The Healing and Empowering Alaskan Lives Toward Healthy-Hearts (HEALTHH) Project: Study protocol for a randomized controlled trial of an intervention for tobacco use and other cardiovascular risk behaviors for Alaska Native People

Contemp Clin Trials. 2018 Aug:71:40-46. doi: 10.1016/j.cct.2018.06.003. Epub 2018 Jun 2.

Abstract

Background: Tobacco use and tobacco-related diseases disproportionately affect Alaska Native (AN) people. Using telemedicine, this study aims to identify culturally-tailored, theoretically-driven, efficacious interventions for tobacco use and other cardiovascular disease (CVD) risk behaviors among AN people in remote areas.

Design: Randomized clinical trial with two intervention arms: 1) tobacco and physical activity; 2) medication adherence and a heart-healthy AN diet.

Participants: Participants are N = 300 AN men and women current smokers with high blood pressure or high cholesterol.

Interventions: All participants receive motivational, stage-tailored, telemedicine-delivered counseling sessions at baseline and 3, 6, and 12 months follow-up; an individualized behavior change plan that is updated at each contact; and a behavior change manual. In Group 1, the focus is on tobacco and physical activity; a pedometer is provided and nicotine replacement therapy is offered. In Group 2, the focus is on medication adherence for treating hypertension and/or hypercholesterolemia; a medication bag and traditional food guide are provided.

Measurements: With assessments at baseline, 3, 6, 12, and 18 months, the primary outcome is smoking status, assessed as 7-day point prevalence abstinence, biochemically verified with urine anabasine. Secondary outcomes include physical activity, blood pressure and cholesterol, medication compliance, diet, multiple risk behavior change indices, and cost-effectiveness.

Comments: The current study has the potential to identify novel, feasible, acceptable, and efficacious interventions for treating the co-occurrence of CVD risk factors in AN people. Findings may inform personalized treatment and the development of effective and cost-effective intervention strategies for use in remote indigenous communities more broadly. Clinical Trial Registration # NCT02137902.

Keywords: Alaska Native; Cardiovascular risk factors; Intervention; Motivational; Randomized controlled trial; Smoking cessation; Telemedicine.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Alaska Natives
  • Behavior Control / methods*
  • Cardiovascular Agents / therapeutic use
  • Cardiovascular Diseases* / epidemiology
  • Cardiovascular Diseases* / prevention & control
  • Cardiovascular Diseases* / psychology
  • Distance Counseling / methods*
  • Exercise* / physiology
  • Exercise* / psychology
  • Female
  • Humans
  • Male
  • Medication Adherence / ethnology
  • Medication Adherence / statistics & numerical data
  • Quality of Life*
  • Randomized Controlled Trials as Topic
  • Risk Factors
  • Risk Reduction Behavior
  • Smoking Cessation* / ethnology
  • Smoking Cessation* / methods
  • Telemedicine / methods
  • Tobacco Use Disorder* / ethnology
  • Tobacco Use Disorder* / therapy

Substances

  • Cardiovascular Agents

Associated data

  • ClinicalTrials.gov/NCT02137902