Smoking CessationHCNCT05188287
A Culturally Tailored Smartphone Application for African American Smokers
A study testing HealthyCells in people with Smoking Cessation, run by University of Oklahoma at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- HealthyCells
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
TSET Health Promotion Research Center
Oklahoma City, Oklahoma, 73118
Adam Alexander, 405-271-5046, adam-alexander@ouhsc.edu
About this study
Official title: Identifying the Barriers and Facilitators of Participation in mHealth Research Among African Americans Using a Mixed-Methods Approach.
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.
Read the detailed description
African Americans are interested in quitting smoking, they attempt to quit smoking at a higher rate than Whites, yet they have lower cessation rates compared to Whites and many other racial/ethnic groups. Successfully increasing cessation rates among African Americans would reduce the racial disparity in mortality between African Americans and Whites by up to 20%. Many smoking cessation interventions include physical activity components to boost cessation rates, but no studies have attempted to promote sedentary behavior reduction as a cessation strategy, which may plausibly share similar benefits with physical activity, such as increased self-efficacy for smoking cessation and reduced smoking urges and cravings.
African Americans also face numerous barriers to seeking in-person treatment for smoking cessation, and research has shown that the use of smartphones can facilitate intensive behavioral interventions without requiring burdensome in-person treatment. Smartphone interventions can also be tailored to address the specific needs of African Americans (e.g., discrimination, and financial strain), and capitalize on cultural strengths (e.g., spirituality and collectivism) to reduce barriers and encourage behavior change. The research team has developed numerous evidence-based smartphone interventions to address a range of modifiable health risk factors among vulnerable populations, which are capable of being culturally tailored for African Americans. One intervention is a smartphone-based contingency management intervention that provides financial rewards for smoking abstinence after remote verification of smoking status using low-cost portable carbon monoxide monitors and facial recognition software (i.e., PrevailGO). The other is a smartphone-based sedentary behavior reduction intervention that uses wrist-worn activity monitors in combination with smartphone technology to monitor activity in real-time and deliver activity prompts when individuals are engaged in prolonged bouts of sedentary behavior (i.e., SMARTpath). SMARTpath also provides graphical feedback about sedentary time over the past day, week, and month. Integrating and tailoring these evidence-based smartphone interventions for African Americans may equip them with the tools, skills, and information needed to remain abstinent from smoking.
The long-term goal of this research study is to improve smoking cessation outcomes among African Americans using evidence-based, culturally tailored smartphone interventions. The overall objectives of this research proposal, which is the next step toward achieving this long-term goal, 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, PrevailGO and SMARTpath, (b) create culturally tailored treatment content (i.e., messages, images, and videos) for African American smokers for the HealthyCells app, 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 (PPA) 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. The aims of this project are the following:
AIM 1: Create HealthyCells and populate the app with culturally tailored content for smoking cessation and sedentary behavior reduction. HealthyCells will be created by integrating PrevailGO with SMARTpath. Culturally tailored treatment content for smoking cessation and sedentary behavior reduction will be developed based on an extensive literature review. African American smokers (N = 15) will demo the HealthyCells application and participate in a post-demo semi-structured interview to obtain their overall impressions of the HealthyCells app and refine the culturally tailored treatment content.
AIM 2: Determine the feasibility and preliminary estimates of the effect of HealthyCells on smoking and sedentary behavior among African Americans. The primary objective is to determine whether the PPA prevalence and changes in sedentary time are sufficient to warrant further use of HealthyCells in this population (> 15% PPA at 8 weeks post-quit and > 30-minute daily net reduction in sedentary time). These feasibility thresholds are based on published findings from a smartphone-based contingency management intervention for smoking cessation and a smartphone-based sedentary behavior reduction intervention.
- Conditions
- Smoking Cessation
- Being tested
- HealthyCells
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthyCellsBehavioural
Smoking cessation smartphone app
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: HealthyCells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically-Verified smoking cessation
Biochemically confirmed 7-day point prevalence abstinence using the CO criteria cutoff of ≤ 6 ppm
Measured: 8 weeks
Accelerometer-verified reduction in sedentary time
Accelerometer-verified confirmation of a > 30-minute daily net reduction in sedentary time
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start3 Feb 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Darla Kendzor, PhD, Study chair, TSET Health Promotion Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188287
- Sponsor's protocol ID
- 14094
- Other IDs
- K01MD015295
- Acronym
- HC
- Status last verified
- Apr 2026
- First submitted
- 26 Dec 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will provide publicly archived de-identified datasets for all published papers related to the project so independent investigators can replicate our findings or use results for meta-analyses.
