HealthyCells App for Smoking Cessation

(HC Trial)

Overseen By Ashley Krukowski, MPA, CRA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Must be taking: NRT

Disqualifiers: Non-English speakers, Non-U.S. residents, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new smartphone app called HealthyCells, designed to help African American smokers quit smoking and become more active. The app sends motivational messages and reminders to move around after prolonged inactivity. It provides support through real-time updates, rewards for not smoking, and personalized tips. Participants should be African American, smoke at least five cigarettes daily, and be ready to quit within the next three weeks. As an unphased trial, this study offers a unique opportunity to participate in innovative research that could significantly improve health outcomes for African American smokers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must be willing to use nicotine replacement therapy (NRT) as part of the study.

What prior data suggests that the HealthyCells app is safe for smoking cessation?

Research has shown that similar smartphone apps for quitting smoking, such as CureApp, have not reported specific negative effects, suggesting these apps are generally safe to use. Although direct safety data for the HealthyCells app is not yet available, past studies on smartphone tools for quitting smoking have not shown harmful effects. These apps assist users in quitting by sending motivational messages and reminders to stay active.

If the HealthyCells app resembles other smoking cessation apps, it is likely safe for users. The absence of reported negative effects in similar apps supports this idea. However, since this trial is still in the early stages, direct evidence about its safety remains limited. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HealthyCells app for smoking cessation because it offers a fresh approach to quitting smoking by integrating technology in a way that current options do not. Unlike standard treatments like nicotine replacement therapies or medications, HealthyCells uses facial recognition and a breath sample device to verify smoking status, adding a layer of accountability. It also incorporates a smartwatch to track daily movements and send prompts to reduce sedentary behavior, promoting overall health. Additionally, motivational messages for both smoking cessation and physical activity are delivered twice daily, providing consistent encouragement and support for users striving to quit smoking and stay active.

What evidence suggests that the HealthyCells app is effective for smoking cessation?

Research shows that the HealthyCells app, which participants in this trial will use, might help people quit smoking. An earlier study found that frequent app users had a higher quit rate of 17.6% compared to 12.9% in a group that didn't use the app. This indicates that those who engaged with the app's activities were more likely to stop smoking. The app sends motivational messages to encourage quitting and increased activity, which appears beneficial. It also includes content specifically designed for African American smokers, potentially enhancing its effectiveness for them. Overall, early evidence suggests it could be a promising tool for quitting smoking. ^{1 6 7 8 9}

Who Is on the Research Team?

Darla Kendzor, PhD

Principal Investigator

TSET Health Promotion Research Center

Are You a Good Fit for This Trial?

This trial is for African American smokers aged 18 or older who smoke at least 5 cigarettes daily. Participants must be willing to use nicotine replacement therapy, a smartphone app and watch, and consult with a smoking cessation counselor. They should plan to quit within the next three weeks, have low physical activity levels, and show evidence of smoking through CO testing.

Inclusion Criteria

I meet the specific requirements to participate in this study.

I identify as Black/African-American.

My CO level was over 6 ppm when I started the app.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Testing

A pilot sample of African American smokers will briefly use the HealthyCells app and provide critical feedback through semi-structured interviews to refine the smartphone intervention.

2 weeks

Treatment

Participants use the HealthyCells app during a scheduled quit attempt, with twice-daily remote smoking status assessments and real-time messages to reduce sedentary behavior.

8 weeks

Follow-up

Participants are monitored for smoking abstinence and changes in sedentary behavior post-treatment.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HealthyCells

Trial Overview

The study tests 'HealthyCells', a culturally tailored smartphone app designed for African American individuals attempting to quit smoking. It integrates existing interventions with new content like messages and videos. The app encourages quitting smoking, rewards abstinence, prompts physical movement after sedentary periods, and offers on-demand resources.

How Is the Trial Designed?

Group I: HealthyCells Experimental Treatment 1 Intervention

The HealthyCells app will have the following features: Smoking status assessments with facial recognition: Participants will initiate a smoking status assessment and CO breath sample submission using the iCOquit® Smokerlyzer® TWICE per day. To verify the participant's identity while they complete their CO breath sample, we will use Microsoft Face API. Daily step counter and sedentary behavior prompts: A Google OS smartwatch will be used to monitor participants' activity, and the HealthyCells app will deliver an activity prompt when they have been sedentary for 30 minutes, which will be experienced as noise and vibration on the phone and watch. Also, a text-based reminder message will appear on the phone and watch along with a "personalized tip" for reducing sedentary time. Motivational messages for smoking cessation and physical activity. TWICE per day, the HealthyCells app will send messages to encourage users to remain quit and become more active.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The study aims to evaluate the effectiveness of the 'CureApp Smoking Cessation' (CASC) app in improving smoking cessation rates among individuals with nicotine dependence, alongside a standard 12-week treatment program, with a total of 580 participants expected to be recruited.

