Smoking Cessation Clinical Trial
Official title:
Mobile Application for Guided Imagery to Address Smoking, Diet and Physical Activity
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.
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.
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