800 Participants NeededMy employer runs this trial

mHealth Intervention for Smoking

(GEMS Trial)

JB
AC
Overseen ByAnna C Edelmann, MScN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Kaiser Permanente
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which of two mHealth app-based programs better helps people change their smoking habits. Participants will use an app designed to support quitting smoking, with one version offering extra help for those not ready to quit yet. The researchers believe that the enhanced app might lead to more people seeking additional resources and reporting positive changes in their smoking behavior. Ideal candidates for this study smoke at least half a pack a day, feel unsure about quitting, and regularly use a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could shape future smoking cessation tools.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does require that you are not actively using any treatment to quit smoking.

What prior data suggests that these smoking cessation programs are safe?

Research has shown that mobile health (mHealth) apps can safely and effectively help people quit smoking. Studies have found that these apps increase the chances of quitting and promote healthier habits. For example, one study found that people using a smoking cessation app were more likely to quit smoking after using it for 4 to 26 weeks. Another study showed that apps with digital peer support led to high rates of people reporting they had quit smoking after 12 weeks.

No significant reports of serious side effects have emerged from using these apps. They are generally well-received because they focus on support and motivation rather than introducing new substances into the body. All features and advice are designed to be safe for users. Overall, mHealth apps are promising tools that can help people quit smoking safely.12345

Why are researchers excited about this trial?

Researchers are excited about this mHealth intervention for smoking cessation because it leverages a study-branded mobile health app, offering a fresh and accessible approach compared to traditional methods like nicotine replacement therapy or prescription medications. While these conventional treatments often rely on physical products or in-person counseling, the mHealth app is designed to be used anytime and anywhere, fitting seamlessly into a user's daily routine. By combining the app with access to other publicly-available, evidence-based interventions, it provides a comprehensive and convenient support system that could enhance users' commitment and success in quitting smoking.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

This trial will compare a Control Intervention with an Experimental Intervention, both using a study-branded mHealth app for smoking cessation. Research has shown that mobile apps can aid in quitting smoking. Studies have found that users of smoking cessation apps, such as the iCanQuit app, are more likely to quit, especially with prolonged use. One study found that these apps are user-friendly and well-received, offering effective support for smoking cessation. Reviews of several studies also highlight that these apps can increase the chances of quitting among smokers. Overall, evidence suggests that mobile health tools hold promise in helping people quit smoking.14678

Are You a Good Fit for This Trial?

This trial is for adults (18+) who currently smoke at least half a pack of cigarettes daily, are unsure about quitting, aren't using any quit-smoking treatments, own and use a smartphone, are willing to install an app and receive study messages, and meet location requirements.

Inclusion Criteria

I currently smoke cigarettes and feel unsure about quitting.
* Not actively using any treatment to quit smoking
* Own and regularly use a smartphone
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive access to a mHealth app and other publicly available stop-smoking resources, with one app version including additional content for those not ready to quit

6 months
Ongoing app engagement

Follow-up

Participants are monitored for smoking abstinence and engagement with smoking cessation resources

6 months
Self-reports and biochemical confirmations at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Control Intervention
  • Experimental Intervention

Trial Overview

The study compares two versions of a stop-smoking mobile app. Both offer standard advice and resources; one version has extra features designed specifically for people not ready to quit smoking. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: ExperimentalExperimental Treatment1 Intervention
Group II: Control InterventionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials
563
Recruited
27,400,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Fred Hutchinson Cancer Center

Collaborator

Trials
583
Recruited
1,341,000+

University of California, Davis

Collaborator

Trials
958
Recruited
4,816,000+

Citations

Smoking Cessation Smartphone App Use Over Time - PMC

There were significantly higher odds of quitting smoking among 4-week users and especially among 26-week users of the iCanQuit app. To improve study outcomes, ...

Development and Usability Study - JMIR mHealth and uHealth

Our study demonstrated that MO is a feasible mobile phone app with high acceptability and usability and can effectively deliver smoking cessation support.

Effectiveness of Mobile Apps for Smoking Cessation

The review of eight selected studies illustrate the use of smartphone applications in increasing quit rates among smokers.

Effectiveness of mobile phone applications for tobacco ...

Our review indicates that mobile phone applications could play a promising role in tobacco cessation.

“Appagalo” a Customized Mobile Health Intervention (mHealth ...

The “Appagalo” app is an effective tool to support smoking cessation in young women. It is a simple mHealth alternative for smoking cessation.

Effectiveness of a Digital Peer-Supported App Intervention in ...

The primary outcome—self-reported smoking abstinence at week 12—was substantially high in the group using both the digital peer-supported app ...

Smoking Cessation Apps: A Systematic Review of Format, ...

Two studies found better abstinence rates in the control group [44,55], and one study found a significant reduction in CPD in both conditions [47]. Concerning ...

Features of mHealth Apps for Tobacco Cessation Important to ...

This study identified preferred features of mHealth apps for tobacco cessation that appeal to Black adults who use tobacco products. While all ...