included studies. Two investigators assessed studies' eligibility against inclusion criteria: randomized or pseudorandomized trials; participants older than 16 years and deciding for themselves; one group received information about possible benefits and/or harms of a potentially beneficial medicine, compared with another who did not; d) a measure of decision about starting or continuing a medicine. One investigator extracted all data, checked by a second. Eight studies were included, covering a range of medicines. There was no consistent impact of interventions on decisions about whether to start or continue medicines (pooled odds ratio 1.08; 95% confidence interval [CI], 0.69-1.70; P = 0.74). Among those who received more information, knowledge was increased (pooled mean difference 8.47; 95% CI 2.17-14.77; P = 0.008), and decisional conflict was reduced (pooled mean difference -0.15; 95% CI -0.24 to -0.06; P = .001). A small number of studies across different clinical contexts, of uncertain heterogeneity, were included. Providing information to patients about possible benefits and/or harms has no consistent effect on the number who decide to start or continue medicines, although it increases patients' knowledge and reduces their decisional conflict.

• Theory of planned behaviour cognitions do not predict self-reported or objective physical activity levels or change in the ProActive trial.

  Authors: Wendy Hardeman, Ann Louise Kinmonth, Susan Michie, Stephen Sutton

  British journal of health psychology. 02/2011; 16(Pt 1):135-50.

  The objective was to test, in a trial cohort of sedentary adults at risk of Type 2 diabetes, whether theory of planned behaviour (TPB) cognitions about becoming more physically active predictedThe objective was to test, in a trial cohort of sedentary adults at risk of Type 2 diabetes, whether theory of planned behaviour (TPB) cognitions about becoming more physically active predicted objective and self-reported activity levels and change. Participants of a randomized controlled trial underwent measurement at baseline, 6 and 12 months. Participants (N= 365, 30-50 years) were recruited via their parent or family history registers at 20 general practices in the UK. Energy expenditure was measured objectively at baseline and 1 year. Participants completed questionnaires assessing physical activity and beliefs about becoming more physically active over the next year at baseline, 6 and 12 months. Between baseline and 12 months, objective energy expenditure in the cohort increased by an average of 20 minutes of brisk walking per day. Based on the 252 participants who provided complete data, affective attitude and perceived behavioural control consistently predicted intention, but intention and perceived behavioural control failed to predict physical activity levels or change (p-values > .05). Failure of the theory to predict behaviour and behaviour change may be due to inapplicability of the theory to this at-risk population or to trial participation and intensive measurement facilitating behaviour change without affecting measured cognitions, or lack of correspondence between cognitive and behavioural measures. A wide range of potential personal and environmental mediators should be considered when designing physical activity interventions among at-risk groups. High-quality experimental tests of the theory are needed in clinical populations.

• Trial Protocol: Communicating DNA-based risk assessments for Crohn's disease: a randomised controlled trial assessing impact upon stopping smoking

  Authors: Sophia Whitwell, Christopher Mathew, Cathryn Lewis, Alastair Forbes, Sally Watts, Jeremy Sanderson, Gareth Hollands, Prevost A Toby, David Armstrong, Ann Kinmonth, Stephen Sutton, Theresa Marteau

  BMC Public Health. 01/2011;

