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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05415371
Other study ID # 14736
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 30, 2022
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 105 Years
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
United States TSET Health Promotion Research Center Oklahoma City Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biochemically verified abstinence 12 weeks post enrollment The outcome measure is biochemically verified over 7-day point prevalence at 12 weeks post-enrollment. 12 weeks post enrollment
Primary Self-reported abstinence 12 weeks postpartum The outcome measure is biochemically verified abstinence over 7-day point prevalence at 12 weeks post-partum 12 weeks postpartum
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