CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 251 enrolled
Drug / intervention
Nicotine gum, Patch, or Lozenge or Zyban® or Chantix® +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02050308
NCT02050308Phase 3Completed

Web-based Smoking Cessation Program for Tribal College Students

Won Choi, PhD, MPH·interventional·Posted Jan 30, 2014·Updated Dec 7, 2021

In Brief

A Phase 3 clinical trial evaluating Internet-All Nations Breath of Life (I-ANBL), Honoring the Gift of Heart Health, and 1 other intervention for Smoking Cessation. Completed, enrolled 251 participants across 2 sites.

Detailed Summary

The purpose of this study is to test the effectiveness of a culturally-tailored Internet-based program that helps American Indian (AI) tribal college students quit smoking.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 30, 2014
Enrollment StartMay 1, 2015
Primary CompletionMar 31, 2019
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 12.4 years ago

Interventions

Internet-All Nations Breath of Life (I-ANBL)other

* Participants will be asked to log into the website prior to the first session to allow for any problems with the site to be fixed prior to sessions starting. Topics we anticipate covering include, but are not limited to: preparing to quit, dealing with cravings, support systems, traditional tobacco, stress reduction, weight management, and staying quit, along with other topics determined during program development. For each session, the tribal college student will begin the session by answering a series of questions to produce an individually-tailored report that will be provided on the screen at the end of each week's session so that the smoker can work on strategies during the week before the next internet session * Weekly procedures will follow the same format as for the first session

Honoring the Gift of Heart Healthother

These sessions help American Indians learn about what they can do to prevent heart disease. We will emphasize the increase consumption of fruits and vegetables as well as addressing other heart healthy activities. Honoring the Gift of Heart Health is a user-friendly program developed especially for American Indians. The manual provides the "how-to" for leading group education sessions. It offers "hands-on" activities that help people build the skills they need to make simple, practical, and lasting changes to help them fight heart disease. The protocol will follow procedures as the I-ANBL arm, however, this fruit and vegetable arm will not include individually tailored components, but just interactive web-based materials related to increasing heart health, including certain activities.

Nicotine gum, Patch, or Lozenge or Zyban® or Chantix®drug

Regardless of the intervention arm to which subjects are assigned, they will choose the option of nicotine replacement therapy they want, as long as they are eligible for it. All participants are offered the medications, but they do not have to take any medication to participate in the study.