Trial Outcomes & Findings for Integrating Use of Self-Affirmation Content Into a Mobile App to Promote Quit Attempts With Text-Based Smoking Cessation Intervention Messaging (NCT NCT03027466)
NCT ID: NCT03027466
Last Updated: 2021-07-23
Results Overview
Participants were asked to report the number of times they attempted to quit smoking at 1 month and 3 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7899 participants
Primary outcome timeframe
1 month and 3 months
Results posted on
2021-07-23
Participant Flow
Participant milestones
| Measure |
Baseline Affirmation and Affirmation Texts
Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study and will receive affirmation text messages throughout the study
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition).Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
Baseline Affirmation and No Affirmation Texts
Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study but will not receive affirmation text messages throughout the study
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
No Baseline Affirmation and Affirmation Texts
Participants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
No Baseline Affirmation and No Affirmation Texts
Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2027
|
1984
|
1903
|
1985
|
|
Overall Study
COMPLETED
|
158
|
165
|
160
|
164
|
|
Overall Study
NOT COMPLETED
|
1869
|
1819
|
1743
|
1821
|
Reasons for withdrawal
| Measure |
Baseline Affirmation and Affirmation Texts
Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study and will receive affirmation text messages throughout the study
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition).Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
Baseline Affirmation and No Affirmation Texts
Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study but will not receive affirmation text messages throughout the study
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
No Baseline Affirmation and Affirmation Texts
Participants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
No Baseline Affirmation and No Affirmation Texts
Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
|---|---|---|---|---|
|
Overall Study
Opting out of the app
|
1869
|
1819
|
1743
|
1821
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Baseline Affirmation and Affirmation Texts
n=2027 Participants
Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study and will receive affirmation text messages throughout the study
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
Baseline Affirmation and No Affirmation Texts
n=1984 Participants
Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study but will not receive affirmation text messages throughout the study
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
No Baseline Affirmation and Affirmation Texts
n=1903 Participants
Participants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
No Baseline Affirmation and No Affirmation Texts
n=1985 Participants
Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
Total
n=7899 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2027 Participants
|
0 Participants
n=1984 Participants
|
0 Participants
n=1903 Participants
|
0 Participants
n=1985 Participants
|
0 Participants
n=7899 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2027 Participants
n=2027 Participants
|
1984 Participants
n=1984 Participants
|
1903 Participants
n=1903 Participants
|
1985 Participants
n=1985 Participants
|
7899 Participants
n=7899 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2027 Participants
|
0 Participants
n=1984 Participants
|
0 Participants
n=1903 Participants
|
0 Participants
n=1985 Participants
|
0 Participants
n=7899 Participants
|
|
Age, Continuous
|
30.6 years
STANDARD_DEVIATION 8.6 • n=2027 Participants
|
30.5 years
STANDARD_DEVIATION 8.6 • n=1984 Participants
|
30.5 years
STANDARD_DEVIATION 8.8 • n=1903 Participants
|
30.5 years
STANDARD_DEVIATION 8.7 • n=1985 Participants
|
30.5 years
STANDARD_DEVIATION 8.7 • n=7899 Participants
|
|
Sex: Female, Male
Female
|
799 Participants
n=2027 Participants
|
759 Participants
n=1984 Participants
|
765 Participants
n=1903 Participants
|
786 Participants
n=1985 Participants
|
3109 Participants
n=7899 Participants
|
|
Sex: Female, Male
Male
|
1228 Participants
n=2027 Participants
|
1225 Participants
n=1984 Participants
|
1138 Participants
n=1903 Participants
|
1199 Participants
n=1985 Participants
|
4790 Participants
n=7899 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
2027 participants
n=2027 Participants
|
1984 participants
n=1984 Participants
|
1903 participants
n=1903 Participants
|
1985 participants
n=1985 Participants
|
7899 participants
n=7899 Participants
|
|
Number of Participants Currently Using Cessation Aid
Yes
|
446 Participants
n=2027 Participants
|
401 Participants
n=1984 Participants
|
434 Participants
n=1903 Participants
|
440 Participants
n=1985 Participants
|
1721 Participants
n=7899 Participants
|
|
Number of Participants Currently Using Cessation Aid
No
|
1581 Participants
n=2027 Participants
|
1583 Participants
n=1984 Participants
|
1469 Participants
n=1903 Participants
|
1545 Participants
n=1985 Participants
|
6178 Participants
n=7899 Participants
|
|
Desire to Smoke
|
3.2 units on a scale
STANDARD_DEVIATION 1.3 • n=2027 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 1.4 • n=1984 Participants
|
3.2 units on a scale
STANDARD_DEVIATION 1.3 • n=1903 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 1.4 • n=1985 Participants
|
3.2 units on a scale
STANDARD_DEVIATION 1.3 • n=7899 Participants
|
|
Quit Attempts in Past Year
|
7.2 Attempts
STANDARD_DEVIATION 22.8 • n=2027 Participants
|
6.5 Attempts
STANDARD_DEVIATION 20.7 • n=1984 Participants
|
6.6 Attempts
STANDARD_DEVIATION 19.6 • n=1903 Participants
|
7.9 Attempts
STANDARD_DEVIATION 27.5 • n=1985 Participants
|
7.9 Attempts
STANDARD_DEVIATION 27.5 • n=7899 Participants
|
PRIMARY outcome
Timeframe: 1 month and 3 monthsParticipants were asked to report the number of times they attempted to quit smoking at 1 month and 3 months.
Outcome measures
| Measure |
Baseline Affirmation and Affirmation Texts
n=2027 Participants
Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study and will receive affirmation text messages throughout the study
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
Baseline Affirmation and No Affirmation Texts
n=1984 Participants
Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study but will not receive affirmation text messages throughout the study
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
No Baseline Affirmation and Affirmation Texts
n=1903 Participants
Participants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
No Baseline Affirmation and No Affirmation Texts
n=1985 Participants
Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
|---|---|---|---|---|
|
Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months
Past Week Cessation at 1 Month
|
142 Participants
|
143 Participants
|
139 Participants
|
145 Participants
|
|
Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months
Past Month Cessation at 1 Month
|
114 Participants
|
128 Participants
|
128 Participants
|
133 Participants
|
|
Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months
Past Week Cessation at 3 Months
|
54 Participants
|
58 Participants
|
55 Participants
|
48 Participants
|
|
Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months
Past Month Cessation at 3 Months
|
46 Participants
|
49 Participants
|
48 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: 1 month and 3 months follow-upPopulation: This outcome measure was not done because there was too little variability, and the data could not be analyzed due to high levels of attrition. The former Principal Investigator left the institute and no data are available or will ever become available for this Outcome.
Participants were asked the number of days they have remained smoke-free at the 1 and 3 month follow-up.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month and 3 months follow-upPopulation: This outcome measure was not done because type of tobacco products were not collected from participants at 1 month and 3 months follow-up.
Participants will be asked the type of tobacco products they use at the 1 and 3 month follow-up.
Outcome measures
Outcome data not reported
Adverse Events
Baseline Affirmation and Affirmation Texts
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Baseline Affirmation and No Affirmation Texts
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Baseline Affirmation and Affirmation Texts
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Baseline Affirmation and No Affirmation Texts
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place