Efficacy of a mobile application for smoking cessation in young people: study protocol for a clustered, randomized trial.
Ontology highlight
ABSTRACT:
SUBMITTER: Valdivieso-Lopez E
PROVIDER: S-EPMC3750394 | biostudies-literature | 2013 Aug
REPOSITORIES: biostudies-literature
Publications
Efficacy of a mobile application for smoking cessation in young people: study protocol for a clustered, randomized trial.
Valdivieso-López Empar E Flores-Mateo Gemma G Molina-Gómez Juan-Domingo JD Rey-Reñones Cristina C Barrera Uriarte María-Luisa ML Duch Jordi J Valverde Araceli A
BMC public health 20130801
<h4>Background</h4>Tobacco consumption is the most preventable cause of morbidity-mortality in the world. One aspect of smoking cessation that merits in-depth study is the use of an application designed for smartphones (app), as a supportive element that could assist younger smokers in their efforts to quit. To assess the efficacy of an intervention that includes the assistance of a smoking cessation smartphone application targeted to young people aged 18 to 30 years who are motivated to stop sm ...[more]
Similar Datasets
Project description:BackgroundYoung adults with serious mental illness are over twice as likely to have tobacco use disorder than those in the general population and are less likely to utilize proven treatment methods during quit attempts. However, little research has evaluated the efficacy of interventions for this group. Smartphone apps may be an underutilized tool for tobacco use disorder among young adults with serious mental illness.ObjectiveThe aim of this study was to explore attitudes toward smoking cessation apps and preferences regarding app design in young adult smokers with serious mental illness.MethodsFive focus groups involving 25- to 35-year-old adults with serious mental illness receiving treatment at a community mental health center were conducted between May 2019 and August 2019. Three researchers independently coded transcripts and identified themes using thematic analysis.ResultsParticipants (n=22) were individuals who smoke daily: 10 (46%) self-identified as female, 18 (82%) self-identified as White, and 9 (41%) had psychotic disorders. Key themes that emerged included a general interest in using health apps; a desire for apps to provide ongoing motivation during a quit attempt via social support, progress tracking, and rewards; a desire for apps to provide distraction from smoking; concerns about app effectiveness due to a lack of external accountability; and concerns that apps could trigger cravings or smoking behavior by mentioning cigarettes or the act of smoking.ConclusionsApps have the potential to support smoking cessation or reduction efforts among young adults with serious mental illness. However, they may require tailoring, optimization, and clinical support to effectively promote cessation in this population.
| S-EPMC7568217 | biostudies-literature
Project description:BackgroundSmoking rates remain high among socioeconomically disadvantaged adults. Offering small escalating financial incentives for abstinence (i.e., contingency management [CM]), alongside clinic-based treatment dramatically increases cessation rates in this vulnerable population. However, innovative approaches are needed for those who are less able to attend office visits. The current study will evaluate an automated mobile phone-based CM approach that will allow socioeconomically disadvantaged individuals to remotely earn financial incentives for smoking cessation.MethodsThe investigators have previously combined technologies, including 1) carbon monoxide monitors that connect with mobile phones to remotely verify abstinence, 2) facial recognition software to confirm identity during breath sample submissions, and 3) automated delivery of incentives triggered by biochemical abstinence confirmation. This automated CM approach will be evaluated in a randomized controlled trial of 532 low-income adults seeking cessation treatment. Participants will be randomly assigned to telephone counseling and nicotine replacement therapy (standard care [SC]) or SC plus mobile financial incentives (CM) for abstinence.ResultsBiochemically-verified 7-day point prevalence abstinence at 26 weeks post-quit is the primary outcome. The cost-effectiveness of the interventions will be evaluated. Potential treatment mechanisms, including self-efficacy, motivation, and treatment engagement, will be explored to optimize future interventions.DiscussionAutomated mobile CM may offer a low-cost approach to smoking cessation that can be combined with telephone counseling and pharmacological interventions. This approach represents a critical step toward the widespread dissemination of CM treatment to real-world settings, to reduce tobacco-related disease and disparities.