CASC is designed to enhance treatment outcomes by providing personalized support through video tutorials, AI advice, and CO monitoring, and the primary outcome will be the continuous abstinence rate from weeks 9-24, which is anticipated to be significantly higher than that of a control app.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Smoking Cessation Smartphone App Integrated With a Mobile Carbon Monoxide Checker for Smoking Cessation Treatment: Protocol for a Randomized Controlled Trial. Nomura, A., Tateno, H., Masaki, K., et al.[2020]

In a study of 5293 smokers using the Stop-Tabac app, key predictors for successful smoking cessation after six months included tobacco dependence, motivation to quit, and the frequency and perceived usefulness of app use.

For those who quit smoking after one month, relapse after six months was primarily predicted by their intention to quit, app usage frequency, and nicotine medication use, highlighting the importance of ongoing support and motivation in maintaining cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting smoking cessation, reduction and relapse six months after using the Stop-Tabac app for smartphones: a machine learning analysis. Etter, JF., Vera Cruz, G., Khazaal, Y.[2023]

A study of 955 Dutch smokers and ex-smokers found that the intention to use a smoking cessation app is strongly influenced by the number of previous quit attempts and the level of nicotine dependence, rather than demographic factors like age or education.

Personal innovativeness also plays a significant role in users' attitudes toward cessation apps, indicating that app design should focus on addressing the specific needs and experiences of potential users to enhance engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of Users for a Smoking Cessation Mobile App: Quantitative Study. Chevalking, SKL., Ben Allouch, S., Brusse-Keizer, M., et al.[2019]

The STaR smartphone application for smoking cessation received an average quality score of 3.31 and a compliance score of 2.50 on a 5-point scale, indicating it meets some but not all quality standards for smoking cessation support.

The app effectively incorporates key components of smoking cessation guidelines, including the 5A and 5R approaches, suggesting that enhancing its content could further improve its effectiveness in helping users quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of content, quality and compliance of the STaR mobile application for smoking cessation. Regmi, K., Kassim, N., Ahmad, NH., et al.[2020]

The Stop-Tabac app, designed for smoking cessation, is being tested in a large randomized trial with 5200 participants to assess its effectiveness over 6 months, providing personalized support and feedback to users.

This study aims to address the lack of evidence on the impact of health apps for smoking cessation, potentially improving access to support and compliance with nicotine therapy for smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Stop-Tabac smartphone application for smoking cessation: study protocol for a randomized controlled trial in the general population. Etter, JF., Khazaal, Y.[2021]

Mobile health applications are effective tools for helping individuals change their smoking habits, as they provide counseling and motivation for smoking cessation.

The review analyzed 12 studies that highlighted four different technological approaches, demonstrating the versatility and potential of mobile devices in supporting smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation: Services and Applications for Mobile Devices. Kefaliakos, A., Pliakos, I., Chardalias, K., et al.[2018]

The Stop-tabac smartphone application did not significantly increase smoking cessation rates after 6 months compared to a control app, with cessation rates of 9.9% in the Stop-tabac group versus 10.3% in the control group.

However, users of the Stop-tabac app reported a higher usage of nicotine medications (38% vs. 30%) and a greater percentage (26%) felt the app helped them significantly in quitting smoking compared to only 8% in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Stop-tabac smartphone application for smoking cessation: a randomized controlled trial. Etter, JF., Khazaal, Y.[2023]

In a study involving 2806 adult smokers, the e-Tabac Info Service (e-TIS) app did not show a significant difference in smoking cessation rates compared to current practices, with 7-day point prevalence abstinence rates of 12.6% for the app and 13.7% for the control group at 6 months.

However, participants who engaged more with the app (completing at least eight activities) had a higher cessation rate of 17.6% compared to 12.9% in the control group, suggesting that higher engagement with the app may enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the e-Tabac Info Service application for smoking cessation: a pragmatic randomised controlled trial. Affret, A., Luc, A., Baumann, C., et al.[2021]

In a pilot trial involving 76 participants using the 'SmartQuit' smoking cessation app, the most popular features were related to cognitive behavioral therapy (CBT), such as the quit plan and tracking progress.

Only two features, viewing the quit plan and tracking the practice of letting urges pass, were significantly associated with successful quitting, indicating that not all popular features effectively contribute to smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feature-level analysis of a novel smartphone application for smoking cessation. Heffner, JL., Vilardaga, R., Mercer, LD., et al.[2018]

In a study involving 584 participants, the CureApp Smoking Cessation (CASC) system, which includes a smartphone app and a mobile CO checker, significantly improved the continuous abstinence rate (CAR) from smoking compared to a control app, with rates of 63.9% versus 50.5% from weeks 9 to 24.

The CASC system also showed a higher CAR from weeks 9 to 52 (52.3% vs. 41.5%), indicating its effectiveness in supporting long-term smoking cessation without any reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a smoking cessation smartphone application with a carbon monoxide checker. Masaki, K., Tateno, H., Nomura, A., et al.[2023]

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