Trial Outcomes & Findings for Incentives for Oklahoma Tobacco Helpline Engagement in Persistent Poverty Counties (NCT NCT05095779)
NCT ID: NCT05095779
Last Updated: 2024-12-30
Results Overview
Self-reported smoking abstinence 7-day point prevalence at 12 weeks post-enrollment (missing considered smoking).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
165 participants
Primary outcome timeframe
12 weeks post-enrollment
Results posted on
2024-12-30
Participant Flow
Participant milestones
| Measure |
Oklahoma Tobacco Helpline (OTH)
Participants randomized to OTH were be offered 5-7 counseling calls and 8 weeks of nicotine replacement therapy.
|
Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI)
Participants randomized to OTH+FI were offered 5-7 counseling calls and 8 weeks of nicotine replacement therapy. In addition, participants had the opportunity to earn incentives for the completion of up to five OTH coaching calls over the first eight weeks post-enrollment.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
84
|
|
Overall Study
COMPLETED
|
65
|
73
|
|
Overall Study
NOT COMPLETED
|
16
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Incentives for Oklahoma Tobacco Helpline Engagement in Persistent Poverty Counties
Baseline characteristics by cohort
| Measure |
Oklahoma Tobacco Helpline (OTH)
n=81 Participants
Participants were offered coaching calls and 8 weeks of nicotine replacement therapy.
|
Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI)
n=84 Participants
Participants were offered coaching calls and 8 weeks of nicotine replacement therapy. In addition, participants had the opportunity to earn incentives for the completion of up to 5 coaching calls over the first 8 weeks post-enrollment.
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.49 years
STANDARD_DEVIATION 13.84 • n=99 Participants
|
46.14 years
STANDARD_DEVIATION 13.65 • n=107 Participants
|
47.79 years
STANDARD_DEVIATION 13.81 • n=206 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
158 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
81 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
165 Participants
n=206 Participants
|
|
Cigarettes Smoked Per Day (pre-quit)
|
21.41 Cigarettes per day
STANDARD_DEVIATION 11.40 • n=99 Participants
|
20.64 Cigarettes per day
STANDARD_DEVIATION 11.97 • n=107 Participants
|
21.01 Cigarettes per day
STANDARD_DEVIATION 11.67 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post-enrollmentSelf-reported smoking abstinence 7-day point prevalence at 12 weeks post-enrollment (missing considered smoking).
Outcome measures
| Measure |
Oklahoma Tobacco Helpline (OTH)
n=81 Participants
Participants were offered 5-7 coaching calls and 8 weeks of nicotine replacement therapy.
|
Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI)
n=84 Participants
Participants were offered 5-7 coaching calls and 8 weeks of nicotine replacement therapy. In addition, participants had the opportunity to earn incentives for the completion of up to 5 coaching calls over the first 8 weeks post-enrollment.
|
|---|---|---|
|
7-Day Point Prevalence Abstinence
|
30 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 8 weeks post-enrollmentSelf-reported 7-day point prevalence abstinence at 8 weeks post-enrollment (missing considered smoking)
Outcome measures
| Measure |
Oklahoma Tobacco Helpline (OTH)
n=81 Participants
Participants were offered 5-7 coaching calls and 8 weeks of nicotine replacement therapy.
|
Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI)
n=84 Participants
Participants were offered 5-7 coaching calls and 8 weeks of nicotine replacement therapy. In addition, participants had the opportunity to earn incentives for the completion of up to 5 coaching calls over the first 8 weeks post-enrollment.
|
|---|---|---|
|
7-Day Point Prevalence Abstinence
|
26 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: First 8 weeks post-enrollmentThe total number of coaching calls completed.
Outcome measures
| Measure |
Oklahoma Tobacco Helpline (OTH)
n=81 Participants
Participants were offered 5-7 coaching calls and 8 weeks of nicotine replacement therapy.
|
Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI)
n=84 Participants
Participants were offered 5-7 coaching calls and 8 weeks of nicotine replacement therapy. In addition, participants had the opportunity to earn incentives for the completion of up to 5 coaching calls over the first 8 weeks post-enrollment.
|
|---|---|---|
|
Coaching Calls Completed (Total Number)
|
2 calls completed
Interval 1.0 to 3.0
|
3 calls completed
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: First 8 weeks post-enrollmentThe proportion of participants who completed at least 3 coaching calls
Outcome measures
| Measure |
Oklahoma Tobacco Helpline (OTH)
n=81 Participants
Participants were offered 5-7 coaching calls and 8 weeks of nicotine replacement therapy.
|
Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI)
n=84 Participants
Participants were offered 5-7 coaching calls and 8 weeks of nicotine replacement therapy. In addition, participants had the opportunity to earn incentives for the completion of up to 5 coaching calls over the first 8 weeks post-enrollment.
|
|---|---|---|
|
Completed >=3 Coaching Calls
|
22 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: 8 weeks post-enrollmentThe number of participants who completed the follow-up assessment.
Outcome measures
| Measure |
Oklahoma Tobacco Helpline (OTH)
n=81 Participants
Participants were offered 5-7 coaching calls and 8 weeks of nicotine replacement therapy.
|
Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI)
n=84 Participants
Participants were offered 5-7 coaching calls and 8 weeks of nicotine replacement therapy. In addition, participants had the opportunity to earn incentives for the completion of up to 5 coaching calls over the first 8 weeks post-enrollment.
|
|---|---|---|
|
Retention
|
69 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: 12 weeks post-enrollmentThe number of participants who completed the follow-up assessment.
Outcome measures
| Measure |
Oklahoma Tobacco Helpline (OTH)
n=81 Participants
Participants were offered 5-7 coaching calls and 8 weeks of nicotine replacement therapy.
|
Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI)
n=84 Participants
Participants were offered 5-7 coaching calls and 8 weeks of nicotine replacement therapy. In addition, participants had the opportunity to earn incentives for the completion of up to 5 coaching calls over the first 8 weeks post-enrollment.
|
|---|---|---|
|
Retention
|
65 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: First 8 weeks post-enrollmentPopulation: Participants in the OTH group did not earn call-contingent incentives.
The mean amount of call-contingent incentives earned among participants assigned to the OTH+FI group.
Outcome measures
| Measure |
Oklahoma Tobacco Helpline (OTH)
Participants were offered 5-7 coaching calls and 8 weeks of nicotine replacement therapy.
|
Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI)
n=84 Participants
Participants were offered 5-7 coaching calls and 8 weeks of nicotine replacement therapy. In addition, participants had the opportunity to earn incentives for the completion of up to 5 coaching calls over the first 8 weeks post-enrollment.
|
|---|---|---|
|
Incentives Earned
|
—
|
60.71 dollars
Standard Error 39.77
|
Adverse Events
Oklahoma Tobacco Helpline (OTH)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI)
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. Darla E. Kendzor
The University of Oklahoma Health Sciences
Phone: (405) 271-7848
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place