Obesity affects 25% of the UK adult population but modest weight loss can reduce the incidence of obesity-related chronic disease. Some effective weight loss treatments exist but there is no nationally available National Health Service (NHS) treatment service, and general practitioners (GPs) rarely discuss weight management with patients or support behavior change. Evidence shows that commercial weight management services, that most primary care trusts have 'on prescription', are more effective than primary care treatment.
We propose a controlled trial where patients will be randomized to receive either the offer of help by referral to a weight management service and follow-up to assess progress, or advice to lose weight on medical grounds. The primary outcome will be weight change at 12-months. Other questions are: what actions do people take to manage their weight in response to the two GP intervention types? How do obese patients feel about GPs opportunistically discussing weight management and how does this vary by intervention type? How do GPs feel about raising the issue opportunistically and giving the two types of brief intervention? What is the cost per kg/m2 lost for each intervention? Research assistants visiting GP practices in England (n = 60) would objectively measure weight and height prior to GP consultations and randomize willing patients (body mass index 30+, excess body fat, 18+ years) using sealed envelopes. Full recruitment (n = 1824) is feasible in 46 weeks, requiring six sessions of advice-giving per GP. Participants will be contacted at 3 months (postintervention) via telephone to identify actions they have taken to manage their weight. We will book appointments for participants to be seen at their GP practice for a 12-month follow-up.
Trial results could make the case for brief interventions for obese people consulting their GP and introduce widespread simple treatments akin to the NHS Stop Smoking Service. Likewise, the intervention could be introduced in the Quality and Outcomes Framework and influence practice worldwide.
Current Controlled Trials ISRCTN26563137.
Obesity; Brief intervention; Weight management; Primary care; Commercial weight management services
We examined whether schools achieving better than expected educational outcomes for their students influence the risk of drug use and delinquency among urban, racial/ethnic minority youth. Adolescents (n=2,621), who were primarily African American and Hispanic and enrolled in Chicago public schools (n=61), completed surveys in 6th (aged 12) and 8th (aged 14) grades. Value-added education was derived from standardized residuals of regression equations predicting school-level academic achievement and attendance from students’ sociodemographic profiles and defined as having higher academic achievement and attendance than that expected given the sociodemographic profile of the schools’ student composition. Multilevel logistic regression estimated the effects of value-added education on students’ drug use and delinquency. After considering initial risk behavior, value-added education was associated with lower incidence of alcohol, cigarette and marijuana use; stealing; and participating in a group-against-group fight. Significant beneficial effects of value-added education remained for cigarette and marijuana use, stealing and participating in a group-against-group fight after adjustment for individual- and school-level covariates. Alcohol use (past month and heavy episodic) showed marginally significant trends in the hypothesized direction after these adjustments. Inner-city schools may break the links between social disadvantage, drug use and delinquency. Identifying the processes related to value-added education in order to improve school environments is warranted given the high costs associated with individual-level interventions.
Schools; Drug use; Delinquency; Urban; Adolescents
Attentive eating means eating devoid of distraction and increasing awareness and memory for food being consumed. Encouraging individuals to eat more attentively could help reduce calorie intake, as a strong evidence base suggests that memory and awareness of food being consumed substantially influence energy intake.
The development and feasibility testing of a smartphone based attentive eating intervention is reported. Informed by models of behavioral change, a smartphone application was developed. Feasibility was tested in twelve overweight and obese volunteers, sampled from university staff. Participants used the application during a four week trial and semi-structured interviews were conducted to assess acceptability and to identify barriers to usage. We also recorded adherence by downloading application usage data from participants’ phones at the end of the trial.
Adherence data indicated that participants used the application regularly. Participants also felt the application was easy to use and lost weight during the trial. Thematic analysis indicated that participants felt that the application raised their awareness of what they were eating. Analysis also indicated barriers to using a smartphone application to change dietary behavior.
An attentive eating based intervention using smartphone technology is feasible and testing of its effectiveness for dietary change and weight loss is warranted.
Attentive eating; Memory; Attention; Awareness; Food intake; Mobile phone
Quitting smokers gain weight. This deters some from trying to stop smoking and may explain the increased incidence of type 2 diabetes after cessation. Dieting when stopping smoking may be counterproductive. Hunger increases cravings for smoking and tackling two behaviours together may undermine quitting success. A meta-analysis of randomized controlled trials (RCTs) showed individualized dietary support may prevent weight gain, although there is insufficient evidence whether it undermines smoking cessation. Commercial weight management providers (CWMPs), such as Slimming World, provide individualized dietary support for National Health Service (NHS) patients; however, there is no evidence that they can prevent cessation-related weight gain.
