Pilot randomized controlled trial of an internet-based smoking cessation intervention for pregnant smokers ('MumsQuit').
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ABSTRACT:
SUBMITTER: Herbec A
PROVIDER: S-EPMC4067748 | biostudies-literature | 2014 Jul
REPOSITORIES: biostudies-literature
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Pilot randomized controlled trial of an internet-based smoking cessation intervention for pregnant smokers ('MumsQuit').
Herbec Aleksandra A Brown Jamie J Tombor Ildiko I Michie Susan S West Robert R
Drug and alcohol dependence 20140424
<h4>Background</h4>Internet-based Smoking Cessation Interventions could help pregnant women quit smoking, especially those who do not wish to, or cannot, access face-to-face or telephone support. This study aimed to preliminarily evaluate the effectiveness and usage of a fully automated smoking cessation website targeted to pregnancy, 'MumsQuit', and obtain an initial effect-size estimate for a full scale trial.<h4>Methods</h4>We recruited 200 UK-based pregnant adult smokers online to a two-arm ...[more]
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Project description:BackgroundAround 2 million Chinese people, mostly men, die annually from tobacco-related diseases; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation support.ObjectiveThis study aimed to test the preliminary effectiveness and feasibility for a mobile social network (WeChat)-based smoking cessation intervention (SCAMPI program) among Chinese male smokers.MethodsChinese male smokers aged 25-44 years were recruited online from WeChat, the most widely used social media platform in China. Individuals using other smoking cessation interventions or who lacked capacity to provide online informed consent were excluded. Participants were randomly assigned (1:1) to intervention or control groups. Neither participants nor researchers were masked to assignment. The trial was fully online. All data were collected via WeChat. The intervention group received access to the full-version SCAMPI program, a Chinese-language smoking cessation program based on the Behaviour Change Wheel framework and relevant cessation guidelines. Specific intervention functions used in the program include: planning to help users make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, information about smoking harms, motivational messages to help users overcome urges, standardized tests for users to assess their levels of nicotine dependence and lung health, as well as a social platform to encourage social support between users. The control group had access to a static WeChat page of contacts for standard smoking cessation care. Both groups received incentive credit payments for participating. The primary outcome was 30-day biochemically verified smoking abstinence at 6 weeks after randomization, with missing data treated as not quitting. Secondary outcomes were other smoking status measures, reduction of cigarette consumption, study feasibility (recruitment and retention rate), and acceptability of and satisfaction with the program.ResultsThe program recorded 5736 visitors over a 13-day recruitment period. We recruited 80 participants who were randomly allocated to two arms (n=40 per arm). At 6 weeks, 36 of 40 (90%) intervention participants and 35 of 40 (88%) control participants provided complete self-reported data on their daily smoking status via WeChat. Biochemically verified smoking abstinence at 6 weeks was determined for 10 of 40 (25%) intervention participants and 2 of 40 (5%) control participants (RR=5, 95% CI 1.2-21.4, P=.03). In the intervention group, the calculator function, motivational messages, and health tests were underused (less than once per week per users). Participants rated their satisfaction with the intervention program as 4.56 out of 5.00.ConclusionsOur program is a novel, accessible, and acceptable smoking cessation intervention for Chinese male smokers. A future trial with a greater sample size and longer follow-up will identify if it is as effective as these preliminary data suggest.Trial registrationANZCTR registry, ACTRN12618001089224; https://tinyurl.com/y536n7sx.International registered report identifier (irrid)RR2-18071.
| S-EPMC7647814 | biostudies-literature
Project description:AIMS:To estimate the effectiveness of pregnancy smoking cessation support delivered by short message service (SMS) text message and key parameters needed to plan a definitive trial. DESIGN:Multi-centre, parallel-group, single-blinded, individual randomized controlled trial. SETTING:Sixteen antenatal clinics in England. PARTICIPANTS:Four hundred and seven participants were randomized to the intervention (n = 203) or usual care (n = 204). Eligible women were < 25 weeks gestation, smoked at least one daily cigarette (> 5 pre-pregnancy), were able to receive and understand English SMS texts and were not already using text-based cessation support. INTERVENTION:All participants received a smoking cessation leaflet; intervention participants also received a 12-week programme of individually tailored, automated, interactive, self-help smoking cessation text messages (MiQuit). OUTCOME MEASUREMENTS:Seven smoking outcomes, including validated continuous abstinence from 4 weeks post-randomization until 36 weeks gestation, design parameters for a future trial and cost-per-quitter. FINDINGS:Using the validated, continuous abstinence outcome, 5.4% (11 of 203) of MiQuit participants were abstinent versus 2.0% (four of 204) of usual care participants [odds ratio (OR) = 2.7, 95% confidence interval (CI) = 0.93-9.35]. The Bayes factor for this outcome was 2.23. Completeness of follow-up at 36 weeks gestation was similar in both groups; provision of self-report smoking data was 64% (MiQuit) and 65% (usual care) and abstinence validation rates were 56% (MiQuit) and 61% (usual care). The incremental cost-per-quitter was £133.53 (95% CI = -£395.78 to 843.62). CONCLUSIONS:There was some evidence, although not conclusive, that a text-messaging programme may increase cessation rates in pregnant smokers when provided alongside routine NHS cessation care.
| S-EPMC5488183 | 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:BackgroundTobacco smoking remains the leading cause of preventable death and disease worldwide. Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness.ObjectiveOur objective was to test the preliminary effectiveness of Quit Genius, a novel digital therapeutic intervention for smoking cessation.MethodsA 2-arm, single-blinded, parallel-group randomized controlled trial design was used. Participants were recruited via referrals from primary care practices and social media advertisements in the United Kingdom. A total of 556 adult smokers (aged 18 years or older) smoking at least 5 cigarettes a day for the past year were recruited. Of these, 530 were included for the final analysis. Participants were randomized to one of 2 interventions. Treatment consisted of a digital therapeutic intervention for smoking cessation consisting of a smartphone app delivering cognitive behavioral therapy content, one-to-one coaching, craving tools, and tracking capabilities. The control intervention was very brief advice along the Ask, Advise, Act model. All participants were offered nicotine replacement therapy for 3 months. Participants in a random half of each arm were pseudorandomly assigned a carbon monoxide device for biochemical verification. Outcomes were self-reported via phone or online. The primary outcome was self-reported 7-day point prevalence abstinence at 4 weeks post quit date.ResultsA total of 556 participants were randomized (treatment: n=277; control: n=279). The intention-to-treat analysis included 530 participants (n=265 in each arm; 11 excluded for randomization before trial registration and 15 for protocol violations at baseline visit). By the quit date (an average of 16 days after randomization), 89.1% (236/265) of those in the treatment arm were still actively engaged. At the time of the primary outcome, 74.0% (196/265) of participants were still engaging with the app. At 4 weeks post quit date, 44.5% (118/265) of participants in the treatment arm had not smoked in the preceding 7 days compared with 28.7% (76/265) in the control group (risk ratio 1.55, 95% CI 1.23-1.96; P<.001; intention-to-treat, n=530). Self-reported 7-day abstinence agreed with carbon monoxide measurement (carbon monoxide <10 ppm) in 96% of cases (80/83) where carbon monoxide readings were available. No harmful effects of the intervention were observed.ConclusionsThe Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN) 65853476; https://www.isrctn.com/ISRCTN65853476.
