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1.  A randomised controlled trial of the effectiveness of self-weighing as a weight loss intervention 
There is a need to find simple cost effective weight loss interventions that can be used in primary care. There is evidence that self-monitoring is an effective intervention for problem drinking and self-weighing might be an effective intervention for weight loss.
To examine the efficacy of daily self-weighing as an intervention for weight loss.
A randomised controlled trial of 183 obese adults, follow-up three months. The intervention group were given a set of weighing scales and instructed to weigh themselves daily and record their weight. Both groups received two weight loss consultations which were known to be ineffective.
92 participants were randomised to the intervention group and 91 to the control group. The intervention group lost 0.5 kg (95% CI 0.3 to 1.3 kg) more than the control group, but this was not significant. There was no evidence that self-weighing frequency was associated with more weight loss.
As an intervention for weight loss, instruction to weigh daily is ineffective. Unlike other studies, there was no evidence that greater frequency of self-weighing is associated with greater weight loss.
Trial registration
PMCID: PMC4195875  PMID: 25301251
Weight loss; Obesity; Self-weighing; Self-monitoring
2.  Diet or Exercise Interventions vs Combined Behavioral Weight Management Programs: A Systematic Review and Meta-Analysis of Direct Comparisons 
Weight loss can reduce the health risks associated with being overweight or obese. However, the most effective method of weight loss remains unclear. Some programs emphasize physical activity, others diet, but existing evidence is mixed as to whether these are more effective individually or in combination. We aimed to examine the clinical effectiveness of combined behavioral weight management programs (BWMPs) targeting weight loss in comparison to single component programs, using within study comparisons. We included randomized controlled trials of combined BWMPs compared with diet-only or physical activity-only programs with at least 12 months of follow-up, conducted in overweight and obese adults (body mass index ≥25). Systematic searches of nine databases were run and two reviewers extracted data independently. Random effects meta-analyses were conducted for mean difference in weight change at 3 to 6 months and 12 to 18 months using a baseline observation carried forward approach for combined BWMPs vs diet-only BWMPs and combined BWMPs vs physical activity-only BWMPs. In total, eight studies were included, representing 1,022 participants, the majority of whom were women. Six studies met the inclusion criteria for combined BWMP vs diet-only. Pooled results showed no significant difference in weight loss from baseline or at 3 to 6 months between the BWMPs and diet-only arms (–0.62 kg; 95% CI –1.67 to 0.44). However, at 12 months, a significantly greater weight-loss was detected in the combined BWMPs (–1.72 kg; 95% CI –2.80 to –0.64). Five studies met the inclusion criteria for combined BWMP vs physical activity-only. Pooled results showed significantly greater weight loss in the combined BWMPs at 3 to 6 months (–5.33 kg; 95% CI –7.61 to –3.04) and 12 to 18 months (–6.29 kg; 95% CI –7.33 to –5.25). Weight loss is similar in the short-term for diet-only and combined BWMPs but in the longer-term weight loss is increased when diet and physical activity are combined. Programs based on physical activity alone are less effective than combined BWMPs in both the short and long term.
PMCID: PMC4180002  PMID: 25257365
Weight loss; Obesity; Diet; Exercise; Behavioral programme
3.  Adherence to and Consumption of Nicotine Replacement Therapy and the Relationship With Abstinence Within a Smoking Cessation Trial in Primary Care 
Nicotine & Tobacco Research  2013;15(9):1537-1544.
Nicotine replacement therapy (NRT) medications have been shown to be effective in increasing smoking cessation rates. There is, however, a lack of good evidence describing how individuals in primary care use these medications and which factors are likely to affect this. The study objectives are to describe adherence and consumption, examine key factors that may determine use, and examine the relationship between consumption of NRT and abstinence from smoking.
Secondary analysis of data from a randomized controlled trial conducted in smoking cessation services in primary care. Adult smokers (n = 633) starting a quit attempt within smoking cessation clinics were followed for 6 months, with NRT use closely monitored for an initial treatment period of 4 weeks. The main outcomes were 4-week adherence to prescribed NRT, mean daily consumption of NRT over the 4-week period, and abstinence from smoking at 4 weeks.
