A Smartphone App to Assist Smoking Cessation Among Aboriginal Australians: Findings From a Pilot Randomized Controlled Trial (Preprint)

BACKGROUND Mobile health (mHealth) apps have the potential to increase smoking cessation, but little research has been conducted with Aboriginal communities in Australia. OBJECTIVE We conducted a pilot study to assess the feasibility and acceptability and explore the effectiveness of a novel mHealth app to assist Aboriginal people to quit smoking. METHODS A pilot randomized controlled trial (RCT) and process evaluation comprising usage analytics data and in-depth interviews was conducted. Current Aboriginal smokers (>16 years old), who were willing to make a quit attempt in the next month, were recruited from Aboriginal Community Controlled Health Services and a government telephone coaching service. The intervention was a multifaceted Android or iOS app comprising a personalized profile and quit plan, text and in-app motivational messages, and a challenge feature allowing users to compete with others. The comparator was usual cessation support services. Outcome data collection and analysis were conducted blinded to treatment allocation. The primary outcome was self-reported continuous smoking abstinence verified by carbon monoxide breath testing at 6 months. Secondary outcomes included point prevalence of abstinence and use of smoking cessation therapies and services. RESULTS A total of 49 participants were recruited. Competing service delivery priorities, the lack of resources for research, and lack of support for randomization to a control group were the major recruitment barriers. At baseline, 23/49 (47%) of participants had tried to quit in recent weeks. At 6-month follow-up, only 1 participant (intervention arm) was abstinent. The process evaluation highlighted low to moderate app usage (3-10 new users per month and 4-8 returning users per month), an average of 2.9 sessions per user per month and 6.3 min per session. Key themes from interviews with intervention participants (n=15) included the following: (1) the powerful influence of prevailing social norms around acceptability of smoking; (2) high usage of mobile devices for phone, text, and social media but very low use of other smartphone apps; (3) the role of family and social group support in supporting quit attempts; and (4) low awareness and utilization of smoking cessation support services. Despite the broad acceptability of the app, participants also recommended technical improvements to improve functionality, greater customization of text messages, integration with existing social media platforms, and gamification features. CONCLUSIONS Smoking cessation apps need to be integrated with commonly used functions of mobile phones and draw on social networks to support their use. Although they have the potential to increase utilization of cessation support services and treatments, more research is needed to identify optimal implementation models. Robust evaluation is critical to determine their impact; however, an RCT design may not be feasible in this setting. CLINICALTRIAL Australian and New Zealand Clinical Trials Registry ACTRN12616001550493; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371792 (Archived by WebCite at http://www.webcitation.org/76TiV7HA6).

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Exploring the Experiences of Individuals Allocated to a Control Setting: Findings From a Mobile Health Smoking Cessation Trial (Preprint)

10.2196/preprints.12139 ◽

2018 ◽

Author(s):

Ulrika Müssener ◽

Catharina Linderoth ◽

Marcus Bendtsen

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

University Students ◽

Mobile Health ◽

Controlled Trial ◽

Text Messages ◽

Control Group ◽

Free Text ◽

Randomized Controlled ◽

Quit Smoking

BACKGROUND Tobacco smoking is the primary cause of preventable premature disease and death worldwide. Evidence of the efficacy of text messaging interventions to reduce smoking behavior is well established, but there is still a need for studies targeting young people, especially because young adult smokers are less likely to seek treatment than older adults. A mobile health intervention, Nicotine Exit (NEXit), targeting smoking among university students was developed to support university students to quit smoking. Short-term effectiveness was measured through a randomized controlled trial, which found that immediately after the 12-week intervention, 26% of smokers in the intervention group had prolonged abstinence compared with 15% in the control group. OBJECTIVE The objective of this study was to explore the experience of being allocated to the control group in the NEXit smoking cessation intervention. METHODS We asked students who were allocated to the control group in the main NEXit randomized controlled trial to report their experiences. An email was sent to the participants with an electronic link to a short questionnaire. We assessed the distribution of the responses to the questionnaire by descriptive analysis. We analyzed free-text comments to 4 questions. RESULTS The response rate for the questionnaire was 33.8% (258/763), and we collected 143 free-text comments. Of the responders, 60.9% (157/258) experienced frustration, disappointment, and irritation about being allocated to the control group; they felt they were being denied support by having to wait for the intervention. Monthly text messages during the waiting period thanking them for taking part in the trial were perceived as negative by 72.3% (189/258), but for some the messages served as a reminder about the decision to quit smoking. Of the responders, 61.2% (158/258) chose to wait to quit smoking until they had access to the intervention, and 29.8% (77/258) decided to try to quit smoking without support. Of the respondents, 77.5% (200/258) claimed they were still smoking and had signed up or were thinking about signing up for the smoking cessation program at the time of the questionnaire. CONCLUSIONS Most of the respondents reported negative feelings about having to wait for the support of the intervention and that they had decided to continue smoking. A similar number decided to wait to quit smoking until they had access to the intervention, and these respondents reported a high interest in the intervention. Free-text comments indicated that some control group participants believed that they had been excluded from the trial, while others were confused when asked to sign up for the intervention again. CLINICALTRIAL ISRCTN Registry ISRCTN75766527; http://www.isrctn.com/ISRCTN75766527 (Archived by WebCite at http://www.webcitation.org/7678sUKbR)

