Remote Incentives for Smoking Cessation Among AN Pregnant Women

Not Applicable

Terminated

• Conditions: Smoking Cessation; Smoking
• Interventions: Behavioral: Best Practices; Behavioral: Smartphone-based Financial Incentives

• Registration Number: NCT05019170
• Lead Sponsor: University of Vermont

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-09
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-24
• Study Start: 2021-12-15
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Best Practices	Best Practices	Participants assigned to this condition will receive the best practices treatment alone.
Best Practices + Incentives group	Smartphone-based Financial Incentives	Participants assigned to this condition will receive the best practices treatment plus the financial incentives intervention.
Best Practices + Incentives group	Best Practices	Participants assigned to this condition will receive the best practices treatment plus the financial incentives intervention.

Primary Outcome Measures

Name	Time	Method
Late Pregnancy Quit Rate	28 weeks gestation through date of delivery	Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)

Secondary Outcome Measures

Name	Time	Method
8-Week Postpartum Quit Rate	8 weeks following the date that participants deliver their infant	Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
24-Week Postpartum Quit Rate	24 weeks following the date that participants deliver their infant	Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Longest Duration of Abstinence (LDA)	LDA will be measured from participant's date of enrollment in the study to 24-weeks postpartum	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)
12-Week Postpartum Quit Rate	12 weeks following the date that participants deliver their infant	Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Early Pregnancy Quit Rate	One month after participant's enrollment date	Point prevalence smoking abstinence (defined as a cotinine negative saliva test AND self-reported no smoking in the past seven days)
4-Week Postpartum Quit Rate	4 weeks following the date that participants deliver their infant	Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)

Trial Locations

Locations (2)

University of Vermont; 🇺🇸 Burlington, Vermont, United States

Alaska Native Tribal Health Consortium; 🇺🇸 Anchorage, Alaska, United States