NCT05019170

Remote Incentives for Smoking Cessation Among AN Pregnant Women

Smartphone-based Financial Incentives to Promote Smoking Cessation Among Alaska Native Pregnant Women

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Vermont · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Cigarette smoking during pregnancy increases risk for catastrophic pregnancy complications, growth retardation, other adverse infant health problems, and later-in-life chronic conditions. One group that is particularly at risk for these complications are Alaska Native (AN) women. Prevalence of smoking during pregnancy is disproportionally high among AN women compared to US pregnant women overall (i.e., \~36% and \~13%, respectively) and few smoking-cessation interventions have been evaluated among this population. A substantive barrier to offering evidence-based interventions to AN women is the geographic remoteness of Alaska. The most effective intervention for promoting smoking cessation during pregnancy is financial incentives in which participants earn incentives (e.g., cash) contingent on objective evidence of smoking abstinence. This intervention has been adapted to be delivered entirely through a smartphone meaning that the geographic remoteness of Alaska will not be a barrier with this intervention. Participants submit videos of themselves completing breath and saliva tests, and incentives are then delivered through the application if the tests indicate smoking abstinence. Through a collaboration between the University of Vermont and the Alaska Native Tribal Health Consortium, the goal of this study is to examine the preliminary feasibility and efficacy of this smartphone-based incentives intervention among AN women. Pregnant AN women will be recruited through ads posted on social media. Eligible participants who complete the informed consent process will be randomized to either: Best Practices or Best Practices + Incentives. In the Best Practices condition, participants will receive three brief educational sessions and a referral to the Alaska state quitline. In the Best Practices + Incentives condition, participants will receive the same education sessions and quitline referral, plus financial incentives contingent on the smartphone-based testing of breath and saliva specimens indicating abstinence from recent smoking. Outcomes will include point prevalence smoking abstinence at assessments conducted in late pregnancy and 4-, 8-, 12-, and 24-weeks postpartum, continuous abstinence during antepartum and postpartum, and perceived barriers and facilitators of treatment engagement. Overall, this project has the potential to address disparities in access to efficacious, evidence-based smoking cessation treatments among AN pregnant women.

Conditions

• Smoking
• Smoking Cessation

Interventions

Type	Name	Description
BEHAVIORAL	Smartphone-based Financial Incentives	Financial Incentives - Beginning on the quit date and extending for one week, participants will be required to submit twice daily CO samples. All samples \< 6 ppm will be considered negative and those \> 6 ppm will be considered positive. Participants will earn incentives for breath tests indicating smoking abstinence, and incentive values will increase with each consecutive negative sample. Following the initial quit week, the schedule of monitoring will be reduced, and incentives will be contingent on submitting a negative saliva cotinine test.
BEHAVIORAL	Best Practices	Best Practices- The 2008 Clinical Practice Guidelines for smoking cessation recommends that pregnant smokers be provided with the 5As. Research staff will implement the 5As at assessments that take place during pregnancy.

Timeline

• Start date: 2021-12-15
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2021-08-24
• Last updated: 2023-12-01

Locations

2 sites across 1 country: United States