| S-EPMC7576529 | biostudies-literature
Project description:BACKGROUND:Smartphone apps for smoking cessation could offer easily accessible, highly tailored, intensive interventions at a fraction of the cost of traditional counseling. Although there are hundreds of publicly available smoking cessation apps, few have been empirically evaluated using a randomized controlled trial (RCT) design. The Smart-Treatment (Smart-T2) app is a just-in-time adaptive intervention that uses ecological momentary assessments (EMAs) to assess the risk for imminent smoking lapse and tailors treatment messages based on the risk of lapse and reported symptoms. OBJECTIVE:This 3-armed pilot RCT aimed to determine the feasibility and preliminary efficacy of an automated smartphone-based smoking cessation intervention (Smart-T2) relative to standard in-person smoking cessation clinic care and the National Cancer Institute's free smoking cessation app, QuitGuide. METHODS:Adult smokers who attended a clinic-based tobacco cessation program were randomized into groups and followed for 13 weeks (1 week prequitting through 12 weeks postquitting). All study participants received nicotine patches and gum and were asked to complete EMAs five times a day on study-provided smartphones for 5 weeks. Participants in the Smart-T2 group received tailored treatment messages after the completion of each EMA. Both Smart-T2 and QuitGuide apps offer on-demand smoking cessation treatment. RESULTS:Of 81 participants, 41 (50%) were women and 55 (68%) were white. On average, participants were aged 49.6 years and smoked 22.4 cigarettes per day at baseline. A total of 17% (14/81) of participants were biochemically confirmed 7-day point prevalence abstinent at 12 weeks postquitting (Smart-T2: 6/27, 22%, QuitGuide: 4/27, 15%, and usual care: 4/27, 15%), with no significant differences across groups (P>.05). Participants in the Smart-T2 group rated the app positively, with most participants agreeing that they can rely on the app to help them quit smoking, and endorsed the belief that the app would help them stay quit, and these responses were not significantly different from the ratings given by participants in the usual care group. CONCLUSIONS:Dynamic smartphone apps that tailor intervention content in real time may increase user engagement and exposure to treatment-related materials. The results of this pilot RCT suggest that smartphone-based smoking cessation treatments may be capable of providing similar outcomes to traditional, in-person counseling. TRIAL REGISTRATION:ClinicalTrials.gov NCT02930200; https://clinicaltrials.gov/show/NCT02930200.
| S-EPMC7091024 | biostudies-literature
Project description:AimsTo evaluate the effectiveness of a combined internet and text message intervention for smoking cessation compared with an internet intervention alone. The text message intervention was optimized for engagement in an earlier multiphase optimization (MOST) screening phase.DesignA parallel, two-group, individually randomized clinical trial (RCT) was conducted in a MOST confirming phase. Recruitment spanned December 2018 to March 2019. Follow-up was conducted at 3 and 9 months, beginning March 2019 and ending January 2020.SettingUnited States: a digital study conducted among new registrants on a free tobacco cessation website.ParticipantsEligible individuals were 618 adult current smokers in the United States, age 18 years or older who signed up for text messages during website registration (67.2% female, 70.4% white).InterventionsThe treatment arm (WEB+TXT; n = 311) received access to the website and text messaging. The control arm (WEB; n = 307) received access to the website alone.MeasurementsThe primary outcome was self-reported 30-day point prevalence abstinence (ppa) at 9 months post-randomization analyzed under intent to treat (ITT), counting non-responders as smoking. Secondary outcomes included 3-month measures of 30-day ppa, intervention engagement and intervention satisfaction.FindingsAbstinence rates at 9 months were 23.1% among WEB+TXT and 23.2% among WEB (OR = 1.00, 95% CI = 0.69-1.45; P = 0.99). WEB+TXT increased engagement with 5 of 6 interactive features (standardized mean difference (SMD) = 0.26-0.47, all P < 0.001) and repeat website visits (48.7% vs 38.9%, SMD = 0.14, P = 0.02). Satisfaction metrics favored WEB+TXT (satisfied: 96.3% vs 90.5%, SMD = 0.17, P = 0.008; recommend to friend: 95.9% vs 90.1%, SMD = 0.16, P = 0.028).ConclusionsA randomized controlled trial found no evidence that a combined internet and text message intervention for smoking cessation compared with an internet intervention alone increased 9-month abstinence rates among adult current smokers in the United States, despite evidence of higher levels of intervention engagement and satisfaction at 3 months.
| S-EPMC9293135 | biostudies-literature
Project description:OBJECTIVE:Greater depressive symptoms and low positive affect (PA) are associated with poor smoking cessation outcomes. Smoking cessation approaches that incorporate a focus on PA may benefit smokers trying to quit. The purpose of this study was to conduct a pilot randomized clinical trial to compare standard smoking cessation treatment (ST) with smoking cessation treatment that targets positive affect, termed positive psychotherapy for smoking cessation (PPT-S). METHOD:Smokers who were seeking smoking cessation treatment were assigned by urn randomization to receive, along with 8 weeks of nicotine replacement therapy, either ST (n = 31) or PPT-S (n = 35). Seven-day point prevalence smoking abstinence was biochemically confirmed at 8, 16, and 26 weeks. RESULTS:Compared to ST, a greater percentage of participants in PPT-S were abstinent at 8 weeks, 16 weeks, and 26 weeks, but these differences were nonsignificant. In a more statistically powerful longitudinal model, participants in PPT-S had a significantly higher odds of abstinence (adjusted odds ratio [AOR] = 2.75; 95% CI = 1.02, 7.42; p = .046) across follow-ups compared to those in ST. The positive effect of PPT-S was stronger for those higher in PA (OR = 6.69, 95% CI = 1.16, 38.47, p = .03). Greater use of PPT-S strategies during the initial 8 weeks of quitting was associated with a less steep decline in smoking abstinence rates over time (OR = 2.64, 95% CI = 1.06, 6.56, p =.04). CONCLUSION:This trial suggests substantial promise for incorporating PPT into smoking cessation treatment.
| S-EPMC4612345 | biostudies-literature
Project description:ObjectiveThere is some evidence for biomarker feedback when combined with cessation counseling for reducing smoking in pregnancy. This randomized controlled pilot study evaluated feasibility and potential efficacy of a social-cognitive theory (SCT)-based biomarker feedback intervention among pregnant Alaska Native (AN) smokers.MethodsParticipants were randomly assigned to receive three study calls (10-20 min each): (1) biomarker feedback intervention (n = 30) including personalized cotinine results and feedback on their baby's likely exposure to carcinogen metabolite NNAL, or (2) contact control usual care condition based on the 5As (n = 30). Assessments were conducted at baseline, post-treatment, and delivery.ResultsHigh rates of treatment compliance, study retention, and treatment acceptability were observed in both groups. 7-day point prevalence smoking abstinence rates at delivery verified with urinary cotinine were the same in both study groups (20% intent-to-treat analysis, 26% per-protocol). SCT-based measures did not change differentially from baseline by study group.ConclusionThis trial supports the feasibility and acceptability of providing biomarker feedback within the clinical care delivery system, but the intervention did not promote increased smoking cessation during pregnancy compared to usual care.Practice implicationsEfforts are needed to promote the usual care and to develop alternative biomarker feedback messaging for pregnant AN women.
| S-EPMC6421103 | biostudies-literature
Project description:BackgroundText message (ie, short message service, SMS) smoking cessation interventions have demonstrated efficacy in high-income countries but are less well studied in low- and middle-income countries, including Vietnam.ObjectiveThe goal of the research is to assess the feasibility, acceptability, and preliminary efficacy of a fully automated bidirectional SMS cessation intervention adapted for Vietnamese smokers.MethodsThe study was conducted in 3 phases. In phase 1, we adapted the SMS library from US-based SMS cessation programs (ie, SmokefreeTXT and Text2Quit). The adaptation process consisted of 7 focus groups with 58 smokers to provide data on culturally relevant patterns of tobacco use and assess message preferences. In phase 2, we conducted a single-arm pilot test of the SMS intervention with 40 smokers followed by in-depth interviews with 10 participants to inform additional changes to the SMS library. In phase 3, we conducted a 2-arm pilot randomized controlled trial (RCT) with 100 smokers. Participants received either the SMS program (intervention; n=50) or weekly text assessment on smoking status (control; n=50). The 6-week SMS program consisted of a 2-week prequit period and a 4-week postquit period. Participants received 2 to 4 automated messages per day. The main outcomes were engagement and acceptability which were assessed at 6 weeks (end of intervention). We assessed biochemically confirmed smoking abstinence at 6 weeks and 12 weeks. Postintervention in-depth interviews explored user experiences among a random sample of 16 participants in the intervention arm.ResultsParticipants in both arms reported high levels of engagement and acceptability. Participants reported using the program for an average of 36.4 (SD 3.4) days for the intervention arm and 36.0 (SD 3.9) days for the control arm. Four of the 50 participants in the intervention arm (8%) reset the quit date and 19 (38%) texted the keyword TIPS. The majority of participants in both arms reported that they always or usually read the text messages. Compared to the control arm, a higher proportion of participants in the intervention arm reported being satisfied with the program (98% [49/50] vs 82% [41/50]). Biochemically verified abstinence was higher in the intervention arm at 6 weeks (20% [10/50] vs 2% [1/50]; P=.01), but the effect was not significant at 12 weeks (12% [6/50] vs 6% [3/50]; P=.49). In-depth interviews conducted after the RCT suggested additional modifications to enhance the program including tailoring the timing of messages, adding more opportunities to interact with the program, and placing a greater emphasis on messages that described the harms of smoking.ConclusionsThe study supported the feasibility and acceptability of an SMS program adapted for Vietnamese smokers. Future studies need to assess whether, with additional modifications, the program is associated with prolonged abstinence.Trial registrationClinicalTrials.gov NCT03219541; https://clinicaltrials.gov/ct2/show/NCT03219541.
| S-EPMC8538032 | biostudies-literature
Project description:IntroductionNegative affect has been identified as a factor influencing continued smoking during pregnancy. In this study, a multi-component emotion regulation intervention was developed to address negative emotional smoking triggers and pilot-tested among low-income pregnant smokers. Treatment feasibility and acceptability, cotinine-verified rates of smoking cessation, and self-report of mean cigarettes smoked were assessed.MethodsPregnant smokers who self-reported smoking in response to negative affect (N = 70) were randomly assigned to receive one of two 8-session interventions: (1) emotion regulation treatment combined with standard cognitive-behavioral smoking cessation (ERT + CBT) or (2) a health and lifestyle plus standard smoking cessation active control (HLS + CBT). Outcomes for the 4-month period following the quit date are reported.ResultsTreatment attendance and subjective ratings provide evidence for the feasibility and acceptability of the ERT + CBT intervention. Compared with the HLS + CBT control condition, the ERT + CBT condition demonstrated higher abstinence rates at 2 months (ERT + CBT = 23% vs. HLS + CBT = 0%, OR = 13.51; 95% CI = 0.70-261.59) and 4 months (ERT = 18% vs. HLS = 5%; OR = 2.98; 95% CI = 0.39-22.72) post-quit. Mean number of cigarettes per day was significantly lower in ERT + CBT at 2 months (ERT + CBT = 2.73 (3.35) vs. HLS + CBT = 5.84 (6.24); p = .05) but not at 4 months (ERT + CBT = 2.15 (3.17) vs. HLS + CBT = 5.18 (2.88); p = .06) post-quit.ConclusionsThe development and initial test of the ERT + CBT intervention supports its feasibility and acceptability in this difficult-to-treat population. Further development and testing in a Stage II randomized clinical trial are warranted.ImplicationsNegative affect has been identified as a motivator for continued smoking during pregnancy. To date, smoking cessation interventions for pregnant smokers have not specifically addressed the role of negative affect as a smoking trigger. This treatment development pilot study provides support for the feasibility and acceptability of a multi-component ERT + CBT for low-income pregnant smokers who self-report smoking in response to negative affect. Study findings support further testing in a fully-powered Stage II efficacy trial powered to assess mediators and moderators of treatment effects.
| S-EPMC5939632 | biostudies-literature