Dataset Information

Motivating the unmotivated for health behavior change: a randomized trial of cessation induction for smokers.

ABSTRACT: Many smokers remain unwilling or unable to make a quit attempt. For these smokers, novel strategies to induce quit attempts are necessary to achieve further reductions in smoking prevalence.This article describes the design and methods of an ongoing nationwide telephone-based clinical trial for cessation induction, the principal aim of which is to test the hypothesis that samples of nicotine replacement therapy (NRT), can induce quit attempts among smokers otherwise unmotivated to quit.Smokers are recruited proactively through online channels. A 'behavioral filter' is used to identify and separate motivated versus unmotivated smokers, the latter of whom (N = 750) are formally entered into the clinical trial. Participants are randomized to one of two treatment conditions designed to promote self-efficacy and motivation to quit: (1) practice quit attempt (PQA) or (2) PQA plus NRT sampling. The primary outcome measure tested over a 6-month follow-up is the incidence of additional quit attempts as well as hypothesized mediators of treatment effects.This study details the challenges of identifying and treating smokers who are unmotivated to quit. Strengths include a novel treatment approach, tested among a group of proactively recruited smokers nationwide, with a unique method of identifying cessation-resistant smokers.The omission of a true control group, testing the effect of the PQA itself, is an inherent limitation to the study design. Online recruitment presents additional study challenges, all of which are discussed in detail.The study has translational potential to guide both clinical and policy recommendations for cessation induction. Further, while the focus is on smoking, this trial may serve as an example to researchers and clinicians who focus on other health behaviors, and who themselves are challenged with motivating people who are unmotivated for change.

SUBMITTER: Carpenter MJ

PROVIDER: S-EPMC2902976 | biostudies-literature | 2010 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Motivating the unmotivated for health behavior change: a randomized trial of cessation induction for smokers.

Carpenter Matthew J MJ Alberg Anthony J AJ Gray Kevin M KM Saladin Michael E ME

Clinical trials (London, England) 20100325 2

<h4>Background</h4>Many smokers remain unwilling or unable to make a quit attempt. For these smokers, novel strategies to induce quit attempts are necessary to achieve further reductions in smoking prevalence.<h4>Purpose</h4>This article describes the design and methods of an ongoing nationwide telephone-based clinical trial for cessation induction, the principal aim of which is to test the hypothesis that samples of nicotine replacement therapy (NRT), can induce quit attempts among smokers othe ...[more]

PMID: 20338901

Similar Datasets

Project description:IntroductionDespite limitations in evidence, the current Clinical Practice Guideline advocates Motivational Interviewing for smokers not ready to quit. This study evaluated the efficacy of Motivational Interviewing for inducing cessation-related behaviors among smokers with low motivation to quit.DesignRandomized clinical trial.Setting/participantsTwo-hundred fifty-five daily smokers reporting low desire to quit smoking were recruited from an urban community during 2010-2011 and randomly assigned to Motivational Interviewing, health education, or brief advice using a 2:2:1 allocation. Data were analyzed from 2012 to 2014.InterventionFour sessions of Motivational Interviewing utilized a patient-centered communication style that explored patients' own reasons for change. Four sessions of health education provided education related to smoking cessation while excluding elements characteristic of Motivational Interviewing. A single session of brief advice consisted of brief, personalized advice to quit.Main outcomes measuresSelf-reported quit attempts; smoking abstinence (biochemically verified); use of cessation pharmacotherapies; motivation; and confidence to quit were assessed at baseline and 3- and 6-month follow-ups.ResultsUnexpectedly, no significant differences emerged between groups in the proportion who made a quit attempt by 6-month follow-up (Motivational Interviewing, 52.0%; health education, 60.8%; brief advice, 45.1%; p=0.157). Health education had significantly higher biochemically verified abstinence rates at 6 months (7.8%) than brief advice (0.0%) (8% risk difference, 95% CI=3%, 13%, p=0.003), with the Motivational Interviewing group falling in between (2.9% abstinent, 3% risk difference, 95% CI=0%, 6%, p=0.079). Both Motivational Interviewing and health education groups showed greater increases in cessation medication use, motivation, and confidence to quit relative to brief advice (all p<0.05), and health education showed greater increases in motivation relative to Motivational Interviewing (Cohen's d=0.36, 95% CI=0.12, 0.60).ConclusionsAlthough Motivational Interviewing was generally more efficacious than brief advice in inducing cessation behaviors, health education appeared the most efficacious. These results highlight the need to identify the contexts in which Motivational Interviewing may be most efficacious and question recommendations to use Motivational Interviewing rather than other less complex cessation induction interventions.Trial registrationThis study is registered at www.clinicaltrials.gov NCT01188018.