Publications
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.
PubMed 39888657
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Barriers and Facilitators of Participation in mHealth Research Among African Americans Using a Mixed-Methods Approach.
- ClinicalTrials.gov ID
- NCT05188287
- Acronym / sponsor ID
- HC / 14094
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
African Americans are interested in quitting smoking, they attempt to quit smoking at a higher rate than Whites, yet they have lower cessation rates compared to Whites and many other racial/ethnic groups. Successfully increasing cessation rates among African Americans would reduce the racial disparity in mortality between African Americans and Whites by up to 20%. Many smoking cessation interventions include physical activity components to boost cessation rates, but no studies have attempted to promote sedentary behavior reduction as a cessation strategy, which may plausibly share similar benefits with physical activity, such as increased self-efficacy for smoking cessation and reduced smoking urges and cravings.
African Americans also face numerous barriers to seeking in-person treatment for smoking cessation, and research has shown that the use of smartphones can facilitate intensive behavioral interventions without requiring burdensome in-person treatment. Smartphone interventions can also be tailored to address the specific needs of African Americans (e.g., discrimination, and financial strain), and capitalize on cultural strengths (e.g., spirituality and collectivism) to reduce barriers and encourage behavior change. The research team has developed numerous evidence-based smartphone interventions to address a range of modifiable health risk factors among vulnerable populations, which are capable of being culturally tailored for African Americans. One intervention is a smartphone-based contingency management intervention that provides financial rewards for smoking abstinence after remote verification of smoking status using low-cost portable carbon monoxide monitors and facial recognition software (i.e., PrevailGO). The other is a smartphone-based sedentary behavior reduction intervention that uses wrist-worn activity monitors in combination with smartphone technology to monitor activity in real-time and deliver activity prompts when individuals are engaged in prolonged bouts of sedentary behavior (i.e., SMARTpath). SMARTpath also provides graphical feedback about sedentary time over the past day, week, and month. Integrating and tailoring these evidence-based smartphone interventions for African Americans may equip them with the tools, skills, and information needed to remain abstinent from smoking.
The long-term goal of this research study is to improve smoking cessation outcomes among African Americans using evidence-based, culturally tailored smartphone interventions. The overall objectives of this research proposal, which is the next step toward achieving this long-term goal, 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, PrevailGO and SMARTpath, (b) create culturally tailored treatment content (i.e., messages, images, and videos) for African American smokers for the HealthyCells app, 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 (PPA) 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. The aims of this project are the following:
AIM 1: Create HealthyCells and populate the app with culturally tailored content for smoking cessation and sedentary behavior reduction. HealthyCells will be created by integrating PrevailGO with SMARTpath. Culturally tailored treatment content for smoking cessation and sedentary behavior reduction will be developed based on an extensive literature review. African American smokers (N = 15) will demo the HealthyCells application and participate in a post-demo semi-structured interview to obtain their overall impressions of the HealthyCells app and refine the culturally tailored treatment content.
AIM 2: Determine the feasibility and preliminary estimates of the effect of HealthyCells on smoking and sedentary behavior among African Americans. The primary objective is to determine whether the PPA prevalence and changes in sedentary time are sufficient to warrant further use of HealthyCells in this population (> 15% PPA at 8 weeks post-quit and > 30-minute daily net reduction in sedentary time). These feasibility thresholds are based on published findings from a smartphone-based contingency management intervention for smoking cessation and a smartphone-based sedentary behavior reduction intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HealthyCells | Experimental | Behavioral: HealthyCellsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealthyCellsSmoking cessation smartphone app | Behavioural | HealthyCells |
Primary outcome
Biochemically-Verified smoking cessation
Time frame: 8 weeks
Biochemically confirmed 7-day point prevalence abstinence using the CO criteria cutoff of ≤ 6 ppm
Accelerometer-verified reduction in sedentary time
Time frame: 8 weeks
Accelerometer-verified confirmation of a > 30-minute daily net reduction in sedentary time
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 39888657Alexander 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.
- Individual participant dataSharing planned: Yes. We will provide publicly archived de-identified datasets for all published papers related to the project so independent investigators can replicate our findings or use results for meta-analyses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Darla Kendzor, PhD study chair
TSET Health Promotion Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealthyCells in people with Smoking Cessation, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam C Alexander, PhD (1+ (405) 965-0558, adam-alexander@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically-Verified smoking cessation (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05188287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.