Trial Outcomes & Findings for Mobile Application for Guided Imagery to Address Smoking, Diet and Physical Activity (NCT NCT02972515)

NCT ID: NCT02972515

Last Updated: 2018-12-19

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

166 participants

Primary outcome timeframe

3 months

Results posted on

2018-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	See Me Smoke-Free Participants received access to the See Me Smoke-Free mobile application (app), 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. 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. Smart phone: See Me Smoke-Free mHealth app delivered via a smart phone
Overall Study STARTED	166
Overall Study COMPLETED	88
Overall Study NOT COMPLETED	78

Reasons for withdrawal

Reasons for withdrawal
Measure	See Me Smoke-Free Participants received access to the See Me Smoke-Free mobile application (app), 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. 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. Smart phone: See Me Smoke-Free mHealth app delivered via a smart phone
Overall Study Lost to Follow-up	78

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	See Me Smoke-Free n=73 Participants Participants received access to the See Me Smoke-Free mobile application (app), 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. 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. Smart phone: See Me Smoke-Free mHealth app delivered via a smart phone
Age, Continuous	39.1 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	73 participants n=5 Participants
Smoked last 30 days	73 Participants n=5 Participants
Cigarettes per day	16.0 Cigarettes per Day STANDARD_DEVIATION 13.2 • n=5 Participants
Weight	169.8 pounds STANDARD_DEVIATION 43.0 • n=5 Participants
Frequency of fruit intake	3.70 servings of fruit per day STANDARD_DEVIATION 1.91 • n=5 Participants
Minutes of Exercise per Day	25.48 Minutes of exercise per day STANDARD_DEVIATION 23.75 • n=5 Participants
Use of any guided imagery	1.77 minutes of any guided imagery daily STANDARD_DEVIATION 1.19 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 63 feasibility participants with both baseline and 3-month data.

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

Outcome measures

Outcome measures
Measure	See Me Smoke-Free n=63 Participants Participants received access to the See Me Smoke-Free mobile application (app), 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. 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. Smart phone: See Me Smoke-Free mHealth app delivered via a smart phone
Number of Participants Reporting Smoking Abstinence	30 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Data analyzed on 60 feasibility participants with both baseline and 3-month data.

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

Outcome measures

Outcome measures
Measure	See Me Smoke-Free n=60 Participants Participants received access to the See Me Smoke-Free mobile application (app), 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. 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. Smart phone: See Me Smoke-Free mHealth app delivered via a smart phone
Weekly Minutes of Exercise	269 minutes of exercise per week Standard Deviation 161

SECONDARY outcome

Timeframe: 3 months

Population: 62 feasibility participants with data from both baseline and follow-up

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

Outcome measures

Outcome measures
Measure	See Me Smoke-Free n=62 Participants Participants received access to the See Me Smoke-Free mobile application (app), 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. 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. Smart phone: See Me Smoke-Free mHealth app delivered via a smart phone
Servings of Fruit Per Day	5.0 servings of fruit per day Standard Deviation 202

SECONDARY outcome

Timeframe: Collected throughout each day for up to 90 days

Population: 62 feasibility participant with both baseline and 3-month data.

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.

Outcome measures

Outcome measures
Measure	See Me Smoke-Free n=62 Participants Participants received access to the See Me Smoke-Free mobile application (app), 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. 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. Smart phone: See Me Smoke-Free mHealth app delivered via a smart phone
Minutes of Guided Imagery Use Per Day	2.7 minutes of guided imagery user per day Standard Deviation 1.2

Adverse Events

See Me Smoke-Free

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Judith Gordon

University of Arizona

Phone: 520-626-4970

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place