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Incentives for Oklahoma Tobacco Helpline Engagement in Persistent Poverty Counties

NCT ID: NCT05095779

Last Updated: 2024-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-09

Study Completion Date

2023-08-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cigarette Smoking Nicotine Dependence

Keywords

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Persistent Poverty Smoking Cessation Financial Incentives Contingency Management Tobacco Helpline Tobacco Quitline Socioeconomic Status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oklahoma Tobacco Helpline (OTH)

Participants randomized to OTH will be offered coaching calls and nicotine replacement therapy.

Group Type ACTIVE_COMPARATOR

Coaching calls

Intervention Type BEHAVIORAL

OTH coaching calls

Nicotine replacement therapy

Intervention Type DRUG

8 weeks of nicotine replacement therapy

OTH + Financial Incentives (OTH+FI)

Participants will receive standard OTH care (coaching calls + nicotine replacement therapy) and escalating financial incentives for completing up to 5 coaching calls.

Group Type EXPERIMENTAL

Coaching calls

Intervention Type BEHAVIORAL

OTH coaching calls

Nicotine replacement therapy

Intervention Type DRUG

8 weeks of nicotine replacement therapy

Financial Incentives

Intervention Type BEHAVIORAL

Escalating financial incentives for completing up to 5 coaching calls

Interventions

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Coaching calls

OTH coaching calls

Intervention Type BEHAVIORAL

Nicotine replacement therapy

8 weeks of nicotine replacement therapy

Intervention Type DRUG

Financial Incentives

Escalating financial incentives for completing up to 5 coaching calls

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oklahoma Tobacco Settlement Endowment Trust (TSET)

UNKNOWN

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Darla E. Kendzor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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TSET Health Promotion Research Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 39477130 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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P30CA225520

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K01MD015295

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R25MD011564

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13859

Identifier Type: -

Identifier Source: org_study_id