Remote Incentives for Smoking Cessation Among AN Pregnant Women

NCT ID: NCT05019170

Last Updated: 2023-12-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2023-08-31

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.

Conditions

Smoking; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Best Practices + Incentives group

Participants assigned to this condition will receive the best practices treatment plus the financial incentives intervention.

Group Type: EXPERIMENTAL

Smartphone-based Financial Incentives

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Best Practices

Participants assigned to this condition will receive the best practices treatment alone.

Group Type: ACTIVE_COMPARATOR

Best Practices

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Contingency Management

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Alaska Native Tribal Health Consortium

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Diann Gaalema

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diann Gaalema, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

Alaska Native Tribal Health Consortium

Anchorage, Alaska, United States

University of Vermont

Burlington, Vermont, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 32652133 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1558083

Identifier Type: -

Identifier Source: org_study_id