Persistent Poverty Counties Pregnant Women With Medicaid
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Care + Financial Incentives, Standard Care.
- Who it may be relevant to
- Registry conditions: Tobacco Cessation, Tobacco Use, Tobacco Smoking, Smoking Cessation Financial Incentives. Basic parameters: 18 years — 105 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Monetary Incentives to Promote Engagement With the Oklahoma Tobacco Helpline Among Pregnant Women With Medicaid
Overview
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
- Behavioral Standard Care + Financial Incentives
Financial incentive participants will receive standard care and receive incentives for completing counseling calls and for abstinence. - Other Standard Care
Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.
Primary outcome measures
- Biochemically verified abstinence 12 weeks post enrollment [Time frame: 12 weeks post enrollment]
- Self-reported abstinence 12 weeks postpartum [Time frame: 12 weeks postpartum]
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
Exclusion criteria
- participants will be excluded if they do not meet the inclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- TSET Health Promotion Research Center — Oklahoma City
Identifiers
NCT: NCT05415371 · 14736