Clinical trial NCT05019170: Remote Incentives for Smoking Cessation Among AN Pregnant Women
Official title: Smartphone-based Financial Incentives to Promote Smoking Cessation Among Alaska Native Pregnant Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Smoking
Smoking Cessation
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Alaska Native Tribal Health Consortium
name: Mayo Clinic
First posted: 2021-08-24
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators are proposing a two-condition, parallel groups, randomized controlled pilot study of a smartphone-based financial incentives intervention for AN pregnant smokers. The experimental group will receive financial incentives (money loaded onto a debit card) contingent on the remote submission of breath carbon monoxide and saliva cotinine tests indicating smoking abstinence in addition to best practices for promoting smoking cessation (Best Practices + Incentives). The control group will receive best practices alone (Best Practices). The use of a best practices group reflects a real-world comparison condition in that all women will receive the treatment that practitioners in the community are instructed to provide (the 5As + quitline referral) thereby enhancing the ecological validity of the study. Additionally, the investigators will minimize between-subject variability in the participant's exposure to these practices by implementing these treatment components themselves.
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Late Pregnancy Quit Rate
timeFrame: 28 weeks gestation through date of delivery
Secondary outcomes:
measure: Early Pregnancy Quit Rate
timeFrame: One month after participant's enrollment date
measure: 4-Week Postpartum Quit Rate
timeFrame: 4 weeks following the date that participants deliver their infant
measure: 8-Week Postpartum Quit Rate
timeFrame: 8 weeks following the date that participants deliver their infant
measure: 12-Week Postpartum Quit Rate
timeFrame: 12 weeks following the date that participants deliver their infant
measure: 24-Week Postpartum Quit Rate
timeFrame: 24 weeks following the date that participants deliver their infant
measure: Longest Duration of Abstinence (LDA)
timeFrame: LDA will be measured from participant's date of enrollment in the study to 24-weeks postpartum
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Native Tribal Health Consortium
state: Alaska
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Diann Gaalema, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.