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Randomized factorial experiment of components of the SmokeFree Baby smartphone application to aid smoking cessation in pregnancy.

ABSTRACT: Smartphone applications (apps) might be able to reach pregnant smokers who do not engage with face-to-face support. However, we do not know how far pregnant smokers will engage with smoking cessation apps or what components are likely to be effective. This study aimed to assess pregnant smokers' engagement with the SmokeFree Baby app (v1) and to assess the short-term efficacy of selected components ("modules") for smoking abstinence. Positive outcomes would provide a basis for further development and evaluation. SmokeFree Baby was developed drawing on behavior change theories and relevant evidence. Pregnant smokers (18+) who were interested in quitting and set a quit date were recruited. Following multiphase optimization development principles, participants (N = 565) were randomly allocated to one of 32 (2 × 2 × 2 × 2 × 2) experimental groups in a full factorial design to evaluate five modules (each in minimal and full version: identity, health information, stress management, face-to-face support, and behavioral substitution). Measures of engagement included duration and frequency of engagement with the app. Smoking abstinence was measured by self-reported number of smoke-free days up to 4 weeks from the quit date. Participants engaged with the app for a mean of 4.5 days (SD = 8.5) and logged in a mean of 2.9 times (SD = 3.1). Main effects of the modules on the number of smoke-free days were not statistically significant (identity: p = .782, health information: p = .905, stress management: p = .103, face-to-face support: p = .397, behavioral substitution: p = .945). Despite systematic development and usability testing, engagement with SmokeFree Baby (v1) was low and the app did not appear to increase smoking abstinence during pregnancy.

SUBMITTER: Tombor I

PROVIDER: S-EPMC6629841 | biostudies-other | 2018 Jul

REPOSITORIES: biostudies-other

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Randomized factorial experiment of components of the SmokeFree Baby smartphone application to aid smoking cessation in pregnancy.

Tombor Ildiko I Beard Emma E Brown Jamie J Shahab Lion L Michie Susan S West Robert R

Translational behavioral medicine 20190701 4

Smartphone applications (apps) might be able to reach pregnant smokers who do not engage with face-to-face support. However, we do not know how far pregnant smokers will engage with smoking cessation apps or what components are likely to be effective. This study aimed to assess pregnant smokers' engagement with the SmokeFree Baby app (v1) and to assess the short-term efficacy of selected components ("modules") for smoking abstinence. Positive outcomes would provide a basis for further developmen ...[more]

PMID: 30011020

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Project description:Cigarette smoking during pregnancy increases risk for pregnancy complications, growth restriction, and other adverse health outcomes. The most effective intervention for reducing smoking during pregnancy is financial incentives contingent on biochemically-verified smoking abstinence. The present study examined the efficacy of a smartphone-based intervention whereby smoking monitoring and incentive delivery occurred remotely using a mobile app. If efficacious, this remote intervention would allow pregnant women residing in geographically remote areas to benefit from incentives-based cessation interventions. Sixty U.S. pregnant smokers were recruited between May 2018 to May 2019 via obstetrical clinics, Women, Infants, and Children (WIC) offices, and Facebook. Participants were assigned sequentially to one of two treatments: best practices alone (N = 30) or best practices plus financial incentives (N = 30). Outcomes were analyzed using repeated measures analysis based on generalized estimating equations (GEE). Seven-day point prevalence abstinence rates were greater in the incentives versus best practices arms early- (46.7% vs 20.0%, OR = 3.50, 95%CI = 1.11,11.02) and late-antepartum (36.7% vs 13.3%, OR = 3.76, 95%CI = 1.04,13.65), and four- (36.7% vs 10.0%, OR = 5.21, 95%CI = 1.28,21.24) and eight-weeks postpartum (40.0% vs 6.7%, OR = 9.33, 95%CI = 1.87,46.68), although not at the 12- (23.3% vs 10.0%, OR = 2.74, 95%CI = 0.63,11.82) or 24-week (20.0% vs 6.7%, OR = 3.50, 95%CI = 0.65,18.98) postpartum assessments likely due to this pilot study being underpowered for discerning differences at the later assessments, especially 24-weeks postpartum which was three months after treatment completion. These results support the efficacy of this remote, incentives-based intervention for pregnant smokers. Further research evaluating its efficacy and cost-effectiveness in a well-powered, randomized controlled trial appears warranted.