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Improving Calcium Knowledge and Intake in Young Adults Via Social Media and Text Messages: Randomized Controlled Trial (Preprint)

10.2196/preprints.16499 ◽

2019 ◽

Author(s):

Anika Rouf ◽

Monica Nour ◽

Margaret Allman-Farinelli

Keyword(s):

Social Media ◽

Randomized Controlled Trial ◽

Young Adults ◽

Calcium Intake ◽

Text Messaging ◽

Habit Formation ◽

Controlled Trial ◽

Text Messages ◽

Control Group ◽

Randomized Controlled

BACKGROUND Calcium is an important nutrient for the attainment of peak bone mass during adolescence and young adulthood. However, these life phases are characterized as hard to reach for health promotion. Social media platforms offer a promising channel as they are relatively low cost but used ubiquitously by youth. OBJECTIVE The aim of the CAlcium Nutrition-Dietary Opportunities (CAN-DO) study was to conduct a randomized controlled trial to test the effectiveness of Facebook alone or with text messaging as channels to deliver a theory-based program to encourage optimal calcium intake. METHODS The intervention was a 3-arm parallel trial. Young adults aged 18 to 25 years were recruited through university and social media for a 6-week trial. Participants were randomized to 1 of the 3 arms (ie, Facebook posts, Facebook posts plus text messages, and control group that received an electronic leaflet containing information on calcium intake). The primary outcome was change in intake of milk and other calcium-rich foods, and secondary outcomes were knowledge, self-efficacy, motivation, and habit formation concerning calcium-rich foods. Changes were assessed before and after the intervention, and the differences in change between groups were compared using multivariate regression models with multiple imputations for missing data. RESULTS A total of 211 participants (64/211, 30.3% males) participated (mean age 21.4 years, SD 2.1) in this study. At the end of the program, no increase in milk intake (odds ratio [OR] 1.51, 95% CI 0.61-3.75 Facebook; OR 1.77, 95% CI 0.74-4.24 Facebook plus text messages; P=.41) nor calcium-rich food was detected (P=.57). There was a significant improvement in knowledge in the Facebook plus text messages group (P<.001), but habit formation improved less than that in the other 2 groups (P=.01). Our results showed a moderate level of engagement with intervention content and positive qualitative feedback from participants. CONCLUSIONS The CAN-DO study delivered via Facebook (with the additional support of text messages) was found to improve knowledge and was acceptable among young adults. However, further research is needed to better understand social media engagement and how to optimize the program for participants to be sufficiently motivated to increase their intake of calcium-rich foods. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12620000097943; http://www.anzctr.org.au/ACTRN12620000097943.aspx

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Improving Calcium Knowledge and Intake in Young Adults Via Social Media and Text Messages: Randomized Controlled Trial

JMIR mhealth and uhealth ◽

10.2196/16499 ◽

2020 ◽

Vol 8 (2) ◽

pp. e16499

Author(s):

Anika Rouf ◽

Monica Nour ◽

Margaret Allman-Farinelli

Keyword(s):

