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

Trial Summary

What is the purpose of this trial?

The overall objectives of this research proposal, are to (a) create a smartphone application for smoking cessation (i.e., HealthyCells), which will be achieved by integrating two pre-existing evidence-based smartphone interventions, (b) create culturally tailored treatment content (i.e., messages, images, and videos) for African American smokers, and (c) evaluate the feasibility of HealthyCells at addressing smoking and sedentary behavior among African Americans. A pilot sample of African American smokers (N = 15) will briefly use the HealthyCells app and provide critical feedback through semi-structured interviews to refine the smartphone intervention. Once the HealthyCells app is refined, African Americans (N = 30) who are interested in quitting smoking will use the app during a scheduled quit attempt. Starting on the scheduled quit date, HealthyCells will prompt participants to complete twice-daily remote smoking status assessments to earn rewards for abstinence. The app will deliver real-time messages telling participants to stand up and move around during prolonged bouts of sedentary behavior (i.e., ≥ 30 minutes of uninterrupted time spent in a sitting, reclining, or lying posture). Participants will also have on-demand access to culturally tailored information and strategies for remaining abstinent and reducing sedentary behavior within the HealthyCells app. The primary outcomes will be biochemically confirmed point prevalence smoking abstinence at 8 weeks post-quit date, and the difference in sedentary time 7 consecutive days before quitting compared with 7 consecutive days at 8-weeks post-quit, as measured by a research-grade accelerometer.

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 data supports the effectiveness of the HealthyCells treatment for smoking cessation?

Research on similar smartphone apps, like Stop-Tabac and e-Tabac Info Service, shows that these apps can help people quit smoking by providing support and increasing compliance with nicotine therapy. These apps have been tested in studies and shown to improve smoking cessation rates, suggesting that smartphone-based treatments can be effective. ^{1 2 3 4 5}

Is the HealthyCells app safe for smoking cessation?

In a study of a similar app called CureApp Smoking Cessation, no specific adverse events were reported, suggesting it is generally safe for use in humans. ^{3 5 6 7 8}

How is the HealthyCells app treatment for smoking cessation different from other treatments?

The HealthyCells app is unique because it leverages mobile technology to provide personalized support and motivation for quitting smoking, unlike traditional methods that may rely on medication or in-person counseling. This app-based approach can reach a wide audience and offers a convenient, accessible way to support smoking cessation efforts. ^{5 6 8 9 10}

Research Team

Darla Kendzor, PhD

Principal Investigator

TSET Health Promotion Research Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of the e-Tabac Info Service application for smoking cessation: a pragmatic randomised controlled trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The Stop-tabac smartphone application for smoking cessation: a randomized controlled trial. [2023]

3. Canada 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. [2020]

4. England 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. [2023]

5. England pubmed.ncbi.nlm.nih.gov

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

6. Canada pubmed.ncbi.nlm.nih.gov

Identification of Users for a Smoking Cessation Mobile App: Quantitative Study. [2019]

7. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a smoking cessation smartphone application with a carbon monoxide checker. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Smoking Cessation: Services and Applications for Mobile Devices. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Feature-level analysis of a novel smartphone application for smoking cessation. [2018]

10. Greece pubmed.ncbi.nlm.nih.gov

Assessment of content, quality and compliance of the STaR mobile application for smoking cessation. [2020]