Culturally-tailored smoking cessation for American Indians: study protocol for a randomized controlled trial.
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ABSTRACT:
SUBMITTER: Choi WS
PROVIDER: S-EPMC3117716 | biostudies-literature | 2011 May
REPOSITORIES: biostudies-literature
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Culturally-tailored smoking cessation for American Indians: study protocol for a randomized controlled trial.
Choi Won S WS Faseru Babalola B Beebe Laura A LA Greiner Allen K AK Yeh Hung-Wen HW Shireman Theresa I TI Talawyma Myrietta M Cully Lance L Kaur Baljit B Daley Christine M CM
Trials 20110518
<h4>Background</h4>Cigarette smoking is the number one cause of preventable death among American Indian and Alaska Natives, AI/ANs. Two out of every five AI/AN will die from tobacco-related diseases if the current smoking rates of AI/ANs (40.8%) persist. Currently, there is no proven, effective culturally-tailored smoking cessation program designed specifically for a heterogeneous population of AI.The primary aim of this group randomized clinical trial is to test the efficacy of "All Nations Bre ...[more]
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Project description:IntroductionTobacco use is a serious public health problem among low-income Chinese Americans with limited English proficiency. Chinese men are at high risk for smoking-related morbidity and mortality. We tested the feasibility of a culturally and linguistically sensitive smoking intervention program with combined counseling and pharmacological components for Chinese smokers in New York City; identified factors and techniques that enhance the administration and appropriateness of the intervention program; and examined the overall impact of this program on quit attempts, quit rates, and overall smoking reduction.MethodsWe were guided by the transtheoretical model and used an adapted motivational interviewing (MI) approach. The study involved a randomized sample with pretreatment assessment and multiple follow-up measures. Eligible participants (N = 122) were randomly assigned to intervention (4 individualized counselor-led MI sessions and nicotine replacement therapy [NRT]) or control groups (4 general health education sessions, self-help materials, and NRT).ResultsQuit rate at 6 months in the intervention group was 67% versus 32% for the control group, indicating minimal relapse and a highly successful intervention program. Increase in self-efficacy and decease in pros of smoking from baseline to 6-month follow-up were positively associated with smoking cessation. The number of cigarette smoked at baseline was inversely related to smoking cessation. Results indicate that a combined intensive behavioral counseling and pharmacological intervention can reduce smoking substantially.ConclusionThe results of this pilot will be used as a basis for a large-scale randomized trial of an intervention with combined culturally and linguistically sensitive MI and NRT components for Chinese and other Asian ethnic groups.
| S-EPMC2784492 | biostudies-literature
Project description:To date, no smoking cessation programs are available for Arab American (ARA) men, who are a vulnerable population with high rates of smoking. Thus, the primary aim of this one group pre-test/post-test study was to assess the effectiveness of Sehatack-a culturally and linguistically tailored smoking cessation program for ARA men. The study sample was 79 ARA men with a mean age of 43 years who smoked between 5 and 40 cigarettes (mean = 19.75, SD = 9.1) per day (98.7%). All of the participants reported more interest in smoking cessation post-intervention and many of the participants in the baseline (38.5%) and post-intervention phases (47.7%) wanted to quit smoking "very much". For daily smokers who completed the smoking cessation program, the median number of cigarettes smoked daily was significantly lower than those in the post-intervention phase (Z = -6.915, p < 0.001). Results of this preliminary study indicate that: (a) Sehatack may be a promising way for ARA men to quit smoking, and (b) culturally relevant smoking cessation counselors can be trained to recruit and retain ARA smokers in an intensive group smoking cessation program. Strengths of this study were community engagement and rapport between three faith organizations and the University of Florida College of Nursing. However, a larger trial is needed to address study limitations and to confirm benefits in this population.
| S-EPMC5409612 | biostudies-literature
Project description: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.Current Controlled Trials ISRCTN33031001. Registered 27 April 2012.
| S-EPMC4223826 | biostudies-other
Project description:BackgroundAmerican Indian (AI) and Alaska Native (AN) communities experience disproportionately high rates of tobacco use when compared to the overall U.S. population, especially among rural populations.MethodsWe implemented a single-blind, randomized clinical trial of a text messaging-based smoking cessation intervention through the tobacco quitlines of five states (Alaska, Minnesota, New Mexico, Oklahoma, and Wisconsin) with high percentages of AI residents. We partnered with state quitlines and Optum, a multi-state entity that manages quitlines. Participants who called the quitlines and identified as AI/AN were given the option to enroll in this trial. Upon consent, they were randomly assigned to either the standard quitline program (control) or a program culturally tailored for AI/ANs (intervention), which used a text messaging intervention to encourage smoking cessation. We adapted the text messages based on key informant and focus group input. Baseline data was analyzed for differences across age, sex, and the Fagerström Test for Nicotine Dependence.ResultsWe recruited n = 487 AIs into the trial. Participants had an average age of 41.9 years (SD = 11.7) and 66% were female. The average Fagerström Test for Nicotine Dependence score was 5.38 (SD = 2.37). The intervention and control arms did not significantly differ across any of the baseline characteristics.ConclusionImplementation of this trial illustrated important lessons in adapting, implementing, and evaluating trials in collaboration with AI communities and local and national organizations. This work will inform future efforts to implement culturally-tailored interventions with AI/ANs and advance our knowledge about adapting and implementing smoking cessation interventions.
| S-EPMC6484287 | biostudies-literature
Project description:The primary care visit represents an important venue for intervening with a large population of smokers. However, physician adherence to the Smoking Cessation Clinical Guideline (5As) remains low. We evaluated the effectiveness of a computer-tailored intervention designed to increase smoking cessation counseling by primary care physicians.Physicians and their patients were randomized to either intervention or control conditions. In addition to brief smoking cessation training, intervention physicians and patients received a one-page report that characterized the patients' smoking habit and history and offered tailored recommendations. Physician performance of the 5As was assessed via patient exit interviews. Quit rates and smoking behaviors were assessed 6 months postintervention via patient phone interviews. Intervention effects were tested in a sample of 70 physicians and 518 of their patients. Results were analyzed via generalized and mixed linear modeling controlling for clustering.Intervention physicians exceeded controls on "Assess" (OR 5.06; 95% CI 3.22, 7.95), "Advise" (OR 2.79; 95% CI 1.70, 4.59), "Assist-set goals" (OR 4.31; 95% CI 2.59, 7.16), "Assist-provide written materials" (OR 5.14; 95% CI 2.60, 10.14), "Assist-provide referral" (OR 6.48; 95% CI 3.11, 13.49), "Assist-discuss medication" (OR 4.72;95% CI 2.90, 7.68), and "Arrange" (OR 8.14; 95% CI 3.98, 16.68), all p values being < 0.0001. Intervention patients were 1.77 (CI 0.94, 3.34,p = 0.078) times more likely than controls to be abstinent (12 versus 8%), a difference that approached, but did not reach statistical significance, and surpassed controls on number of days quit (18.4 versus 12.2, p < .05) but not on number of quit attempts.The use of a brief computer-tailored report improved physicians' implementation of the 5As and had a modest effect on patients' smoking behaviors 6 months postintervention.
| S-EPMC1829425 | biostudies-other
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.
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Project description:African Americans suffer disproportionately from tobacco-related illness and have more difficulty quitting smoking than other racial/ethnic groups. Previous research indicates that African American treatment-seekers are high utilizers of tobacco quitlines, yet cessation rates via quitlines are lower relative to whites. The goal of the present study is to test the effectiveness of adding a culturally specific, video-based, adjunct to standard quitline care. It is hypothesized that the integration of an evidence-based intervention (Pathways to Freedom: Leading the Way to a Smoke-Free Community©; PTF) into quitline services will increase cessation and treatment engagement compared to control conditions, and that effects will be moderated by sociocultural factors (e.g., culturally specific intervention expectancies, acculturation, and ethnic identity).This study is a 3-arm semi-pragmatic randomized controlled trial (RCT). Participants will be 1050 enrollees in the North Carolina State quitline (QuitlineNC) who self-identify as African American. Usual quitline care includes up to 4 proactive quit coaching calls, website access, and two-weeks of nicotine patch therapy. Eligible study participants will be randomized to receive (1) standard quitline services plus PTF (PTF); (2) quitline services plus a standard tobacco cessation DVD (attention control); or (3) quitline services alone (usual care). Assessments will be conducted at baseline, 3 and 6-months post-enrollment. The primary outcome will be biochemically verified 7 day ppa at 6-months. Generalized linear mixed models (GLMMs) and hierarchical logistic regression will be used to assess the effects of treatment group on cessation outcomes and to test potential moderators.This study will answer questions regarding the implementation and effectiveness of integrating a culturally specific video intervention into a real-world, population-level tobacco intervention. It will also aid our understanding of individual-difference variables that are associated with success. If an incremental benefit is found, this trial will have implications for increasing the responsiveness of tobacco quitlines for African Americans, reducing tobacco cessation disparities, and best practices for improving minority health. In addition, the PTF intervention has the potential for widespread disseminated through quitlines, which are available across the United States.Clinicaltrials.gov NCT03064971 . Registered on February 22, 2017.
