Dataset Information

Trial Protocol: randomised controlled trial of the effects of very low calorie diet, modest dietary restriction, and sequential behavioural programme on hunger, urges to smoke, abstinence and weight gain in overweight smokers stopping smoking.

ABSTRACT:

Background

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.

Methods

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.

Trial registration

Current controlled trials ISRCTN83865809.

SUBMITTER: Lycett D

PROVIDER: S-EPMC2959046 | biostudies-literature | 2010 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Trial Protocol: randomised controlled trial of the effects of very low calorie diet, modest dietary restriction, and sequential behavioural programme on hunger, urges to smoke, abstinence and weight gain in overweight smokers stopping smoking.

Lycett Deborah D Hajek Peter P Aveyard Paul P

Trials 20101007

<h4>Background</h4>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.<h4>Methods</h4>This is a 3 armed, unblinded, randomized controlled trial in overweight (BMI > 25 kg/m2), daily sm ...[more]

PMID: 20929584

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Project description:Introduction:Three-quarters of homeless people smoke cigarettes. Financial incentives for smoking abstinence have appeared promising in nonexperimental studies of homeless smokers, but randomized controlled trial (RCT) data are lacking. Methods:We conducted a pilot RCT of financial incentives for homeless smokers. Incentive arm participants (N = 25) could earn escalating $15-$35 rewards for brief smoking abstinence (exhaled carbon monoxide <8 parts per million) assessed 14 times over 8 weeks. Control arm participants (N = 25) were given $10 at each assessment regardless of abstinence. All participants were offered nicotine patches and counseling. The primary outcome was a repeated measure of brief smoking abstinence across 14 assessments. The secondary outcome was brief abstinence at 8 weeks. Exploratory outcomes were self-reported 1-day and 7-day abstinence from (1) any cigarette and (2) any puff of a cigarette. Other outcomes included 24-hour quit attempts, nicotine patch use, counseling attendance, and changes in alcohol and drug use. Results:Compared to control, incentive arm participants were more likely to achieve brief abstinence overall (odds ratio 7.28, 95% confidence interval 2.89 to 18.3) and at 8 weeks (48% vs. 8%, p = .004). Similar effects were seen for 1-day abstinence, but 7-day puff abstinence was negligible in both arms. Incentive arm participants made more quit attempts (p = .03). Nicotine patch use and counseling attendance were not significantly different between the groups. Alcohol and drug use did not change significantly in either group. Conclusions:Among homeless smokers, financial incentives increased brief smoking abstinence and quit attempts without worsening substance use. This approach merits further development focused on promoting sustained abstinence. Registration:ClinicalTrials.gov (NCT02565381). Implications:Smoking is common among homeless people, and conventional tobacco treatment strategies have yielded modest results in this population. This pilot RCT suggests that financial incentives may be a safe way to promote brief smoking abstinence and quit attempts in this vulnerable group of smokers. However, further development is necessary to translate this approach into real-world settings and to promote sustained periods of smoking abstinence.

Project description:IntroductionThe major aim of this study was to test whether abstinence from e-cigarettes causes withdrawal symptoms in former smokers.MethodsWe conducted an unblinded, within-participants, pre-post clinical trial in which 109 former smokers who were current daily electronic cigarette (e-cigarette) users used their own e-cigarette for 7 days followed by 6 days of biologically confirmed abstinence engendered via an escalating contingency payment system. Participants monitored symptoms of nicotine withdrawal daily via an Interactive Voice Response system. They also attended three laboratory visits per week for carbon monoxide and cotinine testing to verify abstinence.ResultsHalf of participants completely abstained for a week. All the Diagnostic and Statistical Manual, Fifth Edition (DSM-5) tobacco withdrawal symptoms, craving for e-cigarettes, craving for tobacco cigarettes, and the four possible new withdrawal symptoms (anhedonia, impulsivity, mood swings, and positive affect) increased during abstinence. Weight increased and heart rate decreased with abstinence. Symptoms showed the prototypical inverted U time pattern of a withdrawal state. The magnitude of withdrawal appeared to be somewhat less than that in a prior study of abstinent daily tobacco cigarette smokers. More severe withdrawal on the first 2 days of abstinence did not predict abstinence on the last day of the study.ConclusionsFormer smokers who are daily e-cigarette users transfer physical dependence on tobacco cigarettes to dependence on e-cigarettes. The severity of withdrawal from e-cigarettes appears to be only somewhat less than that from daily tobacco cigarette use. Replication tests that include placebo controls, testing for pharmacological specificity, and including never-smokers, non-daily e-cigarette users and dual users are indicated.ImplicationsOur results indicate e-cigarettes can maintain physical dependence. This adverse effect should be included in any risk vs. benefit calculation. Also, potential and current e-cigarette users should be informed that abrupt cessation of e-cigarettes can cause withdrawal symptoms.Trial registrationNCT02825459.

Dataset Information

Trial Protocol: randomised controlled trial of the effects of very low calorie diet, modest dietary restriction, and sequential behavioural programme on hunger, urges to smoke, abstinence and weight gain in overweight smokers stopping smoking.

Background

Methods

Trial registration

Publications

Trial Protocol: randomised controlled trial of the effects of very low calorie diet, modest dietary restriction, and sequential behavioural programme on hunger, urges to smoke, abstinence and weight gain in overweight smokers stopping smoking.

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