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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA225520 | U.S. NIH Grant/Contract | View source | |
| K01MD015295 | U.S. NIH Grant/Contract | View source | |
| R25MD011564 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Oklahoma Tobacco Settlement Endowment Trust (TSET) | UNKNOWN |
| National Cancer Institute (NCI) | NIH |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oklahoma Tobacco Helpline (OTH) | Active Comparator | Participants randomized to OTH will be offered coaching calls and nicotine replacement therapy. |
|
| OTH + Financial Incentives (OTH+FI) | Experimental | Participants will receive standard OTH care (coaching calls + nicotine replacement therapy) and escalating financial incentives for completing up to 5 coaching calls. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coaching calls | Behavioral | OTH coaching calls |
|
| Measure | Description | Time Frame |
|---|---|---|
| 7-Day Point Prevalence Abstinence | Self-reported smoking abstinence 7-day point prevalence at 12 weeks post-enrollment (missing considered smoking). | 12 weeks post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 7-Day Point Prevalence Abstinence | Self-reported 7-day point prevalence abstinence at 8 weeks post-enrollment (missing considered smoking) | 8 weeks post-enrollment |
| Coaching Calls Completed (Total Number) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darla E. Kendzor, PhD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TSET Health Promotion Research Center | Oklahoma City | Oklahoma | 73104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39477130 | Result | Kendzor DE, Davie M, Chen M, Hart J, Frank-Pearce SG, Doescher MP, Alexander AC, Businelle MS, Ogunsanya ME, Sifat MS, Boozary LK. Incentivizing Tobacco Helpline Engagement in Persistent Poverty Counties: A Randomized Trial. Am J Prev Med. 2025 Feb;68(2):336-347. doi: 10.1016/j.amepre.2024.10.014. Epub 2024 Oct 29. |
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De-identified data will be made available to investigators upon request, after publication of the primary study findings, and with a data-sharing agreement that specifies the investigator(s) will 1) use the data only for research purposes and not to identify any individual participant, 2) store the data on a secure device (e.g., encrypted, password-protected), and 3) destroy or return the data after completion of the analyses.
De-identified data will be made available to investigators upon request after publication of the primary study findings.
Data sharing agreement
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| ID | Title | Description |
|---|---|---|
| FG000 | Oklahoma Tobacco Helpline (OTH) | Participants randomized to OTH were be offered 5-7 counseling calls and 8 weeks of nicotine replacement therapy. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oklahoma Tobacco Helpline (OTH) | Participants were offered coaching calls and 8 weeks of nicotine replacement therapy. |
| BG001 | Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 7-Day Point Prevalence Abstinence | Self-reported smoking abstinence 7-day point prevalence at 12 weeks post-enrollment (missing considered smoking). | Posted | Count of Participants | Participants | 12 weeks post-enrollment |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oklahoma Tobacco Helpline (OTH) | Participants were offered 5-7 coaching calls and 8 weeks of nicotine replacement therapy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Darla E. Kendzor | The University of Oklahoma Health Sciences | (405) 271-7848 | Darla-Kendzor@ouhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2023 | Jun 19, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D019966 |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Nicotine replacement therapy | Drug | 8 weeks of nicotine replacement therapy |
|
| Financial Incentives | Behavioral | Escalating financial incentives for completing up to 5 coaching calls |
|
The total number of coaching calls completed.
| First 8 weeks post-enrollment |
| Completed >=3 Coaching Calls | The proportion of participants who completed at least 3 coaching calls | First 8 weeks post-enrollment |
| Retention | The number of participants who completed the follow-up assessment. | 8 weeks post-enrollment |
| Retention | The number of participants who completed the follow-up assessment. | 12 weeks post-enrollment |
| Incentives Earned | The mean amount of call-contingent incentives earned among participants assigned to the OTH+FI group. | First 8 weeks post-enrollment |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Cigarettes Smoked Per Day (pre-quit) | Mean | Standard Deviation | Cigarettes per day |
|
|
|
| Secondary | 7-Day Point Prevalence Abstinence | Self-reported 7-day point prevalence abstinence at 8 weeks post-enrollment (missing considered smoking) | Posted | Count of Participants | Participants | 8 weeks post-enrollment |
|
|
|
| Secondary | Coaching Calls Completed (Total Number) | The total number of coaching calls completed. | Posted | Median | Inter-Quartile Range | calls completed | First 8 weeks post-enrollment |
|
|
|
| Secondary | Completed >=3 Coaching Calls | The proportion of participants who completed at least 3 coaching calls | Posted | Count of Participants | Participants | First 8 weeks post-enrollment |
|
|
|
| Secondary | Retention | The number of participants who completed the follow-up assessment. | Posted | Count of Participants | Participants | 8 weeks post-enrollment |
|
|
|
| Secondary | Retention | The number of participants who completed the follow-up assessment. | Posted | Count of Participants | Participants | 12 weeks post-enrollment |
|
|
|
| Secondary | Incentives Earned | The mean amount of call-contingent incentives earned among participants assigned to the OTH+FI group. | Participants in the OTH group did not earn call-contingent incentives. | Posted | Mean | Standard Error | dollars | First 8 weeks post-enrollment |
|
|
|
| 0 |
| 81 |
| 0 |
| 81 |
| 0 |
| 81 |
| EG001 | Oklahoma Tobacco Helpline + Financial Incentives (OTH+FI) | 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. | 0 | 84 | 0 | 84 | 0 | 84 |
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| Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |