Persistent Poverty Counties Pregnant Women With Medicaid

University of Oklahoma (OU)

Status: Invitation-only

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

Treatments: Other: Standard Care; Behavioral: Standard Care + Financial Incentives

Study type: Interventional

Funder types: Other

Identifiers

NCT05415371

14736

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 105 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Exclusion Criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Standard Care

Active Comparator group

Description:

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

Treatment:

Other: Standard Care

Standard Care + Financial Incentives

Experimental group

Description:

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

Treatment:

Behavioral: Standard Care + Financial Incentives

Other: Standard Care