AzTrials
AzTrials

Smoking CessationImageryNCT02972515

Mobile Application for Guided Imagery to Address Smoking, Diet and Physical Activity

A study testing See Me Smoke-Free and Smart phone in people with Smoking Cessation, run by University of Arizona.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Tobacco use among women now approaches that of men, with approximately 27 million women smokers in the United States alone. Women report greater difficulties quitting smoking and are more likely to relapse than men. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
See Me Smoke-Free and Smart phone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
No sites listed yet
Study dates
Jan 2013to 30 Dec 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Must be female
  • Report smoking in the past 30 days
  • Use an Android cell phone
  • Have a valid email address
  • Have a valid phone number
  • Speak English

Who cannot join

  • Male
  • Not a current smoker
  • Do not use an Android cell phone
  • Do not have a valid email address
  • Do not have a valid phone number
  • Do not speak English

About this study

Tobacco use among women now approaches that of men, with approximately 27 million women smokers in the United States alone. Women report greater difficulties quitting smoking and are more likely to relapse than men. In addition, tobacco use co-varies with poor dietary practices and lack of physical activity, with 92% of smokers reporting at least one other health risk factor. Concerns surrounding weight gain, negative body image, and low self-efficacy, may be key factors affecting smoking cessation among weight-concerned women smokers. Guided imagery has been successfully employed in separate lines of inquiry to address physical activity, diet and smoking cessation. However, guided imagery has not been employed to target weight concerned women who smoke or to simultaneously target smoking, diet, and exercise behavior in a single intervention. The proposed study would be the first of its kind to create a theory-based, guided imagery intervention to assist weight-concerned women smokers to quit. The use of a mobile app offers an innovative approach to addressing the multiple behaviors involved in smoking cessation efforts of weight-concerned women, and has the potential to reach large numbers of women smokers. The project aims to develop and test the feasibility of a mobile health application using guided imagery in order to increase smoking cessation among a population of weight-concerned women smokers.

Read the detailed description

SPECIFIC AIMS Tobacco use among women now approaches that of men, with approximately 27 million women smokers in the United States alone. Lung cancer is the leading cause of cancer death among women, and more than 180,000 women die of other illnesses linked to smoking annually. Women report greater difficulties quitting smoking and are more likely to relapse than men. In addition, tobacco use co-varies with poor dietary practices and lack of physical activity, with 92% of smokers reporting at least one other health risk factor. The presence of multiple behavioral risk factors greatly increases the risk of developing many acute and chronic conditions.

Concerns about weight gain, negative body image, and lack of self-efficacy may be key factors affecting smoking, diet, and exercise behavior of women. Women smokers are less satisfied with their bodies, have lower self-esteem, and are more concerned about becoming overweight than non-smokers. Approximately 50% of women smokers report that concerns about body weight are reasons they do not quit. Research indicates that women report lower self-efficacy in quitting than men, especially women concerned about controlling their weight. These findings suggest that targeting weight concerns, body image, and self-efficacy to quit with weight-concerned women who smoke may be an effective intervention strategy. Recent studies suggest that a multi-behavioral approach, including diet and physical activity, may be more effective at helping weight-concerned smokers to quit.

One cognitive approach, guided imagery, has been successfully employed in separate lines of inquiry to address body image concerns and self-efficacy in our three target behaviors-exercise, diet and smoking cessation. However, guided imagery has not been employed to target weight concerned women who smoke or to simultaneously target smoking, diet, and exercise behavior in a single intervention. The proposed study would be the first of its kind to create a theory-based, guided imagery intervention to assist weight-concerned women smokers to quit.

While imagery is an effective therapeutic tool for behavior change, the mode of delivery has generally been in-person, limiting the dissemination of guided imagery-based interventions to large populations. Mobile health applications (mobile apps) delivered via smart phones offer a unique channel through which to distribute imagery-based interventions. Mobile apps may enhance the use of guided imagery through the use of audio files. The app may allow guided imagery scripts to be tailored by the user, and flexibly administered at varying times (e.g., during nicotine cravings). This approach could be especially useful for women, who are more likely than men to use the Internet to obtain health information. The use of a mobile app offers an innovative approach to addressing the multiple behaviors involved in smoking cessation efforts of weight-concerned women, and has the potential to reach large numbers of women smokers. If successful, a mobile application for guided imagery could be used to address other health behaviors as well. The present project aims to develop and test the feasibility of a mobile health application using guided imagery in order to increase smoking cessation among weight-concerned women smokers.

The Specific Aims for this study are to:

Aim 1. Develop guided imagery content, user interface, and resources to reduce weight concern, and increase body image and self-efficacy for behavior change among weight-concerned women smokers. Scripts incorporating imagery across these domains will be developed specifically for smoking cessation, eating a healthy diet and engaging in physical activity. The investigators will develop initial content and user interface ideas based on experience in using guided imagery for increasing physical activity, and using technology to assist tobacco cessation and healthy eating. Ten focus group participants (weight-concerned women smokers who own a smart phone, representing various racial/ethnic groups) will provide feedback on content, potential tailoring of content by race/ethnicity, functions, and design, which will inform development of the mobile app.

Aim 2. Program a prototype of the app that contains all the necessary elements of text, graphics, multimedia and interactive features. Users will be able to customize certain elements of the application, and be required to provide input in response to app prompts. The investigators will conduct usability testing, observing 10 participants using "think aloud" procedures as they interact with the app, to ensure that it is fully functional and easy to use.

Aim 3. Evaluate the feasibility, acceptability, and preliminary efficacy of the app with 50 weight-concerned women smokers. The primary outcome will be self-reported tobacco abstinence at 3 months post-enrollment. The investigators will also measure: dietary intake; level of physical activity; body image; self-efficacy; cravings; and participants' use of the app, including the imagery scripts, diary, and resource links.

The potential impact of this proposed intervention is great, because it addresses behavioral risk factors that can be applied to populations beyond smokers. This proposal is significant because it intervenes with women smokers; innovative, in that it uses guided imagery to change lifestyle behaviors important for the prevention of chronic diseases, and, technology to maximize dissemination potential. The proposed investigation takes a theory-based approach, builds on the considerable track records of the investigators, and will be conducted in an environment highly suited for this study. Results of this study will be used to prepare for a future randomized controlled trial to test the efficacy and cost-effectiveness of a multi-behavioral, guided imagery mobile health application versus a single smoking cessation imagery mobile health application.

Being tested
See Me Smoke-Free, Smart phone
Keywords
Smoking, Smoking cessation, Multiple behaviors, mHealth, Mobile Application
Medical subject headings
Smoking Cessation, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • See Me Smoke-FreeBehavioural

    See Me Smoke-Free is a multi-behavioral mobile application focusing on increasing smoking cessation, healthy eating, and moderate to intense physical activity. The app tracks the participant's quit date, and eating/physical activity goals. Participants have access to guided imagery audio files that they are instructed to listen to every day for at least 30 days. Participants can earn awards for meeting the study goals.

  • Smart phoneDevice

    See Me Smoke-Free mHealth app delivered via a smart phone

Study groups in NCT02972515
Study groupRoleWhat they receive
See Me Smoke-FreeExperimentalParticipants received access to the See Me Smoke-Free mobile application (app) delivered via smart phone, and were asked to use the app "most days" for 30 days post-enrollment. The app contained five guided imagery audio files (Introduction to Guided Imagery, Be Smoke Free, Eat Well, Get Active, and Feel Fantastic), a tracking calendar, awards, resources, reminders, and tips and techniques.
Receives: Behavioral: See Me Smoke-Free; Device: Smart phone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Reporting Smoking Abstinence

    Self-reported smoking abstinence will be collected via online questionnaire at 3-months post-enrollment.

    Measured: 3 months

Secondary outcomes (3)
  1. Weekly Minutes of Exercise

    Self-reported level of moderate to strenuous physical activity will be collected via online questionnaire at 3-months post-enrollment.

    Measured: 3 months

  2. Servings of Fruit Per Day

    Self-reported consumption of servings of fruits per day will be collected via online questionnaire at 3-months post-enrollment.

    Measured: 3 months

  3. Minutes of Guided Imagery Use Per Day

    Interaction with the mHealth app will be measured automatically and unobtrusively by the app on an on-going basis. The app will collect the number of minutes per day that the guided imagery audio files are listened to.

    Measured: Collected throughout each day for up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2016 (estimated)
  2. Study startJan 2013
  3. Primary completionDec 2015
  4. Study completion30 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02972515
Sponsor's protocol ID
1R21CA174639
Other IDs
1R21CA174639
Acronym
Imagery
Status last verified
Nov 2016
First submitted
16 Nov 2016
Last updated
19 Dec 2018
Data monitoring committee
No
Individual data sharing
No

Publications

  • Giacobbi P Jr, Hingle M, Johnson T, Cunningham JK, Armin J, Gordon JS. See Me Smoke-Free: Protocol for a Research Study to Develop and Test the Feasibility of an mHealth App for Women to Address Smoking, Diet, and Physical Activity. JMIR Res Protoc. 2016 Jan 21;5(1):e12. doi: 10.2196/resprot.5126.

    PubMed 26795257
  • Armin J, Johnson T, Hingle M, Giacobbi P Jr, Gordon JS. Development of a Multi-Behavioral mHealth App for Women Smokers. J Health Commun. 2017 Feb;22(2):153-162. doi: 10.1080/10810730.2016.1256454. Epub 2017 Jan 25.

    PubMed 28121240

Questions about this trial

What is this clinical trial studying?

A study testing See Me Smoke-Free and Smart phone in people with Smoking Cessation, run by University of Arizona.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting Smoking Abstinence (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02972515, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in