Our objective is to determine whether attending Slimming World from quit date, through referral from NHS Stop Smoking Services, is more effective than usual care at preventing cessation-related weight gain.
This RCT will examine the effectiveness of usual cessation support plus referral to Slimming World compared to usual cessation support alone. Healthy weight, overweight and obese adult smokers attending Stop Smoking Services will be included. The primary outcome is weight change in quitters 12 weeks post-randomization. Multivariable linear regression analysis will compare weight change between trial arms and adjust for known predictors of cessation-related weight gain.
We will recruit 320 participants, with 160 participants in each arm. An alpha error rate of 5% and 90% power will detect a 2 kg (SD = 2.5) difference in weight gain at 12 weeks, assuming 20% remain abstinent by then.
This trial will establish whether referral to the 12-week Slimming World programme plus usual care is an effective intervention to prevent cessation-related weight gain. If so, we will seek to establish whether weight control comes at the expense of a successful quit attempt in a further non-inferiority trial.
Positive results from both these trials would provide a potential solution to cessation-related weight gain, which could be rolled out across England within Stop Smoking Services to better meet the needs of 0.75 million smokers stopping with NHS support every year.
Current Controlled Trials ISRCTN65705512
Weight gain; Smoking cessation; Prevention; Obesity; Commercial weight management provider
Consumption of high calorie junk foods has increased recently, especially among young adults and higher intake may cause weight gain. There is a need to develop public health approaches to motivate people to reduce their intake of junk food.
To assess the effect of health and social norm messages on high calorie snack food intake (a type of junk food) as a function of usual intake of junk food.
In a between-subjects design, 129 young adults (45 men and 84 women, mean age = 22.4 years, SD = 4.5) were assigned to one of three conditions: 1) a social norm condition, in which participants saw a message about the junk food eating habits of others; 2) a health condition, in which participants saw a message outlining the health benefits of reducing junk food consumption and; 3) a control condition, in which participants saw a non-food related message. After exposure to the poster messages, participants consumed a snack and the choice and amount of snack food consumed was examined covertly. We also examined whether usual intake of junk food moderated the effect of message type on high calorie snack food intake.
The amount of high calorie snack food consumed was significantly lower in both the health and the social norm message condition compared with the control message condition (36% and 28%, both p < 0.05). There was no significant difference in snack food or energy intake between the health and social norm message conditions. There was no evidence that the effect of the messages depended upon usual consumption of junk food.
Messages about the health effects of junk food and social normative messages about intake of junk food can motivate people to reduce their consumption of high calorie snack food.
Social norms; Health messages; Junk food
Smoking during pregnancy and in the postnatal period is a major cause of low birth weight and a range of adverse infant health outcomes. Stop smoking services can double quit rates, but only 17% of pregnant women smoking at the time they book for antenatal care use these services. In a recent Cochrane review on the effectiveness of smoking cessation interventions in pregnancy, financial incentives were found to be the single most effective intervention. We describe a single arm intervention study offering participation in a financial incentive scheme for smoking cessation to all pregnant smokers receiving antenatal care in one area in England. The aim of the study is to assess the potential effectiveness of using financial incentives to achieve smoking cessation in pregnant women who smoke, to inform the use of financial incentive schemes in routine clinical practice as well as the interpretation of existing trials and the design of future studies.
500 consecutive pregnant smokers are offered participation in the scheme, which involves attending for up to 32 assessments until six months post-partum, to verify smoking cessation by self report and a negative exhaled carbon monoxide measurement. At each visit when cessation is verified, participants receive a shopping voucher starting at a value of £8 and increasing by £1 at each consecutive successful visit. Assessments decline in frequency, occurring most frequently during the first two weeks after quitting and the first two weeks after delivery. The maximum cumulative total that can be earned through the scheme is £752.
The results of this study will inform the use of financial incentive schemes in routine clinical practice as well as the interpretation of existing trials and the design of future studies. The main results are (a) an estimate of the proportion of pregnant smokers who enrol in the scheme; (b) estimates of the proportion of pregnant smokers who participate in the scheme and who achieve prolonged abstinence at: i. delivery and ii. six months postpartum; (c) predictors of i. participation in the scheme, and ii. smoking cessation; and (d) estimates of the adverse effects of using incentives to achieve quitting as indexed by: i. the delay in quitting smoking to enrol in an incentive scheme and, ii. false reporting of smoking status, either to gain entry into the scheme or to gain an incentive.
Smoking cessation; Financial incentives; Pregnancy; Vouchers
Smoking is common in people infected with HIV but cessation support is not a routine part of clinical care. The aim was to assess whether smoking is a risk factor for pneumonia in people with HIV and whether smoking cessation ameliorates excess risk.
We performed MEDLINE and Embase database searches and included cohort or case-control studies conducted in adult patients infected with HIV extracting a hazard ratio (HR) or odds ratio (OR) that compared the incidence of bacterial pneumonia or pneumonia caused by Pneumocystis jiroveci (PCP) between two smoking categories. Studies were appraised for quality and combined using inverse variance meta-analysis.
Fourteen cohort and case-control studies were included. Assessment of outcome was good, but assessment of exposure status was poor. Current smokers were at higher risk of bacterial pneumonia than former smokers: HR 1.37 (95% confidence interval (CI): 1.06, 1.78). There was no evidence that former smokers were at higher risk than never smokers: HR 1.24 (95%CI: 0.96, 1.60). Current smokers were at higher risk of bacterial pneumonia than current non-smokers: HR of 1.73 (95%CI: 1.44, 2.06). There was no evidence that smoking increased the incidence of PCP. The HR for current versus non-smokers was 0.94 (95%CI: 0.79, 1.12), but from case-control studies the OR was 1.76 (95%CI: 1.25, 2.48) with heterogeneity. Confined to higher quality studies, the OR was 0.97 (95%CI: 0.81, 1.16). Residual confounding is possible, but available data suggest this is not an adequate explanation.
Smoking is a risk factor for bacterial pneumonia but not PCP and smoking cessation reduces this risk.
See related article: http://www.biomedcentral.com/1741-7015/11/16
HIV; meta-analysis; pneumonia; smoking; smoking cessation
Stopping smoking results in weight gain. Avoidance of alcohol is often advocated to reduce cues to smoking, but the effect of alcohol consumption on body weight is unclear.
We used regression models to examine weight change by baseline alcohol consumption in quitting and continuing smokers. Weight was measured at baseline and at 8 years, and weekly alcohol consumption was reported at baseline in participants from the Oxfordshire general practices nicotine patch/placebo trial. Of 698 smokers attempting to stop smoking, 85 were abstinent for 8 years and 613 continued to smoke.
The association between baseline alcohol consumption and weight change depended upon smoking status (p for interaction = .019). In smokers, there was no association with weight change, 0.005 (95% CI: −0.037 to 0.056) kg per UK unit (U) (8 g of ethanol) consumed each week. This was unmodified by gender and baseline body mass index (BMI). In quitters, there was a negative association with weight change, −0.174 (95% CI: −0.315 to −0.034) kg per U consumed each week (unmodified by gender and baseline BMI). Quitters who consumed 14 U (112 g ethanol) a week weighed a mean 2.4 kg less than quitters who did not drink.
Quitting smokers who drink more alcohol appear to gain less weight after quitting than those who do not drink. This is consistent across studies, it may be accounted for by unmeasured confounders or it may be that alcohol reduces weight gain. If alcohol reduces weight gain, the advice for quitting smokers must balance the benefits and hazards of alcohol consumption. However, there is currently insufficient evidence to advise quitters who drink little or no alcohol to increase consumption.
Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA) interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP) trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date.
The LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy), and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation) or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations). The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome.
This trial will assess whether a PA intervention is effective when used for smoking cessation during pregnancy.
Smoking cessation; Pregnancy; Physical activity; Intervention; Randomized controlled trial
The rs1051730 genetic variant within the CHRNA5-A3-B4 gene cluster is associated with heaviness of smoking and has recently been reported to be associated with likelihood of stopping smoking. We investigated the potential association of rs1051730 genotype with reduced likelihood of smoking cessation in 2 cohorts of treatment-seeking smokers in primary care in the United Kingdom.
