Quit Smoking Text Message Study

Not Applicable

Active, not recruiting

• Conditions: Smoking Cessation
• Interventions: Other: SmokefreeTXT; Device: Smartband

• Registration Number: NCT06111755
• Lead Sponsor: Yale University

Brief Summary

This project will address research gaps and advance the science of smoking cessation by conducting a randomized controlled trial of an evidence-based, population-level quit smoking text messaging program with or without a smartband.

Detailed Description

Aim 1 of this study is to test within-treatment effects for smoking cessation. The primary outcome will be biochemically (cotinine)-confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks). Secondary outcomes will be percent days smoke-free, time to relapse, and rated treatment satisfaction.

Aim 2 of this study is to explore sex/gender differences in treatment effects for smoking cessation. Given established sex/gender differences in smoking behavior and cessation,randomization will be stratified by sex/gender and we will measure effects of sex/gender on outcomes. Effect sizes will be estimated for smoking outcomes by sex.

Outcomes will be evaluated for those who complete enrollment, defined as those who complete study onboarding.

Study Timeline

• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-10-26
• Study First Posted: 2023-11-01
• Study Start: 2024-03-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• daily smokers for at least 6 months
• report an interest in quitting smoking.

Exclusion Criteria

• reporting being currently enrolled in another quit smoking program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SmokefreeTXT	SmokefreeTXT	Daily smokers for at least 6 months who report an interest in quitting will be randomized to receive the National Cancer Institute's SmokefreeTXT.
SmokefreeTXT + smartband	Smartband	Daily smokers for at least 6 months who report an interest in quitting will be randomized to receive the National Cancer Institute's SmokefreeTXT + smartband.
SmokefreeTXT + smartband	SmokefreeTXT	Daily smokers for at least 6 months who report an interest in quitting will be randomized to receive the National Cancer Institute's SmokefreeTXT + smartband.

Primary Outcome Measures

Name	Time	Method
Number of participants with cotinine confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks)	8 weeks	7-day PPA at end of treatment with be confirmed via cotinine testing in saliva

Secondary Outcome Measures

Name	Time	Method
Percent days smoke-free	up to 8 weeks	Percentage of smoke-free days by self report
Change in cigarettes smoked per day	baseline, 4 weeks and 8 weeks	Change in average number cigarettes smoked per day by self report
Average number of days to relapse	2 weeks post quit date	Relapse is defined as 7 consecutive days of smoking after quitting and will be measured using self-report or smartband detection. This will be assessed after their quit date.
Treatment satisfaction assessed using the Mobile Application Rating Scale User version	up to 8 weeks	This 20-item scale uses 5-point multiple choice ratings and has 6 subscales. Scores are reported as: 1) mean app quality, which is the mean score for the 4 subscales engagement, functionality, aesthetics, information quality; 2) mean of the app subjective quality subscale, and 3) mean of the perceived impact subscale. Higher scores indicate higher app quality, higher app subjective quality, and higher perceived impact. Mean scores range 1-5, with higher scores indicate higher app quality, higher app subjective quality, and higher perceived impact.

Trial Locations

Locations (1)

National online recruitment; 🇺🇸 New Haven, Connecticut, United States