Social Media ◽

Randomized Controlled Trial ◽

Young Adults ◽

Calcium Intake ◽

Text Messaging ◽

Habit Formation ◽

Controlled Trial ◽

Text Messages ◽

Control Group ◽

Randomized Controlled

Background Calcium is an important nutrient for the attainment of peak bone mass during adolescence and young adulthood. However, these life phases are characterized as hard to reach for health promotion. Social media platforms offer a promising channel as they are relatively low cost but used ubiquitously by youth. Objective The aim of the CAlcium Nutrition-Dietary Opportunities (CAN-DO) study was to conduct a randomized controlled trial to test the effectiveness of Facebook alone or with text messaging as channels to deliver a theory-based program to encourage optimal calcium intake. Methods The intervention was a 3-arm parallel trial. Young adults aged 18 to 25 years were recruited through university and social media for a 6-week trial. Participants were randomized to 1 of the 3 arms (ie, Facebook posts, Facebook posts plus text messages, and control group that received an electronic leaflet containing information on calcium intake). The primary outcome was change in intake of milk and other calcium-rich foods, and secondary outcomes were knowledge, self-efficacy, motivation, and habit formation concerning calcium-rich foods. Changes were assessed before and after the intervention, and the differences in change between groups were compared using multivariate regression models with multiple imputations for missing data. Results A total of 211 participants (64/211, 30.3% males) participated (mean age 21.4 years, SD 2.1) in this study. At the end of the program, no increase in milk intake (odds ratio [OR] 1.51, 95% CI 0.61-3.75 Facebook; OR 1.77, 95% CI 0.74-4.24 Facebook plus text messages; P=.41) nor calcium-rich food was detected (P=.57). There was a significant improvement in knowledge in the Facebook plus text messages group (P<.001), but habit formation improved less than that in the other 2 groups (P=.01). Our results showed a moderate level of engagement with intervention content and positive qualitative feedback from participants. Conclusions The CAN-DO study delivered via Facebook (with the additional support of text messages) was found to improve knowledge and was acceptable among young adults. However, further research is needed to better understand social media engagement and how to optimize the program for participants to be sufficiently motivated to increase their intake of calcium-rich foods. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12620000097943; http://www.anzctr.org.au/ACTRN12620000097943.aspx

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Virtual Reality Smartphone-Based Intervention for Smoking Cessation: Pilot Randomized Controlled Trial on Initial Clinical Efficacy and Adherence

Journal of Medical Internet Research ◽

10.2196/17571 ◽

2020 ◽

Vol 22 (7) ◽

pp. e17571

Author(s):

Emilio Goldenhersch ◽

Johannes Thrul ◽

Joaquín Ungaretti ◽

Nicolas Rosencovich ◽

Cristian Waitman ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Virtual Reality ◽

Tobacco Cessation ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Digital Interventions ◽

Pilot Randomized Controlled Trial

Background Obstacles to current tobacco cessation programs include limited access and adherence to effective interventions. Digital interventions offer a great opportunity to overcome these difficulties, yet virtual reality has not been used as a remote and self-administered tool to help increase adherence and effectiveness of digital interventions for tobacco cessation. Objective This study aimed to evaluate participant adherence and smoking cessation outcomes in a pilot randomized controlled trial of the digital intervention Mindcotine (MindCotine Inc) using a self-administered treatment of virtual reality combined with mindfulness. Methods A sample of 120 participants was recruited in the city of Buenos Aires, Argentina (mean age 43.20 years, SD 9.50; 57/120, 47.5% female). Participants were randomly assigned to a treatment group (TG), which received a self-assisted 21-day program based on virtual reality mindful exposure therapy (VR-MET) sessions, daily surveys, and online peer-to-peer support moderated by psychologists, or a control group (CG), which received the online version of the smoking cessation manual from the Argentine Ministry of Health. Follow-up assessments were conducted by online surveys at postintervention and 90-day follow-up. The primary outcome was self-reported abstinence at postintervention, with missing data assumed as still smoking. Secondary outcomes included sustained abstinence at 90-day follow-up, adherence to the program, and readiness to quit. Results Follow-up rates at day 1 were 93% (56/60) for the TG and 100% (60/60) for the CG. At postintervention, the TG reported 23% (14/60) abstinence on that day compared with 5% (3/60) in the CG. This difference was statistically significant (χ21=8.3; P=.004). The TG reported sustained abstinence of 33% (20/60) at 90 days. Since only 20% (12/60) of participants in the CG completed the 90-day follow-up, we did not conduct a statistical comparison between groups at this follow-up time point. Among participants still smoking at postintervention, the TG was significantly more ready to quit compared to the CG (TG: mean 7.71, SD 0.13; CG: mean 7.16, SD 0.13; P=.005). A total of 41% (23/56) of participants completed the treatment in the time frame recommended by the program. Conclusions Results provide initial support for participant adherence to and efficacy of Mindcotine and warrant testing the intervention in a fully powered randomized trial. However, feasibility of trial follow-up assessment procedures for control group participants needs to be improved. Further research is needed on the impact of VR-MET on long-term outcomes. Trial Registration ISRCTN Registry ISRCTN50586181; http://www.isrctn.com/ISRCTN50586181

