Smartphone-delivered Automated Video-assisted Smoking Treatment for Patrons of a Food Resource Center
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 4

Summary: 
      The proposed pilot study seeks to address the smoking cessation treatment needs of
      underserved smokers with limited resources by evaluating the feasibility and preliminary
      efficacy of a smartphone delivered automated video-assisted smoking treatment (AVAST). AVAST
      will enable smoking cessation treatment content to be presented with voice/audio, images,
      videos, and text in an interactive, structured format anytime and anywhere. Participants will
      be recruited from the Urban Mission, a non-profit food and resource center that serves
      approximately 20,000 people each year in the Oklahoma City metro area.
    

Detailed description: 
      Smoking remains the leading cause of preventable morbidity and mortality in the United
      States,1-3 with tobacco use accounting for more deaths each year than the combined deaths
      attributable to alcohol, other drugs, homicide, suicide, motor vehicle accidents, and sexual
      behavior.4 While smoking cessation decreases the risk of lung cancer, other cancers, heart
      attack, stroke, and chronic lung disease,5 smoking quit rates are low. Approximately 40-50%
      of adult daily smokers make a quit attempt each year, but less than 14% of those smokers are
      able to maintain abstinence for even a single month.6 Individuals with low socioeconomic
      status are far more likely to smoke and are less successful at quitting.7-9 Thus, smoking is
      a critically significant behavioral risk factor that contributes to social disparities in the
      incidence and mortality of disease.10-15 Data indicate that smokers with higher socioeconomic
      status are more likely than those with lower socioeconomic status to use effective resources
      for quitting smoking, which appears to partially explain their higher cessation rates.16
      Therefore, efficiently connecting underserved smokers with limited resources to efficacious
      tobacco cessation programs that are easily accessible is crucial for disease prevention and
      the elimination of health disparities.

      Food security is defined by the United States Department of Agriculture (USDA) as having
      consistent, dependable access to enough food for all household members to lead an active,
      healthy life.17 In 2014, 14% of US households were classified as food insecure,17 a condition
      that describes limited or uncertain access to nutritionally adequate, personally acceptable,
      and safe foods.18 National studies indicate food insecurity within low-income households is
      associated with hypertension (24.6%), self-reported hyperlipidemia (43.3%), diabetes (10.2%),
      and smoking (35%).19 Emerging data suggests populations accessing foods at food pantries fare
      worse compared to the general low income, food insecure population, with self-reported
      hypertension (65.4%) and diabetes (25.9%) being notably higher.20

      Participants (n=20) will be randomized to one of two treatment conditions: 1) Standard
      Treatment (ST; n=10) or Automated Treatment (AT; n=10). In the ST condition, research staff
      will provide participants with in- person brief advice to quit and enroll them in a proactive
      telephone counseling program for smoking cessation. This ST approach mirrors the Ask Advise
      Connect (AAC) approach that our team has previously developed and implemented in numerous
      clinic settings.21,22 ST will be evaluated against AT, the fully automated AVAST approach. In
      the AT condition, smokers will be provided with brief in-person advice to quit and be
      enrolled in a fully automated and interactive smartphone-based treatment program that
      comprises interactive text messaging, images and audio/video clips. Participants in both
      treatment conditions will be provided with nicotine replacement therapy (NRT) in the form of
      transdermal patches. The goal of this pilot project is to establish the preliminary efficacy
      and feasibility of AT. Data collected in the pilot will then be used to support the
      submission of a NIH R01 application (or equivalent), and to determine if AT performs no worse
      than the more resource intensive ST approach. If lack of inferiority is established in the
      larger project, the AT approach will be readily scalable; easily implemented by
      community-based clinics and organizations; and offer an efficient way to allocate limited
      public health resources to tobacco control interventions.
    

Intervention name(s): Self-help materials; nicotine patch; Smartphone-delivered automated treatment; Counseling
Intervention type(s): Behavioral; Drug; Other; Behavioral
Intervention description(s): Self-help smoking cessation materials.; Participants who smoke >10 cigarettes per day will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg nicotine patches. Participants who smoke < 10 cigarettes per day will receive 6 weeks of 14 mg and 2 weeks of 7 mg nicotine patches.; Tailored video clips, text and graphical messages delivered automatically each week to the participant.; Proactive phone counseling with a Certified Tobacco Treatment Counselor
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking cessation, food pantry