| S-EPMC9514803 | biostudies-literature
Project description:IntroductionYoung smokers always partake in both smoking and drinking. However, drinking undermines their likelihood to attempt quitting smoking or to successfully abstain from smoking. Hence, this trial will examine the feasibility of implementing an integrated smoking cessation and alcohol intervention in young Hong Kong Chinese people. Effect sizes of the integrated intervention (II) on self-reported and biochemically validated quit rates will also be calculated.MethodsThe study will be a three-arm randomized controlled trial in a convenience sample of 150 smokers aged 18-25 years with alcohol drinking. Participants will be randomized into a standard treatment (ST), II, or control arm. The ST group will receive a brief smoking cessation intervention based on the 5A (Ask, Assess, Advice, Assist, Arrange) and 5R (Relevance, Risks, Rewards, Roadblocks, Repetition) models. The II group will receive brief advice on alcohol use based on the FRAMES (Feedback, Responsibility, Advice, Menu, Empathy, Efficacy) model in addition to the brief smoking cessation intervention. Both the ST and II groups will receive booster interventions at 1-week, 1-month, 3-month, and 6-month follow-up. The control group will receive leaflets on smoking cessation and alcohol reduction. Self-reported quitters at 6-month follow-up will be invited for biochemical validation. The primary outcomes are feasibility measures. The secondary outcomes are effect size of II on self-reported and biochemically validated quit rates at 6 months relative to control and ST. Outcomes will be assessed at baseline and at 1-week, 1-month, 3-month, and 6-month follow-ups.AnalysisDescriptive statistics will be used to calculate the feasibility measures. The three arms will be compared using analysis of variance for continuous variables and chi-square test for categorical variables. Effect sizes of II for self-reported and biochemically validated quit rates at 6 months will be determined using the generalized estimating equation model.
| S-EPMC10399896 | biostudies-literature
Project description:Importance:Limited evidence supports mobile phone-delivered cessation interventions for socioeconomically disadvantaged individuals. Objective:To assess the efficacy of mobile phone-delivered cessation interventions targeted to smokers at neighborhood sites serving racial/ethnic minority and socioeconomically disadvantaged individuals. Design, Setting, and Participants:This group-randomized clinical trial with neighborhood site serving as the sampling unit compared smoking cessation interventions that included (1) nicotine replacement therapy (NRT), (2) NRT plus text messaging, and (3) NRT plus text messaging plus proactive counseling via mobile phone. Recruitment took place at churches, public housing complexes, and community centers located throughout the Houston, Texas, area. A total of 624 current cigarette smokers 18 years or older were enrolled at neighborhood sites from August 13, 2011, through December 12, 2014. Final follow-up was completed on June 12, 2015, and data were analyzed from August 17, 2017, through May 10, 2018, based on intention to treat. Interventions:Nicotine replacement therapy consisted of transdermal nicotine patches; NRT plus text messages, transdermal nicotine patches and individually tailored mobile phone text messages; and NRT plus text plus call, transdermal patches, individually tailored mobile phone text messages, and proactive counseling via mobile phone. Main Outcomes and Measures:The primary outcome was smoking abstinence at 6 months, defined as (1) biochemically verified smoking abstinence (calculated among a subgroup of 377 participants) as determined by saliva cotinine level; and (2) self-reported 30-day abstinence (calculated among all 624 participants). Results:The study sample included 624 current cigarette smokers (50.6% female; mean [SD] age, 45.8 [12.8] years). Among the 377 participants eligible for biochemical verification, 127 self-reported 30-day abstinence and were asked to provide saliva samples. Of these, 98 samples were returned (participants who did not return samples were coded as smoking). Biochemically verified abstinence rates were 12.0% for NRT, 12.0% for NRT plus text, and 25.5% for NRT plus text plus call. Participants in the NRT plus text plus call group were 2.11 (95% CI, 1.00-4.48) times more likely to be biochemically verified as abstinent compared with the NRT group. No differences in biochemically verified abstinence between the NRT plus text group and the NRT group were observed. Similar associations were observed with the self-report cessation outcomes. Conclusions and Relevance:Findings indicate that assignment to an intervention consisting of text messaging alone may not increase cessation rates for socioeconomically disadvantaged smokers. However, text messaging plus proactive counseling may be an efficacious option. Trial Registration:ClinicalTrials.gov identifier: NCT00948129.
