Healing and Empowering Alaskan Lives Towards Healthy-Hearts Study (HEALTHH)

This study aims to identify effective and cost-effective interventions for tobacco use and other risk behaviors for cardiovascular disease among Alaska Native people in rural villages. In a randomized controlled trial, the study will compare interventions using telemedicine to promote the American Heart Association's identified ideal health behaviors (nonsmoking and physical activity) relative to ideal health factors (managing cholesterol and blood pressure).

Study Overview

• Status: Completed
• Conditions: Tobacco Dependence
• Intervention / Treatment: Behavioral: Tobacco/Physical Activity Intervention; Behavioral: Diet plus BP/CHOL Intervention

Detailed Description

In an RCT, we will compare 2 active treatments delivered over 12-months via telehealth services linking participants in rural villages to Anchorage and Stanford-based study counselors overcoming access-to-care for CV preventive health issues. The village AN health aides will facilitate data collection and telehealth connectivity. Intervention contacts occur at baseline, 3-, 6- and 12-months follow-up, with the final assessment at 18-months. The repeated intervention contacts provide iterative computerized feedback reflecting prior responses and encouragement of adoption and maintenance of behavioral health goals. The groups are:

1. Tobacco/Physical Activity Intervention (n=150), consisting of a psychosocial component that includes counselor-facing computer-assisted intervention with tailored counseling feedback focused on increasing intrinsic motivation, goal setting for tobacco and physical activity, adherence with nicotine replacement therapy (NRT, patch plus gum or lozenge), and self-monitoring with a pedometer-based walking program. The study will provide 12-weeks of NRT for participants randomized to this intervention condition.
2. HTN/HCL (HTN/HC, n=150), consisting of a psychosocial component that includes counselor-facing computer-assisted intervention with tailored counseling feedback focused on increasing intrinsic motivation, goal setting for managing HTN and HCL, and adherence with antihypertensives and statins with supportive dietary changes. The AN health plan covers antihypertensive and statins as a benefit to patients and would be prescribed as part of standard of care (i.e., not prescribed for the purposes of this research); however, strategies to maximize medication adherence are needed, hence the focus of this intervention.

The counseling and print materials are highly individualized, unique to the participant, thereby minimizing the likelihood of cross-condition contamination, determined to be minimal in prior investigations. For the research study, participant eligibility criteria include AN heritage; daily cigarette smoking; and hypertension, hyperlipidemia, or established vascular disease. Intention to change the targeted risk behaviors will not be required to participate. Utilizing telemedicine technology and Transtheoretical Model-tailored interventions, the trial aims to reach at-risk AN people regardless of residential location or current motivation. The primary outcome is biochemically-confirmed tobacco abstinence using anabasine. Secondary outcomes include moderate-to-vigorous physical activity assessed by self-report, blood pressure, cholesterol ratio, medication adherence, dietary change, body mass index, Framingham index, multibehavioral impact factor, a linear index, and cost effectiveness.

• Study Type: Interventional
• Enrollment (Actual): 299
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Nome, Alaska, United States, 99762
      • Norton Sound Health Corporation
  • California
    • Stanford, California, United States, 94304
      • Stanford Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Smoking > 5 cigarettes/day and > 100 cigarettes in one's lifetime
• Hypertension, hypercholesterolemia, or established vascular disease
• Fluent in English language

Exclusion Criteria:

• Dementia or other brain injury
• Pregnancy or breastfeeding
• Currently engaged in tobacco treatment or using cessation pharmacotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tobacco/Physical Activity Intervention; Includes a psychosocial component that utilizes a counselor-facing computer-assisted intervention with tailored counseling feedback focused on increasing intrinsic motivation, goal setting for tobacco and physical activity, adherence with nicotine replacement therapy, and self-monitoring with a pedometer-based walking program. The intervention will provide 12 weeks of nicotine replacement therapy for participants.	Behavioral: Tobacco/Physical Activity Intervention; Telemedicine stage-tailored counseling intervention focused on increasing intrinsic motivation and goal setting for tobacco and physical activity, adherence with nicotine replacement therapy (NRT, patch plus gum or lozenge), and self-monitoring with a pedometer-based walking program.
Experimental: Diet plus BP/CHOL Intervention; Consists of a psychosocial component that includes counselor-facing computer-assisted intervention with tailored counseling feedback focused on increasing intrinsic motivation, goal setting for managing hypertension and hypercholesterolemia, and adherence with antihypertensives and statins with supportive dietary changes. The intervention provides a cookbook of heart healthy regional recipes and medication bag for storing medications.	Behavioral: Diet plus BP/CHOL Intervention; Telemedicine stage-tailored counseling intervention focused on increasing intrinsic motivation, goal setting for managing HTN and HCL, and adherence with antihypertensives and statins with supportive dietary changes. Includes a native diet cookbook and medication bag.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Status: 7-day point prevalence abstinence	Change from baseline as no tobacco use, including a puff, in the past 7 days	Assessed at baseline, 3, 6, 12, and 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minutes of moderate-to-vigorous physical activity in past 7 days	self-reported minutes of moderate-to-vigorous physical activity	Assessed at baseline, 3, 6, 12, and 18 months
Blood pressure	Measured as systolic/diastolic in mmHg	Assessed at baseline, 3, 6, 12, and 18 months
Total, LDL, and HDL cholesterol	measured in milligrams per deciliter of blood (mg/dL)	Assessed at baseline and 18 months
Body Mass Index (BMI)	weight (in kilograms) over height squared (in centimeters)	Assessed at baseline, 3, 6, 12, and 18 months
Framingham Risk Factor Score	gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual	Assessed at baseline and 18 months
Medication Adherence	self-reported assessment of adherence to BP and CHOL meds	Assessed at baseline, 3, 6, 12 and 18 months
Dietary Quality	culturally tailored FFQ assessing consumption of native and non-native foods	Assessed at baseline, 3, 6, 12 and 18 months
Multiple Risk Behavior Change Impact Factor	intervention efficacy times participation summed over the multiple behavioral targets, I = ∑# of behaviors(n) (En × Pn)	Assessed at baseline, 3, 6, 12 and 18 months
Linear index of multiple behavior change	computed by subtracting baseline scores from follow-up scores for each risk behavior, dividing by the standard deviation of the difference (i.e., z-score), and summing across the individual risks (smoking, exercise, diet, adherence)	Assessed at baseline, 3, 6, 12 and 18 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of California, San Francisco; Alaska Native Tribal Health Consortium; University of Alaska Anchorage; Norton Sound Health Corporation
• Investigators: Principal Investigator: Judith J Prochaska, PhD, MPH, Stanford University

Publications and helpful links

General Publications

• Prochaska JJ, Benowitz NL. The Past, Present, and Future of Nicotine Addiction Therapy. Annu Rev Med. 2016;67:467-86. doi: 10.1146/annurev-med-111314-033712. Epub 2015 Aug 26.
• Prochaska JJ, Benowitz NL. Smoking cessation and the cardiovascular patient. Curr Opin Cardiol. 2015 Sep;30(5):506-11. doi: 10.1097/HCO.0000000000000204.
• Prochaska JJ, Epperson A, Skan J, Oppezzo M, Barnett P, Delucchi K, Schnellbaecher M, Benowitz NL. 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 12, 2014
• First Posted (Estimate): May 14, 2014

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Smoking; Physical activity; Tobacco dependence; Risk behaviors; Alaska Native people
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 29638; 1R01HL117736 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO