Persistent Poverty Counties Pregnant Women With Medicaid

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT05415371
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 105 Years
Healthy Volunteers
Accepted

Interventions

  • Standard Care + Financial Incentives — BEHAVIORAL
    Financial incentive participants will receive standard care and receive incentives for completing counseling calls and for abstinence.
  • Standard Care — OTHER
    Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.

Study Details

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.

Key Dates

Start date
Sep 30, 2022
Status verified
Sep 2024
Primary completion
Jun 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.

Primary Outcome Measure

Biochemically verified abstinence 12 weeks post enrollment [ Time Frame: 12 weeks post enrollment ]

Locations (1)

FacilityCityStateZIPSite coordinators
TSET Health Promotion Research CenterOklahoma CityOklahoma73104-

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TSET Health Promotion Research Center· Oklahoma City, OK

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