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

Smoking Cessation Clinical Trial

— Imagery  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02972515
• Other study ID #: 1R21CA174639
• Secondary ID: 1R21CA174639
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 30, 2016

Study information

• Verified date: November 2016
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: December 30, 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria include the following:

• 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

Exclusion Criteria including the following:

• 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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• See Me Smoke-Free
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.

Device:
• Smart phone
See Me Smoke-Free mHealth app delivered via a smart phone

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Arizona	National Cancer Institute (NCI), West Virginia University

References & Publications (2)

Armin J.S., Cunningham J.K., Giacobbi P., Hingle M., Johnson T., & Gordon J.S. (2016). Development of a Multibehavioral mHealth app for Women Smokers. Journal of Health Communication. DOI: 10.1080/10810730.2016.1256454.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Reporting Smoking Abstinence	Self-reported smoking abstinence will be collected via online questionnaire at 3-months post-enrollment.	3 months
Secondary	Weekly Minutes of Exercise	Self-reported level of moderate to strenuous physical activity will be collected via online questionnaire at 3-months post-enrollment.	3 months
Secondary	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.	3 months
Secondary	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.	Collected throughout each day for up to 90 days