NCT07431619

Brief Summary

Cigarette smoking prevalence has decreased to \~12% in 2022; however, over 40 million U.S. adults were current cigarette smokers in the same year. Rural-urban disparities in tobacco use are persistent, with higher tobacco use and lower cessation in rural areas. Less research has been dedicated to addressing rural-urban tobacco use disparities, perhaps due to logistics, difficulty recruiting and following participants from rural areas, and challenges with conducting clinic-based interventions. Mississippi is one of the states with higher rurality, as 79% of Mississippi counties are classified as rural. Additionally, Mississippi has a higher prevalence of tobacco use and lower cessation rates compared with the national average. Moreover, Mississippi is one of the few states that did not expand Medicaid, which covers comprehensive tobacco cessation services. This may add to the persistent disparity in tobacco use and cessation between rural and urban Mississippians. To overcome these challenges, the investigators propose a randomized clinical trial to test the effectiveness of theory-driven text messaging for tobacco cessation in rural Mississippi among users of cigarettes, smokeless tobacco (SLT), and dual users of cigarettes and SLT. Specifically, this proposal has the following specific aims: (1) To conduct a two-arm, randomized, clinical trial (RCT) of a web-based, text messaging approach for tobacco cessation among cigarette smokers, SLT users and dual users from rural Mississippi; (2) To assess the effectiveness of a web-based, text messaging intervention on tobacco cessation among cigarette smokers, SLT users and dual users; and (3) To identify barriers to and facilitators of tobacco cessation using ecological momentary assessment (EMA). To achieve these aims, a sample of 150 tobacco users (50 cigarette smokers, 50 SLT users, 50 dual users) who intend to quit and have made ≥1 quit attempt in the past 6 months will be recruited via a web-based, crowdsourcing platform (ResearchMatch.org). ResearchMatch.org is a large crowdsourcing platform that facilitates recruitment of a desired research sample from an online panel. Eligible participants will be randomized to intervention and control arms and will be asked to set up a quit date within the first 4 weeks post-intervention. Participants in the intervention arm will receive up to 3 motivational text messages daily during the first 4 weeks, and up to 2 daily during the last 2 weeks. The same frequency will be followed for the control group, but they will receive non-specific text messages. Participants will also receive a daily, midday text message during weeks 1-10 post-intervention to document the barriers and facilitators of tobacco cessation using EMA approach. After week 10 and to the end of 6 months post-intervention, the frequency of EMA texts will be reduced to once per week. Two-way text messaging will be facilitated via a web-based service called Mosio. The investigators will assess prolonged and 7-day point prevalence abstinence at 6 weeks, 3 months, and 6 months post-intervention. This project represents an attempt to test a simple and innovative approach to reducing rural-urban tobacco use disparities and overall tobacco-related morbidity and mortality. The findings can facilitate applying for extramural funding for a larger trial.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Dec 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

September 22, 2025

Last Update Submit

February 18, 2026

Conditions

Keywords

RuralText messagingSmokeless tobacco

Outcome Measures

Primary Outcomes (2)

  • Prolonged abstinence

    Prolonged abstinence is defined as self-report of not using cigarettes (among cigarette smokers), SLT (among SLT users), and both SLT and cigarettes (among dual users) between baseline and 6 months post-randomization. This outcome will be measured at three time points: 6 weeks, 3 months, and 6 months post-randomization.

    Baseline to 6 months post-randomization

  • 7-day point prevalence abstinence

    At each time point (6 weeks, 3 months, and 6 months), participants will complete a survey and self-report their tobacco use during the past 7 days prior to the survey. 7-day point prevalence abstinence is defined as not using cigarettes (among cigarette smokers), SLT (among SLT users), and both SLT and cigarettes (among dual users) during the 7 days prior to the survey.

    Past 7 days

Secondary Outcomes (1)

  • Prolonged abstinence of all tobacco products

    Baseline to 6 months

Study Arms (2)

Motivational text messaging

ACTIVE COMPARATOR

Participants will receive motivational text messaging for tobacco cessation

Behavioral: Motivational text messaging for tobacco cessation

Non-specific text messaging

PLACEBO COMPARATOR

Participants will receive non-specific text messaging

Behavioral: Non-specific text messaging

Interventions

Participants will receive motivational text messaging for tobacco cessation.

Motivational text messaging

Non-specific text messaging

Non-specific text messaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 years-old
  • resident of rural Mississippi (verified by a ZIP code)
  • not planning to move out of Mississippi during the next 6 months
  • own a personal cellphone with an unlimited texting plan
  • having the intention to quit tobacco and having made at least 1 quit attempt in the past 6 months
  • smokes ≥5 cigarettes per day during the past 6 months (for the cigarette smoking condition)
  • uses SLT ≥3 times per day during the past 6 months (for the SLT condition)
  • concurrent use of cigarettes and SLT on ≥15 days monthly during the past 6 months (for the dual use condition).

You may not qualify if:

  • a self-report of being diagnosed with or taking medications for severe mental illness
  • refusal to provide informed consent
  • having no intention to quit tobacco
  • currently using electronic cigarettes or pharmacological medications for tobacco cessation
  • currently participating in another RCT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Tobacco Use CessationTobacco Use

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Central Study Contacts

Raed A Bahelah, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2025

First Posted

February 24, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

The dataset will be used as pilot data to apply for larger grants. It is uncertain when the team will be able to obtain external funding based on this pilot dataset, and therefore, sharing IDP is not appropriate.