Cigarette Smoking, Nicotine Dependence
Conditions
Keywords
Persistent Poverty, Smoking Cessation, Financial Incentives, Contingency Management, Tobacco Helpline, Tobacco Quitline, Socioeconomic Status
Brief summary
The proposed pilot project is designed to evaluate the feasibility and potential efficacy of offering small financial incentives for the completion of smoking cessation counseling and self-reported abstinence at follow-up among Oklahoma Tobacco Helpline (OTH) callers living in persistent poverty counties (PPCs). The study will enroll at least 160 adults who reside in any of the 16 persistent poverty counties in Oklahoma, who are seeking smoking cessation treatment through the OTH.
Detailed description
The proposed randomized controlled trial will enroll adults who are seeking smoking cessation treatment through the OTH and who reside in any of the 16 PPCs in Oklahoma. Participants will be randomly assigned to OTH (coaching calls + nicotine replacement therapy) or OTH plus escalating financial incentives (OTH+FI) for completing up to 5 counseling calls over 8 weeks. Feasibility outcomes for the incentives-based intervention will focus on counseling call completions, follow-up assessment completion, smoking cessation, and incentive costs. Potential effectiveness will be evaluated based on comparisons of counseling call completions over the first 8 weeks post-enrollment and rates of self-reported smoking abstinence through 12 weeks post-enrollment (4 weeks after incentives have ended) in OTH+FI relative to OTH alone.
Interventions
BEHAVIORALCoaching calls
OTH coaching calls
DRUGNicotine replacement therapy
8 weeks of nicotine replacement therapy
BEHAVIORALFinancial Incentives
Escalating financial incentives for completing up to 5 coaching calls
Sponsors
Oklahoma Tobacco Settlement Endowment Trust (TSET)
National Cancer Institute (NCI)
National Institute on Minority Health and Health Disparities (NIMHD)
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Contact the OTH seeking smoking cessation treatment 2. Reside in any of the 16 PPCs in Oklahoma (Adair, Caddo, Cherokee, Choctaw, Greer, Harmon, Haskell, Hughes, Johnston, McCurtain, Okfuskee, Payne, Pushmataha, Seminole, Sequoyah, Tillman) 3. Report smoking ≥ 5 cigarettes per day 4. Are ≥ 18 years of age 5. Are able to provide a copy/photo of their ID/driver's license or other documentation of identity and residence 6. Be able to read, speak, and understand English 7. Have no contradictions for NRT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-Day Point Prevalence Abstinence | 12 weeks post-enrollment | Self-reported smoking abstinence 7-day point prevalence at 12 weeks post-enrollment (missing considered smoking). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7-Day Point Prevalence Abstinence | 8 weeks post-enrollment | Self-reported 7-day point prevalence abstinence at 8 weeks post-enrollment (missing considered smoking) |
| Coaching Calls Completed (Total Number) | First 8 weeks post-enrollment | The total number of coaching calls completed. |
| Completed >=3 Coaching Calls | First 8 weeks post-enrollment | The proportion of participants who completed at least 3 coaching calls |
| Retention | 8 weeks post-enrollment | The number of participants who completed the follow-up assessment. |
| Incentives Earned | First 8 weeks post-enrollment | The mean amount of call-contingent incentives earned among participants assigned to the OTH+FI group. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oklahoma Tobacco Helpline (OTH) Participants were offered coaching calls and 8 weeks of nicotine replacement therapy. | 81 |
| Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI) 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. | 84 |
| Total | 165 |
Baseline characteristics
| Characteristic | Oklahoma Tobacco Helpline (OTH) | Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI) | Total |
|---|---|---|---|
| Age, Continuous | 49.49 years STANDARD_DEVIATION 13.84 | 46.14 years STANDARD_DEVIATION 13.65 | 47.79 years STANDARD_DEVIATION 13.81 |
| Cigarettes Smoked Per Day (pre-quit) | 21.41 Cigarettes per day STANDARD_DEVIATION 11.4 | 20.64 Cigarettes per day STANDARD_DEVIATION 11.97 | 21.01 Cigarettes per day STANDARD_DEVIATION 11.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 78 Participants | 80 Participants | 158 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 8 Participants | 12 Participants | 20 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 63 Participants | 67 Participants | 130 Participants |
| Region of Enrollment United States | 81 Participants | 84 Participants | 165 Participants |
| Sex: Female, Male Female | 52 Participants | 53 Participants | 105 Participants |
| Sex: Female, Male Male | 29 Participants | 31 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 84 |
| other Total, other adverse events | 0 / 81 | 0 / 84 |
| serious Total, serious adverse events | 0 / 81 | 0 / 84 |
Outcome results
Primary
7-Day Point Prevalence Abstinence
Self-reported smoking abstinence 7-day point prevalence at 12 weeks post-enrollment (missing considered smoking).
Time frame: 12 weeks post-enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oklahoma Tobacco Helpline (OTH) | 7-Day Point Prevalence Abstinence | 30 Participants |
| Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI) | 7-Day Point Prevalence Abstinence | 44 Participants |
Secondary
7-Day Point Prevalence Abstinence
Self-reported 7-day point prevalence abstinence at 8 weeks post-enrollment (missing considered smoking)
Time frame: 8 weeks post-enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oklahoma Tobacco Helpline (OTH) | 7-Day Point Prevalence Abstinence | 26 Participants |
| Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI) | 7-Day Point Prevalence Abstinence | 42 Participants |
Secondary
Coaching Calls Completed (Total Number)
The total number of coaching calls completed.
Time frame: First 8 weeks post-enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oklahoma Tobacco Helpline (OTH) | Coaching Calls Completed (Total Number) | 2 calls completed |
| Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI) | Coaching Calls Completed (Total Number) | 3 calls completed |
Secondary
Completed >=3 Coaching Calls
The proportion of participants who completed at least 3 coaching calls
Time frame: First 8 weeks post-enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oklahoma Tobacco Helpline (OTH) | Completed >=3 Coaching Calls | 22 Participants |
| Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI) | Completed >=3 Coaching Calls | 46 Participants |
Secondary
Incentives Earned
The mean amount of call-contingent incentives earned among participants assigned to the OTH+FI group.
Time frame: First 8 weeks post-enrollment
Population: Participants in the OTH group did not earn call-contingent incentives.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI) | Incentives Earned | 60.71 dollars | Standard Error 39.77 |
Secondary
Retention
The number of participants who completed the follow-up assessment.
Time frame: 12 weeks post-enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oklahoma Tobacco Helpline (OTH) | Retention | 65 Participants |
| Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI) | Retention | 73 Participants |
Secondary
Retention
The number of participants who completed the follow-up assessment.
Time frame: 8 weeks post-enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oklahoma Tobacco Helpline (OTH) | Retention | 69 Participants |
| Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI) | Retention | 71 Participants |