| S-EPMC5763652 | biostudies-literature
Project description:BackgroundThere is an ongoing debate whether electronic cigarettes (e-cigarettes) should be advocated for smoking cessation. Because of this uncertainty, information about the use of e-cigarettes for smoking cessation is usually not provided in governmental smoking cessation communications. However, there is an information need among smokers because despite this uncertainty, e-cigarettes are used by many smokers to reduce and quit tobacco smoking.ObjectiveThe aim of this study is to describe the protocol of a randomized controlled trial that assesses the effect of providing tailored information about e-cigarettes compared to not providing this information on determinants of decision making and smoking reduction and abstinence. This information is provided in the context of a digital smoking cessation intervention.MethodsA randomized controlled trial with a 6-month follow-up period will be conducted among adult smokers motivated to quit smoking within 5 years. Participants will be 1:1 randomized into either the intervention condition or control condition. In this trial, which is grounded on the I-Change model, participants in both conditions will receive tailored feedback on attitude, social influence, preparatory plans, self-efficacy, and coping plans. Information on 6 clusters of smoking cessation methods (face-to-face counselling, eHealth interventions, telephone counselling, group-based programs, nicotine replacement therapy, and prescription medication) will be provided in both conditions. Smokers in the intervention condition will also receive detailed tailored information on e-cigarettes, while smokers in the control condition will not receive this information. The primary outcome measure will be the number of tobacco cigarettes smoked in the past 7 days. Secondary outcome measures will include 7-day point prevalence tobacco abstinence, 7-day point prevalence e-cigarette abstinence, and determinants of decision making (ie, knowledge and attitude regarding e-cigarettes). All outcomes will be self-assessed through web-based questionnaires.ResultsThis project is supported by a research grant of the National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu). Ethical approval was granted by the Ethics Review Committee Health, Medicine and Life Sciences at Maastricht University (FHML-REC/2019/072). Recruitment began in March 2020 and was completed by July 2020. We enrolled 492 smokers in this study. The results are expected to be published in June 2021.ConclusionsThe experimental design of this study allows conclusions to be formed regarding the effects of tailored information about e-cigarettes on decision making and smoking behavior. Our findings can inform the development of future smoking cessation interventions.Trial registrationDutch Trial Register Trial NL8330; https://www.trialregister.nl/trial/8330.International registered report identifier (irrid)DERR1-10.2196/27088.
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Project description:Heavy users and addicted individuals have shown to develop an approach action tendency - or approach bias - toward stimuli related to the substance of interest. Emerging evidence points to approach bias retraining (ABR) as an effective aid for the treatment of addictive behaviors. The current study seeks to extend this work by testing, in a pilot study, whether standard smoking cessation treatment involving cognitive-behavioral therapy (CBT) and nicotine replacement therapy can be augmented by ABR. To this end, we will randomly assign 100 adult smokers to either ABR-augmented treatment or placebo-augmented treatment and compare the two conditions on short-term and long-term abstinence rates. The hope is that the findings of this study can inform treatment development for adult smokers.
| S-EPMC6406622 | biostudies-literature
Project description:Tobacco use remains prevalent among Veterans of military service and those residing in rural areas. Smokers frequently experience tobacco-related issues including risky alcohol use, post-cessation weight gain, and depressive symptoms that may adversely impact their likelihood of quitting and maintaining abstinence. Telephone-based interventions that simultaneously address these issues may help to increase treatment access and improve outcomes.This study was a two-group randomized controlled pilot trial. Participants were randomly assigned to an individually-tailored telephone tobacco intervention combining counseling for tobacco use and related issues including depressive symptoms, risky alcohol use, and weight concerns or to treatment provided through their state tobacco quitline. Selection of pharmacotherapy was based on medical history and a shared decision interview in both groups. Participants included 63 rural Veteran smokers (mean age?=?56.8 years; 87 % male; mean number of cigarettes/day?=?24.7). The primary outcome was self-reported 7-day point prevalence abstinence at 12 weeks and 6 months.Twelve-week quit rates based on an intention-to-treat analysis did not differ significantly by group (Tailored?=?39 %; Quitline Referral?=?25 %; odds ratio [OR]; 95 % confidence interval [CI]?=?1.90; 0.56, 5.57). Six-month quit rates for the Tailored and Quitline Referral conditions were 29 and 28 %, respectively (OR; 95 % CI?=?1.05; 0.35, 3.12). Satisfaction with the Tailored tobacco intervention was high.Telephone-based treatment that concomitantly addresses other health-related factors that may adversely affect quitting appears to be a promising strategy. Larger studies are needed to determine whether this approach improves cessation outcomes.ClinicalTrials.gov identifier number NCT01592695 registered 11 April 2012.
| S-EPMC4989380 | biostudies-literature