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Persistent Poverty Counties Pregnant Women With Medicaid

StatusUnknown
PhaseNot applicable
Started
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Record status
This record was last updated October 2, 2024 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Enrolling by Invitation
  2. Primary completion date: Jun 30, 2024 to Jun 30, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v7
  3. Primary completion date: Nov 30, 2023 to Jun 30, 2024
    • Study completion date: May 30, 2024 to Dec 31, 2024
    v6
  4. Start date changed from estimate of Nov 1, 2022 to Sep 30, 2022v5
  5. Primary completion date: Oct 30, 2023 to Nov 30, 2023
    • Study completion date: Apr 30, 2024 to May 30, 2024
    • Start date: Oct 10, 2022 to Nov 1, 2022
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Enrolling by Invitationv3 Show 5 more changesShow less
    • Start date: Sep 1, 2022 to Oct 10, 2022
    • Primary endpoints revised (2)
    • Primary completion date: Jul 30, 2023 to Oct 30, 2023
    • Study completion date: Oct 30, 2023 to Apr 30, 2024
    • Site contact updated
  2. Start date: Jul 1, 2022 to Sep 1, 2022v2 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Primary completion date: Jun 30, 2023 to Jul 30, 2023
    • Study completion date: Sep 30, 2023 to Oct 30, 2023
    • Eligibility criteria shortened, about 18 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05415371
Lead Sponsor University of Oklahoma
Conditions
(from sponsor)		 Tobacco Cessation, Tobacco Use, Tobacco Smoking, Smoking Cessation Financial Incentives, Socioeconomic Status, Contingency Management, Pregnancy
Related terms Tobacco Smoking, Tobacco Use, Tobacco Use Cessation
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov