Pregnancy Clinical Trial
Official title:
Monetary Incentives to Promote Engagement With the Oklahoma Tobacco Helpline Among Pregnant Women With Medicaid
Verified date | January 2024 |
Source | University of Oklahoma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | TSET Health Promotion Research Center | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma |
United States,
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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