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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL117736 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| Alaska Native Tribal Health Consortium | OTHER |
| University of Alaska Anchorage | OTHER |
| Norton Sound Health Corporation |
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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).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith J Prochaska, PhD, MPH | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norton Sound Health Corporation | Nome | Alaska | 99762 | United States | ||
| Stanford Hospital and Clinics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26332005 | Background | 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. | |
| 26196657 | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 14, 2018 | Jan 28, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D002318 | Cardiovascular Diseases |
| D012309 | Risk-Taking |
| D012907 | Smoking |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D062789 | Tobacco Products |
| D004032 | Diet |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D009747 | Nutritional Physiological Phenomena |
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| OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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| 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. |
|
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 |
| Stanford |
| California |
| 94304 |
| United States |
| 29864548 | Derived | 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. |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |