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OpenTrials
Enrolling by Invitation

NCT Number: NCT05415371

Persistent Poverty Counties Pregnant Women With Medicaid

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.

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Key information

Age range

18 year–105 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Biochemically verified abstinence 12 weeks post enrollment

    Time frame: 12 weeks post enrollment

    The outcome measure is biochemically verified over 7-day point prevalence at 12 weeks post-enrollment.

  2. Self-reported abstinence 12 weeks postpartum

    Time frame: 12 weeks postpartum

    The outcome measure is biochemically verified abstinence over 7-day point prevalence at 12 weeks post-partum

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2022
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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