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Persistent Poverty Counties Pregnant Women With Medicaid

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05415371
Enrollment
100
Registered
2022-06-13
Start date
2022-09-30
Completion date
2025-12-31
Last updated
2024-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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

OTHERStandard Care

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

Sponsors

University of Oklahoma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 105 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Biochemically verified abstinence 12 weeks post enrollment12 weeks post enrollmentThe outcome measure is biochemically verified over 7-day point prevalence at 12 weeks post-enrollment.
Self-reported abstinence 12 weeks postpartum12 weeks postpartumThe outcome measure is biochemically verified abstinence over 7-day point prevalence at 12 weeks post-partum

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026