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CompletedNCT02972515ImageryUpdated Dec 19, 2018Results posted

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

An interventional study of See Me Smoke-Free and Smart phone in Smoking Cessation, sponsored by University of Arizona. Completed. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-19.

Sponsored by University of Arizona · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
166
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Smoking Cessation

Keywords

  • Smoking
  • Smoking cessation
  • Multiple behaviors
  • mHealth
  • Mobile Application
03

In context

Lead sponsor

University of Arizona is the lead sponsor of 466 studies on the registry; 87 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
166 participants (actual)

Study arms

  • Experimental
    See Me Smoke-Free

    Participants 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.

    Behavioral: See Me Smoke-Free · Device: Smart phone

Interventions

  • BehavioralSee 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.

  • DeviceSmart phone

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

06

What researchers measure

Primary outcomes

  1. Number of Participants Reporting Smoking Abstinence

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

    Time frame: 3 months

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Collected throughout each day for up to 90 days

07

Results

Posted Dec 19, 2018

Participant flow

Participant flow — Overall Study
MilestoneSee Me Smoke-Free
Started166
Completed88
Not completed78
Withdrew: Lost to follow-up78

Outcome measures

PrimaryNumber of Participants Reporting Smoking Abstinence

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

Time frame:
3 months
Reported as:
Count of participants · Participants
Number of Participants Reporting Smoking Abstinence
ParticipantsSee Me Smoke-Free
Number of Participants Reporting Smoking Abstinence30
SecondaryWeekly Minutes of Exercise

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

Time frame:
3 months
Reported as:
Mean · minutes of exercise per week
Weekly Minutes of Exercise
minutes of exercise per weekSee Me Smoke-Free
Weekly Minutes of Exercise269 ± 161
SecondaryServings of Fruit Per Day

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

Time frame:
3 months
Reported as:
Mean · servings of fruit per day
Servings of Fruit Per Day
servings of fruit per daySee Me Smoke-Free
Servings of Fruit Per Day5.0 ± 202
SecondaryMinutes 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.

Time frame:
Collected throughout each day for up to 90 days
Reported as:
Mean · minutes of guided imagery user per day
Minutes of Guided Imagery Use Per Day
minutes of guided imagery user per daySee Me Smoke-Free
Minutes of Guided Imagery Use Per Day2.7 ± 1.2

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
See Me Smoke-Free0/73 (0%)0/73 (0%)0/73 (0%)

Baseline characteristics

Data reported for 73 participants who completed the feasibility trial. These data do not include participants from the formative phase of the study or those lost to follow-up.

Age, Continuous
Age, Continuous(years)See Me Smoke-Free
Mean39.1 ± 13.1
Sex: Female, Male
Sex: Female, Male(Participants)See Me Smoke-Free
Female73
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)See Me Smoke-Free
Hispanic or Latino6
Not Hispanic or Latino64
Unknown or Not Reported3
Race (NIH/OMB)
Race (NIH/OMB)(Participants)See Me Smoke-Free
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American12
White53
More than one race3
Unknown or Not Reported4
Region of Enrollment
Region of Enrollment(participants)See Me Smoke-Free
United States73
Smoked last 30 days
Smoked last 30 days(Participants)See Me Smoke-Free
Count of participants73
Cigarettes per day
Cigarettes per day(Cigarettes per Day)See Me Smoke-Free
Mean16.0 ± 13.2
Weight
Weight(pounds)See Me Smoke-Free
Mean169.8 ± 43.0

3 further baseline measures are reported on the registry.

08

Study locations

No study locations are listed for this record.

09

References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02972515
Lead sponsor
University of Arizona
Collaborators
West Virginia University, National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Nov 23, 2016
Start date
Jan 2013
Primary completion
Dec 2015
Completion
Dec 30, 2016
Results posted
Dec 19, 2018
Last update
Dec 19, 2018

Study contacts

Judith Gordon, PhD
principal investigator · University of Arizona

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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