Telephone-based smoking cessation program for American Indians
Assessing Telephone All Nations Breath of Life for Efficacy
This study is testing a phone-based program to help American Indians quit smoking by providing counseling and support, and it will see if this tailored approach works better than a standard program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lehigh University Academic / other |
| Locations | 1 site (Bethlehem, Pennsylvania) |
| Trial ID | NCT04764175 on ClinicalTrials.gov |
What this trial studies
This project tests a telephone-based version of the All Nations Breath of Life smoking cessation program specifically designed for American Indians. Participants will receive individual counseling sessions, motivational text messaging, and educational materials, with the option to use pharmacotherapy. The study compares the efficacy of this culturally tailored program against a non-tailored comparison program, focusing on smoking cessation rates at 6 and 12 months. The approach utilizes a Bayesian Adaptive Design to assess outcomes and demographic predictors of cessation.
Who should consider this trial
Good fit: Ideal candidates are American Indian adults aged 18 or older who smoke at least one cigarette per day.
Not a fit: Patients who cannot provide a stable phone number for the duration of the study or have a household member already participating will not benefit.
Why it matters
Potential benefit: If successful, this program could significantly improve smoking cessation rates among American Indian populations.
How similar studies have performed: Other studies have shown success with culturally tailored smoking cessation programs, indicating potential for positive outcomes with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older * Self-reported American Indian * Smokes at least 1 cigarette per day * Have a home address or stable address to which we can mail program supplies * Have a stable telephone number that can be used for the purpose of the study * Willing to be followed for 12 months Exclusion Criteria: * Cannot provide a stable phone number for the purpose of the study that will be available for a minimum of 12 months * Household member already in the study
Where this trial is running
Bethlehem, Pennsylvania
- Lehigh University — Bethlehem, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Christine M Daley, PhD, MA, SM — Lehigh University
- Study coordinator: Christine M Daley, PhD, MA, SM
- Email: cmdaley@lehigh.edu
- Phone: 610-758-1878
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.