Data were drawn from 2 clinical trials on which DNA was available. One sample was a randomized placebo-controlled trial of nicotine transdermal patch and the other sample an open-label trial where all participants received nicotine transdermal patch. Smoking status was biochemically verified. Logistic regression was used to assess evidence for association in each sample, and data were combined within a meta-analysis.
There was evidence of association of rs1051730 genotype with short-term (4-week) cessation in our open-label trial sample but not our placebo-controlled trial sample. When combined in a meta-analysis, this effect remained. There was no evidence of association at later follow-up intervals. Adjustment for cigarette consumption and tobacco dependence did not alter these results substantially.
Our data, taken together with previous recent studies, provide some support for a weak association between this variant and short-term smoking cessation in treatment-seeking smokers, which does not seem to operate only among those receiving nicotine replacement therapy. Moreover, the rs1051730 variant may not merely operate as a marker for dependence or heaviness of smoking.
Previous studies found lower substance use in schools achieving better examination and truancy results than expected, given their pupil populations (high value-added schools). This study examines whether these findings are replicated in West Scotland and whether school ethos indicators focussing on pupils' perceptions of schooling (environment, involvement, engagement and teacher–pupil relations) mediate the associations. Teenagers from forty-one schools (S2, aged 13, n = 2268; S4, aged 15, n = 2096) previously surveyed in primary school (aged 11, n = 2482) were surveyed in the late 1990s. School value-added scores were derived from standardised residuals of two regression equations separately predicting from pupils' socio-demographic characteristics (1) proportions of pupils passing five Scottish Standard Grade Examinations, and (2) half-day truancy loss. Outcomes were current smoking, monthly drinking, ever illicit drug use. Random effects logistic regression models adjusted for potential pupil-level confounders were used to assess (1) associations between substance use and school-level value-added scores and (2) whether these associations were mediated by pupils' perceptions of schooling or other school-level factors (school roll, religious denomination and mean aggregated school-level ethos scores). Against expectations, value-added education was positively associated with smoking (Odds Ratios [95% confidence intervals] for one standard deviation increase in value-added scores were 1.28 [1.02–1.61] in S2 and 1.13 [1.00–1.27] in S4) and positively but weakly and non-significantly associated with drinking and drug use. Engagement and positive teacher–pupil relations were strongly and negatively associated with all substance use outcomes at both ages. Other school-level factors appeared weakly and largely non-significantly related to substance use. Value-added scores were unrelated to school ethos measures and no ethos measure mediated associations between value-added education and substance use. We conclude that substance use in Scotland is more likely in high value-added schools, among disengaged students and those with poorer student–teacher relationships. Understanding the underpinning mechanisms is a potentially important public health concern.
► Contrary to previous studies, high value-added schools were associated with greater substance use prevalence in West Scotland. ► High value-added schools occurred throughout the socio-economic spectrum and ranges of exam results and truancy rates. ► Substance use in Scotland is more likely among disengaged students and those with poorer student–teacher relationships. ► Associations between value-added education and substance use were not mediated by pupils' perceptions of school ethos. ► Scottish schools may influence pupils' substance use through at least two pathways related to school ethos.
Teenagers; Substance use; School ethos; Value-added education; Scotland; Adolescents
Most people who stop smoking successfully for a few weeks will return to smoking again in the medium term. There are few effective interventions to prevent this relapse and none used routinely in clinical practice. A previous exploratory meta-analysis suggested that self-help booklets may be effective but requires confirmation. This trial aims to evaluate the effectiveness and cost-effectiveness of a set of self-help educational materials to prevent smoking relapse in the National Health Service (NHS) Stop Smoking Service.
This is an open, randomized controlled trial. The target population is carbon monoxide (CO) verified quitters at four weeks in the NHS stop smoking clinic (total sample size N = 1,400). The experimental intervention tested is a set of eight revised Forever Free booklets, including an introduction booklet and more extensive information on all important issues for relapse prevention. The control intervention is a leaflet that has no evidence to suggest it is effective but is currently given to some patients using NHS stop smoking services.
Two follow-up telephone interviews will be conducted at three and 12 months after the quit date. The primary outcome will be prolonged abstinence from months four to 12 with no more than five lapses, confirmed by a CO test at the 12-month assessment. The secondary outcomes will be seven-day self-report point prevalence abstinence at three months and seven-day biochemically confirmed point prevalence abstinence at 12 months. To assess cost-effectiveness, costs will be estimated from a health service perspective and the EQ-5D will be used to estimate the QALY (Quality Adjusted Life Year) gain associated with each intervention.
The comparison of smoking abstinence rates (and any other binary outcomes) between the two trial arms will be carried out using odds ratio as the outcome statistic and other related statistical tests. Exploratory subgroup analyses, including logistic regression analyses with interaction terms, will be conducted to investigate possible effect-modifying variables.
The possible effect of self-help educational materials for the prevention of smoking relapse has important public health implications.
Current Controlled Trials ISRCTN36980856
Smoking relapse; Self-help booklets; Effectiveness; Intervention
Two single-nucleotide polymorphisms, rs1051730 and rs16969968, located within the nicotinic acetylcholine receptor gene cluster on chromosome 15q25 locus, are associated with heaviness of smoking, risk for lung cancer, and other smoking-related health outcomes. Previous studies have typically relied on self-reported smoking behavior, which may not fully capture interindividual variation in tobacco exposure.
We investigated the association of rs1051730 and rs16969968 genotype (referred to as rs1051730–rs16969968, because these are in perfect linkage disequilibrium and interchangeable) with both self-reported daily cigarette consumption and biochemically measured plasma or serum cotinine levels among cigarette smokers. Summary estimates and descriptive statistical data for 12 364 subjects were obtained from six independent studies, and 2932 smokers were included in the analyses. Linear regression was used to calculate the per-allele association of rs1051730–rs16969968 genotype with cigarette consumption and cotinine levels in current smokers for each study. Meta-analysis of per-allele associations was conducted using a random effects method. The likely resulting association between genotype and lung cancer risk was assessed using published data on the association between cotinine levels and lung cancer risk. All statistical tests were two-sided.
Pooled per-allele associations showed that current smokers with one or two copies of the rs1051730–rs16969968 risk allele had increased self-reported cigarette consumption (mean increase in unadjusted number of cigarettes per day per allele = 1.0 cigarette, 95% confidence interval [CI] = 0.57 to 1.43 cigarettes, P = 5.22 × 10−6) and cotinine levels (mean increase in unadjusted cotinine levels per allele = 138.72 nmol/L, 95% CI = 97.91 to 179.53 nmol/L, P = 2.71 × 10−11). The increase in cotinine levels indicated an increased risk of lung cancer with each additional copy of the rs1051730–rs16969968 risk allele (per-allele odds ratio = 1.31, 95% CI = 1.21 to 1.42).
Our data show a stronger association of rs1051730–rs16969968 genotype with objective measures of tobacco exposure compared with self-reported cigarette consumption. The association of these variants with lung cancer risk is likely to be mediated largely, if not wholly, via tobacco exposure.
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.
Methods and Findings
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.
Public policy and clinical treatment in tobacco addiction in the UK has focused on cessation: an abrupt attempt to stop all cigarettes. However, recent evidence suggests that allowing more gradual withdrawal from tobacco or even permanent partial substitution by nicotine replacement therapy (NRT) could lead to net benefits to public health. No jurisdiction has introduced smoking reduction programmes in normal clinical care and the best methods for their implementation is uncertain. Community pharmacists offering smoking cessation services in the UK are ideally placed to implement reduction programmes.
This pilot study aims therefore to examine the feasibility of implementing smoking reduction programme in pharmacies, and also to see if behavioural support and a longer treatment affect the success rate for cessation.
Design and methods
This is a 2 × 2 randomised factorial trial of behavioural support versus no support and short versus standard length reduction programme. The pharmacists will recruit 16 patients per pharmacy, 160 smokers altogether. Pharmacists will randomise each participant by sealed envelopes. In a standard supported programme, the pharmacist will give support for 34 weeks, inviting participants to set a treatment goal and providing advice on how to reduce cigarette use. Participants in the short programme will be given the same advice on how to reduce but will reduce smoking over four weeks. Participants in the no support arms will be given a leaflet that describes the reduction programmes in 4-week and 34-week format. All participants are encouraged to use of NRT to support the reduction. These processes will be measured by recording the number of recruited smokers; percentage of those who reduce and sustain their consumption to at least 50% of baseline value, and the proportion of people who attain 4 weeks abstinence and 6 months abstinence. Interviews will assess smokers' and pharmacists' views on the way the programme ran.
This is a pilot study to assess the feasibility of offering smoking reduction programme within pharmacies that offer naturalistic setting to show population benefit from these programmes. Findings from this trial will inform the development of evidence-based treatment for smokers who want to reduce and best approaches to engage reluctant quitters onto the programme.
Current Controlled Trials ISRCTN 2010-019259-24
Smoking; Tobacco Dependence; Controlled Clinical Trials; Randomized; Pharmacists; Harm Reduction
Cigarette smoking remains the leading cause of preventable death worldwide. However, the efficacy of available first-line therapies remains low, particularly in primary care practice where most smokers seek and receive treatment. These observations reinforce the notion that ‘one size fits all’ smoking cessation therapies may not be optimal. Therefore, a translational research effort was launched by the Imperial Cancer Research Fund (later Cancer Research UK) General Practice Research Group, who led a decade-long research enterprise that examined the influence of pharmacological hypothesis-driven research into genetic influences on drug response for smoking cessation with transdermal nicotine replacement therapy in general practice.
New and previously published smoking cessation genetic association results of 30 candidate gene polymorphisms genotyped for participants in two transdermal nicotine replacement clinical trials based in UK general practices, which employed an intention to analyze approach.
By this high bar, one of the polymorphisms (COMT rs4680) was robust to correction for multiple comparisons. Moreover, future research directions are outlined; and lessons learned as well as best-practice models for designing, analyzing, and translating results into clinical practice are proposed.
The results and lessons learned from this general practice-based pharmacogenetic research programme provide transportable insights at the transition to the second generation of pharmacogenetic and genomic investigations of smoking cessation and its translation to primary care.
Smoking prevalence is high among Pakistani and Bangladeshi men in the UK, but there are few tailored smoking cessation programmes for Pakistani and Bangladeshi communities. The aim of this study was to pilot a cluster randomised controlled trial comparing the effectiveness of Pakistani and Bangladeshi smoking cessation outreach workers with standard care to improve access to and the success of English smoking cessation services.
A pilot cluster randomised controlled trial was conducted in Birmingham, UK. Geographical lower layer super output areas were used to identify natural communities where more than 10% of the population were of Pakistani and Bangladeshi origin. 16 agglomerations of super output areas were randomised to normal care controls vs. outreach intervention. The number of people setting quit dates using NHS services, validated abstinence from smoking at four weeks, and stated abstinence at three and six months were assessed. The impact of the intervention on choice and adherence to treatments, attendance at clinic appointments and patient satisfaction were also assessed.
We were able to randomise geographical areas and deliver the outreach worker-based services. More Pakistani and Bangladeshi men made quit attempts with NHS services in intervention areas compared with control areas, rate ratio (RR) 1.32 (95%CI: 1.03-1.69). There was a small increase in the number of 4-week abstinent smokers in intervention areas (RR 1.30, 95%CI: 0.82-2.06). The proportion of service users attending weekly appointments was lower in intervention areas than control areas. No difference was found between intervention and control areas in choice and adherence to treatments or patient satisfaction with the service. The total cost of the intervention was £124,000; an estimated cost per quality-adjusted life year (QALY) gained of £8,500.
The intervention proved feasible and acceptable. Outreach workers expanded reach of smoking cessation services in diverse locations of relevance to Pakistani and Bangladeshi communities. The outreach worker model has the potential to increase community cessation rates and could prove cost-effective, but needs evaluating definitively in a larger, appropriately powered, randomised controlled trial. These future trials of outreach interventions need to be of sufficient duration to allow embedding of new models of service delivery.
Current Controlled Trials ISRCTN82127540
Despite having high smoking rates, there have been few tailored cessation programmes for male Bangladeshi and Pakistani smokers in the UK. We report on a qualitative evaluation of a community-based, outreach worker delivered, intervention that aimed to increase uptake of NHS smoking cessation services and tailor services to meet the needs of Bangladeshi and Pakistani men.
This was a longitudinal, qualitative study, nested within a phase II cluster randomised controlled trial of a complex intervention. We explored the perspectives and experiences of five outreach workers, two stop smoking service managers and a specialist stop smoking advisor. Data were collected through focus group discussions, weekly diaries, observations of management meetings, shadowing of outreach workers, and one-to-one interviews with outreach workers and their managers. Analysis was undertaken using a modified Framework approach.
Outreach workers promoted cessation services by word of mouth on the streets, in health service premises, in local businesses and at a wide range of community events. They emphasised the reasons for cessation, especially health effects, financial implications, and the impact of smoking on the family. Many smokers agreed to be referred to cessation services, but few attended, this in part being explained by concerns about the relative inflexibility of existing service provision. Although outreach workers successfully expanded service reach, they faced the challenges of perceived lack of awareness of the health risks associated with smoking in older smokers and apathy in younger smokers. These were compounded by perceptions of "lip service" being given to their role by community organisations and tensions both amongst the outreach workers and with the wider management team.
Outreach workers expanded reach of the service through taking it to diverse locations of relevance to Pakistani and Bangladeshi communities. The optimum method of outreach to retain and treat Bangladeshi and Pakistani smokers effectively in cessation programmes needs further development.
To confirm and extend to primary care settings prior genome-wide association results that distinguish smokers who successfully quit from individuals who were not able to quit smoking in clinical trials.
Materials & methods
Affymetrix® 6.0 Arrays were used to study DNA from successful quitters and matched individuals who did not quit from the Patch in Practice study of 925 smokers in 26 UK general practices who were provided with 15 mg/16 h nicotine-replacement therapy and varying degrees of behavioral support.
Only a few SNPs provided results near ‘genome-wide’ levels of significance. Nominally significant (p < 0.01) SNP results identify the same chromosomal regions identified by prior genome-wide association studies to a much greater extent than expected by chance.
Ability to change smoking behavior in a general practice setting appears to share substantial underlying genetics with the ability to change this behavior in clinical trials, though the modest sample sizes available for these studies provides some caution to these conclusions.
DNA microarray; genetic susceptibility; nicotine dependence; nicotine replacement; smoking cessation
Many young people report they want to stop smoking and have tried to do so, but most of their quit attempts fail. For adult smokers, there is strong evidence that group behavioural support enhances quit rates. However, it is uncertain whether group behavioural support enhances abstinence in young smokers trying to quit.
A cluster randomised trial for young people trying to stop smoking to compare the efficacy of a school-based 9 week intensive group behavioural support course versus a school-based 7 week brief advice only course. Participants were assessed for evidence of tobacco addiction and nicotine replacement therapy (NRT) was used if it was deemed appropriate by the therapist. Both types of course aimed to recruit approximately one hundred participants from approximately ten schools.
The primary outcome was successful quitting at 4 weeks after quit day judged according to the Russell standard. Had the trial been completed, abstinence at 6 months after quit day and the relationships between successful quit attempts and 1) psychological assessments of dependence prior to quitting 2) salivary cotinine concentration prior to quitting and 3) sociodemographic characteristics would also have been assessed. The proportion of participants who stopped smoking in each arm of the trial were compared using Chi square tests.
The trial was stopped shortly after it had started because funding to support the therapists running the stop smoking group behavioural support programme was withdrawn. Only three stop smoking courses were completed (two group support courses and one brief advice pharmacotherapy course). Seventeen participants in total entered the trial. At the end of the courses, one participant (10%) attending the group support programme had stopped smoking and no participant attending the brief advice programme had stopped smoking.
The trial was stopped so we were unable to determine whether group support helped more young people to stop smoking than brief advice. Engagement and recruitment of participants proved much more difficult than had been anticipated. Fifteen of the seventeen participants reported that quitting smoking was either pretty important or very important to them. Thus, the stop smoking success rate could, nevertheless, be considered disappointing.
Current Controlled Trials ISRCTN25181936
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.
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).
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.
Funder: Medical Research Council (MRC)
Grant number: G0500274
Date trial stated: June 2007
Expected end date: December 2009
Expected reporting date: December 2010
Weight gain accompanies smoking cessation, but dieting during quitting is controversial as hunger may increase urges to smoke. This is a feasibility trial for the investigation of a very low calorie diet (VLCD), individual modest energy restriction, and usual advice on hunger, ketosis, urges to smoke, abstinence and weight gain in overweight smokers trying to quit.