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A Digital Smoking Cessation Program for Heavy Drinkers: Pilot Randomized Controlled Trial

JMIR Formative Research ◽

10.2196/formative.7570 ◽

2020 ◽

Vol 4 (6) ◽

pp. e7570 ◽

Cited By ~ 1

Author(s):

Christopher W Kahler ◽

Amy M Cohn ◽

Catherine Costantino ◽

Benjamin A Toll ◽

Nichea S Spillane ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Text Messaging ◽

Controlled Trial ◽

Text Messages ◽

Smoking Cessation Program ◽

Web Based ◽

Randomized Controlled ◽

To Receive ◽

Pilot Randomized Controlled Trial

Background Heavy drinking (HD) is far more common among smokers compared with nonsmokers and interferes with successful smoking cessation. Alcohol-focused smoking cessation interventions delivered by counselors have shown promise, but digital versions of these interventions—which could have far greater population reach—have not yet been tested. Objective This pilot randomized controlled trial aimed to examine the feasibility, acceptability, and effect sizes of an automated digital smoking cessation program that specifically addresses HD using an interactive web-based intervention with an optional text messaging component. Methods Participants (83/119, 69.7% female; 98/119, 82.4% white; mean age 38.0 years) were daily smokers recruited on the web from a free automated digital smoking cessation program (BecomeAnEX.org, EX) who met the criteria for HD: women drinking 8+ drinks/week or 4+ drinks on any day and men drinking 15+ drinks/week or 5+ drinks on any day. Participants were randomized to receive EX with standard content (EX-S) or an EX with additional content specific to HD (EX-HD). Outcomes were assessed by web-based surveys at 1 and 6 months. Results Participants reported high satisfaction with the website and the optional text messaging component. Total engagement with both EX-S and EX-HD was modest, with participants visiting the website a median of 2 times, and 52.9% of the participants enrolled to receive text messages. Participants in both the conditions showed substantial, significant reductions in drinking across 6 months of follow-up, with no condition effects observed. Although smoking outcomes tended to favor EX-HD, the condition effects were small and nonsignificant. A significantly smaller proportion of participants in EX-HD reported having a lapse back to smoking when drinking alcohol (7/58, 16%) compared with those in EX-S (18/61, 41%; χ21=6.2; P=.01). Conclusions This is the first trial to examine a digital smoking cessation program tailored to HD smokers. The results provide some initial evidence that delivering such a program is feasible and may reduce the risk of alcohol-involved smoking lapses. However, increasing engagement in this and other web-based interventions is a crucial challenge to address in future work. Trial Registration ClinicalTrials.gov NCT03068611; https://clinicaltrials.gov/ct2/show/NCT03068611

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Virtual Reality Smartphone-Based Intervention for Smoking Cessation: Pilot Randomized Controlled Trial on Initial Clinical Efficacy and Adherence (Preprint)

10.2196/preprints.17571 ◽

2019 ◽

Author(s):

Emilio Goldenhersch ◽

Johannes Thrul ◽

Joaquín Ungaretti ◽

Nicolas Rosencovich ◽

Cristian Waitman ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Virtual Reality ◽

Tobacco Cessation ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Digital Interventions ◽

