NCT02972515

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
2 years until next milestone

Results Posted

Study results publicly available

December 19, 2018

Completed
Last Updated

December 19, 2018

Status Verified

November 1, 2016

Enrollment Period

2.9 years

First QC Date

November 16, 2016

Results QC Date

October 9, 2018

Last Update Submit

November 27, 2018

Conditions

Keywords

SmokingSmoking cessationMultiple behaviorsmHealthMobile Application

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Reporting Smoking Abstinence

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

    3 months

Secondary Outcomes (3)

  • Weekly Minutes of Exercise

    3 months

  • Servings of Fruit Per Day

    3 months

  • Minutes of Guided Imagery Use Per Day

    Collected throughout each day for up to 90 days

Study Arms (1)

See Me Smoke-Free

EXPERIMENTAL

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-FreeDevice: Smart phone

Interventions

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.

See Me Smoke-Free

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

See Me Smoke-Free

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 26795257BACKGROUND
  • 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.

    PMID: 28121240BACKGROUND

MeSH Terms

Conditions

Smoking CessationSmoking

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Results Point of Contact

Title
Judith Gordon
Organization
University of Arizona

Study Officials

  • Judith Gordon, PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 23, 2016

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 30, 2016

Last Updated

December 19, 2018

Results First Posted

December 19, 2018

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share