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| ID | Type | Description | Link |
|---|---|---|---|
| 1K22CA237639 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to pretest the design of a text-based smoking cessation program tailored to sexual minority individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beta testing group | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmokefreeSGM | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Usability as Assessed by the System Usability Scale (SUS) | 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. | 1 month after quit date |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement as Assessed by the Number of Text Messages Sent and Received by Study Participants After Enrollment. | A 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. |
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Inclusion Criteria:
Exclusion Criteria:
Self-identified as a lesbian, gay, or bisexual individual
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| Name | Affiliation | Role |
|---|---|---|
| Irene Tami-Maury, DMD, MSc, DrPH | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36485022 | Derived | Tami-Maury I, Klaff R, Hussin A, Smith NG, Chang S, McNeill L, Reitzel LR, Shete S, Abroms LC. A Text-Based Smoking Cessation Intervention for Sexual and Gender Minority Groups: Protocol for a Feasibility Trial. JMIR Res Protoc. 2022 Dec 9;11(12):e42553. doi: 10.2196/42553. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Perceived Usability as Assessed by the System Usability Scale (SUS) | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 month after quit date |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Irene Tami-Maury, DMD, MSc, DrPH | The University of Texas Health Science Center at Houston | (713) 500-9234 | Irene.M.Tami-Maury@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2022 | Jul 9, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 13, 2021 | Jul 9, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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|
| 1 month after enrollment |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Sexual Orientation | Count of Participants | Participants |
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| Work Status | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Marital status | Count of Participants | Participants |
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| Children in household | Count of Participants | Participants |
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| Age at which participant first smoked | Mean | Standard Deviation | years |
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| Number of Participants who live with other smokers | Count of Participants | Participants |
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| Number of times participants tried to quit smoking | Count of Participants | Participants |
|
| Nicotine dependence as assessed by the Fagerstrom Test for Nicotine Dependence | The Fagerström Test for Nicotine Dependence (FTND) is a standard instrument for assessing the intensity of physical addiction to nicotine. The total score ranges from 0 to 10. Participants were categorized as low (less than 4), moderate(between 4 and 6) or high (greater than 6) nicotine dependence based on their FTND score. | Count of Participants | Participants |
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| Level of Smoking | Count of Participants | Participants |
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| Secondary | Engagement as Assessed by the Number of Text Messages Sent and Received by Study Participants After Enrollment. | A 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. | Posted | Count of Participants | Participants | 1 month after enrollment |
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| 0 |
| 18 |
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| 18 |
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| 18 |
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| Title | Measurements |
|---|---|
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