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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.

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.

SUBMITTER: Prochaska JJ

PROVIDER: S-EPMC6636857 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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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.

Prochaska Judith J JJ Epperson Anna A Skan Jordan J Oppezzo Marily M Barnett Paul P Delucchi Kevin K Schnellbaecher Matthew M Benowitz Neal L NL

Contemporary clinical trials 20180602

<h4>Background</h4>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.<h4>Design</h4>Randomized clinical trial with two intervention arms: 1) tobacco and physical activity; 2) medication adherence and a heart-healthy AN diet.<h4>Participa ...[more]

PMID: 29864548

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Project description:INTRODUCTION:In general population samples, higher levels of stress and depression have been associated with increased prevalence of smoking in pregnancy. Little is known about the association of prenatal tobacco use, stress, and depression among American Indian or Alaska Native (AI/AN) women. METHODS:The Healthy Pregnancies Project is a cluster-randomized controlled trial, evaluating a community-level intervention compared with usual care, for reducing tobacco use during pregnancy and postpartum among AN women in 16 villages in western Alaska. This cross-sectional study analyzed baseline data from enrolled pregnant women. Baseline measures included the self-reported, 7-day, point-prevalence current use of any tobacco, Perceived Stress Scale (PSS), and the Center for Epidemiological Studies-Depression (CES-D). Generalized estimating equations (GEE) analyses adjusted for village, participant age, and gestational age. RESULTS:Participants (N = 352) were on average (SD) 25.8 (5.0) years of age and at 26.8 (9.8) weeks gestation. 66.5% were current tobacco users, of which 77% used Iqmik, a homemade form of smokeless tobacco. Compared with nonusers, tobacco users reported lower PSS score (p = .020) and less clinical levels of depression (CES-D ? 16) (18.1% vs. 9.3%, p = .21). Findings were not accounted for by nicotine dependence severity or self-reported tobacco use before pregnancy. CONCLUSIONS:In this sample of pregnant AN women, tobacco users report less stress and clinical levels of depression than nonusers. A potential challenge with tobacco treatment for pregnant AN women is to provide alternative ways of deescalating stress and affect management instead of using tobacco. IMPLICATIONS:This study contributes novel information on the association of tobacco use, perceived stress, and depression among Alaska Native women enrolled in a clinical trial to promote healthy pregnancies. Most prior studies addressing this topic were conducted among general population samples of pregnant women who smoked cigarettes. Little is known about these associations with prenatal smokeless tobacco, or among American Indian or Alaska Native women. The results are contrary to findings reported previously, because current tobacco use was associated with less stress and depression than nonuse. The study findings have implications for cessation treatment for this tobacco-use disparity group.

Dataset Information

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.

Publications

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.

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