Remote Incentives for Smoking Cessation Among AN Pregnant Women

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05019170
• Other study ID #: 1558083
• Status: Terminated
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: November 2023
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years of age
• report being smokers at the time they learned of the current pregnancy
• report smoking in the 7 days prior to completing their preliminary eligibility screening
• < 25 weeks pregnant
• speak English
• own a smartphone (Android or iOS)
• self-report as an Alaska Native
• current smoker as verified by saliva cotinine test

Exclusion Criteria:

• current or prior mental or medical condition that may interfere with study participation
• smoke marijuana more than once each week and not willing to quit (marijuana smoking can inflate breath CO)
• exposed to unavoidable occupational sources of CO (e.g., car mechanic)
• report currently receiving opioid maintenance therapy (e.g., methadone, buprenorphine)

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Alaska Native Tribal Health Consortium	Anchorage	Alaska
United States	University of Vermont	Burlington	Vermont

Sponsors (3)

Lead Sponsor	Collaborator
University of Vermont	Alaska Native Tribal Health Consortium, Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kurti AN, Tang K, Bolivar HA, Evemy C, Medina N, Skelly J, Nighbor T, Higgins ST. Smartphone-based financial incentives to promote smoking cessation during pregnancy: A pilot study. Prev Med. 2020 Nov;140:106201. doi: 10.1016/j.ypmed.2020.106201. Epub 2020 Jul 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	28 weeks gestation through date of delivery
Secondary	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)	One month after participant's enrollment date
Secondary	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)	4 weeks following the date that participants deliver their infant
Secondary	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)	8 weeks following the date that participants deliver their infant
Secondary	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)	12 weeks following the date that participants deliver their infant
Secondary	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)	24 weeks following the date that participants deliver their infant
Secondary	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)	LDA will be measured from participant's date of enrollment in the study to 24-weeks postpartum