Healing and Empowering Alaskan Lives Towards Healthy-Hearts Study

NCT02137902 | Completed

• 2 other identifiers: 296381R01HL117736
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Tobacco Dependence

Keywords

Tobacco dependence; Cardiovascular disease; Risk behaviors; Smoking; Physical activity; Alaska Native people

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Minutes of moderate-to-vigorous physical activity in past 7 days

  Assessed at baseline, 3, 6, 12, and 18 months

• Blood pressure

  Assessed at baseline, 3, 6, 12, and 18 months

• Total, LDL, and HDL cholesterol

  Assessed at baseline and 18 months

• Body Mass Index (BMI)

  Assessed at baseline, 3, 6, 12, and 18 months

• Framingham Risk Factor Score

  Assessed at baseline and 18 months

Study Arms (2)

Tobacco/Physical Activity Intervention

EXPERIMENTAL

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

Diet plus BP/CHOL Intervention

EXPERIMENTAL

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

Interventions

Tobacco/Physical Activity Intervention BEHAVIORAL

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.

Tobacco/Physical Activity Intervention

Diet plus BP/CHOL Intervention BEHAVIORAL

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.

Diet plus BP/CHOL Intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• University of California, San Francisco: collaborator
• Alaska Native Tribal Health Consortium: collaborator
• University of Alaska Anchorage: collaborator
• Norton Sound Health Corporation: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Norton Sound Health Corporation

Nome, Alaska, 99762, United States

Location

Stanford Hospital and Clinics

Stanford, California, 94304, United States

Location

Related Publications (3)

• 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.

  PMID: 26332005 BACKGROUND

• Prochaska JJ, Benowitz NL. Smoking cessation and the cardiovascular patient. Curr Opin Cardiol. 2015 Sep;30(5):506-11. doi: 10.1097/HCO.0000000000000204.

  PMID: 26196657 BACKGROUND

• 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.

  PMID: 29864548 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Cardiovascular Diseases; Risk-Taking; Smoking; Motor Activity

Interventions

Tobacco Products; Diet

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Judith J Prochaska, PhD, MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 14, 2014
• Study Start: June 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: February 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)