Project description:BackgroundAlthough the current Clinical Practice Guideline recommend Motivational Interviewing for use with smokers not ready to quit, the strength of evidence for its use is rated as not optimal. The purpose of the present study is to address key methodological limitations of previous studies by ensuring fidelity in the delivery of the Motivational Interviewing intervention, using an attention-matched control condition, and focusing on unmotivated smokers whom meta-analyses have indicated may benefit most from Motivational Interviewing. It is hypothesized that MI will be more effective at inducing quit attempts and smoking cessation at 6-month follow-up than brief advice to quit and an intensity-matched health education condition.Methods/designA sample of adult community resident smokers (N = 255) who report low motivation and readiness to quit are being randomized using a 2:2:1 treatment allocation to Motivational Interviewing, Health Education, or Brief Advice. Over 6 months, participants in Motivational Interviewing and Health Education receive 4 individual counseling sessions and participants in Brief Advice receive one brief in-person individual session at baseline. Rigorous monitoring and independent verification of fidelity will assure the counseling approaches are distinct and delivered as planned. Participants complete surveys at baseline, week 12 and 6-month follow-up to assess demographics, smoking characteristics, and smoking outcomes. Participants who decide to quit are provided with a self-help guide to quitting, help with a quit plan, and free pharmacotherapy. The primary outcome is self-report of one or more quit attempts lasting at least 24 hours between randomization and 6-month follow-up. The secondary outcome is biochemically confirmed 7-day point prevalence cessation at 6-month follow-up. Hypothesized mediators of the presumed treatment effect on quit attempts are greater perceived autonomy support and autonomous motivation. Use of pharmacotherapy is a hypothesized mediator of Motivational Interviewing's effect on cessation.DiscussionThis trial will provide the most rigorous evaluation to date of Motivational Interviewing's efficacy for encouraging unmotivated smokers to make a quit attempt. It will also provide effect-size estimates of MI's impact on smoking cessation to inform future clinical trials and inform the Clinical Practice Guideline.Trial registrationClinicalTrials.gov NCT01188018.

Project description:Previous research demonstrated the efficacy of sustained release bupropion (bupropion SR) for smoking cessation in whites as well as moderate to heavy (?10 cigarettes per day [CPD]) African American smokers. We evaluated whether bupropion SR was effective for smoking cessation among African American light smokers (?10 CPD).A randomized, double-blind placebo-controlled trial was conducted from December 27, 2007, to May 13, 2010. All participants were African American light smokers (?10 CPD), aged 18 years or older. Participants were randomly assigned to receive 300 mg bupropion SR (150 mg once daily for 3 days and then 150 mg twice daily) (n = 270 participants) or placebo (n = 270 participants) for 7 weeks, and up to six sessions of health education counseling. Serum cotinine was measured at baseline (week 0). The primary outcome was salivary cotinine-verified 7-day point prevalence smoking abstinence at week 26; a cut point of 15 ng/mL differentiated smokers from nonsmokers. Salivary cotinine-verified smoking abstinence at end of medication treatment at week 7 was also examined. Odds ratios (OR) for smoking abstinence and 95% confidence intervals (CIs) were calculated using logistic regression models. All statistical tests were two-sided.Participants at baseline visit (week 0) smoked an average of 8.0 CPD and had a mean serum cotinine level of 275.8 ng/mL (SD = 155.8 ng/mL); most used menthol cigarettes (83.7%) and smoked within 30 minutes of waking (72.2%). After imputing those lost to follow-up as smokers, no statistically significant difference in long-term smoking abstinence rates at week 26 was observed between bupropion SR and placebo groups (13.3% vs 10.0%, OR = 1.39, 95% CI = 0.82 to 2.35, P = .23). Cotinine-verified smoking abstinence rate at end of medication week 7 was higher in the bupropion SR vs placebo group (23.7% vs 9.6%, OR = 2.92, 95% CI = 1.78 to 4.77, P < .001).Bupropion SR was effective in promoting smoking cessation during the medication phase of treatment but showed no effect on long-term smoking cessation among African American light smokers. More research is needed to identify strategies for sustaining abstinence among African American light smokers.

