A Culturally Tailored Smartphone Application for African American Smokers

NCT05188287 | Recruiting DMC

• 2 other identifiers: 14094K01MD015295
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objectives of this research proposal, are to (a) create a smartphone application for smoking cessation (i.e., HealthyCells), which will be achieved by integrating two pre-existing evidence-based smartphone interventions, (b) create culturally tailored treatment content (i.e., messages, images, and videos) for African American smokers, and (c) evaluate the feasibility of HealthyCells at addressing smoking and sedentary behavior among African Americans. A pilot sample of African American smokers (N = 15) will briefly use the HealthyCells app and provide critical feedback through semi-structured interviews to refine the smartphone intervention. Once the HealthyCells app is refined, African Americans (N = 30) who are interested in quitting smoking will use the app during a scheduled quit attempt. Starting on the scheduled quit date, HealthyCells will prompt participants to complete twice-daily remote smoking status assessments to earn rewards for abstinence. The app will deliver real-time messages telling participants to stand up and move around during prolonged bouts of sedentary behavior (i.e., ≥ 30 minutes of uninterrupted time spent in a sitting, reclining, or lying posture). Participants will also have on-demand access to culturally tailored information and strategies for remaining abstinent and reducing sedentary behavior within the HealthyCells app. The primary outcomes will be biochemically confirmed point prevalence smoking abstinence at 8 weeks post-quit date, and the difference in sedentary time 7 consecutive days before quitting compared with 7 consecutive days at 8-weeks post-quit, as measured by a research-grade accelerometer.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• Biochemically-Verified smoking cessation

  Biochemically confirmed 7-day point prevalence abstinence using the CO criteria cutoff of ≤ 6 ppm

  8 weeks

• Accelerometer-verified reduction in sedentary time

  Accelerometer-verified confirmation of a \> 30-minute daily net reduction in sedentary time

  8 weeks

Study Arms (1)

HealthyCells

EXPERIMENTAL

The HealthyCells app will have the following features: Smoking status assessments with facial recognition: Participants will initiate a smoking status assessment and CO breath sample submission using the iCOquit® Smokerlyzer® TWICE per day. To verify the participant's identity while they complete their CO breath sample, we will use Microsoft Face API. Daily step counter and sedentary behavior prompts: A Google OS smartwatch will be used to monitor participants' activity, and the HealthyCells app will deliver an activity prompt when they have been sedentary for 30 minutes, which will be experienced as noise and vibration on the phone and watch. Also, a text-based reminder message will appear on the phone and watch along with a "personalized tip" for reducing sedentary time. Motivational messages for smoking cessation and physical activity. TWICE per day, the HealthyCells app will send messages to encourage users to remain quit and become more active.

Behavioral: HealthyCells

Interventions

HealthyCells BEHAVIORAL

Smoking cessation smartphone app

HealthyCells

Eligibility Criteria

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

You may qualify if:

• Must be 18 years of age or older
• Must identify as Black/African-American
• Must smoke at least 5 cigarettes or cigarette equivalents per day (i.e., cigarettes, cigars, and cigarillos)
• Must be willing to use NRT, a smartphone watch and app, and a smoking cessation counselor to help them quit smoking
• Must be willing to quit smoking within the next 3 weeks
• Must have a CO level of \>6 ppm at app activation.
• Are not currently active, defined as engaging in less than 150 minutes of moderate-intensity aerobic physical activity (e.g., brisk walking) or 75 minutes of vigorous-intensity aerobic physical activity (e.g., running or jogging) each week?

You may not qualify if:

• Does not give permission to administer screening survey
• Does not understand or speak English
• Is not a U.S. citizen or permanent U.S. resident
• Does not use tobacco products
• Does not want to provide SSN, residency status, or OUHSC employee status
• Is not willing to abstain from smoking marijuana or cannabis during their quit attempt
• Is not willing to upload a picture of their tobacco product
• Is not ready to quit smoking as defined by scoring 4 or lower on the readiness to quit ladder
• Has a medical condition that prevents the use of NRT without approval from a healthcare provider
• Has had a serious allergic reaction or side effect from the use of NRT
• Does not give permission to collect contact information
• Must not be currently active, defined as engaging in less than 150 minutes of moderate-intensity aerobic physical activity (e.g., brisk walking) or 75 minutes of vigorous-intensity aerobic physical activity (e.g., running or jogging) each week.

Sponsors & Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• University of Oklahoma: lead

Study Sites (1)

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, 73118, United States

RECRUITING

Related Publications (1)

• Alexander A, Businelle M, Cheney M, Cohn A, McNeill L, Short K, Frank-Pearce S, Bradley D, Estrada K, Flores I, Fronheiser J, Kendzor D. An mHealth Intervention With Financial Incentives to Promote Smoking Cessation and Physical Activity Among Black Adults: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 31;14:e69771. doi: 10.2196/69771.

  PMID: 39888657 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Darla Kendzor, PhD

  TSET Health Promotion Research Center

  STUDY CHAIR

Central Study Contacts

Adam C Alexander, PhD

CONTACT

1+ (405) 965-0558; adam-alexander@ouhsc.edu

Ashley Krukowski, MPA, CRA

CONTACT

(405) 271-2090; Ashley-Krukowski@ouhsc.edu

Study Design

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

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: January 12, 2022
• Study Start: February 3, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: De-identified data will be made available one-year after the publication of the primary outcome data.
• Access Criteria: Data can be requested from the primary study contact, or retrieved from public data repository.

Locations

US (1)