Persistent Poverty Counties Pregnant Women With Medicaid

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05415371
• Other study ID #: 14736
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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