| S-EPMC6439644 | biostudies-literature
Project description:BACKGROUND:Several large studies have shown that the risk of cardiovascular, respiratory, and wound-healing complications (including death) within 30 days of surgery is greater for smokers than for nonsmokers. However, there is evidence that even short-term perioperative smoking cessation may reduce postoperative morbidity. Over the past few years, it has become more evident that short message service (SMS)-based interventions can help individuals quit smoking. OBJECTIVE:The overall aim of this project is to fill the knowledge gap on whether an SMS-based smoking-cessation intervention can be effective in helping patients stop smoking perioperatively. The aim of this trial is to evaluate the effectiveness of an SMS-based intervention on smoking behavior of patients undergoing elective surgery. METHODS:A two-arm parallel-group randomized controlled trial will be conducted at 20 surgical departments in southeast Sweden. Smokers undergoing elective surgery who own a mobile phone will be included. Power calculations indicate that it will be necessary to randomize 434 participants. One group will be given access to a novel 12-week SMS program, which includes daily SMS messages with behavior change-enforcing text content and hyperlinks to interactive modules, while the other group will not be given access to the intervention. Both groups will have access to the surgical departments' current routine for smoking cessation prior to surgery. Primary outcome measures, prolonged abstinence, and point prevalence of smoking cessation will be measured through questionnaires at 3, 6, and 12 months after randomization. Logistic regression models adjusted using baseline characteristics will be explored to identify potential effects of the intervention. RESULTS:Recruitment started in late October 2018 and is expected to last for a maximum of 30 months. The first results are expected to be available approximately 3 months after the final date of recruitment. CONCLUSIONS:Owing to the structural problems and scarcity of time and resources, patients at most Swedish surgical departments are simply instructed to quit smoking, and perhaps, referred to a primary health care clinic. An SMS-based smoking-cessation aid can be effective in helping individuals quit smoking and is a very simple and time-efficient tool for surgical departments to use. TRIAL REGISTRATION:ISRCTN Registry ISRCTN33869008; http://www.isrctn.com/ISRCTN33869008. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/12511.
| S-EPMC6454332 | biostudies-literature
Project description:BACKGROUND:Smoking cessation is a persistent leading public health challenge. Mobile health (mHealth) solutions are emerging to improve smoking cessation treatments. Previous approaches have proposed supporting cessation with tailored motivational messages. Some managed to provide short-term improvements in smoking cessation. Yet, these approaches were either static in terms of personalization or human-based nonscalable solutions. Additionally, long-term effects were neither presented nor assessed in combination with existing psychopharmacological therapies. OBJECTIVE:This study aimed to analyze the long-term efficacy of a mobile app supporting psychopharmacological therapy for smoking cessation and complementarily assess the involved innovative technology. METHODS:A 12-month, randomized, open-label, parallel-group trial comparing smoking cessation rates was performed at Virgen del Rocío University Hospital in Seville (Spain). Smokers were randomly allocated to a control group (CG) receiving usual care (psychopharmacological treatment, n=120) or an intervention group (IG) receiving psychopharmacological treatment and using a mobile app providing artificial intelligence-generated and tailored smoking cessation support messages (n=120). The secondary objectives were to analyze health-related quality of life and monitor healthy lifestyle and physical exercise habits. Safety was assessed according to the presence of adverse events related to the pharmacological therapy. Per-protocol and intention-to-treat analyses were performed. Incomplete data and multinomial regression analyses were performed to assess the variables influencing participant cessation probability. The technical solution was assessed according to the precision of the tailored motivational smoking cessation messages and user engagement. Cessation and no cessation subgroups were compared using t tests. A voluntary satisfaction questionnaire was administered at the end of the intervention to all participants who completed the trial. RESULTS:In the IG, abstinence was 2.75 times higher (adjusted OR 3.45, P=.01) in the per-protocol analysis and 2.15 times higher (adjusted OR 3.13, P=.002) in the intention-to-treat analysis. Lost data analysis and multinomial logistic models showed different patterns in participants who dropped out. Regarding safety, 14 of 120 (11.7%) IG participants and 13 of 120 (10.8%) CG participants had 19 and 23 adverse events, respectively (P=.84). None of the clinical secondary objective measures showed relevant differences between the groups. The system was able to learn and tailor messages for improved effectiveness in supporting smoking cessation but was unable to reduce the time between a message being sent and opened. In either case, there was no relevant difference between the cessation and no cessation subgroups. However, a significant difference was found in system engagement at 6 months (P=.04) but not in all subsequent months. High system appreciation was reported at the end of the study. CONCLUSIONS:The proposed mHealth solution complementing psychopharmacological therapy showed greater efficacy for achieving 1-year tobacco abstinence as compared with psychopharmacological therapy alone. It provides a basis for artificial intelligence-based future approaches. TRIAL REGISTRATION:ClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/NCT03553173. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.2196/12464.
