A Culturally Tailored Smartphone Application for African American Smokers

Study Overview
=================
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.

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.

Official Title
-----------------
Identifying the Barriers and Facilitators of Participation in mHealth Research Among African Americans Using a Mixed-Methods Approach.

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: HealthyCells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: self-identify as Black or African American earn a score ≥ 4 on the REALM indicating > 6th grade English literacy level (i.e., a 7th-grade reading level is necessary to complete assessments); are ≥ 18 years of age; (4) smoke ≥ 5 cigarettes per day have a CO level of > 6 ppm, to verify current smoking status are willing to quit smoking 7 days after enrollment are willing to abstain from smoking cannabis and other combustible tobacco product use because these will raise CO levels and mask cigarette abstinence Exclusion Criteria: • Self-report contraindications for NRT.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HealthyCells<br>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<br>* Smoking cessation smartphone app<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |