Trial Outcomes & Findings for Web-based Smoking Cessation Program for Tribal College Students (NCT NCT02050308)
NCT ID: NCT02050308
Last Updated: 2021-12-07
Results Overview
self-reported and biochemically (salivary cotinine) verified point prevalence abstinence, defined as no smoking for the previous 7 days, at the 6-month follow-up.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
251 participants
Primary outcome timeframe
6 months
Results posted on
2021-12-07
Participant Flow
Participant milestones
| Measure |
Honoring the Gift of Heart Health
The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to heart health (like: Assessing risk for heart disease, increasing fruit and vegetable consumption, physical activity, etc.).
Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy.
|
Internet-All Nations Breath of Life (I-ANBL)
The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to quitting smoking (like: preparing to quit, dealing with cravings, and support systems, etc.) and topics relevant to American Indian culture (like traditional use of tobacco).
Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
124
|
|
Overall Study
COMPLETED
|
28
|
22
|
|
Overall Study
NOT COMPLETED
|
99
|
102
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The row populations only includes participants with available data.
Baseline characteristics by cohort
| Measure |
Honoring the Gift of Heart Health
n=127 Participants
The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to heart health (like: Assessing risk for heart disease, increasing fruit and vegetable consumption, physical activity, etc.).
Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy.
|
Internet-All Nations Breath of Life (I-ANBL)
n=124 Participants
The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to quitting smoking (like: preparing to quit, dealing with cravings, and support systems, etc.) and topics relevant to American Indian culture (like traditional use of tobacco).
Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy.
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=127 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=251 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
127 Participants
n=127 Participants
|
124 Participants
n=124 Participants
|
251 Participants
n=251 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=127 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=251 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=126 Participants • The row populations only includes participants with available data.
|
61 Participants
n=124 Participants • The row populations only includes participants with available data.
|
128 Participants
n=250 Participants • The row populations only includes participants with available data.
|
|
Sex: Female, Male
Male
|
59 Participants
n=126 Participants • The row populations only includes participants with available data.
|
63 Participants
n=124 Participants • The row populations only includes participants with available data.
|
122 Participants
n=250 Participants • The row populations only includes participants with available data.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
127 Participants
n=127 Participants
|
124 Participants
n=124 Participants
|
251 Participants
n=251 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=127 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=251 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=127 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=251 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=127 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=251 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=127 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=251 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=127 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=251 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=127 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=251 Participants
|
|
Region of Enrollment
United States
|
127 participants
n=127 Participants
|
124 participants
n=124 Participants
|
251 participants
n=251 Participants
|
PRIMARY outcome
Timeframe: 6 monthsself-reported and biochemically (salivary cotinine) verified point prevalence abstinence, defined as no smoking for the previous 7 days, at the 6-month follow-up.
Outcome measures
| Measure |
Honoring the Gift of Heart Health
n=127 Participants
The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to heart health (like: Assessing risk for heart disease, increasing fruit and vegetable consumption, physical activity, etc.).
Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy.
|
Internet-All Nations Breath of Life (I-ANBL)
n=124 Participants
The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to quitting smoking (like: preparing to quit, dealing with cravings, and support systems, etc.) and topics relevant to American Indian culture (like traditional use of tobacco).
Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy.
|
|---|---|---|
|
Number of Participants With 7-day Point Prevalence Abstinence
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline in number of cigarettes smoked daily at 6 monthsPopulation: Smokers who were randomized to the Internet All Nations Breath of Life intervention or the Heart Healthy arm focusing on increasing fruits and vegetables. Due to very low retention rate at 6 months (less than 20%), no data were collected at 6 months. Therefore, the data below are baseline mean number of cigarettes smoked by intervention arm.
effect of intervention on the number of cigarettes smoked daily among those who continue to smoke at Month 6
Outcome measures
| Measure |
Honoring the Gift of Heart Health
n=124 Participants
The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to heart health (like: Assessing risk for heart disease, increasing fruit and vegetable consumption, physical activity, etc.).
Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy.
|
Internet-All Nations Breath of Life (I-ANBL)
n=127 Participants
The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to quitting smoking (like: preparing to quit, dealing with cravings, and support systems, etc.) and topics relevant to American Indian culture (like traditional use of tobacco).
Participants in our cessation program have a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy.
|
|---|---|---|
|
Cigarettes Per Day
|
4.00 Cigarettes/day
Standard Deviation 5.15
|
5.43 Cigarettes/day
Standard Deviation 5.42
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Overall retention at 6 months was low at 20% so no data were collected at 6 months.
comparison of the number of serious quit attempts between the two groups using Poisson regression
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: The overall retention rate at 6 months was low at 20% so no data were collected at 6 months.
Number of participants who participated in all online sessions and study protocol procedures over the course of 6 months
Outcome measures
Outcome data not reported
Adverse Events
Honoring the Gift of Heart Health
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Internet-All Nations Breath of Life (I-ANBL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Won S. Choi
The University of Kansas Medical Center
Phone: (913) 588-4742
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place