  Abstract Background Estimates of the risk of developing Crohn&apos;s disease (CD) can be made using DNA testing for mutations in the NOD2 (CARD15) gene, family history, and smoking status. SmokingAbstract Background Estimates of the risk of developing Crohn&apos;s disease (CD) can be made using DNA testing for mutations in the NOD2 (CARD15) gene, family history, and smoking status. Smoking doubles the risk of CD, a risk that is reduced by stopping. CD therefore serves as a timely and novel paradigm within which to assess the utility of predictive genetic testing to motivate behaviour change to reduce the risk of disease. The aim of the study is to describe the impact upon stopping smoking of communicating a risk of developing CD that incorporates DNA analysis. We will test the following main hypothesis: Smokers who are first degree relatives (FDRs) of CD probands are more likely to make smoking cessation attempts following communication of risk estimates of developing CD that incorporate DNA analysis, compared with an equivalent communication that does not incorporate DNA analysis. Methods/design A parallel groups randomised controlled trial in which smokers who are FDRs of probands with CD are randomly allocated in families to undergo one of two types of assessment of risk for developing CD based on either: i. DNA analysis, family history of CD and smoking status, or ii. Family history of CD and smoking status The primary outcome is stopping smoking for 24 hours or longer in the six months following provision of risk information. The secondary outcomes are seven-day smoking abstinence at one week and six month follow-ups. Randomisation of 470 smoking FDRs of CD probands, with 400 followed up (85%), provides 80% power to detect a difference in the primary outcome of 14% between randomised arms, at the 5% significance level. Discussion This trial provides one of the strongest tests to date of the impact of communicating DNA-based risk assessment on risk-reducing behaviour change. Specific issues regarding the choice of trial design are discussed. Trial Registration ISRCTN: ISRCTN21633644

• Trial Protocol: Communicating DNA-based risk assessments for Crohn's disease: a randomised controlled trial assessing impact upon stopping smoking.

  Authors: Sophia C L Whitwell, Christopher G Mathew, Cathryn M Lewis, Alastair Forbes, Sally Watts, Jeremy Sanderson, Gareth J Hollands, A Toby Prevost, David Armstrong, Ann Louise Kinmonth, Stephen Sutton, Theresa M Marteau

  BMC public health. 01/2011; 11:44.

  Estimates of the risk of developing Crohn's disease (CD) can be made using DNA testing for mutations in the NOD2 (CARD15) gene, family history, and smoking status. Smoking doubles the risk of CD, aEstimates of the risk of developing Crohn's disease (CD) can be made using DNA testing for mutations in the NOD2 (CARD15) gene, family history, and smoking status. Smoking doubles the risk of CD, a risk that is reduced by stopping. CD therefore serves as a timely and novel paradigm within which to assess the utility of predictive genetic testing to motivate behaviour change to reduce the risk of disease. The aim of the study is to describe the impact upon stopping smoking of communicating a risk of developing CD that incorporates DNA analysis. We will test the following main hypothesis:Smokers who are first degree relatives (FDRs) of CD probands are more likely to make smoking cessation attempts following communication of risk estimates of developing CD that incorporate DNA analysis, compared with an equivalent communication that does not incorporate DNA analysis. A parallel groups randomised controlled trial in which smokers who are FDRs of probands with CD are randomly allocated in families to undergo one of two types of assessment of risk for developing CD based on either: i. DNA analysis, family history of CD and smoking status, or ii. Family history of CD and smoking status. The primary outcome is stopping smoking for 24 hours or longer in the six months following provision of risk information. The secondary outcomes are seven-day smoking abstinence at one week and six month follow-ups. Randomisation of 470 smoking FDRs of CD probands, with 400 followed up (85%), provides 80% power to detect a difference in the primary outcome of 14% between randomised arms, at the 5% significance level. This trial provides one of the strongest tests to date of the impact of communicating DNA-based risk assessment on risk-reducing behaviour change. Specific issues regarding the choice of trial design are discussed.

• Do increases in physical activity encourage positive beliefs about further change in the ProActive cohort?

  Authors: Wendy Hardeman, Susan Michie, Ann Louise Kinmonth, Stephen Sutton

  Psychology & health. 01/2011; 26(7):899-914.

  Effects of behaviour change on cognitions are rarely examined within the Theory of Planned Behaviour. We tested whether increases in physical activity resulted in more positive beliefs about furtherEffects of behaviour change on cognitions are rarely examined within the Theory of Planned Behaviour. We tested whether increases in physical activity resulted in more positive beliefs about further change among a cohort of sedentary adults participating in a behavioural intervention trial (ProActive). At baseline, 6 and 12 months, 365 adults completed questionnaires assessing physical activity and cognitions about becoming more active over the coming year. Objective activity was assessed at baseline and 12 months. Participants reporting larger increases in activity were no more positive about making further increases than those reporting less behaviour change (p-values>0.05). Participants with larger increases in objective activity reported weaker perceived control (β=-0.342; p=0.001) and more negative instrumental attitudes (β=-0.230; p=0.017) at 12 months. Participants may have felt that they had changed enough or measures of perceived success may be more sensitive to behaviour change. Alternatively, long measurement intervals may have missed immediate cognitive and affective consequences of behaviour change, or such effects may require participants to consistently self-monitor or receive feedback on performance. Future studies could test the effect of such techniques on physical activity and a wider range of cognitive, affective and physiological consequences, using more frequent measurement intervals.

• Commentary on Collins et al. (2010): Why readiness to change may not predict behaviour.

  Authors: Stephen Sutton

  Addiction (Abingdon, England). 11/2010; 105(11):1910-1.

• Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence.

  Authors: Theresa M Marteau, Marcus R Munafò, Paul Aveyard, Chloe Hill, Sophia Whitwell, Thomas A Willis, Rachel A Crockett, Gareth J Hollands, Elaine C Johnstone, Alison J Wright, A Toby Prevost, David Armstrong, Stephen Sutton, Ann Louise Kinmonth

  BMC public health. 11/2010; 10:680.

  The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. TheThe behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT) of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows: I Adherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype), compared to one tailored to nicotine dependence questionnaire score (phenotype). II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype. An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily) using National Health Service (NHS) stop smoking services in primary care are randomly allocated to one of two groups:i. NRT oral dose tailored by DNA analysis (OPRM1 gene) (genotype), orii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype)The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples t-test and by estimating the 95% confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I). Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II). This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. Specific issues regarding the choice of design for trials of interventions of this kind are discussed. TRIAL DETAILS: Funder: Medical Research Council (MRC)Grant number: G0500274. ISRCTN: 14352545. Date trial stated: June 2007. Expected end date: December 2009. Expected reporting date: December 2010.

• Psychometric properties of the processes of change scale for smoking cessation in UK adolescents.

  Authors: Boliang Guo, Antony Fielding, Stephen Sutton, Paul Aveyard

  International journal of behavioral medicine. 04/2010; 18(1):71-8.

  The transtheoretical model (TTM) proposes that individuals move stage and hence change behaviour through the use of processes of change (POC)--cognitive, emotional and behavioural activities relatedThe transtheoretical model (TTM) proposes that individuals move stage and hence change behaviour through the use of processes of change (POC)--cognitive, emotional and behavioural activities related to the target behaviour. This study was a test of the psychometric properties of the POC scale. The sample consisted of year 9 students from 26 schools who completed a computer-based version of the POC questionnaire on up to three occasions. There were 1,160 former and current smokers who completed the questionnaire on the first occasion, 978 on the second, and 836 on the third occasion. Confirmatory factor analysis was used to explore three alternative factor structures. Cronbach alpha and test-retest reliability coefficients were examined. Construct validity was examined by calculating POC means for each stage and testing differences between means using analysis of variance. The TTM-hypothesised second-order factor that clustered ten primary factors into experiential and behavioural processes fitted the data reasonably, though an alternative model, removing the second-order factors, was a significantly improved fit. Cronbach alpha coefficients were reasonable except for two processes. Test-retest reliabilities were modest. Experiential processes showed differences across precontemplation to preparation, but differences between preparation, action, and maintenance were slight. Behavioural processes showed linear differences between stages, though helping relationships was not different across stages. There is evidence of some specific difficulties with the POC questionnaire that may be overcome with some reformulation. The POC questionnaire shows evidence of adequate factorial validity, sufficient to allow its use in future predictive testing.

• Reactivity of measurement in health psychology: how much of a problem is it? What can be done about it?

  Authors: David P French, Stephen Sutton

  British journal of health psychology. 03/2010; 15(Pt 3):453-68.

  Measurement reactivity is defined as being present where measurement results in changes in the people being measured. The main aim of this review is to provide an overview of the current state ofMeasurement reactivity is defined as being present where measurement results in changes in the people being measured. The main aim of this review is to provide an overview of the current state of knowledge concerning the extent and nature of psychological measurement affecting people who complete the measures. Other aims are to describe how this may affect conclusions drawn in health psychology research and to outline where more research is needed. Narrative review. Several studies, using a variety of methods, have found measurement procedures to alter subsequent cognition, emotion, and behaviour. In many instances, the effects obtained were of up to medium size. However, the extent to which such studies are representative is not clear: do other studies which find no reactive effects of measurement not exist or do they exist but are not reported? Although measurement reactivity can yield medium-sized effects, our understanding of this phenomenon is still rudimentary. We do not know the precise circumstances that are likely to result in measurement reactivity: we cannot predict when problems are more likely to arise. There is a particular absence of studies of the mechanisms by which measurement reactivity arises. There is a need for a systematic review of this literature, which should aim to quantify the extent of measurement reactivity effects and to provide a firmer evidence base for theorizing about the sources of reactivity.

• Randomised controlled trial of the effects of physical activity feedback on awareness and behaviour in UK adults: the FAB study protocol [ISRCTN92551397].

  Authors: Clare Watkinson, Esther M F van Sluijs, Stephen Sutton, Theresa Marteau, Simon J Griffin

  BMC public health. 03/2010; 10(1):144.

  While there are increasing data implicating poor recognition of physical inactivity as a potential barrier to healthy behaviour change, the efficacy of feedback to promote physical activity isWhile there are increasing data implicating poor recognition of physical inactivity as a potential barrier to healthy behaviour change, the efficacy of feedback to promote physical activity is uncertain. Using a randomised controlled trial nested within a population-based cohort study, we plan to test three variations of physical activity feedback against a control group. Our primary objective is to assess the efficacy of physical activity feedback in promoting physical activity behaviour change. Secondary objectives are to determine the influence of feedback on physical activity awareness and cognitions, and to compare behavioural effects by type of feedback. We aim to recruit 500 healthy participants aged 30 to 55 years from the ongoing Fenland Study (Cambridge, UK). Following careful phenotyping during baseline measurement (anthropometric, clinical, body composition and fitness measurements, as well as questionnaires assessing self-reported and self-rated physical activity, psychosocial correlates of physical activity behaviour, diet, lifestyle and general health), participants wear a combined heart rate and movement sensor (Actiheart(R)) for six continuous days and nights. After receipt of the physical activity data (around 2 weeks later), participants are randomly allocated to either a control group (no feedback) or one of three types of personalised physical activity feedback ('simple', 'visualised' or 'contextualised'), and complete repeat measures of self-rated physical activity and psychosocial correlates. Approximately five weeks after receiving feedback, all participants wear the Actiheart(R) for another six-day follow-up period and complete repeat questionnaires. Values at outcome, adjusted for baseline, will be compared between randomised groups. Given the randomised trial design and use of objective measure of physical activity, this study is likely to provide valuable insights into the efficacy of a feedback intervention in changing physical activity behaviour, as well as the psychological mechanisms involved. Current Controlled Trials: ISRCTN92551397.

• Randomised controlled trial of the effects of physical activity feedback on awareness and behaviour in UK adults: the FAB study protocol [ISRCTN92551397]

  Authors: Clare Watkinson, van Sluijs Esther, Stephen Sutton, Theresa Marteau, Simon Griffin

  BMC Public Health. 01/2010;

  Abstract Background While there are increasing data implicating poor recognition of physical inactivity as a potential barrier to healthy behaviour change, the efficacy of feedback to promoteAbstract Background While there are increasing data implicating poor recognition of physical inactivity as a potential barrier to healthy behaviour change, the efficacy of feedback to promote physical activity is uncertain. Using a randomised controlled trial nested within a population-based cohort study, we plan to test three variations of physical activity feedback against a control group. Our primary objective is to assess the efficacy of physical activity feedback in promoting physical activity behaviour change. Secondary objectives are to determine the influence of feedback on physical activity awareness and cognitions, and to compare behavioural effects by type of feedback. Methods/Design We aim to recruit 500 healthy participants aged 30 to 55 years from the ongoing Fenland Study (Cambridge, UK). Following careful phenotyping during baseline measurement (anthropometric, clinical, body composition and fitness measurements, as well as questionnaires assessing self-reported and self-rated physical activity, psychosocial correlates of physical activity behaviour, diet, lifestyle and general health), participants wear a combined heart rate and movement sensor (Actiheart^®) for six continuous days and nights. After receipt of the physical activity data (around 2 weeks later), participants are randomly allocated to either a control group (no feedback) or one of three types of personalised physical activity feedback ('simple', 'visualised' or 'contextualised'), and complete repeat measures of self-rated physical activity and psychosocial correlates. Approximately five weeks after receiving feedback, all participants wear the Actiheart^®for another six-day follow-up period and complete repeat questionnaires. Values at outcome, adjusted for baseline, will be compared between randomised groups. Discussion Given the randomised trial design and use of objective measure of physical activity, this study is likely to provide valuable insights into the efficacy of a feedback intervention in changing physical activity behaviour, as well as the psychological mechanisms involved. Trial Registration Current Controlled Trials: ISRCTN92551397

• Who will increase their physical activity? Predictors of change in objectively measured physical activity over 12 months in the ProActive cohort

  Authors: Rebecca Simmons, van Sluijs Esther, Wendy Hardeman, Stephen Sutton, Simon Griffin

  BMC Public Health. 01/2010;

  Abstract Background The aim was to identify predictors of change in objectively measured physical activity over 12 months in the ProActive cohort to improve understanding of factors influencingAbstract Background The aim was to identify predictors of change in objectively measured physical activity over 12 months in the ProActive cohort to improve understanding of factors influencing change in physical activity. Methods ProActive is a physical activity promotion trial that took place in Eastern England (1999-2004). 365 offspring of people with type 2 diabetes underwent measurement of physical activity energy expenditure (PAEE) using heart rate monitoring, fitness, and anthropometric and biochemical status at baseline and 1 year ( n = 321). Linear regression was used to quantify the associations between baseline demographic, clinical, psychosocial and behavioural variables and change in PAEE over 12 months. This study is registered as ISRCTN 61323766. Results ProActive participants significantly increased their PAEE by 0.6 kj/min (SD 4.2, p = 0.006) over one year, the equivalent of around 20 minutes brisk walking/day. Male sex and higher fitness at baseline predicted increase in PAEE. No significant associations were found for any other variables. Very few baseline demographic, clinical, psychosocial and behavioural predictors were associated with change in objectively measured physical activity. Conclusions Traditional baseline determinants of self-reported physical activity targeted by behavioural interventions may be relatively weak predictors of change in objectively measured physical activity. Further research is needed to improve our understanding of factors influencing change in physical activity to inform the development and targeting of interventions.

• Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence

  Authors: Theresa Marteau, Marcus Munafò, Paul Aveyard, Chloe Hill, Sophia Whitwell, Thomas Willis, Rachel Crockett, Gareth Hollands, Elaine Johnstone, Alison Wright, Prevost A Toby, David Armstrong, Stephen Sutton, Ann Kinmonth

  BMC Public Health. 01/2010;

  Abstract Background The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to thisAbstract Background The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT) of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows: I Adherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype), compared to one tailored to nicotine dependence questionnaire score (phenotype). II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype. Methods/Design An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily) using National Health Service (NHS) stop smoking services in primary care are randomly allocated to one of two groups: i. NRT oral dose tailored by DNA analysis (OPRM1 gene) (genotype), or ii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype) The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples t-test and by estimating the 95% confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I). Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II). Discussion This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. Specific issues regarding the choice of design for trials of interventions of this kind are discussed. Trial details Funder: Medical Research Council (MRC) Grant number: G0500274 ISRCTN: 14352545 Date trial stated: June 2007 Expected end date: December 2009 Expected reporting date: December 2010