Levels of adherence to prescribed NRT were high: more than 94% in participants who completed the treatment period. After controlling for possible confounders, prescribing higher doses of patch and oral NRT was associated with higher mean daily consumption of NRT. Using an inhalator to deliver oral NRT was associated with both higher adherence and higher consumption. The amount of NRT consumed predicted future abstinence when reverse causation was accounted for.
Most individuals within a clinical trial in primary care who persisted with a quit attempt adhered closely to their prescription. Prescribing higher doses of NRT led to higher consumption and higher consumption to higher abstinence.
PMCID: PMC3741059  PMID: 23430709
4.  Nicotine patch preloading for smoking cessation (the preloading trial): study protocol for a randomized controlled trial 
Trials  2014;15:296.
The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed.
This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support.
Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect.
This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been considered to try and compensate for any challenges encountered in recruiting the large sample, and the multicentre design means that knowledge can be shared between recruitment teams. The pragmatic study design means that results will give a realistic estimate of the success of the intervention if it were to be rolled out as part of standard smoking cessation service practice.
Trial registration
Current Controlled Trials ISRCTN33031001. Registered 27 April 2012.
PMCID: PMC4223826  PMID: 25052334
Smoking; Nicotine; Preloading; Tobacco; Cessation; Quitting; Addiction; Treatment
5.  Weight loss referrals for adults in primary care (WRAP): protocol for a multi-centre randomised controlled trial comparing the clinical and cost-effectiveness of primary care referral to a commercial weight loss provider for 12 weeks, referral for 52 weeks, and a brief self-help intervention [ISRCTN82857232] 
BMC Public Health  2014;14:620.
Recent trials demonstrate the acceptability and short term efficacy of primary care referral to a commercial weight loss provider for weight management. Commissioners now need information on the optimal duration of intervention and the longer term outcomes and cost effectiveness of such treatment to give best value for money.
This multicentre, randomised controlled trial with a parallel design will recruit 1200 overweight adults (BMI ≥28 kg/m2) through their primary care provider. They will be randomised in a 2:5:5 allocation to: Brief Intervention, Commercial Programme for 12 weeks, or Commercial Programme for 52 weeks. Participants will be followed up for two years, with assessments at 0, 3, 12 and 24 months. The sequential primary research questions are whether the CP interventions achieve significantly greater weight loss from baseline to 12 months than BI, and whether CP52 achieves significantly greater weight loss from baseline to 12 months than CP12. The primary outcomes will be an intention to treat analysis of between treatment differences in body weight at 12 months. Clinical effectiveness will be also be assessed by measures of weight, fat mass, and blood pressure at each time point and biochemical risk factors at 12 months. Self-report questionnaires will collect data on psychosocial factors associated with adherence, weight-loss and weight-loss maintenance. A within-trial and long-term cost-effectiveness analysis will be conducted from an NHS perspective. Qualitative methods will be used to examine the participant experience.
The current trial compares the clinical and cost effectiveness of referral to a commercial provider with a brief intervention. This trial will specifically examine whether providing longer weight-loss treatment without altering content or intensity (12 months commercial referral vs. 12 weeks) leads to greater weight loss at one year and is sustained at 2 years. It will also evaluate the relative cost-effectiveness of the three interventions. This study has direct implications for primary care practice in the UK and will provide important information to inform the decisions of practitioners and commissioners about service provision.
Trial Registration
Current Controlled Trials ISRCTN82857232. Date registered: 15/10/2012.
PMCID: PMC4230033  PMID: 24943673
Obesity; Weight-loss; Primary care; Adults
6.  Should we educate about the risks of medication overuse headache? 
Medication-overuse headache (MOH) is caused by the regular use of medications to treat headache. There has been a lack of research into awareness of MOH. We distributed an electronic survey to undergraduate students and their contacts via social networking sites. Analgesic use, awareness of MOH, perceived change in behaviour following educational intervention about the risks of MOH and preferred terminology for MOH was evaluated.
485 respondents completed the questionnaire (41% having received healthcare training). 77% were unaware of the possibility of MOH resulting from regular analgesic use for headache. Following education about MOH, 80% stated they would reduce analgesic consumption or seek medical advice. 83% indicated that over the counter analgesia should carry a warning of MOH. The preferred terminology for MOH was painkiller-induced headache.
