Testing a Novel Smartphone Application for Smoking Cessation With the Oklahoma Helpline

NCT05539209 | Completed

• 1 other identifier: 14792
• Study Type: interventional
• Target: 512
• Locations: 1 country
• Sites: 1

Brief Summary

Over 470,000 tobacco users have been served by the Oklahoma Tobacco Helpline (OTH). The OTH reaches a substantial number of smokers each year, but follow-up rates are notoriously low and many smokers may prefer smartphone-based smoking cessation interventions rather than web- or phone-based OTH programming (e.g., counseling). Highly flexible and low burden technology-based treatment approaches may overcome barriers that have limited the use and effectiveness of traditional smoking cessation treatments among underserved adult smokers (e.g., racial/ethnic minorities, rural residence, low socioeconomic status). This study is a randomized controlled trial that will evaluate the feasibility and initial efficacy of an innovative, evidence-based smoking cessation app tailored for smokers that contact the OTH for services. A total of 500 treatment-seeking men and women will be randomly assigned to receive either Standard Helpline Care plus brief (30 second) daily check-ins and weekly smartphone-based surveys through the Insight app (SC) or SC plus the OKquit smoking cessation app (OKq). All participants will receive standard Helpline services (e.g., nicotine replacement therapy), but only the OKq group will receive on-demand content and tailored messages through the app. All participants will be followed for 27 weeks after they are randomized to an intervention group and complete smartphone-based survey assessments. Participants that report smoking abstinence during the 26-week EMA will be sent a low-cost carbon monoxide monitor to verify smoking status.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Smoking abstinence

  Biochemically verified smoking abstinence will be assessed using a portable carbon monoxide monitor.

  27 Weeks

Secondary Outcomes (2)

• Treatment engagement

  27 weeks

• Cessation motivation

  27 weeks

Study Arms (2)

The Standard Helpline Care (SC) group

ACTIVE COMPARATOR

The SC group will receive standard Oklahoma Smoking Cessation Helpline care AND complete daily check-ins and weekly surveys for 27 weeks.

Behavioral: Standard Helpline Care

OKquit group

ACTIVE COMPARATOR

The OKquit group will receive SC plus daily check-ins and weekly surveys for 27 weeks. In addition, the OKquit group will receive tailored smoking cessation messages in the smartphone application following completion of each survey. Further, the OKquit group will have access to on-demand smoking cessation content through the app.

Behavioral: OKquit

Interventions

OKquit BEHAVIORAL

Standard Oklahoma Helpline care plus smartphone-based daily check-ins and weekly surveys plus OKquit Smartphone App including tailored messages and on-demand content designed to assist participants in their cessation attempt.

OKquit group

Standard Helpline Care BEHAVIORAL

Standard Oklahoma Helpline care plus smartphone-based daily check-ins and weekly surveys.

The Standard Helpline Care (SC) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are ≥ 18 years of age
• Expressed interest in participating in this study by allowing the OTH provider to share their contact details with the study research team
• Valid Oklahoma residential address to mail study materials
• Score of ≥ 4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF)
• Willing to quit smoking within 21 days after the randomization phone call
• Currently smoke ≥ 5 cigarettes per day
• Agree to complete daily 30 second EMA check-ins and 27 weekly 3-5 minute smartphone-based surveys
• Possession of an active smartphone that is compatible with the Insight mHealth Platform
• Agree to complete the 27-week post-randomization follow-up assessment (which may include biochemical verification of smoking abstinence)
• Provide evidence that they are a current smoker (e.g., text a picture of their pack of cigarettes when requested during the screening call)

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

• Businelle M, Becerra J, Witten C, Chen S, Kezbers K, Beebe LA, Kendzor DE. Smartphone-Based Smoking Cessation Intervention (OKquit) for Oklahoma Tobacco Helpline Users: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Aug 1;13:e56827. doi: 10.2196/56827.

  PMID: 39088254 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Michael S Businelle, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 14, 2022
• Study Start: September 13, 2022
• Primary Completion: September 29, 2025
• Study Completion: September 29, 2025
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)