Culturally-tailored smoking cessation for American Indians: study protocol for a randomized controlled trial

Trials. 2011 May 18:12:126. doi: 10.1186/1745-6215-12-126.

Abstract

Background: Cigarette smoking is the number one cause of preventable death among American Indian and Alaska Natives, AI/ANs. Two out of every five AI/AN will die from tobacco-related diseases if the current smoking rates of AI/ANs (40.8%) persist. Currently, there is no proven, effective culturally-tailored smoking cessation program designed specifically for a heterogeneous population of AI.The primary aim of this group randomized clinical trial is to test the efficacy of "All Nations Breath of Life" (ANBL) program compared to a non-tailored "Current Best Practices" smoking cessation program among AI smokers.

Methods: We will randomize 56 groups (8 smokers per group) to the tailored program or non-tailored program for a total sample size of 448 American Indian smokers. All participants in the proposed study will be offered pharmacotherapy, regardless of group assignment. This study is the first controlled trial to examine the efficacy of a culturally-tailored smoking cessation program for American Indians. If the intervention is successful, the potential health impact is significant because the prevalence of smoking is the highest in this population.

Trial registration: ClinicalTrials.gov: NCT01106456.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Benzazepines / therapeutic use
  • Bupropion / therapeutic use
  • Counseling
  • Cultural Characteristics*
  • Health Behavior
  • Health Knowledge, Attitudes, Practice
  • Humans
  • Indians, North American* / psychology
  • Kansas / epidemiology
  • Nicotinic Agonists / therapeutic use
  • Oklahoma / epidemiology
  • Patient Education as Topic
  • Quinoxalines / therapeutic use
  • Research Design*
  • Self-Help Groups
  • Smoking / ethnology
  • Smoking / psychology
  • Smoking Cessation / ethnology*
  • Smoking Cessation / methods
  • Smoking Cessation / psychology
  • Smoking Prevention*
  • Tobacco Use Disorder / ethnology
  • Tobacco Use Disorder / psychology
  • Tobacco Use Disorder / therapy*
  • Treatment Outcome
  • Varenicline

Substances

  • Benzazepines
  • Nicotinic Agonists
  • Quinoxalines
  • Bupropion
  • Varenicline

Associated data

  • ClinicalTrials.gov/NCT01106456