Project description:BackgroundDespite promising data in Western countries, there is a dearth of research into the efficacy of text messaging-based smoking cessation programs in other settings, including the Middle East, where smoking prevalence rates are higher.ObjectiveThis paper reports cessation rates observed in SMS Turkey, a text messaging-based smoking cessation program for adult smokers in Ankara, Turkey.MethodsThis study was a small-scale, parallel-group randomized controlled trial (RCT) conducted in Ankara, Turkey. Participants were adult daily smokers who were seriously thinking about quitting in the next 15 days and living in Ankara, Turkey. The text messaging intervention, SMS Turkey, provided 6 weeks of daily messages aimed at giving participants skills to help them quit smoking. Messages were sent in an automated fashion, except 2 days and 7 days after the initial quit day. On days 2 and 7, the research assistant manually assigned participants to content "paths" based on whether they were still not smoking or had relapsed. The control arm received a brochure that provided similar information about smoking cessation. The main outcome measure was self-reported 3-month sustained abstinence, verified by carbon monoxide (CO) readings. Neither participants nor researchers were blinded to arm assignment.ResultsThe 151 participants were randomly assigned to 1 of 2 groups: 76 to the SMS Turkey intervention group and 75 to the brochure control group. Using intention to treat, all 151 participants were included in analyses. Three-month cessation trends were not significantly higher in the intervention group: 11% intervention vs 5% control had quit (χ(2)(1)=1.4, P=.24; R(2)=2.0, 95% CI 0.62-6.3). When the sample was stratified by sex, female intervention participants (14%, n=5) were significantly more likely to have quit at 3 months than female control participants (0%, n=0; χ(2)(1)=3.7, P=.05). Among light smokers (ie, those smoking less than 20 cigarettes per day), intervention participants (17%, n=5) also were significantly more likely to have quit compared to control participants (0%, n=0; χ(2)(1)=5.3, P=.02). We noted no difference in cessation rates for males or heavy smokers. Participants experienced significant technology problems during the study. Some participants received duplicate text messages at least once during the trial; others failed to receive some program messages. Neither receiving duplicate messages (χ(2)(1)=0.12, P=.73), or missing 5 or more program messages (χ(2)(1)=0.75, P=.39) negatively affected quitting rates.ConclusionsAlthough the study was not powered to detect statistically significant differences, as the primary aim was to provide estimates of effect size that could be used to better inform a power analysis for a larger trial, findings provide optimism that SMS Turkey may be able to affect quitting rates in environments with high smoking prevalence, such as Ankara, Turkey. The SMS Turkey software program did not work as well as it did 2 years previous. The system will need to be updated to maintain software compatibility with ongoing technology evolution.Trial registrationClinicaltrials.gov NCT00912795 http://clinicaltrials.gov/ct2/show/NCT00912795 (Archived by WebCite® at http://www.webcitation.org/6Ch1cIA8l).

Project description:Widening socioeconomic disparities in mortality in the United States are largely explained by slower declines in tobacco use among smokers of low socioeconomic status (SES) than among those of higher SES, which points to the need for targeted tobacco cessation interventions. Documentation of smoking status in electronic health records (EHRs) provides the tools for health systems to proactively offer tobacco treatment to socioeconomically disadvantaged smokers.To evaluate a proactive tobacco cessation strategy that addresses sociocontextual mediators of tobacco use for low-SES smokers.This prospective, randomized clinical trial included low-SES adult smokers who described their race and/or ethnicity as black, Hispanic, or white and received primary care at 1 of 13 practices in the greater Boston area (intervention group, n?=?399; control group, n?=?308).We analyzed EHRs to identify potentially eligible participants and then used interactive voice response (IVR) techniques to reach out to them. Consenting patients were randomized to either receive usual care from their own health care team or enter an intervention program that included (1) telephone-based motivational counseling, (2) free nicotine replacement therapy (NRT) for 6 weeks, (3) access to community-based referrals to address sociocontextual mediators of tobacco use, and (4) integration of all these components into their normal health care through the EHR system.Self-reported past-7-day tobacco abstinence 9 months after randomization ("quitting"), assessed by automated caller or blinded study staff.The intervention group had a higher quit rate than the usual care group (17.8% vs 8.1%; odds ratio, 2.5; 95% CI, 1.5-4.0; number needed to treat, 10). We examined whether use of intervention components was associated with quitting among individuals in the intervention group: individuals who participated in the telephone counseling were more likely to quit than those who did not (21.2% vs 10.4%; P?<?.001). There was no difference in quitting by use of NRT. Quitting did not differ by a request for a community referral, but individuals who used their referral were more likely to quit than those who did not (43.6% vs 15.3%; P?<?.001).Proactive, IVR-facilitated outreach enables engagement with low-SES smokers. Providing counseling, NRT, and access to community-based resources to address sociocontextual mediators among smokers reached in this setting is effective.clinicaltrials.gov Identifier: NCT01156610.

Dataset Information

Motivating the unmotivated for health behavior change: a randomized trial of cessation induction for smokers.

Publications

Motivating the unmotivated for health behavior change: a randomized trial of cessation induction for smokers.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets