Incentives for Oklahoma Tobacco Helpline Engagement in Persistent Poverty Counties (CLIMB)

December 12, 2024 updated by: University of Oklahoma

Monetary Incentives to Promote Engagement With the Oklahoma Tobacco Helpline in Counties Experiencing Persistent Poverty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • TSET Health Promotion Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oklahoma Tobacco Helpline (OTH)
Participants randomized to OTH will be offered coaching calls and nicotine replacement therapy.
Behavioral: Coaching calls
OTH coaching calls
Drug: Nicotine replacement therapy
8 weeks of nicotine replacement therapy
Experimental: 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.
Behavioral: Coaching calls
OTH coaching calls
Drug: Nicotine replacement therapy
8 weeks of nicotine replacement therapy
Behavioral: Financial Incentives
Escalating financial incentives for completing up to 5 coaching calls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-Day Point Prevalence Abstinence
Time Frame: 12 weeks post-enrollment
Self-reported smoking abstinence 7-day point prevalence at 12 weeks post-enrollment (missing considered smoking).
12 weeks post-enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-Day Point Prevalence Abstinence
Time Frame: 8 weeks post-enrollment
Self-reported 7-day point prevalence abstinence at 8 weeks post-enrollment (missing considered smoking)
8 weeks post-enrollment
Coaching Calls Completed (Total Number)
Time Frame: First 8 weeks post-enrollment
The total number of coaching calls completed.
First 8 weeks post-enrollment
Completed >=3 Coaching Calls
Time Frame: First 8 weeks post-enrollment
The proportion of participants who completed at least 3 coaching calls
First 8 weeks post-enrollment
Retention
Time Frame: 8 weeks post-enrollment
The number of participants who completed the follow-up assessment.
8 weeks post-enrollment
Retention
Time Frame: 12 weeks post-enrollment
The number of participants who completed the follow-up assessment.
12 weeks post-enrollment
Incentives Earned
Time Frame: First 8 weeks post-enrollment
The mean amount of call-contingent incentives earned among participants assigned to the OTH+FI group.
First 8 weeks post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Collaborators

National Cancer Institute (NCI)
National Institute on Minority Health and Health Disparities (NIMHD)
Oklahoma Tobacco Settlement Endowment Trust (TSET)

Investigators

  • Principal Investigator: Darla E. Kendzor, PhD, University of Oklahoma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2022

Primary Completion (Actual)

August 11, 2023

Study Completion (Actual)

August 11, 2023

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 14, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13859
  • K01MD015295 (U.S. NIH Grant/Contract)
  • P30CA225520 (U.S. NIH Grant/Contract)
  • R25MD011564 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

De-identified data will be made available to investigators upon request after publication of the primary study findings.

IPD Sharing Access Criteria

Data sharing agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nicotine Dependence

Clinical Trials on Coaching calls

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe