An interventional study of Smartphone-based Financial Incentives and Best Practices in Smoking and Smoking Cessation, sponsored by University of Vermont. Terminated at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-01.
Sponsored by University of Vermont · Not applicable, Interventional, and Treatment
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.
325 studies on the registry are indexed under Smoking; 141 are open to participants now.
This study's enrollment of 5 is below the median of 117 across 250 interventional studies indexed under Smoking.
Browse Smoking studies →University of Vermont is the lead sponsor of 221 studies on the registry; 27 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.
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Exclusion Criteria:
Participants assigned to this condition will receive the best practices treatment plus the financial incentives intervention.
Behavioral: Smartphone-based Financial Incentives · Behavioral: Best Practices
Participants assigned to this condition will receive the best practices treatment alone.
Behavioral: Best Practices
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.
Also known as: Contingency Management
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.
Late Pregnancy Quit Rate
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Time frame: 28 weeks gestation through date of delivery
Early Pregnancy Quit Rate
Point prevalence smoking abstinence (defined as a cotinine negative saliva test AND self-reported no smoking in the past seven days)
Time frame: One month after participant's enrollment date
4-Week Postpartum Quit Rate
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Time frame: 4 weeks following the date that participants deliver their infant
8-Week Postpartum Quit Rate
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Time frame: 8 weeks following the date that participants deliver their infant
12-Week Postpartum Quit Rate
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Time frame: 12 weeks following the date that participants deliver their infant
24-Week Postpartum Quit Rate
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Time frame: 24 weeks following the date that participants deliver their infant
Longest Duration of Abstinence (LDA)
Consecutive days of no smoking using biochemical verification (cotinine-negative saliva at the formal assessments) plus self-report (cigarettes per day from enrollment to 24 weeks postpartum reported during timeline follow-back conducted over the phone)
Time frame: LDA will be measured from participant's date of enrollment in the study to 24-weeks postpartum
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Plan to share: No
This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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