| S-EPMC7215523 | biostudies-literature
Project description:BackgroundApproximately 2 million Chinese people die annually from tobacco-related diseases, mostly men; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation advice or support. A social network-based gamified smoking cessation intervention (SCAMPI: Smoking Cessation App for Chinese Male: Pilot Intervention) is designed to help Chinese male smokers to quit smoking.ObjectiveThis paper aims to present the protocol of a study examining the preliminary effectiveness of SCAMPI by comparing the prolonged abstinence rate of a group of users with a comparator group during a 6-week follow-up period.MethodsA two-arm pilot randomized controlled trial was conducted to assess the preliminary effectiveness and acceptability of the SCAMPI program as a smoking cessation intervention. After initial web-based screening, the first 80 eligible individuals who had gone through the required registration process were registered as participants of the trial. Participants were randomly allocated to the intervention group (n=40) and the control group (n=40). Participants in the intervention group used the full version of the SCAMPI program, which is a Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users. The program delivers a range of smoking cessation approaches, including helping users to make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, providing information about smoking harms, motivational messages to help users overcome urges, providing standardized tests to users for assessing their levels of nicotine dependence and lung health, and providing a platform to encourage social support between users. Participants in the control group used the restricted version of the SCAMPI program (placebo app).ResultsRecruitment for this project commenced in January 2019 and proceeded until March 2019. Follow-up data collection was commenced and completed by June 2019. The primary outcome measure of the study was the 30-day bio-verified smoking abstinence at the 6-week follow-up (self-reported data verified by the Nicotine Cotinine Saliva Test). The secondary outcome measures of the study included participants' cigarette consumption reduction (compared baseline daily cigarette consumption with end-of-trial daily cigarette consumption), participants' 7-day smoking abstinence at 4-week and 6-week follow-up (self-reported), participants' 30-day smoking abstinence at 6-week follow-up (self-reported data only), and participants' acceptability and satisfaction levels of using the SCAMPI program (measured by the Mobile App Rating Scale questionnaire).ConclusionsIf the SCAMPI program is shown to be preliminary effective, the study will be rolled out to be a future trial with a larger sample size and longer follow-up (6 months) to identify if it is an effective social network-based tool to support Chinese male smokers to quit smoking.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12618001089224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375381.International registered report identifier (irrid)RR1-10.2196/18071.
| S-EPMC7532454 | biostudies-literature
Project description:BackgroundSmoking is considered the main cause of preventable illness and early deaths worldwide. The treatment usually prescribed to people who wish to quit smoking is a multidisciplinary intervention, combining both psychological advice and pharmacological therapy, since the application of both strategies significantly increases the chance of success in a quit attempt.ObjectiveWe present a study protocol of a 12-month randomized open-label parallel-group trial whose primary objective is to analyze the efficacy and efficiency of usual psychopharmacological therapy plus the Social-Local-Mobile app (intervention group) applied to the smoking cessation process compared with usual psychopharmacological therapy alone (control group).MethodsThe target population consists of adult smokers (both male and female) attending the Smoking Cessation Unit at Virgen del Rocío University Hospital, Seville, Spain. Social-Local-Mobile is an innovative intervention based on mobile technologies and their capacity to trigger behavioral changes. The app is a complement to pharmacological therapies to quit smoking by providing personalized motivational messages, physical activity monitoring, lifestyle advice, and distractions (minigames) to help overcome cravings. Usual pharmacological therapy consists of bupropion (Zyntabac 150 mg) or varenicline (Champix 0.5 mg or 1 mg). The main outcomes will be (1) the smoking abstinence rate at 1 year measured by means of exhaled carbon monoxide and urinary cotinine tests, and (2) the result of the cost-effectiveness analysis, which will be expressed in terms of an incremental cost-effectiveness ratio. Secondary outcome measures will be (1) analysis of the safety of pharmacological therapy, (2) analysis of the health-related quality of life of patients, and (3) monitoring of healthy lifestyle and physical exercise habits.ResultsOf 548 patients identified using the hospital's electronic records system, we excluded 308 patients: 188 declined to participate and 120 did not meet the inclusion criteria. A total of 240 patients were enrolled: the control group (n=120) will receive usual psychopharmacological therapy, while the intervention group (n=120) will receive usual psychopharmacological therapy plus the So-Lo-Mo app. The project was approved for funding in June 2015. Enrollment started in October 2016 and was completed in October 2017. Data gathering was completed in November 2018, and data analysis is under way. The first results are expected to be submitted for publication in early 2019.ConclusionsSocial networks and mobile technologies influence our daily lives and, therefore, may influence our smoking habits as well. As part of the SmokeFreeBrain H2020 European Commission project, this study aims at elucidating the potential role of these technologies when used as an extra aid to quit smoking.Trial registrationClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/record/NCT03553173 (Archived by WebCite at http://www.webcitation.org/74DuHypOW).International registered report identifier (irrid)PRR1-10.2196/12464.
