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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.

  • Author(s): Prochaska, Judith J;
  • Epperson, Anna;
  • Skan, Jordan;
  • Oppezzo, Marily;
  • Barnett, Paul;
  • Delucchi, Kevin;
  • Schnellbaecher, Matthew;
  • Benowitz, Neal L
  • et al.
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.

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