Tobacco DependenceHEALTHHNCT02137902
Healing and Empowering Alaskan Lives Towards Healthy-Hearts Study
A study testing Tobacco/Physical Activity Intervention and Diet plus BP/CHOL Intervention in people with Tobacco Dependence, run by Stanford University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Tobacco/Physical Activity Intervention and Diet plus BP/CHOL Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2015to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smoking > 5 cigarettes/day and > 100 cigarettes in one's lifetime
- Hypertension, hypercholesterolemia, or established vascular disease
- Fluent in English language
Who cannot join
- Dementia or other brain injury
- Pregnancy or breastfeeding
- Currently engaged in tobacco treatment or using cessation pharmacotherapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Norton Sound Health Corporation
Nome, Alaska, 99762
Stanford Hospital and Clinics
Stanford, California, 94304
About this study
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).
Read the 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:
- 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.
- 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.
- Conditions
- Tobacco Dependence
- Being tested
- Tobacco/Physical Activity Intervention, Diet plus BP/CHOL Intervention
- Keywords
- Tobacco dependence, Cardiovascular disease, Risk behaviors, Smoking, Physical activity, Alaska Native people
- Medical subject headings
- Tobacco Use Disorder, Cardiovascular Diseases, Risk-Taking, Smoking, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco/Physical Activity InterventionBehavioural
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.
Diet plus BP/CHOL InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Diet plus BP/CHOL Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Status: 7-day point prevalence abstinence
Change from baseline as no tobacco use, including a puff, in the past 7 days
Measured: Assessed at baseline, 3, 6, 12, and 18 months
Secondary outcomes (9)
Minutes of moderate-to-vigorous physical activity in past 7 days
self-reported minutes of moderate-to-vigorous physical activity
Measured: Assessed at baseline, 3, 6, 12, and 18 months
Blood pressure
Measured as systolic/diastolic in mmHg
Measured: Assessed at baseline, 3, 6, 12, and 18 months
Total, LDL, and HDL cholesterol
measured in milligrams per deciliter of blood (mg/dL)
Measured: Assessed at baseline and 18 months
Body Mass Index (BMI)
weight (in kilograms) over height squared (in centimeters)
Measured: 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
Measured: Assessed at baseline and 18 months
Medication Adherence
self-reported assessment of adherence to BP and CHOL meds
Measured: Assessed at baseline, 3, 6, 12 and 18 months
Dietary Quality
culturally tailored FFQ assessing consumption of native and non-native foods
Measured: 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)
Measured: 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)
Measured: Assessed at baseline, 3, 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study start1 Jun 2015
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Alaska Native Tribal Health Consortium, University of Alaska Anchorage, Norton Sound Health Corporation, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Judith Prochaska, Stanford University
- Investigators
- Judith J Prochaska, PhD, MPH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137902
- Sponsor's protocol ID
- 29638
- Other IDs
- 1R01HL117736
- Acronym
- HEALTHH
- Status last verified
- Jan 2022
- First submitted
- 12 May 2014
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 26332005Prochaska JJ, Benowitz NL. Smoking cessation and the cardiovascular patient. Curr Opin Cardiol. 2015 Sep;30(5):506-11. doi: 10.1097/HCO.0000000000000204.
PubMed 26196657Prochaska 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.
PubMed 29864548
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing and Empowering Alaskan Lives Towards Healthy-Hearts Study
- ClinicalTrials.gov ID
- NCT02137902
- Acronym / sponsor ID
- HEALTHH / 29638
- Conditions
- Tobacco Dependence
- Keywords
- Tobacco dependence, Cardiovascular disease, Risk behaviors, Smoking, Physical activity, Alaska Native people
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Alaska Native Tribal Health Consortium, University of Alaska Anchorage, Norton Sound Health Corporation, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jun 2015
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tobacco/Physical Activity Intervention | Experimental | Behavioral: Tobacco/Physical Activity InterventionIncludes 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. |
| Diet plus BP/CHOL Intervention | Experimental | Behavioral: Diet plus BP/CHOL InterventionConsists 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Smoking > 5 cigarettes/day and > 100 cigarettes in one's lifetime
- Hypertension, hypercholesterolemia, or established vascular disease
- Fluent in English language
Key exclusion criteria (3 listed)
- Dementia or other brain injury
- Pregnancy or breastfeeding
- Currently engaged in tobacco treatment or using cessation pharmacotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobacco/Physical Activity InterventionTelemedicine 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. | Behavioural | Tobacco/Physical Activity Intervention |
| Diet plus BP/CHOL InterventionTelemedicine 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. | Behavioural | Diet plus BP/CHOL Intervention |
Primary outcome
Smoking Status: 7-day point prevalence abstinence
Time frame: Assessed at baseline, 3, 6, 12, and 18 months
Change from baseline as no tobacco use, including a puff, in the past 7 days
9 secondary outcomes
Minutes of moderate-to-vigorous physical activity in past 7 days
Time frame: Assessed at baseline, 3, 6, 12, and 18 months
Blood pressure
Time frame: Assessed at baseline, 3, 6, 12, and 18 months
Total, LDL, and HDL cholesterol
Time frame: Assessed at baseline and 18 months
Body Mass Index (BMI)
Time frame: Assessed at baseline, 3, 6, 12, and 18 months
Framingham Risk Factor Score
Time frame: Assessed at baseline and 18 months
Medication Adherence
Time frame: Assessed at baseline, 3, 6, 12 and 18 months
Dietary Quality
Time frame: Assessed at baseline, 3, 6, 12 and 18 months
Multiple Risk Behavior Change Impact Factor
Time frame: Assessed at baseline, 3, 6, 12 and 18 months
Linear index of multiple behavior change
Time frame: Assessed at baseline, 3, 6, 12 and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Background: PubMed 26332005Prochaska 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.
- Background: PubMed 26196657Prochaska JJ, Benowitz NL. Smoking cessation and the cardiovascular patient. Curr Opin Cardiol. 2015 Sep;30(5):506-11. doi: 10.1097/HCO.0000000000000204.
- Derived from this study: PubMed 29864548Prochaska 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith J Prochaska, PhD, MPH principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco/Physical Activity Intervention and Diet plus BP/CHOL Intervention in people with Tobacco Dependence, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Status: 7-day point prevalence abstinence (time frame: Assessed at baseline, 3, 6, 12, and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02137902, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.