This study highlights the lack of awareness of MOH. Improved education about MOH and informative packaging of analgesics, highlighting the risks in preferred lay terminology (i.e. painkiller-induced headache), may reduce this iatrogenic morbidity and warrants further evaluation.
PMCID: PMC3942071  PMID: 24524380
Medication-overuse headache; Analgesia; Headache; Prevention; Education
7.  Attentional bias retraining in cigarette smokers attempting smoking cessation (ARTS): Study protocol for a double blind randomised controlled trial 
BMC Public Health  2013;13:1176.
Smokers attend preferentially to cigarettes and other smoking-related cues in the environment, in what is known as an attentional bias. There is evidence that attentional bias may contribute to craving and failure to stop smoking. Attentional retraining procedures have been used in laboratory studies to train smokers to reduce attentional bias, although these procedures have not been applied in smoking cessation programmes. This trial will examine the efficacy of multiple sessions of attentional retraining on attentional bias, craving, and abstinence in smokers attempting cessation.
This is a double-blind randomised controlled trial. Adult smokers attending a 7-session weekly stop smoking clinic will be randomised to either a modified visual probe task with attentional retraining or placebo training. Training will start 1 week prior to quit day and be given weekly for 5 sessions. Both groups will receive 21 mg transdermal nicotine patches for 8–12 weeks and withdrawal-orientated behavioural support for 7 sessions. Primary outcome measures are the change in attentional bias reaction time and urge to smoke on the Mood and Physical Symptoms Scale at 4 weeks post-quit. Secondary outcome measures include differences in withdrawal, time to first lapse and prolonged abstinence at 4 weeks post-quit, which will be biochemically validated at each clinic visit. Follow-up will take place at 8 weeks, 3 months and 6 months post-quit.
This is the first randomised controlled trial of attentional retraining in smokers attempting cessation. This trial could provide proof of principle for a treatment aimed at a fundamental cause of addiction.
Trial registration
Current Controlled Trials: ISRCTN54375405.
PMCID: PMC3890623  PMID: 24330656
8.  A brief intervention for weight management in primary care: study protocol for a randomized controlled trial 
Trials  2013;14:393.
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.
Trial registration
Current Controlled Trials ISRCTN26563137.
PMCID: PMC3842709  PMID: 24252510
Obesity; Brief intervention; Weight management; Primary care; Commercial weight management services
9.  Factors Associated With Smoking Cessation in Early and Late Pregnancy in the Smoking, Nicotine, and Pregnancy Trial: A Trial of Nicotine Replacement Therapy 
Nicotine & Tobacco Research  2013;16(4):381-389.
Previous studies have found partners’ smoking status, multiparity, and nicotine dependence to be associated with smoking cessation in pregnancy. However, no studies have investigated influences on cessation among women using nicotine replacement therapy (NRT). We analyzed data from a trial of NRT in pregnancy to determine factors associated with shorter- and longer-term cessation.
Data were collected at baseline, 1 month, and delivery from 1,050 pregnant women. Two multivariable logistic models for validated cessation at 1 month and delivery were created with a systematic strategy for selection of included factors.
All findings are from multivariable analyses. At 1 month, odds of cessation were greater among those who completed full time education at >16 years of age (odds ratio [OR] = 1.82, 95% confidence interval CI = 1.24–2.67, p = .002) but they were lower in women with higher baseline cotinine levels (OR = 0.93, 95% CI = 0.90–0.95, p < .001). At delivery, the odds of cessation were greater among those who completed full time education at >16 years of age (OR = 1.89, 95% CI = 1.16–3.07, p = 0.010) but were inversely associated with higher baseline cotinine levels (OR = 0.96, 95% CI = 0.92–0.99, p = .010).
Women who are better educated and have lower pretreatment cotinine concentrations had higher odds of stopping smoking and factors associated with shorter and longer term cessation were similar.
PMCID: PMC3954418  PMID: 24127265
10.  Preventing the Link Between SES and High-Risk Behaviors: “Value-Added” Education, Drug Use and Delinquency in High-Risk, Urban Schools 
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.
