Persistent Poverty Counties Pregnant Women With Medicaid

NCT ID: NCT05415371

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Tobacco Cessation; Tobacco Use; Tobacco Smoking; Smoking Cessation Financial Incentives; Socioeconomic Status; Contingency Management; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Care

Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: OTHER

Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.

Standard Care + Financial Incentives

Financial Incentives participants will receive standard care plus incentives for completing counseling calls and abstinence.

Group Type: EXPERIMENTAL

Standard Care + Financial Incentives

Intervention Type: BEHAVIORAL

Financial incentive participants will receive standard care and receive incentives for completing counseling calls and for abstinence.

Standard Care

Intervention Type: OTHER

Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.

Interventions

Standard Care + Financial Incentives

Financial incentive participants will receive standard care and receive incentives for completing counseling calls and for abstinence.

Intervention Type: BEHAVIORAL

Standard Care

Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

14736

Identifier Type: -

Identifier Source: org_study_id