Persistent Poverty Counties Pregnant Women With Medicaid

Monetary Incentives to Promote Engagement With the Oklahoma Tobacco Helpline Among Pregnant Women With Medicaid

Although many women initially quit smoking during pregnancy, most will return to smoking by the end of pregnancy or during the first 6 months postpartum. The proposed pilot project is designed to evaluate the feasibility and potential efficacy of offering small financial incentives for the completion of smoking cessation coaching and biochemically-verified smoking abstinence at follow-up among pregnant women with Medicaid insurance who contact the Oklahoma Tobacco Helpline (OTH). The study will enroll 100 pregnant women who will be randomly assigned to OTH care or OTH plus escalating incentives (OTH+I) for completing up to 5 coaching calls over the first 8 weeks after enrolling (prepartum) and for biochemically-verified smoking abstinence at 9 weeks post-enrollment (assessed remotely via smartphone). In addition, participants will be incentivized for completing a postpartum coaching call by 8 weeks postpartum. Feasibility outcomes for the incentives based intervention will focus on coaching call completion, rates of prepartum and postpartum follow-up, biochemically-verified smoking cessation, and perceptions of the intervention. Potential effectiveness will be evaluated by comparing biochemically-verified smoking abstinence rates in OTH+I relative to OTH alone at 12 weeks post-enrollment (prepartum) and 12 weeks postpartum.

Study Overview

• Status: Enrolling by invitation
• Conditions: Tobacco Cessation; Tobacco Use; Tobacco Smoking; Smoking Cessation Financial Incentives; Socioeconomic Status; Contingency Management; Pregnancy
• Intervention / Treatment: Other: Standard Care; Behavioral: Standard Care + Financial Incentives

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

• contact the Oklahoma Tobacco Helpline seeking smoking cessation treatment, and enroll in the multiple call program
• are a female ≤ 25 weeks pregnant
• report smoking ≥ 5 cigarettes per day
• are ≥ 18 years of age
• are able to provide a copy/photo of their ID/driver's license or other documentation of identity
• are able to read, speak, and understand English

Exclusion Criteria

• participants will be excluded if they do not meet the inclusion criteria

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care; Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.	Other: Standard Care; Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.
Experimental: Standard Care + Financial Incentives; Financial Incentives participants will receive standard care plus incentives for completing counseling calls and abstinence.	Other: Standard Care; Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.; Behavioral: Standard Care + Financial Incentives; Financial incentive participants will receive standard care and receive incentives for completing counseling calls and for abstinence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically verified abstinence 12 weeks post enrollment	The outcome measure is biochemically verified over 7-day point prevalence at 12 weeks post-enrollment.	12 weeks post enrollment
Self-reported abstinence 12 weeks postpartum	The outcome measure is biochemically verified abstinence over 7-day point prevalence at 12 weeks post-partum	12 weeks postpartum

Collaborators and Investigators

• Sponsor: University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 14736

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No