Comparative Effectiveness of Mobile Health Smoking Cessation Approaches Among Underserved Patients in Primary Care (PROMOTE-UP)

This study will evaluate the comparative effectiveness of three smoking cessation therapies: mobile health (mHealth) application iCanQuit, mHealth application iCanQuit + Motiv8, and the Florida quit line.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Use Cessation
• Intervention / Treatment: Behavioral: iCanQuit; Behavioral: iCanQuit+Motiv8; Behavioral: Florida quit line

Detailed Description

The research team will recruit 1,332 adult patients who smoke from primary care clinics in North Central Florida, focusing on: (a) the relative effectiveness of the 3 treatments in adult patients who smoke cigarettes, in underserved urban and rural primary care settings. The team will assign patients by chance to one of the 3 treatments. Smoking cessation will be confirmed with a breath test (measured at 2, 6, and 12 months). The study will measure the effects of these treatments in based on gender, race, ethnicity, rurality, and social vulnerability; (b) their effects on patients' quality of life, self-confidence in quitting, and satisfaction with the treatments; and (c) their impact on patients' reported levels of motivation, commitment to values, and acceptance of triggers for smoking.

• Study Type: Interventional
• Enrollment (Estimated): 1332
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jesse Dallery, PhD; Phone Number: 352-273-2182; Email: dallery@ufl.edu
• Study Contact Backup: Name: Ramzi Salloum, PhD; Phone Number: 352-294-4997; Email: rsalloum@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida
      • Principal Investigator: Jesse Dallery, PhD
      • Contact: Ashley Dwarka; Phone Number: 352-294-8417; Email: dwarkaa12@ufl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ≥21 years old
• Referred by the provider via Ask-Advise-Connect
• Receiving care at one of the participating clinics
• Daily access to their own smart phone (the study team will provide assistance to patients without a phone to obtain one through aid programs for low-income patients)
• No household members already enrolled

Exclusion Criteria:

• Unstable medical or psychiatric illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: iCanQuit; iCanQuit is a modern, cognitive behavioral treatment which promotes cessation through greater acceptance of triggers for smoking and commitment to personal values. It is a smart phone-based acceptance and commitment therapy (ACT). For patients randomized to the iCanQuit arm (444 total), research staff will assist in downloading the app onto the patient's phone.	Behavioral: iCanQuit; iCanQuit is a smoking cessation smart phone application that uses acceptance and commitment therapy (ACT) approach, a cognitive behavioral treatment
Active Comparator: iCanQuit+Motiv8; Motiv8 is an internet-and smart phone-based contingency management (CM) intervention. Motiv8 verifies smoking status via a hand-held breath carbon monoxide (CO) monitor that is connected to a smart phone. For patients randomized to the iCanQuit+Motiv8 arm (444 total), research staff will assist in downloading the combined pp and connecting the iCO to the patient's phone. Smokers will also be asked to complete the first 4 iCanQuit modules, which contain exercises designed to prepare the users for their quit day. The end of the preparation phase will also mark each patient's quit date. During the intervention (7 weeks), participants will be considered abstinent from smoking if their breath CO sample is ≤ 5 ppm or if the CO value has decreased by 5% per hour from the last sample provided.	Behavioral: iCanQuit+Motiv8; iCanQuit + Motiv8 is a integrated version of iCanQuit (Cognitive Behavioral Therapy smoking cessation therapy application) with Motiv8 (a contingency management program that rewards decreased smoking determined by measuring CO levels of participant)
Active Comparator: Florida quit line; The Florida quit line provides telephone counseling for smoking cessation. Patients randomized to the Florida quit line arm (444 total) will be enrolled after contact information is sent electronically.	Behavioral: Florida quit line; An evidence-based, existing smoking cessation healthcare option recommended by the U.S. clinical practice that connects active smokers to trained quit coaches via referral by their providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Point-Prevalence Abstinence (PPA)	negative CO breath sample ≤ 5 ppm using an iCO monitor, and self-reported abstinence from smoking in the last 7 days	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Point-Prevalence Abstinence (PPA)	negative CO breath sample ≤ 5 ppm using an iCO monitor, and self-reported abstinence from smoking in the last 7 days	Months 2 and 12
Treatment Satisfaction	5-item scale measuring treatment by interest, usefulness, concern with privacy, how easy to understand, and satisfaction. Items will be measured on a 0-10 point scale, with higher scores corresponding to greater acceptability.	Month 12
Quality of Life and Well-Being	World Health Organization Quality of Life-BREF (WHOQOL-BREF): 26-item scale that measures quality of life. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5), with a higher score indicating a higher quality of life.	Baseline, and month 6
Self Efficacy	Self-Efficacy Questionnaire (SEQ-12): 12-item scale. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5), with higher scores indicating greater self-efficacy.	Baseline, and month 6
Acceptance	9-item physical sensations subscale of the Avoidance and Inflexibility Scale. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5), with higher scores reflecting more inflexibility/avoidance in the presence of difficult smoking-related thoughts, feelings, and sensations.	Months 2 and 6
Values	Valuing Questionnaire (VQ): 10-item measure assessing the extent to which one lives consistently with their values, including Progress and Obstruction subscales. Both subscales total scores range from 0 to 30. A psychologically healthier score is indicated by a higher score on the Progress scale along with a lower score on the Obstructions scale.	Months 2 and 6
Motivation	Motivational Engagement Questionnaire: 5-item measure. Items are rated on a 7-point Likert scale (low score of 1 to high score of 7), with higher scores indicating more motivation to quit smoking.	Months 2 and 6
Smoking Prolonged Abstinence	Self-reported abstinence from the date of the last time a cigarette was smoked.	Months 6 and 12

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Jesse Dallery, PhD, University of Florida; Principal Investigator: Ramzi Salloum, PhD, University of Florida

Publications and helpful links

General Publications

• Salloum RG, Bricker JB, Lee JH, Theis RP, Pluta K, Williams MP, Naous J, Mulani SR, Cogle CR, Rubin DA, Fahnlander AM, Nordelo B, Sullivan BM, Bloodworth S, Corbin L, Siler K, Willis D, Carrasquillo O, Dallery J. Comparative effectiveness of mobile health smoking cessation approaches among underserved patients in primary care: Study protocol for the PROMOTE-UP trial. Contemp Clin Trials. 2023 Apr;127:107120. doi: 10.1016/j.cct.2023.107120. Epub 2023 Feb 16.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: tobacco use intervention; mobile health aids
• Additional Relevant MeSH Terms: Behavior; Health Behavior; Tobacco Use Cessation
• Other Study ID Numbers: IRB202200918; OCR41824 (Other Identifier: UF OnCore)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No