This is a 3 armed, unblinded, randomized controlled trial in overweight (BMI > 25 kg/m2), daily smokers (CO > 10 ppm); with at least 30 participants in each group. Each group receives identical behavioural support and NRT patches (25 mg(8 weeks),15 mg(2 weeks),10 mg(2 weeks)). The VLCD group receive a 429-559 kcal/day liquid formula beginning 1 week before quitting and continuing for 4 weeks afterwards. The modest energy restricted group (termed individual dietary and activity planning(IDAP)) engage in goal-setting and receive an energy prescription based on individual basal metabolic rate(BMR) aiming for daily reduction of 600 kcal. The control group receive usual dietary advice that accompanies smoking cessation i.e. avoiding feeling hungry but eating healthy snacks. After this, the VLCD participants receive IDAP to provide support for changing eating habits in the longer term; the IDAP group continues receiving this support. The control group receive IDAP 8 weeks after quitting. This allows us to compare IDAP following a successful quit attempt with dieting concurrently during quitting. It also aims to prevent attrition in the unblinded, control group by meeting their need for weight management. Follow-up occurs at 6 and 12 months.
Outcome measures include participant acceptability, measured qualitatively by semi-structured interviewing and quantitatively by recruitment and attrition rates. Feasibility of running the trial within primary care is measured by interview and questionnaire of the treatment providers. Adherence to the VLCD is verified by the presence of urinary ketones measured weekly. Daily urges to smoke, hunger and withdrawal are measured using the Mood and Physical Symptoms Scale-Combined (MPSS-C) and a Hunger Craving Score (HCS). 24 hour, 7 day point prevalence and 4-week prolonged abstinence (Russell Standard) is confirmed by CO < 10 ppm. Weight, waist and hip circumference and percentage body fat are measured at each visit.
Current controlled trials ISRCTN83865809
There is insufficient and conflicting evidence about whether more intensive behavioural support is more effective than basic behavioural support for smoking cessation and whether primary care nurses can deliver effective behavioural support.
A randomised controlled trial was performed in 26 UK general practices. 925 smokers of ⩾10 cigarettes per day were randomly allocated to basic or weekly support. All participants were seen before quitting, telephoned around quit day, and seen 1 and 4 weeks after the initial appointment (basic support). Participants receiving weekly support had an additional telephone call at 10 days and 3 weeks after the initial appointment and an additional visit at 2 weeks to motivate adherence to nicotine replacement and renew quit attempts. 15 mg/16 h nicotine patches were given to all participants. The outcome was assessed by intention to treat analyses of the percentage confirmed sustained abstinence at 4, 12, 26 and 52 weeks after quit day.
Of the 469 and 456 participants in the basic and weekly arms, the numbers (%) who quit and the percentage difference were 105 (22.4%) vs 102 (22.4%), 0.1% (95% CI −5.3% to 5.5%) at 4 weeks, 66 (14.1%) vs 52 (11.4%), −2.6% (95% CI −6.9% to 1.7%) at 12 weeks, 50 (10.7%) vs 40 (8.8%), −1.9% (95% CI −5.7% to 2.0%) at 26 weeks and 36 (7.7%) vs 30 (6.6%), −1.1% (95% CI −4.4% to 2.3%) at 52 weeks.
The absolute quit rates achieved are those expected from nicotine replacement alone, implying that neither basic nor weekly support were effective. Primary care smoking cessation treatment should provide pharmacotherapy with sufficient support only to ensure it is used appropriately, and those in need of support should be referred to specialists.
Developed countries are facing a huge rise in the prevalence of obesity and its associated chronic medical problems. In the UK Primary Care Trusts are charged with addressing this in the populations they serve, but evidence about the most effective ways of delivering services is not available. The aim of this study is to determine the effectiveness of a range of weight loss programmes for obese patients in primary care and to determine the characteristics of patients who respond to an invitation to a free weight management programme.
Lighten Up is a randomised controlled trial comparing a range of 12-week commercial and NHS weight reduction programmes with a comparator group who are provided with 12 vouchers enabling free entrance to a local leisure centre. The weight reduction programmes are: (i) Weight Watchers, (ii) Slimming World, (iii) Rosemary Conley, (iv) a group-based dietetics-led programme (Size Down), (v) general practice one-to-one counselling, (vi) pharmacy-led one-to-one counselling, (vii) choice of any of the 6 programmes. People with obesity or overweight with a co-morbid disorder are invited to take part by a letter from their general practitioner. The sample size is 740 participants.
The primary outcome is weight loss at programme-end (3 months). Secondary outcomes are weight-loss at one year, self-reported physical activity at 3 and 12 months follow-up and percentage weight-loss at 3 months and one year.
This trial will provide evidence about the effectiveness of a range of different weight management programmes in a primary care population.
Current Controlled Trials ISRCTN25072883