PMCID: PMC3707388  PMID: 21360062
Schools; Drug use; Delinquency; Urban; Adolescents
11.  Development and feasibility testing of a smart phone based attentive eating intervention 
BMC Public Health  2013;13:639.
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.
PMCID: PMC3733753  PMID: 23837771
Attentive eating; Memory; Attention; Awareness; Food intake; Mobile phone
12.  Slimming World in Stop Smoking Services (SWISSS): study protocol for a randomized controlled trial 
Trials  2013;14:182.
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.
Trial registration
Current Controlled Trials ISRCTN65705512
PMCID: PMC3698185  PMID: 23782870
Weight gain; Smoking cessation; Prevention; Obesity; Commercial weight management provider
13.  Reducing high calorie snack food in young adults: a role for social norms and health based messages 
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.
PMCID: PMC3681563  PMID: 23738741
Social norms; Health messages; Junk food
14.  Financial incentives for smoking cessation in pregnancy: protocol for a single arm intervention study 
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.
PMCID: PMC3605251  PMID: 23497294
Smoking cessation; Financial incentives; Pregnancy; Vouchers
15.  Systematic review and meta-analysis: influence of smoking cessation on incidence of pneumonia in HIV 
BMC Medicine  2013;11:15.
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:
PMCID: PMC3606464  PMID: 23339513
HIV; meta-analysis; pneumonia; smoking; smoking cessation
16.  Weight Change Over Eight Years in Relation to Alcohol Consumption in a Cohort of Continuing Smokers and Quitters 
Nicotine & Tobacco Research  2011;13(11):1149-1154.
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.
PMCID: PMC3203131  PMID: 21622496
17.  Physical activity as an aid to smoking cessation during pregnancy (LEAP) trial: study protocol for a randomized controlled trial 
Trials  2012;13:186.
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.
Trial registration
PMCID: PMC3519528  PMID: 23035669
Smoking cessation; Pregnancy; Physical activity; Intervention; Randomized controlled trial
18.  CHRNA3 rs1051730 Genotype and Short-Term Smoking Cessation 
Nicotine & Tobacco Research  2011;13(10):982-988.
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.
PMCID: PMC3179672  PMID: 21690317
19.  Does school ethos explain the relationship between value-added education and teenage substance use? A cohort study 
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.
PMCID: PMC3405521  PMID: 22503837
Teenagers; Substance use; School ethos; Value-added education; Scotland; Adolescents
20.  Self-help materials for the prevention of smoking relapse: study protocol for a randomized controlled trial 
Trials  2012;13:69.
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.
Trial registration
Current Controlled Trials ISRCTN36980856
PMCID: PMC3480895  PMID: 22647290
Smoking relapse; Self-help booklets; Effectiveness; Intervention
21.  Association Between Genetic Variants on Chromosome 15q25 Locus and Objective Measures of Tobacco Exposure 
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.
PMCID: PMC3352832  PMID: 22534784
22.  Effect on Adherence to Nicotine Replacement Therapy of Informing Smokers Their Dose Is Determined by Their Genotype: A Randomised Controlled Trial 
PLoS ONE  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.
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.
Trial registration ISRCTN14352545.
PMCID: PMC3324463  PMID: 22509402
23.  A randomised trial of nicotine assisted reduction to stop in pharmacies - the redpharm study 
BMC Public Health  2012;12:182.
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.
Trial Registration
Current Controlled Trials ISRCTN 2010-019259-24
PMCID: PMC3368776  PMID: 22410103
Smoking; Tobacco Dependence; Controlled Clinical Trials; Randomized; Pharmacists; Harm Reduction
24.  Pharmacogenetics of Smoking Cessation in General Practice: Results From the Patch II and Patch in Practice Trials 
Nicotine & Tobacco Research  2011;13(3):157-167.
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.
PMCID: PMC3107615  PMID: 21330274
25.  Promoting smoking cessation in Pakistani and Bangladeshi men in the UK: pilot cluster randomised controlled trial of trained community outreach workers 
Trials  2011;12:197.
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.
Trial registration
Current Controlled Trials ISRCTN82127540
PMCID: PMC3177779  PMID: 21854596

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