Remote Incentives for Smoking Cessation Among AN Pregnant Women

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

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.

Study Overview

• Status: Terminated
• Conditions: Smoking; Smoking Cessation
• Intervention / Treatment: Behavioral: Smartphone-based Financial Incentives; Behavioral: Best Practices

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tyler G Erath, PhD; Phone Number: 336-688-7599; Email: tyler.erath@uvm.edu
• Study Contact Backup: Name: Diann Gaalema, PhD; Phone Number: 802-656-9874; Email: Diann.Gaalema@med.uvm.edu

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Native Tribal Health Consortium
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Best Practices + Incentives group; Participants assigned to this condition will receive the best practices treatment plus the financial incentives 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.; Other Names: Contingency Management; 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.
Active Comparator: Best Practices; Participants assigned to this condition will receive the best practices treatment alone.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Vermont
• Collaborators: Mayo Clinic; Alaska Native Tribal Health Consortium
• Investigators: Principal Investigator: Diann Gaalema, PhD, University of Vermont

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1558083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No