| S-EPMC6302230 | biostudies-literature
Project description:BACKGROUND:There is a need to deliver smoking cessation support at a population level, both in developed and developing countries. Studies on internet-based and mobile phone-based smoking cessation interventions have shown that these methods can be as effective as other methods of support, and they can have a wider reach at a lower cost. OBJECTIVE:This randomized controlled trial (RCT) aimed to compare, on a population level, the efficacy of an identical, tailored smoking cessation intervention delivered by mobile text messaging versus email. METHODS:We conducted a nationwide 2-arm, double-blinded, fully automated RCT, close to a real-world setting, in Norway. We did not offer incentives to increase participation and adherence or to decrease loss to follow-up. We recruited users of the website, slutta.no, an open, free, multi-component Norwegian internet-based smoking cessation program, from May 2010 until October 2012. Enrolled smokers were considered as having completed a time point regardless of their response status if it was 1, 3, 6, or 12 months post cessation. We assessed 7315 participants using the following inclusion criteria: knowledge of the Norwegian language, age 16 years or older, ownership of a Norwegian cell phone, having an email account, current cigarette smoker, willingness to set a cessation date within 14 days (mandatory), and completion of a baseline questionnaire for tailoring algorithms. Altogether, 6137 participants were eligible for the study and 4378 participants (71.33%) provided informed consent to participate in the smoking cessation trial. We calculated the response rates for participants at the completed 1, 3, 6, and 12 months post cessation. For each arm, we conducted an intention-to-treat (ITT) analysis for each completed time point. The main outcome was 7-day self-reported point prevalence abstinence (PPA) at the completed 6 months post cessation. We calculated effect size of the 7-day self-reported PPA in the text message arm compared with the email arm as odds ratios (ORs) with 95% CIs for the 4 time points post cessation. RESULTS:At 6 months follow-up, 21.06% (384/1823) of participants in the text message arm and 18.62% (333/1788) in the email arm responded (P=.07) to the surveys. In the ITT analysis, 11.46% (209/1823) of participants in the text message arm compared with 10.96% (196/1788) in the email arm (OR 1.05, 95% CI 0.86-1.30) reported to have achieved 7 days PPA. CONCLUSIONS:This nationwide, double-blinded, large, fully automated RCT found that 1 in 9 enrolled smokers reported 7-day PPA in both arms, 6 months post cessation. Our study found that identical smoking cessation interventions delivered by mobile text messaging and email may be equally successful at a population level. TRIAL REGISTRATION:ClinicalTrials.gov NCT01103427; https://clinicaltrials.gov/ct2/show/NCT01103427.
| S-EPMC6789425 | biostudies-literature
Project description:This study aimed to determine the efficacy of a smartphone application named Quit with US among young adult smokers. An open-label, parallel, 2-group, randomized controlled trial with a 12-week follow-up was conducted between March and November 2020 among undergraduate students (18 to 24 years) in Chiang Mai Province, Thailand. A total of 273 participants were assigned by simple randomization procedure to the Quit with US intervention group (n = 137) or the control group (n = 136). All participants received pharmacists' smoking cessation counseling at baseline and follow-ups. In addition, the intervention group's participants were advised to use Quit with US. The baseline and 12-week follow-up assessments were conducted at a study unit, whereas other follow-ups were completed over the telephone. The primary abstinence outcome was the exhaled CO concentration level (≤6 ppm) verified 7-day point prevalence abstinence. At baseline, the participants' mean (standard deviation) age was 21.06 (1.62) years. Most identified as daily smokers (57.9%, n = 158), consumed ≤10 cigarettes daily (89.4%, n = 244), and expressed low level of nicotine dependence as measured by Heaviness of Smoking Index score (86.1%, n = 235). Regarding intention-to-treat analyses, participants in the Quit with US intervention group achieved significantly greater smoking abstinence rate than those in the control group (58.4% (80/137) vs. 30.9% (42/136), risk ratio = 1.89, 95% confidence intervals = 1.42 to 2.52, p < 0.001). In conclusion, Quit with US integrated with pharmacists' smoking cessation counseling significantly enhanced smoking abstinence rates among young adult light smokers consuming ≤ 10 cigarettes daily.
| S-EPMC9321212 | biostudies-literature