Pilot Randomized Controlled Trial

BACKGROUND Obstacles to current tobacco cessation programs include limited access and adherence to effective interventions. Digital interventions offer a great opportunity to overcome these difficulties, yet virtual reality has not been used as a remote and self-administered tool to help increase adherence and effectiveness of digital interventions for tobacco cessation. OBJECTIVE This study aimed to evaluate participant adherence and smoking cessation outcomes in a pilot randomized controlled trial of the digital intervention Mindcotine (MindCotine Inc) using a self-administered treatment of virtual reality combined with mindfulness. METHODS A sample of 120 participants was recruited in the city of Buenos Aires, Argentina (mean age 43.20 years, SD 9.50; 57/120, 47.5% female). Participants were randomly assigned to a treatment group (TG), which received a self-assisted 21-day program based on virtual reality mindful exposure therapy (VR-MET) sessions, daily surveys, and online peer-to-peer support moderated by psychologists, or a control group (CG), which received the online version of the smoking cessation manual from the Argentine Ministry of Health. Follow-up assessments were conducted by online surveys at postintervention and 90-day follow-up. The primary outcome was self-reported abstinence at postintervention, with missing data assumed as still smoking. Secondary outcomes included sustained abstinence at 90-day follow-up, adherence to the program, and readiness to quit. RESULTS Follow-up rates at day 1 were 93% (56/60) for the TG and 100% (60/60) for the CG. At postintervention, the TG reported 23% (14/60) abstinence on that day compared with 5% (3/60) in the CG. This difference was statistically significant (χ21=8.3; P=.004). The TG reported sustained abstinence of 33% (20/60) at 90 days. Since only 20% (12/60) of participants in the CG completed the 90-day follow-up, we did not conduct a statistical comparison between groups at this follow-up time point. Among participants still smoking at postintervention, the TG was significantly more ready to quit compared to the CG (TG: mean 7.71, SD 0.13; CG: mean 7.16, SD 0.13; P=.005). A total of 41% (23/56) of participants completed the treatment in the time frame recommended by the program. CONCLUSIONS Results provide initial support for participant adherence to and efficacy of Mindcotine and warrant testing the intervention in a fully powered randomized trial. However, feasibility of trial follow-up assessment procedures for control group participants needs to be improved. Further research is needed on the impact of VR-MET on long-term outcomes. CLINICALTRIAL ISRCTN Registry ISRCTN50586181; http://www.isrctn.com/ISRCTN50586181

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A pilot randomized controlled trial of a tailored smoking cessation program for people living with HIV in the Washington, D.C. metropolitan area

BMC Research Notes ◽

10.1186/s13104-020-05417-3 ◽

2021 ◽

Vol 14 (1) ◽

Author(s):

Elexis C. Kierstead ◽

Emily Harvey ◽

Denisse Sanchez ◽

Kimberly Horn ◽

Lorien C. Abroms ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Self Efficacy ◽

Text Messaging ◽

Controlled Trial ◽

P Value ◽

People Living With Hiv ◽

Randomized Controlled ◽

Living With Hiv ◽

Pilot Randomized Controlled Trial

Abstract Objective Morbidity and mortality from smoking-related diseases among people living with HIV (PLWH) in the U.S. surpasses that due to HIV itself. Conventional smoking cessation treatments have not demonstrated strong efficacy among PLWH. We conducted a pilot randomized controlled trial (RCT) to evaluate a tailored smoking cessation intervention based on the minority stress model. We compared standard of care counseling (SOC) to a tailored intervention (TI) including one face-to-face counseling session incorporating cognitive behavioral therapy to build resilience, and 30 days of 2-way text messaging. Results The primary outcome was smoking cessation. Secondary outcomes included cigarettes per day (CPD), exhaled carbon monoxide (CO), and cessation self-efficacy. A total of 25 participants were enrolled (TI:11, SOC:14), and 2 were lost to follow-up. There were no significant differences in quit rates between study groups. However, there was a significantly greater decrease in CPD in the TI versus SOC (13.5 vs. 0.0, p-value:0.036). Additionally, self-efficacy increased in both groups (TI p-value:0.012, SOC p-value:0.049) and CO decreased in both groups (TI p-value: < 0.001, SOC p-value:0.049). This intervention shows promise to support smoking cessation among PLWH. A larger study is needed to fully evaluate the efficacy of this approach. Clinical trial: Trial Registration: Retrospectively registered (10/20/2020) NCT04594109.

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