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Completed

NCT Number: NCT03060278

Smartphone-delivered Automated Video-assisted Smoking Treatment for Patrons of a Food Resource Center

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oklahoma Tobacco Research Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >/= 18 years
  • Smoked >/= 100 cigarettes in a lifetime
  • English speaking
  • Currently smoking 5 or more cigarettes per day
  • Willing to make a quit attempt within 1 week of enrollment
  • Patron of the Urban Mission Food Resource Center

Exclusion criteria

  • History of medical condition that precludes the use of nicotine replacement therapy
  • Current use of smoking cessation medications
  • Pregnant or nursing
  • Enrolled in another smoking cessation study

Treatment and study plan

Self-help materials

Behavioral

Self-help smoking cessation materials.

Nicotine patch

Drug

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.

Smartphone-delivered automated treatment

Other

Tailored video clips, text and graphical messages delivered automatically each week to the participant.

Counseling

Behavioral

Proactive phone counseling with a Certified Tobacco Treatment Counselor

Primary outcomes

  1. Smoking Status

    Time frame: 3-Month Follow-Up

    Biochemically verifying smoking status on all participants by collecting an expired carbon monoxide breath sample.

Secondary outcomes

  1. Participant satisfaction with treatment

    Time frame: 3-Month Follow-Up

    The investigators will use the Client Satisfaction Questionnaire to evaluate participant satisfaction.

  2. Dropout rate

    Time frame: 3-Month Follow-Up

    The investigators will assess the number of participants who dropped out of the study.

  3. Intervention delivery rate

    Time frame: 3-Month Follow-Up

    The investigators will assess the number of sessions completed by participants.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Smartphone-delivered Automated Video-assisted Smoking Treatment for Patrons of a Food Resource Center: Project AVAST - FRC

Acronym: AVAST-FRC

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 23, 2017
Registry last updated
Apr 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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