Project description:ImportanceSmoking is a leading cause of premature death globally. Smartphone applications for smoking cessation are ubiquitous and address barriers to accessing traditional treatments, yet there is limited evidence for their efficacy.ObjectiveTo determine the efficacy of a smartphone application for smoking cessation based on acceptance and commitment therapy (ACT) vs a National Cancer Institute smoking cessation application based on US clinical practice guidelines (USCPG).Design, setting, and participantsA 2-group, stratified, double-blind, individually randomized clinical trial was conducted from May 27, 2017, to September 28, 2018, among 2415 adult cigarette smokers (n = 1214 for the ACT-based smoking cessation application group and n = 1201 for the USCPG-based smoking cessation application group) with 3-, 6-, and 12-month postrandomization follow-up. The study was prespecified in the trial protocol. Follow-up data collection started on August 26, 2017, and ended at the last randomized participant's 12-month follow-up survey on December 23, 2019. Data were analyzed from February 25 to April 3, 2020. The primary analysis was performed on a complete-case basis, with intent-to-treat missing as smoking and multiple imputation sensitivity analyses.InterventionsiCanQuit, an ACT-based smoking cessation application, which taught acceptance of smoking triggers, and the National Cancer Institute QuitGuide, a USCPG-based smoking cessation application, which taught avoidance of smoking triggers.Main outcomes and measuresThe primary outcome was self-reported 30-day point prevalence abstinence (PPA) at 12 months after randomization. Secondary outcomes were 7-day PPA at 12 months after randomization, prolonged abstinence, 30-day and 7-day PPA at 3 and 6 months after randomization, missing data imputed with multiple imputation or coded as smoking, and cessation of all tobacco products (including e-cigarettes) at 12 months after randomization.ResultsParticipants were 2415 adult cigarette smokers (1700 women [70.4%]; 1666 White individuals [69.0%] and 868 racial/ethnic minorities [35.9%]; mean [SD] age at enrollment, 38.2 [10.9] years) from all 50 US states. The 3-month follow-up data retention rate was 86.7% (2093), the 6-month retention rate was 88.4% (2136), and the 12-month retention rate was 87.2% (2107). For the primary outcome of 30-day PPA at the 12-month follow-up, iCanQuit participants had 1.49 times higher odds of quitting smoking compared with QuitGuide participants (28.2% [293 of 1040] vs 21.1% [225 of 1067]; odds ratio [OR], 1.49; 95% CI, 1.22-1.83; P < .001). Effect sizes were very similar and statistically significant for 7-day PPA at the 12-month follow-up (OR, 1.35; 95% CI, 1.12-1.63; P = .002), prolonged abstinence at the 12-month follow-up (OR, 2.00; 95% CI, 1.45-2.76; P < .001), abstinence from all tobacco products (including e-cigarettes) at the 12-month follow-up (OR, 1.60; 95% CI, 1.28-1.99; P < .001), 30-day PPA at 3-month follow-up (OR, 2.20; 95% CI, 1.68-2.89; P < .001), 30-day PPA at 6-month follow-up (OR, 2.03; 95% CI, 1.63-2.54; P < .001), 7-day PPA at 3-month follow-up (OR, 2.04; 95% CI, 1.64-2.54; P < .001), and 7-day PPA at 6-month follow-up (OR, 1.73; 95% CI, 1.42-2.10; P < .001).Conclusions and relevanceThis trial provides evidence that, compared with a USCPG-based smartphone application, an ACT-based smartphone application was more efficacious for quitting cigarette smoking and thus can be an impactful treatment option.Trial registrationClinicalTrials.gov Identifier: NCT02724462.

Project description:BackgroundMany women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA) interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP) trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date.Methods/designThe LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy), and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation) or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations). The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome.DiscussionThis trial will assess whether a PA intervention is effective when used for smoking cessation during pregnancy.Trial registrationISRCTN48600346.

Project description:BACKGROUND:Smoking remains a leading cause of preventable death and illness. Internet interventions for smoking cessation have the potential to significantly impact public health, given their broad reach and proven effectiveness. Given the dose-response association between engagement and behavior change, identifying strategies to promote engagement is a priority across digital health interventions. Text messaging is a proven smoking cessation treatment modality and a powerful strategy to increase intervention engagement in other areas of health, but it has not been tested as an engagement strategy for a digital cessation intervention. OBJECTIVE:This study examined the impact of 4 experimental text message design factors on adult smokers' engagement with an internet smoking cessation program. METHODS:We conducted a 2×2×2×2 full factorial screening experiment wherein 864 participants were randomized to 1 of 16 experimental conditions after registering with a free internet smoking cessation program and enrolling in its automated text message program. Experimental factors were personalization (on/off), integration between the web and text message platforms (on/off), dynamic tailoring of intervention content based on user engagement (on/off), and message intensity (tapered vs abrupt drop-off). Primary outcomes were 3-month measures of engagement (ie, page views, time on site, and return visits to the website) as well as use of 6 interactive features of the internet program. All metrics were automatically tracked; there were no missing data. RESULTS:Main effects were detected for integration and dynamic tailoring. Integration significantly increased interactive feature use by participants, whereas dynamic tailoring increased the number of features used and page views. No main effects were found for message intensity or personalization alone, although several synergistic interactions with other experimental features were observed. Synergistic effects, when all experimental factors were active, resulted in the highest rates of interactive feature use and the greatest proportion of participants at high levels of engagement. Measured in terms of standardized mean differences (SMDs), effects on interactive feature use were highest for Build Support System (SMD 0.56; 95% CI 0.27 to 0.81), Choose Quit Smoking Aid (SMD 0.38; 95% CI 0.10 to 0.66), and Track Smoking Triggers (SMD 0.33; 95% CI 0.05 to 0.61). Among the engagement metrics, the largest effects were on overall feature utilization (SMD 0.33; 95% CI 0.06 to 0.59) and time on site (SMD 0.29; 95% CI 0.01 to 0.57). As no SMD >0.30 was observed for main effects on any outcome, results suggest that for some outcomes, the combined intervention was stronger than individual factors alone. CONCLUSIONS:This factorial experiment demonstrates the effectiveness of text messaging as a strategy to increase engagement with an internet smoking cessation intervention, resulting in greater overall intervention dose and greater exposure to the core components of tobacco dependence treatment that can promote abstinence. TRIAL REGISTRATION:ClinicalTrials.gov NCT02585206; https://clinicaltrials.gov/ct2/show/NCT02585206. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.1136/bmjopen-2015-010687.

Dataset Information

Randomized factorial experiment of components of the SmokeFree Baby smartphone application to aid smoking cessation in pregnancy.

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Randomized factorial experiment of components of the SmokeFree Baby smartphone application to aid smoking cessation in pregnancy.

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