Trial Outcomes & Findings for SmokefreeSGM, A Text-based Smoking Cessation Intervention for Sexual and Gender Minority Groups (NCT NCT05029362)
NCT ID: NCT05029362
Last Updated: 2025-07-20
Results Overview
The 10-item System Usability Scale (SUS) was used to assess the usability of the SmokefreeSGM text messaging program. Total score ranges from 0 to 100, with a higher score indicating greater acceptability and a score above 75 indicating that the program is perceived as acceptable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
1 month after quit date
Results posted on
2025-07-20
Participant Flow
Participant milestones
| Measure |
Beta Testing Group
SmokefreeSGM: Participants will have access to a text-based smoking cessation program tailored to sexual minority individuals (SmokefreeSGM). The text-based program will be beta-tested by these participants for a period of 2 weeks before and 10 weeks after their quit date. Messages originated from the text-based smoking cessation program will be sent by a fictitious quit coach who will offer evidence-based advice on quitting smoking based on real-life experiences of sexual minority individuals.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Beta Testing Group
SmokefreeSGM: Participants will have access to a text-based smoking cessation program tailored to sexual minority individuals (SmokefreeSGM). The text-based program will be beta-tested by these participants for a period of 2 weeks before and 10 weeks after their quit date. Messages originated from the text-based smoking cessation program will be sent by a fictitious quit coach who will offer evidence-based advice on quitting smoking based on real-life experiences of sexual minority individuals.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
Baseline Characteristics
SmokefreeSGM, A Text-based Smoking Cessation Intervention for Sexual and Gender Minority Groups
Baseline characteristics by cohort
| Measure |
Beta Testing Group
n=18 Participants
SmokefreeSGM: Participants will have access to a text-based smoking cessation program tailored to sexual minority individuals (SmokefreeSGM). The text-based program will be beta-tested by these participants for a period of 2 weeks before and 10 weeks after their quit date. Messages originated from the text-based smoking cessation program will be sent by a fictitious quit coach who will offer evidence-based advice on quitting smoking based on real-life experiences of sexual minority individuals.
|
|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 12.16 • n=99 Participants
|
|
Sex/Gender, Customized
Male
|
7 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Female
|
7 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Nonbinary, genderfluid, or genderqueer
|
4 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
9 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Other
|
2 Participants
n=99 Participants
|
|
Sexual Orientation
Lesbian/gay woman/Women who have sex with women
|
2 Participants
n=99 Participants
|
|
Sexual Orientation
Gay man/Men who have sex with men
|
5 Participants
n=99 Participants
|
|
Sexual Orientation
Bisexual female
|
5 Participants
n=99 Participants
|
|
Sexual Orientation
Bisexual Male
|
3 Participants
n=99 Participants
|
|
Sexual Orientation
Other
|
3 Participants
n=99 Participants
|
|
Work Status
Not working
|
1 Participants
n=99 Participants
|
|
Work Status
Working full time
|
13 Participants
n=99 Participants
|
|
Work Status
Working part-time
|
4 Participants
n=99 Participants
|
|
Education
Some college or less
|
13 Participants
n=99 Participants
|
|
Education
College or higher
|
5 Participants
n=99 Participants
|
|
Marital status
Single/separated/divorced/widowed
|
17 Participants
n=99 Participants
|
|
Marital status
married/living with significant other
|
1 Participants
n=99 Participants
|
|
Children in household
Yes
|
3 Participants
n=99 Participants
|
|
Children in household
No
|
15 Participants
n=99 Participants
|
|
Age at which participant first smoked
|
14.8 years
STANDARD_DEVIATION 2.96 • n=99 Participants
|
|
Number of Participants who live with other smokers
|
2 Participants
n=99 Participants
|
|
Number of times participants tried to quit smoking
More than 5 times
|
8 Participants
n=99 Participants
|
|
Number of times participants tried to quit smoking
Between 1 and 5 times
|
9 Participants
n=99 Participants
|
|
Number of times participants tried to quit smoking
Never
|
1 Participants
n=99 Participants
|
|
Nicotine dependence as assessed by the Fagerstrom Test for Nicotine Dependence
high dependence on nicotine
|
5 Participants
n=99 Participants
|
|
Nicotine dependence as assessed by the Fagerstrom Test for Nicotine Dependence
moderate dependence
|
7 Participants
n=99 Participants
|
|
Nicotine dependence as assessed by the Fagerstrom Test for Nicotine Dependence
low dependence
|
6 Participants
n=99 Participants
|
|
Level of Smoking
Heavy smoker (>10 cigarettes per day)
|
7 Participants
n=99 Participants
|
|
Level of Smoking
Light smoker (less than or equal to 10 cigarettes per day)
|
11 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 month after quit dateThe 10-item System Usability Scale (SUS) was used to assess the usability of the SmokefreeSGM text messaging program. Total score ranges from 0 to 100, with a higher score indicating greater acceptability and a score above 75 indicating that the program is perceived as acceptable.
Outcome measures
| Measure |
Beta Testing Group
n=9 Participants
SmokefreeSGM: Participants will have access to a text-based smoking cessation program tailored to sexual minority individuals (SmokefreeSGM). The text-based program will be beta-tested by these participants for a period of 2 weeks before and 10 weeks after their quit date. Messages originated from the text-based smoking cessation program will be sent by a fictitious quit coach who will offer evidence-based advice on quitting smoking based on real-life experiences of sexual minority individuals.
|
|---|---|
|
Perceived Usability as Assessed by the System Usability Scale (SUS)
|
81.67 score on a scale
Standard Deviation 15.46
|
SECONDARY outcome
Timeframe: 1 month after enrollmentA participant's engagement rate was determined by dividing the total number of participant responses to the bidirectional text messages (numerator) by the total number of bidirectional text messages sent by the text-based platform (denominator). Participants who had rates ≤33.3% were classified as having low engagement, 33.3-66.6% moderate engagement, and ≥66.7% high engagement. Data are reported categorically as number of participants who have low, moderate, or high engagement.
Outcome measures
| Measure |
Beta Testing Group
n=18 Participants
SmokefreeSGM: Participants will have access to a text-based smoking cessation program tailored to sexual minority individuals (SmokefreeSGM). The text-based program will be beta-tested by these participants for a period of 2 weeks before and 10 weeks after their quit date. Messages originated from the text-based smoking cessation program will be sent by a fictitious quit coach who will offer evidence-based advice on quitting smoking based on real-life experiences of sexual minority individuals.
|
|---|---|
|
Engagement as Assessed by the Number of Text Messages Sent and Received by Study Participants After Enrollment.
moderate engagement
|
3 Participants
|
|
Engagement as Assessed by the Number of Text Messages Sent and Received by Study Participants After Enrollment.
high engagement
|
10 Participants
|
|
Engagement as Assessed by the Number of Text Messages Sent and Received by Study Participants After Enrollment.
Low engagement
|
5 Participants
|
Adverse Events
Beta Testing Group
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
Irene Tami-Maury, DMD, MSc, DrPH
The University of Texas Health Science Center at Houston
Phone: (713) 500-9234
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place