Recruiting

HealthyCells

Sponsor:

University of Oklahoma

Code:

NCT05188287

Conditions

Smoking Cessation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

HealthyCells

Study Details

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

Study ID

NCT05188287

Start date

Feb 3, 2025

Status verified date

Apr, 2026

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Inclusion Criteria

  • 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?

Study Exclusion Criteria

  • 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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HealthyCells

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.

Interventions

HealthyCells

Smoking cessation smartphone app

Primary outcome measure

  • Biochemically-Verified smoking cessation [ Time Frame: 8 weeks ]
  • Accelerometer-verified reduction in sedentary time [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Adam C Alexander, PhD

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

Ashley Krukowski, MPA, CRA

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

Locations

TSET Health Promotion Research Center

Recruiting

Oklahoma City, Oklahoma, United States, 73118

Contacts

Adam Alexander

405-271-5046adam-alexander@ouhsc.edu

More Information

Sponsor

University of Oklahoma

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-05-01.